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[genet-news] RISK ASSESSMENT & APPROVAL: SmartStax GE corn seeds sow doubts

                                  PART 1

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SOURCE: The Globe and Mail, Canada

AUTHOR: Martin Mittelstaedt


DATE:   04.08.2009

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Consumer groups worry Health Canada ?abdicated its responsibility? to test seeds? safety

Next spring, farmers in Canada will be able to sow one of the most complicated genetically engineered plants ever designed, a futuristic type of corn containing eight foreign genes.

With so much crammed into one seed, the modified corn will be able to confer multiple benefits, such as resistance to corn borers and rootworms, two caterpillar-like pests that infest the valuable grain crop, as well as withstanding applications of glyphosate, a weed killer better known by its commercial name, Roundup.

But a controversy has arisen over the new seeds, which were approved for use last month by the Canadian Food Inspection Agency: Health Canada hasn?t assessed their safety.

The health agency said in response to questions from The Globe and Mail that it didn?t have to do so, because it is relying on the two companies making the seeds, agriculture giants Monsanto Co. and Dow AgroSciences LLC, to flag any safety concerns. But the companies haven?t tested the seeds either, because they say they aren?t required to.

The companies have checked the safety of each of the eight genes one at a time in individual corn plants, but haven?t done so when they combined the foreign matter together in one seed, says Trish Jordan, a spokesperson for Monsanto Canada Inc.

?Every single one of the traits has been tested singly, and it has gone through the complete rigorous regulatory review process,? Ms. Jordan said.

When the eight traits were subsequently combined into one seed through conventional breeding techniques, there was no trigger for an additional safety assessment, she said.

But the companies?, and Health Canada?s, position is disputed by opponents of genetically modified foods and consumer safety advocates, who say guidelines from the UN?s food standards commission, Codex Alimentarius, recommend such testing, even when the novel traits are introduced through normal plant breeding.

Michael Hansen, senior scientist at Consumers Union, a U.S. advocacy group, says he?s worried that combining a large number of foreign genes could lead to the creation of allergens or other deleterious substances in food that don?t occur when only one gene is involved.

The government?s decision to leave the safety testing to the companies is like ?putting the fox in charge of the hen house,? Mr. Hansen said.

Health Canada ?has entirely abdicated its responsibility? for food safety, echoed Lucy Sharratt, co-ordinator of the Canadian Biotechnology Action Network, an Ottawa-based group that is critical of genetic engineering.

In its statement to The Globe, Health Canada said it approved the new corn because it didn?t find anything untoward in testing conducted from 2002 to 2008 that looked at the safety of the genes two at a time.

?According to Health Canada?s policy, when a company chooses to breed or cross approved genetically modified plants with other approved GM or non-GM plants, the company must inform Health Canada only if there is a change in the safety of the product,? the federal agency said. ?If there was a change, the company would have to provide the necessary information to Health Canada.?

The issue of the safety of the new corn has wide-ranging importance because multiple foreign genes in seeds is the wave of the future in biotechnology. When genetic modification of plants began, breeders would introduce only one gene taken from a foreign source, such as a bacterium, at a time. Corn seeds now on the market have up to three foreign genes.

Ms. Jordan said the eight-gene corn, which the companies call SmartStax because numerous traits are stacked together, will be the basic platform for all Monsanto?s future versions of the crop.

She said researchers are looking to add even more genes to it, including those for drought resistance, yield increases and more efficient use of nitrogen, an important plant nutrient.

The new corn isn?t the sweet type eaten on the cob but is typically used for animal feed. Monsanto expects about 200,000 acres to be planted next year in Canada, mainly in Ontario, and that the crop will have enhanced yields.

Under the UN Codex guidelines, producers of genetically engineered plants, even when the producers subsequently use conventional breeding on their seeds, should provide information ?to reduce the possibility that a food derived from a recombinant-DNA plant would have an unexpected, adverse effect on human health.?

Health Canada says the view that further testing needs to be done on such seeds is ?erroneous? because the Codex guideline doesn?t explicitly mention the stacking of genetic traits as a trigger for such a review.

