New GMO Studies Demonstrate ‘Substantial Non-Equivalence’

Re: New GMO Studies Demonstrate ‘Substantial Non-Equivalence

Postby admin » Fri Jan 22, 2016 7:27 am

The Principle of Substantial equivalence is Unscientific and Arbitrary
by Institute of Science in Society

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Below is an excerpt from our published paper: Ho, M.W. and Steinbrecher, R. (1998). Fatal flaws in food safety assessment: critique of the joint FAO/WHO biotechnology and food safety report, Environmental & Nutritional Interactions 2, 51-84. We are reproducing the Section on the principle of substantial equivalence to show how ridiculous it is.

The Principle of Substantial equivalence is Unscientific and Arbitrary

The most serious shortcomings of the report are in the principle of "substantial equivalence" on which all safety assessment is based.

The Principle is Intentionally Vague and Ill-Defined to Be as Flexible, Malleable, and Open to Interpretation as Possible

"Substantial equivalence embodies the concept that if a new food or food component is found to be substantially equivalent to an existing food or food component, it can be treated in the same manner with respect to safety (i.e., the food or food component can be concluded to be as safe as the conventional food or food component)" (Joint FAO/WHO Biotechnology and Food Safety Report, 1996, p. 4)

This principle is unscientific and arbitrary, encapsulating a dangerously permissive attitude toward producers, and at the same time it offers less than minimalist protection for consumers and biodiversity, because it is designed to be as flexible, malleable, and open to interpretation as possible.

"Establishment of substantial equivalence is not a safety assessment in itself, but a dynamic, analytical exercise in the assessment of the safety of a new food relative to an existing food. The comparison may be a simple task or be very lengthy depending upon the amount available knowledge and the nature of the food or food component under consideration. The reference characteristics for substantial equivalence comparisons need to be flexible and will change over time in accordance with the changing needs of processors and consumers and with experience." (Joint FAO/VMO Biotechnology and Food Safety Report, 1996, pp. 4 and 5)

In other words, one can choose to compare whatever is the most convenient at a particular time, and for a particular purpose. And if on one set of criteria the product is not substantially equivalent, a different set of criteria could be used, always to the advantage of the producers.

Comparisons Are Designed to Conceal Significant Changes Resulting From Genetic Modifications

In practice, this principle allows comparison of the transgenic line to any variety within the species, and even to an abstract entity made up of the composite of selected characteristics from all varieties. That is exemplified in the safety evaluation reported by the company Calgene on several of their products (Redenbaugh et al., 1995). By a judicious use of additional varieties, any changes from the control recipient variety could be bracketed. In theory, a genetically engineered line could have the worst features of every variety and still be substantially equivalent. Such comparisons rather than comparing the transgenic line to the parental nontransgenic line would rarely, if at all, pick up significant changes resulting from the genetic modification per se, which should alert conscientious researchers to a more careful characterisation of the genetically modified organism-

Bernard Shaw was reputed to have been propositioned by a beautiful though not too bright lady who wanted to have his child so it would have his brains and her looks, 'but Shaw was said to have discouraged her by pointing out that the child could end up having her brains and his looks instead. So, it is the particular combination of characteristics that makes all the difference. But under the present safety assessment regime, both combinations would be deemed "substantially equivalent." The danger is that particular combinations of nutrients or metabolises might fall within the "equivalent" range determined in this fashion, and yet be antinutritional, toxic or cumulative lethal.

And if that were not enough, producers are assured that, even when products are not substantially equivalent, they can be shown to be substantially equivalent except for defined differences, and "further safety assessment should focus only on those defined differences" (Joint FAO/W'HO Biotechnology and Food Safety Report, 15)96, p. 8). Lest one is in any doubt, it is stated an page 11 of the report that "UP to the present time, and probably for the near future, there have been few, if any, examples of foods or food components produced using genetic modification which could be considered to be not substantially equivalent to existing foods or food components." Calgene's genetically engineered Laurate canola oil should, by no stretch of the imagination, be considered substantially equivalent to ordinary canola oil. But, "other fatty acids components are Generally Recognised as Safe (GRAS) when evaluated individually because they are present at similar levels in other commonly consumed oils." Similarly, "substitution of Laurate canola for coconut and palm kernal oils does not raise any safety concerns for intended uses, in part because the major components, the fatty acids laurate and myristate, are identical" (Rodenbaugh et al., 1996)

In other words, it is already a foregone conclusion that most, if not all, the products now and for the foreseeable future will be assessed as "substantially equivalent," and if not, then considered GRAS by a judicious choice of a comparator.

It is significant that the Dutch courts have recently ruled Monsanto's genetically engineered soy beans not equivalent in quality to natural soy beans, as was claimed in the advertisement of Albert Heijn, the biggest supermarket chain in the Netherlands. Albert Heijn is itself part of the Dutch multinational Ahold, which owns super-market chains in many countries around the world. The complaint was filed by the Dutch Natural Law Party (Storms, 1997).

The Principle Is Weak and Misleading Even When It Does Not Apply, Effectively Giving Producers Carte Blanche

Given that "substantial equivalence" can be interpreted in the widest possible sense--and if not, then by a judicious choice of comparator the product can be considered as GRAS-it is difficult to imagine which remaining products cannot pass muster.

The report recognised that "products could be developed which could be considered to have no conventional counterpart and for which substantial equivalence could not be applied" (Joint FAO/WHO Biotechnology and Food Safety Report, 1996, p. 11). For example, one phrase used is "products derived from organisms in which there has been transfer of genomic regions which have perhaps been only partly characterised" (p. 11) This gives the impression that such are hypothetical cases that might arise in future.

