Monsanto Quietly Readies Gene-Modified Wheat

Carey Gillam, Reuters,
July 22, 2003

(Friday, July 25, 2003 -- CropChoice news) -- DURBIN, North Dakota, July 22 (Reuters) - From the dusty country road, the secluded wheat field in this rural hamlet appears to be like any other, with slender stalks and ripening heads rustling in the breeze.

But the grain growing here belongs to Monsanto Co. MON.N and is key to the company's plan to bring the world its first genetically modified wheat.

It is also highly controversial. Monsanto's work in this field in southeast North Dakota, and in dozens of other fields around the U.S., comes at a time of global turmoil over whether genetically modified crops should be grown and consumed.

While soybeans and a few other crops have been genetically modified for years, wheat would be the first true food grain to go from test tube to harvest.

And as Monsanto pushes the debate to a new level of urgency by perfecting the biotech wheat, it keeps the precise locations of its wheat fields a closely guarded secret. The company last week began allowing limited visitors to the fields, but still fears a backlash from biotech opponents.

"If that information gets into the wrong hands, it isn't positive," said Monsanto wheat industry affairs leader Michael Doane.

The company's work is in the final stages now. It has already mastered the transfer of DNA from a laboratory-grown bacterium into wheat DNA, so farmers can spray weed killer across entire fields without harming their crop.

Monsanto's current focus is convincing regulators that biotech wheat is safe to grow and eat, while persuading farmers to plant it, and food companies to use it in the bread, cereals, crackers and other products.

Monsanto executives see a future filled with genetic modifications to crops. Scientists have it in their power to alter such things as protein levels, starch levels and carbohydrate counts. And crops that are more tolerant of drought and disease are also being designed.

"All of those things could be within our reach in the next decade or so," said Doane. "We now stand at a very interesting threshold. The potential is just enormous."

Obstacles to Overcome

But while Monsanto champions biotech crops, many farmers worry that foreign countries will shun the U.S. wheat supply if some of it is scientifically altered. Experts say the loss in export business could be staggering.

Also, critics say biotech foods could hold unknown dangers for people and the environment, and they worry that turning crops into patented technologies could translate to eventual corporate control of the world's food supply.

The Bush administration's current effort to sway the European Union to accept biotech foods has thrust the issue onto the world trade front, and angered biotech opponents.

"I think biotechnology represents the worst aspects of science, not the best," said Friends of the Earth spokesman Larry Bohlen. "It is a science driven by profit rather than ethical concerns. The companies are promoting their own interests, not those of the hungry."

Protests have been mounted in North America as well as in Europe. Critics hope the uproar will derail Monsanto regulatory applications in the United States and Canada. Indeed, earlier this month, Monsanto hit a snag when the U.S. Department of Agriculture said it wanted more data to consider.

Undeterred, Monsanto executives plan meetings with farmers and U.S. millers and bakers as well as consumer marketers such as McDonald's Corp. to win them over to the new wheat.

"We recognize there are people with concerns about the wheat," said Doane, adding that it will be "a few years" before the wheat is released. "But we think a number of products that are in the pipeline will share more benefits."

Tests and Tours

Recognizing there are those who do not want biotech wheat, Monsanto is designing a "zoned" approach for grain handling to keep conventional and bioengineered strains separate. The company is also developing a test to detect mixing of biotech wheat with non-biotech grain.

And, Monsanto is allowing food industry leaders and media to access some of its biotech wheat test plots to show how little they have to fear from what the company says is only a slight modification of the workings of a wheat plant.

During a recent tour, flags marked off the boundaries of two acres of the biotech wheat, which was nearly indistinguishable from conventional wheat.

The field, one of 35 Monsanto biotech wheat sites around the country, had wide buffers around it to avoid any mixing with neighboring crops as Monsanto conducts various studies.

The exact locations remain undisclosed because of fears that activists might cause problems. Last month in Canada, activists stormed a wheat test site in Manitoba, and some biotech fields have been destroyed by opposition groups.

"There is such a struggle," said North Dakota Wheat Commission spokesman Jim Peterson, whose organization has been caught up in the debate.

"If it was up to us and it came down to a vote today whether to commercialize it or not," Peterson said, "the vote would probably be 'No.'"

Biodiversity Mystery Theater presents:
The Case of the Mexican Bean Gene Claim

. . . featuring an international cast of characters
. . . in real-life tales drawn from the files of the United States Patent Office

Biotech giant Monsanto has filed for a patent on a gene to be genetically-engineered into soya (soybean) plants. The gene is a seed-specific promoter that can be used as a genetic "switch" in biotech plants to boost, for example, the oil content of seeds or the production of herbicide resistance proteins.

The source of the promoter gene is a bean variety collected in Mexico. That variety is held in trust for the world's farmers by the Cali, Colombia-based International Center for Tropical Agriculture (known by its Spanish acronym, CIAT) under an agreement with the UN Food and Agriculture Organization (FAO). The agreement prohibits the bean from being patented.

Observers may find it ironic that Monsanto is patenting promoter genes from Mexico at a time when the company is embroiled in controversy over genetic pollution to Mexican maize (corn). That controversy involves the unexplained presence of Monsanto promoter gene sequences in farmers' varieties of maize. (3)

Arcelin Genes: Monsanto's patent application (#20030046727) was filed on March 6th, 2003 and is titled "Arcelin-5 promoter and uses thereof". The application is currently under review by the US Patent Office. Arcelin genes initially aroused scientific interest when researchers theorized that the genes might play a role in the resistance of some P. vulgaris varieties to the Mexican bean weevil (Zabrotes subfasciatus). (4) But that interest has expanded because of the special characteristics of Arcelins. Whereas many seed proteins are produced by complicated systems involving several genes (systems that remain difficult to control with biotechnology), Arcelin genes are comparatively simple and can produce an unusually high proportion (over 35%) of protein in seeds, including genetically-engineered seed. (5) This seed-specific activity has drawn the attention of biotechnology firms.