Mr. Hansen believes Health Canada?s interpretation leaves the country open to possible trade disputes because other jurisdictions, such as Europe, could challenge the Canadian corn by citing a failure to follow the Codex guidelines.

                                  PART 2

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AUTHOR: Chris Hayes


DATE:   04.08.2009

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GMWatch: Stacking up the risks - What?s stacked in SmartStax?

There are 8 transgenes stacked in the new Monsanto/Dow SmartStax seeds. 6 of the transgenes generate different forms of the insect-killing toxin Bt - these are the Cry genes:

Attacking insects above-ground:

Cry1A.105 - Monsanto / Cry2Ab2 - Monsanto / Cry1F ? Dow

Attacking insects below-ground (corn rootworms)

Cry3Bb1 ? Monsanto / Cry34Ab1 ? Dow / Cry35Ab1 ? Dow

There are two further transgenes. These confer resistance to specific weedkillers. Tolerance to herbicides:

Glyphosate - Roundup Ready ? Monsanto / Glufosinate ? LibertyLink ? Dow (under licence from Bayer)



NOTE: The following information about EU regulatory responses has been compiled with the help of Chris Hayes.

Note in particular the damning comments in the appraisal of the Austrian Federal Department for Health, who completely reject the lax regulatory approach being promoted.

EXTRACT: ?Insecticidal Cry proteins produced by GM plants as well as transproteins conferring tolerance to herbicides constitute a sum of new plant constituents possibly interacting within the organism. So far, there is absolutely no scientific knowledge about such new combinations and possibly resulting additive and/or synergistic effects.?


SmartStax in Europe

A major scandal is emerging over the lax treatment of SmartStax by regulators, with approvals being rushed through in Canada, the US and Japan, and there are good indications that many regulators in Europe will try to treat what?s been described as one of the most complicated genetically engineered plants ever created in the same way. The concerns are obviously heightened by the EU food safety authority (EFSA)?s reputation for liking GMOs so much they don?t bother to treat them scientifically.

SmartStax is listed by the Canadian Food Inspection Agency (CFIA) as ?the combined trait corn product containing events MON 89034, TC 1507, MON 88017 and DAS-59122-7?. These events have links at

In the EU there?s an application for a GM maize (corn) variety: MON89034 x 1507 x MON88017 x 59122.

GMO-Compass is a pro-GM industry-linked site set up with EU monies which claims to provide a GMO Database that ?Contains information on every GM plant that has been approved or is awaiting authorisation in the EU.? It lists an application for ?Import and processing; Food and Feed? for this maize at:

More technical details of the application, including composition of the gene-constructs (like the fact that some contain CAMV-35 elements) can be found here:

There?s also evidence that approval for cultivation will be sought, with applications for field trials in the EU, such as:

*B/SK/09/02 Slovakia19/02/2009 Slovak Agricultural Research CentreNotification according to Directive 2001/18/EC, Part B, for the deliberate release of MON 89034 × 1507 × MON 88017 × 59122 for the use in field trials in Slovakia.

Slovakian, Romanian and Spanish field trial notifications:

*B/ES/09/02 Spain18/02/2009 Monsanto Europe, S.A.Notification according to Directive 2001/18/EC, Part B, for the deliberate release of MON 89034 × 1507 × MON 88017 × 59122 for the use in field trials in Spain.

*B/RO/09/05 Romania25/03/2009Monsanto CompanyNotification according to Directive 2001/18/EC, Part B, for the deliberate release of MON 89034 × 1507 × MON 88017 × 59122 for the use in field trials in Romania.


?MON 89034 × 1507 × MON 88017 × 59122 was field tested in multiple sites in maize producing states of the U.S. corn belt and southern corn growing regions to assess performance, efficacy, hybrid evaluation, seed production, yield and to collect regulatory data and materials. It was also tested in three locations in Chile to assess performance, efficacy, yield, breeding, and for hybrid evaluation.