But that is not so. The report has failed to point out that at least one such transgenic organism already exists: Tracy, a sheep engineered with a large segment of a human genome--most of which contains unknown sequence with unknown functions--to produce huge quantities of alpha-antitrypsin in her milk (Colman, l996). Tracy and her clones may be walking incubators for cross-species viruses to arise by recombination between human and sheep viral sequences. All genomes contain endogenous proviral sequences, and recombination between endogenous and erogenous viral sequences are already implicated in several kinds of animal cancers (.5ce Ho, 1997a). One might think that the report would treat such cases with extra caution. Not so.

We are assured that even if a food or food component is considered to be not substantially equivalent, producers need not despair, for "it does not necessarily mean it is unsafe and not all such products will necessarily require extensive testing" (Joint FAO/WHO Biotechnology and Food Safety Report, 1996, p. 12). The report seems to prepare the grounds for slipping those products through a regulatory framework that is already worse than toothless.

Further on, in Section 6.6 on "Food organisms expressing pharmaceuticals or industrial chemicals" (Joint FAO/WHO Biotechnology and Food Safety Report, 1996, p. 19), there is the telling statement, "The Consultation recognised that, generally, the genetically modified organism would not he used as food without prior removal of the pharmaceutical or industrial chemical" (p. 19). That is a prelude to serving up the rest of Tracy and the "elite herd' cloned from her, or, more likely, superannuated "pharm" animals and any failed transgenic experiment, whatever, as meat for our dinner tables. Transgenic technology is very inefficient and generates a lot of transgenic wastes--the large numbers of failed experiments. Such "foods" from transgenic wastes may be sources of exotic, cross-species foodborne viruses, as mentioned earlier. Furthermore, they will be exempt from safety assessment if the report is to be taken seriously. A similar category of transgenic waste could be the leftover carcasses of pigs engineered for xenotransplantation. All the signs are that the producers are handed carte blanche to do as they please for maximum profitability, with the regulatory body acting to allay legitimate public fears and opposition.

Insufficiency of Background Information for Assessing Substantial Equivalence

The procedure for establishing substantial equivalence, described in less than three pages in the 27-page report (pp. 6, 7, and 8), comes under two headings: 'background information an the characterisation of the modified organism, and actual determination of substantial equivalence, or characterisation of the food product itself.

One glaring omission in the background information is the propensity of the transgenic organism for gene-rating pathogenic viruses by recombination (and whether experiments have been carried out to investigate this propensity). This information is highly relevant for assessing impacts an biodiversity as well as food safety, in view of our current knowledge that superinfecting viruses may be generated from many transgenic plants at much higher frequencies than previously thought and that insecticidal recombinant viruses may attack human liver cells. There is also disturbing new evidence that viral DNA can survive digestion in the gastrointestinal tract of mice, with large fragments getting into the blood stream and into many kinds of cells (Schubbert et al., 1994, 1997).

Likewise, information on the stability of transgenes, and potential for mobility of introduced genes, which are mentioned on page 6 of the report, ought to 'be based on data collected over a number of generations, documenting the stability of the insert as well as expression of the transgenes and the transgenic line in successive generations, so that both consumers and farmers can have confidence in quality control. In a paper presented at a World Health Organisation (WHO) workshop, Conner stated, "The main difficulty associated with the biosafety assessment of transgenic crops is the unpredictable nature of transformation. This unpredictability raises the concern that transgenic plants will behave in an inconsistent manner when grown commercially" (Conner, 1995) In general, the inheritance of genetically engineered traits is non-Mendelian in subsequent generations (Schuh et al., 1993) necessitating clonal propagation.

Earlier this year, 60,000 bags of genetically engineered canola seeds, enough for planting 600,000 acres, had to be recalled after they were sold in western Canada, because unexpectedly a gene, not yet approved for market, turned up in the seeds. The seeds were bred and sold by Limagrain, under licence from Monsanto (reported in Manitoba co-operator, 24/4/97, and in The Ram's Horn, No. 147, April 1997). If the transgenic plants had been monitored for genetic stability of both the transgenes and the transgenic line in successive generations, as they should have been, and careful records kept, those seeds would never have reached the market. This incident also indicates the necessity for product segregation, clear labelling, and postmarket monitoring as part of the condition for market approval.

Under background information, it is also crucial to include the upstream and downstream effects of transgenic promoter and enhancer sequences, as well as any possible regulatory elements contained in the coding sequences. Furthermore, the need identification and recently the presence of genetic elements in the host that might compromise the stability of the transgenes. A further serious omission in the background information is the lack of an explicit requirement to disclose the presence of marker genes, especially antibiotic marker genes, which are considered in a later section.

There Is No Specification of Tests for Establishing Substantial Equivalence

We are told in the report that "characterisation of the food product" entails "molecular characterisation," "phenotypic characterisation," and "compositional analysis." While the latter two categories are elaborated subsequently, "molecular characterisation" has mysteriously disappeared. Nowhere is it specified which methods of molecular characterisation are required, nor what molecular information should be established. Though this would be crucial for identifying unintended effects. A previous document that reports on a WHO Workshop on the principle of substantial equivalence, Applications of the Principle of Substantial Equivalence to the Safety Evaluation of Foods or Food Components From Plants Derived by Modern Biotechnology (WHO/FNU/FOS/95.1, p. 7), leaves molecular characterisation very vague. It refers to "the inserted DNA," and to "the level and mechanism of expression of the protein," which is considered to 'be "more important than knowing the gene copy number." It appears the inserted DNA sequence need not be well characterised at all. The report then mentions "the level and function of the introduced gene product in the plant may be useful in judging substantial equivalence," again implying that the function of the gene product need not be known as a condition for safety approval. If the gene(s) and gene product(s) transferred are well understood, however, the safety evaluation can then "focus on the safety of the expression product and/or changes "brought about by the expression product." This is an open endorsement of a totally inadequate, reductionist safety assessment that ignores effects on the system as a whole, especially in the longer term.