The results of the releases in these countries showed no evidence that MON 89034 × 1507 × MON 88017 × 59122 is likely to cause any adverse effects to human or animal health and the environment. Except for its protection against certain lepidopteran and coleopteran insect pests and its tolerance to glyphosate and glufosinate herbicides, MON 89034 × 1507 × MON 88017 × 59122 could not be distinguished from conventional maize.?

Safety precautions: visual inspection.


National advisory documents for the respective EU governments ======================================================================

Within the EU, the Netherlands and Austria provide contrasting regulatory responses.

The consistently pro-GM Dutch advisory institute COGEM, advises: ?no problem?, arguing effectively that: ?We already know the traits. We already said OK, so why do you even ask? Maize seeds do not survive in our winter, so there is no problem.?

This view is echoed by the UK?s equally pro-GM ACRE (Advisory Committee on Releases to the Environment). According to meeting minutes from last December: ?Members... considered a new application to import and process a GM maize (and use as food / feed), EFSA/GMO/CZ/2008/62. This is a quadruple stack, which includes 3 events with which ACRE is familiar - 1507, MON88017 and 59122 maize. Information on the remaining event (MON89034) has been considered by ACRE as there is an application to import/process a GM maize containing this single event in the system already. ACRE concluded it did not require further information as this application did not raise any concerns.?

As thorough as the Dutch!

By contrast, the Austrian Federal Department for Health does not buy into this ?We already know all these traits so everything?s hunky dory? line. They state:

?A stacked organism has to be regarded as a new event, even if no new modifications have been introduced. The gene cassette combination is new and only minor conclusions could be drawn from the assessment of the parental lines, since unexpected effects (e.g. synergistic effects of the newly introduced proteins) cannot automatically be excluded. Furthermore, it should not be neglected that two of the parental lines, GM maize MON89034 and GM maize MON88017, have not yet gained authorisation within the European Union.?

Statement overview at

The abridged version (confidential parts not included, but listed) in English at:

The Austrian Federal Department for Health also notes:

?In the technical dossier, the notifier says that the safety of all transproteins, Cry1A.105, Cry2Ab2, Cry1F, Cry3Bb1, Cry34Ab1, Cry35Ab1, PAT and CP4 EPSPS, expressed in the test material GM maize MON89034x1507xMON88017x59122 have been discussed in detail in other applications for authorisation. This concerns, amongst other things, history of safe use, structural description and digestion in simulated gastric fluid. In contrast to this, we would like to point out that:

*there is no history of safe use of the new recombinant protein expressed by an artificially arranged insert such as Cry1A.105.

*concerning all Bt toxins, a history of safe use cannot be argued on the basis of the safety of Bt sprays applied in organic farming. The inserted genes are truncated and arranged with expression modulating DNA parts originating from different

organisms and permanently expressed compared to a tight timely Bt spraying schedule (Lewis et al. 1997; Sexton et al. 2007).

*all eight transproteins used in acute toxicity tests (Cry1A.105, Cry2Ab2, Cry1F, Cry3Bb1, Cry34Ab1, Cry35Ab1, pat CP4 EPSPS) originated from microbial expression systems. Establishing structural and functional equivalence of this test proteins and the plant derived proteins adds uncertainties to the interpretation of the animal tests (Spök et al. 2008), thus, only limited information about the plant expressed transproteins can be obtained.

Additionally, a 90 day rat feeding study with GM maize 59122 (Malley 2004) showed alterations of total protein and albumin levels, and we are still of the opinion that this study should be repeated, as recommended and remarked by Austria in the scientific comment on triple stack GM maize 59122x1507xNK603 transferred to EFSA in September 2007.

Furthermore, according to EFSA, a potential for increased toxicity and/or allergenicity to humans and animals or for modified nutritional value due to the stacked events may arise from additive, synergistic or antagonistic effects of the gene products or by these produced metabolites (EFSA 2007). But the safety of all newly expressed proteins in animal models applied simultaneously and combined was not assessed in the dossier.