In effect, a thorough molecular characterisation of the product is not required. Not even the level of expression of the introduced transgene(s) or marker gene(s) needs to be ascertained, much less the effects of promoters and enhancers on neighbouring genes, as judged by the samples of papers presented in the WHO workshop on substantial equivalence (see Health Aspects of Marker Genes in Genetically Modified Plants, Report of a WHO Workshop, WHO/FNU/FOS.93.6, 1993). If one happens to know what has been transferred, then safety assessment can focus only on the gene product and its effects. So the two main categories of characterisation of the food product are simply the phenotypic characteristics -- agronomic, morphological, and physiological -- and the compositional comparison -- key nutrients and toxicants that are known to be inherently present in the species.

There Is No Requirement to Test for Unintended Effects; Current Tests Are Undiscerning and May Even Serve to Conceal Unintended Effects

Although the report recognises the possibility of "indirect consequences" (p. 4) and that "assessment of the safety of genetically modified organisms must address both intentional and unintentional effects that may result as a consequence of the genetic modification of the food source" (p. 5), these are limited to phenotypic changes that are readily apparent, and alterations in the concentrations of major nutrients or increases in the level of natural (known) toxicants. There is thus no specific requirement to test for unintended effects per se.

Similarly, while it is stated that "attention must be paid to the impact of growth conditions on level of nutrients and toxicants" and "attention must be paid to the impact of different soils and climatic conditions" (p. 5), these are not elaborated further, and certainly are not required for safety assessment recommended in the report.

The range of tests that are actually carried out, as exemplified by WHO's Workshop Report on applying the principle of substantial equivalence, are not sufficiently discerning to pick out unintended effects. Unless there are gross morphological or phenotypic changes, there is no need to look for them. And even when there are gross abnormalities, the product can still be assessed to be "substantially equivalent." One paper presented in the WHO workshop reported, "Field trials on the transgenic lines used in these studies showed marked deformities in shoot morphology and poor tuber yield involving a low number of small, malformed tubers during field trials.... These changes were attributed to somaclonal variation during the tissue culture phase of transformations. Despite these marked morphological abnormalities, virtually no changes in tuber quality attributes were detected" (Conner, 1995). So much for the discerning power of the tests carried out.

There were no metabolic profiles done by routine analytical techniques such as high-pressure liquid chromatography (HPLC), or two-dimensional gel electrophoresis to scan for unintended expression of genes. The compositional analyses reported are limited to uninformative amino acid profiles, or to known components present at levels greater than 0.1%, or 0.01% at best. And, as mentioned earlier, the arbitrariness of the comparison will already hide any changes due to the transferred gene(s) per se, which should alert researchers to unintended effects. Instead, the tests are aimed specifically at intended effects only, and, if anything, at concealing secondary, unintended effects as much as possible.

The hazard of unintended effects is already well attested to by the U.S. epidemic of eosinophilia-myalgia syndrome in the U.S. in 1990, resulting in more than 1500 affected and 37 deaths, which is linked to the consumption of L-tryptophan produced by a genetically modified strain of Bacillus amyloliquefaciens (Mayeno & Glich, 1994). Several trace contaminants identified by HPLC have been implicated in pathogenesis of this syndrome.


A metabolite, mothylglyoxal, was found to accumulate at toxic, mutagenic levels in yeasts engineered with multiple copies of one of several yeast glycolytic enzymes to increase the rate of fermentation (Inose & Murata, 1995). Recently, tobacco plants genetically engineered to produce the gamma-linoleic acid also unexpectedly produced actodecatetraenoic acid, a substance previously unknown in natural tobacco plants (Reddy & Thomas, 1996). In the absence of a metabolic profile on the product, unintended toxic metabolites might have easily escaped notice in safety assessment.

It is equally important to check for unintended gene products being produced, which will not be revealed by routine amino acid analyses of total lysates, as is done by Calgene for canola meal (Redenbaugh et al., 1995). A minimum requirement should be a two-dimensional gel electrephoretogram of the total proteins. Even then, minor modifications in a proportion of the proteins may not be detectable, which may change the properties of the proteins involved. For example, a proportion of the recombinant porcine and bovine somatotropins synthesised in Escherichia coli were found to contain the abnormal amino acid e-N-acetyllysine in place of the normal lysine only when reversed-phase HPLC analyses were carried out (Voland et al., 1994).

Key questions on the allergenic potential of transgenic foods are raised by the recent identification of a brazil-nut allergen in soybean genetically engineered with a brazil-nut gene (Nordlee et al., 1996). It is possible to test for known allergens, as in the case of the brazil-nut soybean, but not for allergenicity to proteins completely new to the foods involved, as acknowledged in the report (Joint FAO/WHO Biotechnology and Food Safety Report, 1996, p. 14). It is significant that allergenicity in plants is thought to be linked to proteins involved in defence against pests and diseases (Franck & Keller, 1995). Therefore, transgenic plants engineered for resistance to diseases and pests may have a higher allergenic potential than the unmodified plants. Furthermore, it has been shown that common food allergens are invariably proteins that have been glycosylated. The whole area of glycosylation and, in fact any post-translational modification of GE proteins, needs urgent attention with regard to allergenicity. One major novel protein is the insecticide produced by the gene from Bacillus thuringiensis (Bt), now incorporated into a range of transgenic crop plants that had never contained them before. Nevertheless, the producers were able to claim substantial equivalence by pointing to its "comparability" (not identity!) "to one of the proteins contained in the commercial microbial formulations that have been used commercially since 1988" (Fuchs et al., 1995). In fact, the genetically engineered Bt toxin is a truncated, immediately active form of the protein produced by the bacteria itself and is thus entirely new to our diet. One important characteristic of an allergen is that it resists digestion in the stomach (gastric digestion). According to a recent publication (Astwood et al., 1996), known allergens were stable for 60 min, whereas nonallergens were fully digested within 15 s. While one study claimed the Bt protein was readily digestible (Fuchs et al., 1995), another report showed that it failed to be completely digested under gastric conditions after 2 h (Noteborn & Kuiper, 1995). In both cases, we are assured that the protein is safe. In view of the recent discoveries that predators eating pests that have ingested the Bt toxin in transgenic crop plants are also harmed (Bigler & Keller, 1997; Hawkes, 1997), it is irresponsible to assume that the toxin is safe for human, especially [in the] long term.