Insecticidal Cry proteins produced by GM plants as well as transproteins conferring tolerance to herbicides constitute a sum of new plant constituents possibly interacting within the organism. So far, there is absolutely no scientific knowledge about such new combinations and possibly resulting additive and/or synergistic effects. Therefore, at least one subchronic feeding study (90 days) with rodents with the whole GM maize plant (MON89034x1507xMON88017x59122) should be carried out.?

                                  PART 3

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SOURCE: Country Guide, Canada



DATE:   01.08.2009

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A new eight-trait herbicide-tolerant, insect-resistant corn developed by Monsanto and Dow AgroSciences and approved for planting next year in the U.S. and Eastern Canada will be allowed for export to Japan.

Monsanto and Dow said in a release Friday that Japan has granted full regulatory approval for imports of the companies? new SmartStax corn.

Canadian and U.S. regulators approved the new corn July 20 for production. ?With these approvals, SmartStax can be produced and planted in the U.S. and Canada and grain can be imported to Australia, New Zealand and Japan,? the companies said Friday.

?As the world?s leading corn-importing country, Japanese approval is a significant milestone to ensure full market access to food and feed derived from SmartStax,? Jerry Hjelle, Monsanto?s vice-president of regulatory affairs, said Friday.

Monsanto and Dow ?are working closely to obtain the few remaining import approvals ahead of the 2010 launch,? Hjelle added in a release.

Monsanto and Dow plan to launch SmartStax on three million to four million acres or more in 2010, the companies said. Monsanto will bring the corn product to market as Genuity SmartStax, while Dow said it would offer SmartStax through its seed brands such as Mycogen, Dairyland, Renze, Brodbeck and Triumph.

The corn includes traits for insect control both above- and below-ground as well as Monsanto?s Roundup Ready and Dow?s Liberty Link genetics for herbicide tolerance.


Japan?s decision comes as green groups in Canada protest the new corn?s approval by the Canadian Food Inspection Agency, as well as CFIA?s approval for smaller required areas of refuge crops to be planted around fields of SmartStax.

The same groups, including Greenpeace Canada and the Council of Canadians, among others under the umbrella of the Canadian Biotechnology Action Network, also called Wednesday on the federal government to ?immediately withdraw? authorization for SmartStax until Health Canada undertakes ?exhaustive and independent tests.?

The groups claimed Wednesday that Health Canada hasn?t assessed the human health safety of SmartStax, as per the United Nations? Codex Alimentarius guidelines for food safety in multi-trait crops.

?Health Canada did not conduct or require any testing for this new eight-trait GE corn and did not even officially authorize it for release into the food system,? network co-ordinator Lucy Sharratt said in a release.

?Health Canada has entirely abdicated its responsibility and just shrugged off the potential health risks of eating eight GE traits in one corn flake.?

Codex Alimentarius? guidelines, developed by the UN?s Food and Agriculture Organization (PAO) and the World Health Organization (WHO) recommend that safety assessment of a modified microorganism should be performed ?on a case-by-case basis depending on the nature and extent of the introduced changes.?

Conventional toxicology studies, Codex says, ?may not be considered necessary where the substance or a closely related substance has, taking into account its function and exposure, been consumed safely in food.?

In other cases, Codex?s guidelines suggest, the use of ?appropriate conventional toxicology or other studies? on a new substance may be needed. Effects of a new recombinant-DNA microorganism on the ?food matrix? should be considered as well, Codex recommends.

                                  PART 4

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SOURCE: Daily Yonder, USA

AUTHOR: Richard Oswald


DATE:   03.08.2009

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Have higher yields been due to genetic modification? Monsanto would have us think so, and now wants to patent more seed with ?stacked traits.?

In 1876, Alexander Graham Bell was given U.S. Patent No. 174,465 for his version of the telephone. Bell took an existing technology and improved it to allow actual voice transmission through undulatory electric current instead of the intermittent electric pulses used by telegraphers as ?dots and dashes.? The patent itself calls Bell?s invention ?improvement to telegraphy.?

Even though Bell?s invention used some key components of older technology, it was revolutionary in that he discovered a way to vary electrical current actually to reproduce the sounds of human speech over great distances. The validity of Bell?s original patent has been challenged (some say an inventor named Elisha Gray beat him to it) but the value of telecommunications to rural America ? and the rest of the world -- is undisputed.

More recently the gene gun, invented and patented by John C. Sanford, has introduced ?improvements? to rural America, changing food production, crops, and access to basic farm inputs like seeds.

Sanford?s invention involved a Crossman air gun used to ?shoot? plant cells with alien gene implants. In the case of corn and soybeans, his gene implants were mostly bacterial. The idea that a gene from an animal could exist inside a plant and bestow certain traits of the animal to the plant seemed other-worldly. But the gene gun has become a regular tool of plant breeders who?ve used it to give plants immunity to chemical herbicides or lethal defenses against certain insects.

Gene implantation is more chance than science. It?s a big casino. Because there is no accurate way to control implants, it takes a number of attempts to generate a single success. Newly implanted cells are grown in Petri dishes, and resistance to antibiotics or other chemicals is the gauge of that success. Any cells that survive treatment with those chemicals are replicated to see exactly what the creation will become and if it has value.

The main difference between Bell?s telephone and Sanford?s gene gun isn?t originality; both used existing technology to create new totally different applications. But while Bell?s telephone never generated other new patentable creations, Sanford?s invention has created plants for large seed companies, companies that have now convinced courts that their ?hit or miss creations? should be protected by patent laws.

The greatest beneficiary of patented genes has been chemical company Monsanto with over $4.5 billion profits in 2007. In its 2008 report to shareholders, Monsanto predicted those profits would double in five years, to more than $9.5 billion by 2012. Most of this profit will be achieved by randomly placing borrowed, naturally-occurring genes into commonly grown grains, oilseeds, and cotton, but Monsanto has also been acquiring the rights to garden seeds.

Prior to the gene gun?s invention, the seed business was highly competitive, though not as profitable as it is now (at least for some). Monsanto and the few other corporations involved with gene implantation say that random gene shots are time consuming and expensive. Patent protection is what enables them to recover costs, but if they can end up with $10 billion after paying Hugh Grant and all the other Monsanto employees, their dealers, and their lawyers, then it must be a pretty good business to be in. When you factor in that since 1995, Monsanto has purchased about 50 seed companies, the reason for those escalating profits is plain to see.

They?ve been eliminating the competition.

Arguably the largest competitor Monsanto faces is Pioneer Hi-Bred. Once a stand-alone, farmer-owned seed house, PHB allowed itself to be purchased by chemical company E. I. Dupont de Nemours.

Challenged by Monsanto for survival in the marketplace, PHB merged with Dupont mainly to assure access to funds and legal resources needed for new product development, and to be able to withstand the Monsanto onslaught. In its quest for supremacy, Monsanto bought out such U.S. agricultural seed mainstays as DeKalb, and Delta and Pine Land Company. The list of Monsanto?s other acquisitions is very long.

The newest patent application has been for ?stacked traits.? That?s where companies put all their eggs in one basket by selling seeds, mostly corn seed, with nearly every trait developed to date. Stacked traits offer resistance to corn borers, corn earworms, corn rootworms, and various sundry other nibbling insects responsible for corn farmer headaches. By asking the courts to give exclusive domain over stacked traits, Monsanto is saying that two or more patented traits combined into one constitutes a totally new creation.

So Monsanto is trying to stack the deck against PHB and its other few remaining competitors with Smart Stax hybrids, a combination of previously patented Monsanto and Dow genes. (They?ve entered into an exclusive agreement with Dow.) In a lawsuit filed against Pioneer, Monsanto lawyers assert that earlier licensing agreements do not permit mixing Monsanto patented genes with those owned by other companies like PHB, effectively denying the same type of stacked product marketing to the competition.

Smart Stax promises to help Monsanto do more than just kill bugs and the competition. Big M is also petitioning the EPA to lessen insect refuge requirements that require farmers to co-mingle GMO fields with conventional plants, lessening the likelihood of insect resistance. Current requirements are that farmers must plant a refuge (non- GMO crop to prevent insect resistance) equal to 20% of their total acreage. Under Monsanto?s plan, refuges would be cut to 5%. Presumably, Monsanto?s sales of GMO seeds would rise accordingly by at least 15%.