We accept that no safety assessment system is foolproof. A case in point is the rigorous testing that goes on with pharmacological products. It is estimated that despite such rigorous testing, 3% of the products approved for market turned out to have such harmful effects that they have to be withdrawn, while an additional 10% have sufficiently harmful side effects that limited use has to be recommended (Suurkula, 1997). This underlines the importance of segregation, clear labelling, and postmarket monitoring of the health and other impacts of genetic engineered foods. Labeling is a matter of traceability, especially for the case of potential allergenicity, and should be a scientific requirement, not only a consumer option.
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Re: New GMO Studies Demonstrate ‘Substantial Non-Equivalence

Postby admin » Fri Jan 22, 2016 7:54 am

Ban GMOs Now: Especially in the Light of the New Genetics
By Dr Mae-Wan Ho and Dr Eva Sirinathsinghji

NOTICE: THIS WORK MAY BE PROTECTED BY COPYRIGHT

YOU ARE REQUIRED TO READ THE COPYRIGHT NOTICE AT THIS LINK BEFORE YOU READ THE FOLLOWING WORK, THAT IS AVAILABLE SOLELY FOR PRIVATE STUDY, SCHOLARSHIP OR RESEARCH PURSUANT TO 17 U.S.C. SECTION 107 AND 108. IN THE EVENT THAT THE LIBRARY DETERMINES THAT UNLAWFUL COPYING OF THIS WORK HAS OCCURRED, THE LIBRARY HAS THE RIGHT TO BLOCK THE I.P. ADDRESS AT WHICH THE UNLAWFUL COPYING APPEARED TO HAVE OCCURRED. THANK YOU FOR RESPECTING THE RIGHTS OF COPYRIGHT OWNERS.


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Preface

The GM battle intensifies


The industry-funded International Service for the Acquisition of Agri-biotech Applications (ISAAA) claims that the global area of genetically modified (GM) crops reached 170.3 m hectares (420 m acres) in 2012; a 100-fold increase since commercialization began in 1996; and the fastest adopted crop technology in the history of modern agriculture [1].

However, GM crops are still confined to 28 countries, with nearly 90 % planted in just five. USA's 69.5 m ha tops the list at 40.8 % of the total area; Brazil and Argentina with 36.6 and 23.9 m ha account for 21.5 % and 14.0 % respectively; and Canada and India with 11.6 and 10.8 m ha account for 6.8 % and 6.3 % respectively. Herbicide (glyphosate) tolerant crops comprise nearly 60 %, Bt crops 15% and stacked traits 25 %. The major crops are just three: herbicide tolerant soybean (47 %) maize (Bt 4%, stacked traits 23 %) and cotton (Bt 11 %, stacked traits 2%).

GM remains limited to two traits in three major crops that are largely kept out of most of the world.

One main reason is its inability to deliver really useful traits. As Geoffrey Lean of the Telegraph remarked in reviewing a new book by Prof Sir Gordon Conway, formerly President of the Rockefeller Foundation and Chief Scientific Adviser to the Department for International Development, and a known GM supporter [2}: "But what emerges from his book, One Billion Hungry" is how little “so far, at least“ GM technology is contributing to beating hunger. In contrast, conventional breeding assisted by genetic markers has been turning out miracles in the meantime, as described in Conway's book. Scientists at Britain's National Institute of Agricultural Botany (NIAB) have just created new wheat hybrids that could increase yields by 30 %. But it is in Africa that major successes have been tumbling out. Nerica rice varieties up to four times as productive as traditional varieties with much shorter growing season, more protein, resist pests and diseases, thrive on poor soils, and withstand drought; also 30 varieties of drought-tolerant maize are boosting yield 20 to 30 % across 13 countries, climbing beans treble production in Central Africa, wheat varieties thriving on salty soils, plus a host of other wonders: blight-resistant potatoes, crops enriched with vitamin A, iron and other essential nutrients.

The other reason is that resistance to GM crops and GMOs (genetically modified organisms including transgenic trees, fish and livestock) has been growing simultaneously worldwide as the failures and hazards are coming to light behind the corporate propaganda.

GM crops are hardly grown in Europe even though the European Commission has given commercial approval for cultivation, showing every sign of caving in to the GM lobby. But at the end of May 2013, Monsanto, the largest producer of GM seeds, announced it is pulling out from Europe. Monsanto's Europe representative Brandon Mitchener told the press the company would no longer engage in any lobbying in Europe and would not apply for approval of any GM plants [3]. German Agriculture Ministry issued a revealing statement: "The promises of GM industry have not come true for European agriculture, nor have they for the agriculture in developing and emerging economies." Monsanto is the last company to depart Germany, if not Europe, following Bayer CropScience, BASF and Syngenta. On 17 July 2013, Monsanto announced it will withdraw all EU approval requests for new GMO crops [4], to concentrate on growing its conventional seeds business in Europe, and to secure EU approvals to import its GM crop varieties widely grown in the US and South America. So, the company has not given up on pushing GMOs on Europe after all. It was setting up a smokescreen to put us off our guard.

Monsanto has been in the news simultaneously for its unapproved glyphosate tolerant GM wheat that has turned up in a farmer's field in Oregon; and Japan and then South Korea suspended their wheat imports for fear of GM contamination, leading to a 4% drop in Monsanto's shares [5]. The shipments were eventually cancelled, which could cost US farmers billions [6].

In fact 8 European Union countries have imposed outright bans on crops approved: Austria, France, Germany, Hungary, Luxembourg, Greece, Bulgaria and Poland [7]. Switzerland has had a moratorium on GM crops since 2008, which was set to end in 2013. But in March 2013, the Swiss Parliament voted to prolong the moratorium ignoring the findings of their National Research Programme 59, which [8] "confirmed the safety of the commercial use of GM crops and recommended an end to the moratorium." Denmark gave up on GM crops after having allowed Monsanto to carry out field trials of GM maize since 2009 [9]. Italy is the latest to ban cultivation of GM maize (MON 810) citing environmental concerns [10]. In addition, regions and local administrations at every level in 37 European countries have declared themselves GMO-free. As of 2010, this comprises 169 main regions (prefectures, etc.); 123 intermediate regions (provinces, districts, etc.), 4,713 local governments (municipalities and communities up to areas of 1 m ha), and 31,357 individuals [11]; and the movement is growing rapidly.

Within the heartland of GMOs the USA, the failures of GM crops and the problems created are most visible and most acute [12] (GM Crops Facing Meltdown in the USA, SiS 46). A new study reveals that the US staple crop system has performed worse than non-GM Europe in yields, pesticide use, genetic diversity and resilience since GM crops were planted [13] (US Staple Crop System Failing from GM and Monoculture, SiS 59); with a dangerous downward trend in recent years. Meanwhile, a pitched battle is taking place to get GM crops out through GMO-labelling legislation that would unleash the power of consumers against the might of the biotech industry [14]. Close to 95 % of Americans support GM labelling. In October 2011, the Center for Food Safety filed a legal petition with the FDA to require labelling of all GM food. In 2012, 55 members of Congress wrote a letter to the FDA commissioner in support of the petition. The FDA has received over one million public comments supporting the petition, the largest response ever received by the agency. Meanwhile, 37 GM food labelling bills have been introduced in 21 states in 2013. In the latest move in Washington, Senator Barbara Boxer and Congressman Peter DeFazio have jointly sponsored new federal legislation that requires labelling of all GM food in the US. The Genetically Engineered Food Right-to-Know Act is the first national labelling bill to be introduced in Congress since 2010. The US Green Party has called Monsanto "a top risk to public health and the environment," and has urged a moratorium on GM food crops [15].

In November 2012, Peru imposed a 10 year ban on GMOs in the country, thanks to the effort of farmers from Parque de la Papa in Cusco, a community of 6,000 anxious to protect indigenous biodiversity especially of corn and potatoes on which their livelihood depends [16].

In the same month, Kenya banned import of all GMOs with immediate effect [13]. This followed a decision made by the cabinet on the basis of "inadequate research done on GMOs and scientific evidence provided to prove the safety of the foods".

On 1 June 2013, the new administration in Venezuela announced a new law to protect farmers against GM seeds [18]

On 22 July 2013, the Indian Supreme Court's expert panel of scientists called for a ban on herbicide tolerant crops for India [19].

A critical juncture

The rising opposition to GMOs has done little to diminish the aggressive expansionist agenda of the GM corporate empire. Mexico is a major target. US biotech firms Monsanto, DuPont and Dow have applied for permits to grow more than two million hectares of GM maize in northern Mexico [20]. Mexico is the birthplace of maize and a centre of biodiversity. Since 2009, the Mexican government has granted 177 permits for experimental plots of GM maize covering 2,664 hectares. Large-scale commercial release of GM maize has not yet been authorised; but GM contamination of native maize has already been discovered, as the result of what some regard as "a carefully and perversely planned strategy".

The other major strategy of the GM corporate empire is seed monopoly and escalating seed costs. Conventional non-GM seeds are pushed out at the expense of GM seeds, thereby reducing farmers' choices [21]. The big four biotech seed companies, Monsanto DuPont/ Pioneer Hi-Bred, Syngenta, and Dow AgroSciences, now own 80 % of the US corn market and 70 % of soybean business. The costs of seeds have increased two to three fold since 1995. This is destroying the lives of farmers around the world; the most visible in India, where the introduction of GM cotton has coincided with an escalation of farm suicides ([22] Farmer Suicides and Bt Cotton Nightmare Unfolding in India, SiS 45). At the same time, farmers who want to return to conventional non-GM seed after experiencing increased pest resistance and crop failures find themselves unable to do so, on account of the limited availability of non-GM seeds [23].

Ban GMOs Now

This is a dangerous situation for the future of food and farming, one that needs to be reversed as quickly as possible, particularly as GM agriculture is failing on all counts. That can only be achieved by a ban on GMOs, an action already taken by countries and local communities around the world. We need to join forces with them, to put an end to the GM corporate empire.

Ten years ago, 24 scientists from around the world formed an Independent Science Panel and produced a report [24] (The Case for A GM-Free Sustainable World, ISIS/TWN publication) summarizing compelling evidence on the hazards of GM crops and the benefits of organic agro-ecological farming, and called for a global ban on environmental releases of GMOs, and a shift to non-GM sustainable agriculture. This report was widely circulated, translated into several languages, and republished in the US a year later. It remains the most succinct and complete account on the subject; but crucial new evidence has come to light within the past decade that strengthens the case considerably.

First of all, decisive evidence has emerged on the unsustainability and destructiveness of conventional industrial agriculture, of which GM is the most extreme; in stark contrast to the proven successes of non-GM ecological farming: its productivity and resilience, environmental and health benefits, and in particular, its enormous potential for saving energy and carbon emissions in mitigating and adapting to climate change. We presented all that in a comprehensive and definitive report published in 2008 ([25] Food Futures Now *Organic *Sustainable *Fossil Fuel Free , ISIS/TWN publication). Â Our report is completely in line with the International Assessment of Agricultural Knowledge, Science and Technology for Development (IAASTD) report [26], which resulted from a three-year consultative process involving 900 participants and 110 countries around the world; a sure sign of the scientific consensus that has emerged around non-GM ecological farming as the way forward in food and farming.