That alone is a pretty clever marketing strategy.

Perhaps even more popular with farmers than insect resistance was the ability to treat corn fields with Roundup herbicide, because it provided a nearly foolproof and inexpensive way to eliminate tough weeds. While the effectiveness of refuges in preventing insect resistance is unproven, weed resistance to glyphosate, the active ingredient in Roundup, is being reported in a wide variety of fields. Those fields are not just in the United States but in South America as well. In addition to applying more chemical herbicides to counter glyphosate resistance there is a growing dependence on foliar applied fungicides, and seed-applied insecticides and fungicides.

The argument that biotechnology has resulted in fewer farm chemical applications simply is not true. Now, with Smart Stax, the modified gene content of our seeds is expected to increase also.

Enhanced yield is the motivation behind using pesticides, and a good part of the yield Monsanto takes credit for is really just better management by producers.

The real reason for corn yield improvement over the last 80 years hasn?t been genetic modification, better disease control, or management, but instead good old fashioned plant breeding.

Over the last 90 years corn yields increased nearly five-fold, with most increases coming before genetic modification came to the fore. In fact yield records from key corn producing counties in Iowa show a high degree of variability in corn yield, with state average yields increasing by about 20 bushels per acre (or 13% ) in the 10 years from 1999 to 2008. Most of the increase could be attributed to improved genetics, higher plant populations, and improved fertility, none of which were the results of genetic implantation. In addition to that are the aforementioned foliar fungicides and seed applied insecticides known to enhance yield. Most of those, like Poncho, an insecticide seed coating developed by Bayer Crop Sciences, were first used just a few years back on both GMO and non-GMO seed. Today, nearly every corn seed is treated with these types of seed coatings.

So what is plant patenting and Smart Stax really about?

Well, it?s about control? control of seed markets, control of hybrid ownership, control of farms, and power in the marketplace. As premier corn breeders in the nation, seed companies like PHB were constantly on the lookout for seed varieties pirated from their own stock. In the days prior to patented GMOs, conventional seed varieties were copyrighted. It was easy then just as it is now to pirate copyrighted materials, even seeds. And when a copyright thief was discovered the penalties were too lenient to discourage further attempts. For a seed company like Monsanto who had few qualms about taking customers to court, the quick solution was a patent, because patents are more easily and stringently enforced than copyrights.

Monsanto, a relative newcomer to the seed business, has effectively used seed patents as weapons against anyone, big or small, who resists paying them whatever royalty they demand. That weapon has been used against other seed companies just as it has been deployed against farmers. While Monsanto points to yield improvement as justification for aggressive tactics, the data suggests that corn yield would have increased through conventional plant breeding with or without added genes that are mostly just pesticides.

Seed patents have forced seed company consolidation giving those on top the lion?s share of profits and an unprecedented control to drive profits ever higher.

Keep in mind that corn and soybean production are already controlled in many ways by the Federal government. Producers report their plantings to the government and are dependent on the government for price support and insurance against crop failures. It has been a normal practice for the government of this country to make acreage allotments to feed grain producers. Now farmers like me find themselves between a rock, Monsanto, and a hard place, the government.

Sometimes there?s just no place to hide.

Among seed companies, Monsanto is unique in its willingness to bring suit not only against competitors but against its own customers as well. That is a fair measure of the power granted to Monsanto by courts that have affirmed their right to patent seeds.

Neither a gene gun nor a telephone can reproduce itself. For Alexander Graham Bell to profit he needed manufacturing to build and market his device. But seeds are living factories that reproduce themselves.

It is worth noting that the gene gun inventor Sanford, an atheist when he created the gene gun, now believes in intelligent design. He testified at hearings in Kansas that we were all created by God.

Now, not only does Monsanto have patent rights to intelligent design, it has been given exclusive control of the manufacture of life.

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