To complete the case, we need to bring together all the damning evidence against GMOs on health and the environment, especially in the light of new discoveries in molecular genetics within the past ten years. That is the main reason for the present report.

GM agriculture is a recipe for disaster, as this report will make clear. It is also standing in the way of the shift to sustainable agriculture already taking place in local communities all over the world that can truly enable people to feed themselves in times of climate change. Future generations will not forgive us if we do not stop the GM takeover now.

Please use this report, circulate it widely, and send it to your political representatives.

Executive Summary

Since the first commercial growing began in 1996, the global area of genetically modified (GM) crops is reported to have increased 100-fold. However, nearly 90 % are confined to 5 countries, with top grower the US accounting for more than 40 %. GM crops have been largely excluded from Europe and most developing countries because opposition has been growing simultaneously as widespread agronomical failures of the GM crops as well the health and environmental impacts are coming to light.

GM remains limited to three major crops -- soybean, maize and cotton -- and two traits: herbicide (mainly glyphosate) tolerance (HT) at nearly 60 % and insect resistance with toxins from the soil bacterium Bacillus thuringiensis (Bt) at 15 %, with the remaining stacked traits (HT and one or more Bt) at 25%.

The failures and hazards of glyphosate and glyphosate tolerant crops and Bt crops are reviewed respectively in Chapter 1 and Chapter 2. Chapter 3 reviews the range of hazards resulting from the uncontrollable, unpredictable process of genetic modification itself in the light of advances in molecular genetics within the past decade, which tells us why the technology cannot be safety applied to grow our crops or produce our food.

Glyphosate & glyphosate tolerant crops

Glyphosate use has gone up sharply worldwide since the introduction of glyphosate-tolerant GM crops. Herbicide use per acre has doubled in the US within the past five years compared with the first five years of commercial GM crops cultivation, the increase almost entirely due to glyphosate herbicides. Glyphosate has contaminated land, water, air, and our food supply. Damning evidence of its serious harm to health and the environment has been piling up, but the maximum permitted levels are set to rise by 100-150 times in the European Union with further hikes of already unacceptably high levels in the US if Monsanto gets its way.

1. Scientific evidence accumulated over three decades documents miscarriages, birth defects, carcinogenesis, endocrine disruption, DNA damage, general toxicity to cells, neurotoxicity, and toxicity to liver and kidney at glyphosate levels well below recommended agricultural use.

2. The major adjuvant POEA in glyphosate Roundup formulations is by far the most cytotoxic for human cells, ahead of glyphosate and its metabolite. It also amplifies the toxic effects of glyphosate.

3. A recent review blames glyphosate for practically all modern diseases as its general chelating action affects numerous biological functions that require metal cofactors. It is the most pervasive environmental chemical pollutant that also inhibits enzymes involved in detoxification of xenobiotics, thereby increasing their toxicity. In addition, it kills beneficial gut bacteria that prevent pathogens from colonizing the gut and promotes the growth of the pathogenic bacteria, leading to autism and other diseases.

4. Rats fed Roundup contaminated and Roundup tolerant maize beyond the required 90 days showed a startling range of health impacts. Females were 2 to 3 times as likely to die as controls and much more likely to develop mammary tumours. In males, liver congestions and necrosis were 2.5 to 5.5 times as frequent as controls, while kidney diseases were 1.3 to 2.3 times controls. Males also develop kidney or skin tumours 4 times as often as the controls and up to 600 days earlier. The harmful effects were found in animals fed the GM maize that was not sprayed with Roundup, as well as those that were, indicating that the GM maize has its own toxicities apart from the herbicide.

5. Livestock illnesses from glyphosate tolerant GM feed including reproductive problems, diarrhoea, bloating, spontaneous abortions, reduced live births, inflamed digestive systems and nutrient deficiencies. Evidence has also emerged of chronic botulism in cattle and farmers as the result of glyphosate use.

6. Glyphosate is lethal to frogs and Roundup is worse; it increases toxic blooms, and accelerates the deterioration of water quality. It use also coincides with the demise of monarch butterflies.

7. Glyphosate poisons crops and soils by killing beneficial microorganisms and encouraging pathogens to flourish. Forty crop diseases are now linked to glyphosate use and the number is increasing.

8. Glyphosate-resistant weeds cover 120 million ha globally (61.8 m acres in the US) and continue to spread; it is a major factor accounting for the enormous increase in pesticide use since herbicide tolerant GM crops were introduced.

9. Contamination of ground water supplies, rain, and air has been documented in Spain and the US. Berlin city residents were found to have glyphosate concentrations above permitted EU drinking water levels.

Bt crops

Bt crops were sold on the premise that they would increase yields and reduce pesticide use; instead they have resulted in too many crop failures, and the introduction of Bt cotton is now acknowledged to be responsible for the escalation in farm suicides in India.

1. Bt crops claim to reduce pesticide use is based on excluding the Bt produced in the crops in total "pesticides applied"; but the Bt toxins leach from the plants and persist in soil and water, with negative impacts on health and the ecosystem comparable to conventional pesticides.

The Bt toxins manufactured within the cells of Bt crops are not counted as insecticides “applied” on Bt-crop acres.

Clearly, this assumption underestimates the pounds of insecticidal compounds required to manage insects on Bt crop acres. Opinions differ among entomologists, the industry, and other experts on whether it is appropriate to count Bt toxins manufactured inside GE plants as equivalent to a liquid Bt insecticide sprayed on the outside of the plant. Uncertainty over the exact mode of action of Bt insecticides and GE toxins is part of the reason for differing opinions.

Those who argue that plant-manufactured Bt toxins should not count as equivalent to an applied insecticide assert that a Bt variety is just like any other new plant variety that has been bred to express some plant protein or phytochemical useful in combating insect-feeding damage.

Those skeptical of this position point to major differences in the two Bt delivery systems and in the source of the Bt toxin. Bt liquid sprays are applied only when and as needed, consistent with the core principles of IPM. Liquid sprays expose pest populations to short-lived selection pressure, thereby reducing the risk of resistance.

Bt plants, however, produce the toxin continuously during the growing season, not just when needed, and in nearly all plant tissues, not just where the toxins are needed to control attacking insects. In a year with low pest pressure, farmers can decide not to spray insecticides on a corn field, but they cannot stop Bt hybrids from manufacturing Bt toxins in nearly all plant cells.29

-- Impacts of Genetically Engineered Crops on Pesticide Use In the United States: The First Thirteen Years, by Charles Benbrook


2. Fungicide use and insecticide treatment of corn and soybean have gone up dramatically since the introduction of Bt crops.

3. The breakdown of Bt traits due to target pest resistance and secondary pests has resulted in increasing use of conventional pesticides; and pesticide companies are reporting 5 to 50% increase in sales for 2012 and the first quarter of 2013.

4. Contrary to industry's claim that Bt is harmless to non-target species, independent studies showed that Bt toxins elicit immune response in mammals in some cases comparable to that due to cholera toxin. This is consistent with farm workers' reports of allergic symptoms affecting the eyes, skin and respiratory tract.

5. A new study found Bt proteins toxic to developing red blood cells as well as bone marrow cells in mice.

6. Toxicity to human kidney cells has been observed in vitro, consistent with in vivo experiments in lab animals showing toxicity to heart, kidney and liver.

7. Bt crops fail to control target pests due to insufficient expression of Bt toxins, thereby promoting the evolution of resistance.

8. Bt crops promote the emergence of secondary pests when target pests are killed. Primary and secondary pests are already huge problems in the US, India and China, and are now hitting multiple crops in Brazil since Bt maize was introduced.

9. Stacked varieties containing multiple Bt toxins are predicted to hasten the evolution of multiple toxin resistance, as resistance to one toxin appears to accelerate the acquisition of resistance to further toxins.

10. Bt toxins harm non-target species including water fleas, lacewings, monarch butterflies, peacock butterflies and bees, which are showing worrying signs of population decline across the world.

11. Bt toxins leach into the soil via the root of Bt crops where they can persist for 180 days; this has been linked to the emergence of new plant diseases and reduced crop yields.

12. Bt toxins also persist in aquatic environments, contaminating streams and water columns and harming important aquatic organisms such as the caddisfly.


New genetics & hazards of genetic modification

The rationale and impetus for genetic engineering and genetic modification was the "central dogma" of molecular biology that assumed DNA carries all the instructions for making an organism. This is contrary to the reality of the fluid and responsive genome that already has come to light since the early 1980s. Instead of linear causal chains leading from DNA to RNA to protein and downstream biological functions, complex feed-forward and feed-back cycles interconnect organism and environment at all levels, marking and changing RNA and DNA down the generations. In order to survive, the organism needs to engage in natural genetic modification in real time, an exquisitely precise molecular dance of life with RNA and DNA responding to and participating fully in "downstream" biological functions. That is why organisms and ecosystems are particularly vulnerable to the crude, artificial genetically modified RNA and DNA created by human genetic engineers. It is also why genetic modification can probably never be safe.

1. Genetic modification done by human genetic engineers is anything but precise; it is uncontrollable and unpredictable, introducing many collateral damage to the host genome as well as new transcripts, proteins and metabolites that could be harmful.

2. GM feed with very different transgenes have been shown to be harmful to a wide range of species, by farmers in the field and independent scientists working in the lab, indicating that genetic modification itself is unsafe.

3. Genetic modification done by human genetic engineers is different from natural genetic modification done by organisms themselves for the following reasons: it relies on making unnatural GM constructs designed to cross species barriers and jump into genomes; it combines and transfers genes between species that would never have exchanged genes in nature; GM constructs tend to be unstable and hence more prone to further horizontal gene transfer after it has integrated into the genome.

4. Horizontal gene transfer and recombination is a major route for creating new viruses and bacteria that cause diseases and spreading drug and antibiotic resistance. Transgenic DNA is especially dangerous because the GM constructs are already combinations of sequences from diverse bacteria and viruses that cause diseases, and contain antibiotic resistance marker genes.

5. There is experimental evidence that transgenes are much more likely to spread and to transfer horizontally.

6. The instability of the GM construct is reflected in the instability of transgenic varieties due to both transgene silencing and the loss of transgenes, for which abundant evidence exists. Transgenic instability makes a mockery of "event-specific" characterization and risk assessment, because any change in transgene expression, or worse, rearrangement or movement of the transgenic DNA insert(s) would create another transgenic plant different from the one that was characterized and risk assessed. And it matters little how thoroughly the original characterization and risk assessment may have been done. Unstable transgenic lines are illegal, they should not be growing commercially, and they are not eligible for patent protection.

7. There is abundant evidence for horizontal transfer of transgenic DNA from plant to bacteria in the lab and it is well known that transgenic DNA can persist in debris and residue in the soil long after the crops have been cultivated. At least 87 species (2 % of all known species) of bacteria can take up foreign DNA and integrate it into their genome; the frequency of that happening being greatly increased when a short homologous anchor sequence is present.

8. The frequency at which transgenic DNA transfers horizontal has been routinely underestimated because the overwhelming majority of natural bacteria cannot be cultured. Using direct detection methods without the need to culture, substantial gene transfers were observed on the surface of intact leaves as well as on rotting damaged leaves.

9. In the only monitoring experiment carried out with appropriate molecular probes so far, China has detected the spread of a GM antibiotic resistance gene to bacteria in all of its major rivers; suggesting that horizontal gene transfer has contributed to the recent rise in antibiotic resistance in animals and humans in the country.

10. GM DNA has been found to survive digestion in the gut of mice, the rumen of sheep and duodenum of cattle and to enter the blood stream.

11. In the only feeding trial carried out on humans, the complete 2,266 bp of the epsps transgene in Roundup Ready soybean flour was recovered from the colostomy bag in 6 out of 7 ileostomy subjects. In 3 out of 7 subjects, bacteria cultured from the contents of the colostomy bag were positive for the GM soya transgene, showing that horizontal transfer of the transgene had occurred; but no bacteria were positive for any natural soybean genes.

12. The gastrointestinal tract of mammals is a hotspot for horizontal gene transfer between bacteria, transfer beginning in the mouth.

13. Evidence is emerging that genomes of higher plants and animals may be even softer targets for horizontal gene transfer than genomes of bacteria.

14. The CaMV 35S promoter, most widely used in commercial GM crops, is known to have a fragmentation hotspot, which makes it prone to horizontal gene transfer; in addition. it is promiscuously active in bacteria, fungi, as well as human cells. Recent evidence also suggests that the promoter may enhance multiplication of disease-associated viruses including HIV and cytomegalovirus through the induction of proteins required for transcription of the viruses. It also overlaps with a viral gene that interferes with gene silencing, an essential function in plants and animals that protects them against viruses.

15. The Agrobacterium vector, most widely used for creating GM plants is now known to transfer genes also to fungi and human cells, and to share genetic signals for gene transfer with common bacteria in the environment. In addition, the Agrobacterium bacteria as well as its gene transfer vector tend to remain in the GM crops created, thereby constituting a ready route for horizontal gene transfer to all organisms interacting with the GM crops, or come into contact with the soil on which GM crops are growing or have been grown.

16. In 2008, Agrobacterium was linked to the outbreak of Morgellons disease. The Centers for Disease Control in the US launched an investigation, which concluded in 2012, with the finding: "no common underlying medical condition or infection source was identified". But they had failed to investigate the involvement of Agrobacterium.

17. New GM crops that produce double-stranded RNA (dsRNA) for specific gene-silencing are hazardous because many off-target effects in the RNA interference process are now known, and cannot be controlled. Furthermore, small dsRNA in food plants were found to survive digestion in the human gut and to enter the bloodstream where they are transported to different tissues and cells to silence genes.

18. Evidence accumulated over the past 50 years have revealed nucleic acids (both DNA and RNA) circulating in the bloodstream of humans and other animals that are actively secreted by cells for intercommunication. The nucleic acids are taken up by target cells to silence genes in the case of double-stranded microRNA (miRNA), and may be integrated into the cells' genome, in the case of DNA. The profile of the circulating nucleic acids change according to states of health and disease. Cancer cells use the system to spread cancer around the body. This nucleic acid intercom leaves the body very vulnerable to genetically modified nucleic acids that can take over the system to do considerable harm.


Conclusion

The serious harm to health and the ecological and agronomical impacts of glyphosate and glyphosate tolerant crops are the most thoroughly researched, and for which there is little remaining doubt. The same kind of evidence has now emerged for Bt crops and Bt toxins. Evidence that genetic modification per se is harmful is also convincing, and can be attributed to the uncontrollable process of genetic modification itself as well as the dangers from the horizontal transfer of the GM constructs, which can spread antibiotic resistance, create new pathogens and trigger˜insertion carcinogenesis", as well as taking over the body's natural nucleic acid intercom to do harm.

There is a compelling case for banning all environmental releases of GMOs now, and with that the glyphosate herbicides. Action can be taken locally in communities, villages, towns, municipalities, regions, as well as nationally and globally. It must be done now; for time is running out. We need to shift comprehensively to non-GM sustainable ecological farming in order to feed ourselves under climate change. We the people need to reclaim our food and seed sovereignty from the corporate empire before they destroy our food and farming irreversibly.

Contents

Preface
Executive Summary
1 Double Jeopardy of Glyphosate & Glyphosate Tolerant Crops
1 Introduction
2 Regulators and industry both culpable
3 How glyphosate works
4 Health impacts
4.1 Teratogenicity and reproductive effects
4.2 Endocrine disruption
4.3 Carcinogenicity
4.4 Genotoxicity
4.5 Cytotoxicity of glyphosate & adjuvant
4.6 Neurotoxicity
4.7 Internal organ toxicity
4.8 Acute toxicity
4.9 Glyphosate & modern diseases
5 Environmental and agronomic effects
5.1 Glyphosate resistant weeds
5.2 Effects on crop and plant health
5.3 Effects on soil ecology
5.4 Effects on ecosystems
5.5 Diseases of livestock
5.6 pr
6 To conclude
2 Crops Failing & Harmful to Health and Environment
1. Crop failures, farm suicides, & false accounting
2. Risks to human health
3. Breakdown of pest control
3.1 Bt toxin levels insufficient to kill pests
3.2 Secondary pest and disease infestations
3.3 Bt resistance in target pests
4. Environmental and ecological damage
5. To conclude
3 New Genetics & Hazards of GMOs
1. What's a GMO?
2. The fluid genome and natural genetic engineering
3. GM inherently hazardous
4. What are the hazards of GMOs
5. Transgene instability & the illegality of GMOs
6. Horizontal gene transfer from GMOs does happen
7. Hazards of the CaMV 35S promoter
8. Hazards of Agrobacterium vector
8.1 Agrobacterium & Morgellons disease
9. RNA interference and double stranded RNA
10. The nucleic acid intercom
11. To conclude
4 References
Authors' biographies
About ISIS
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