Seven related Arcelin genes have been identified, all in Phaseolus vulgaris varieties from Mexico.(6) The first, called Arcelin-1, was found in a farmers' variety of P. vulgaris that was collected in the 1960s near the town of Arcelia (hence the name "Arcelin") in southeastern Guerrero state. The area is home to Náhuatl and Tlapaneco indigenous peoples. The Arcelin-5 promoter comes from another Mexican bean collected in the 1960s near the town of Jomulco, Nayarit. Jomulco is in a mountainous, volcanic region north of the tourist resort of Puerto Vallarta. It has a rich indigenous heritage and an archaelogical site, "Los Toriles", considered among the most important in western Mexico.

In 1999, a Belgian research team inserted Arcelin-5 into the tepary bean (P. acutifolius) and Arabidopsis. The transgenic plants produced high levels of the Arcelin-5 protein, suggesting that the promoter remains active when moved to a different species. It was this seed-specific activity of the promoter that interested Monsanto, whose scientists took the Arcelin-5 promoter, sequenced it, inserted it into soya, and filed for the patent.

Genebank Details: In scientific publications, the Mexican source of Arcelin-5 is identified by its accession number in the CIAT genebank (G2771, G02771, or CIATBEAN-G 2771). The same seed is also held by the US Department of Agriculture (where it is designated PI 318702). The two genebanks list different collection dates (1962 and 1966, respectively) but they agree that the bean was collected by US researcher Howard Scott Gentry and that the bean is the source of the Arcelin-5 genes. Gentry was a prolific plant collector who died in 1993.

The Arcelin-5 source is subject to a trust agreement between CIAT and the UN Food and Agriculture Organization that stipulates that in-trust materials cannot be subject to intellectual property claims. Under the recently-completed International Treaty on Plant Genetic Resources for Food and Agriculture,(7) P. vulgaris (and CIAT's collections of it) will become part of a multilateral germplasm exchange system. A link to CIAT's material transfer agreement is provided below.

Open Questions: If a variety cannot be patented, can specific genes copied from that variety be the subject of patents? If the bean that is at the heart of Monsanto's patent application was held in trust for the world's farmers, how can the bean's genetic constituents be patented? Whose job is it to enforce whatever rules apply? Will patent claims like that on the Mexican Gene Bean chill research on Arcelin genes, even public sector research? Will those who shared the bean with genebanks benefit from the inventions of those whose access the genebank collections? If not, why not?

Only further research . . . hopefully carried out by those whose biodiversity is the subject of the patent . . . will provide the necessary answers.

Footnotes

1. To be held in Cancun, Mexico, in September, 2003.

2. See Is the TRIPS review at a turning point?, a July 2003 paper by Genetic Resources Action International (GRAIN), available at  http://www.grain.org, and TRIPS Council debates patents on life, traditional knowledge, and Article 27.3(b), Third World Network Information Service on WTO Issues, 11 June 2003, at  http://www.twnside.org.sg/title/twninfo21.htm.

3. Fragments of "35S", a promoter gene from the cauliflower mosiac virus used in Monsanto's transgenic maize varieties, have been detected in Mexican farmers' varieties of maize. Scientists theorize that the promoter may have come from Monsanto maize imported into Mexico as food (Mexico has not approved commercial planting of GMO corn).

4. Goossens, A. et al. 1999. The arcelin-5 Gene of Phaseolus vulgaris Directs High Seed-Specific Expression in Transgenic Phaseolus acutifolius and Arabidopsis Plants. Plant Physiology 120 (4): 1095-1104.

5. De Jaeger, G. et al. 2002. Boosting heterologous protein production in transgenic dicotyledonous seeds using Phaseolus vulgaris regulatory sequences. Nature Biotechnology 20(12):1265-8.

6. Lioi L. et al. 2003. Lectin-related resistance factors against bruchids evolved through a number of duplication events. Theoretical Applied Genetics. 2003 Jun 18 (online first article); URL:  http:/www.springerlink.com/link.asp?ID=N1WN84J2P8QJK0Q5.

7. For more information, see the homepage of the International Treaty on Plant Genetic Resources for Food and Agriculture at URL:  http://www.fao.org/ag/cgrfa/itpgr.htm.

8. Source: CGIAR System-wide Information Network for Genetic Resources (SINGER), URL:  http://www.singer.cgiar.org and Lioi, L. et al. Op. cit.

For more information on today's case

1. Examine: "Arcelin-5 promoter and uses thereof", US Patent application #20030046727, filed on March 6th, 2003. The application can be accessed at the website of the United States Patent and Trademark Office:  http://appft1.uspto.gov/netahtml/PTO/search-bool.html . Enter the application number to view the full text.

2. Go to the website of CIAT (Centro Internacional de Agricultura Tropical) at  http://www.ciat.cgiar.org  and view the CIAT Material Transfer Agreement at  http://www.ciat.cgiar.org/pgr/mta.htm.

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New Codex Alimentarius Guidelines:
United States Out Of Step From World Scientific Opinion

This week, the Codex Alimentarius Commission adopted two new guidelines regarding the safety of foods derived from genetically engineered organisms: Principles for the Risk Analysis of Foods Derived from Modern Biotechnology and Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants. These documents represent an important step forward in defining at an international level the acceptable procedures for evaluating the safety of genetically engineered foods. Notably, the guidelines serve to highlight the inadequacies and lack of scientific rigor used in the approval process in the United States, where the bulk of the genetically engineered varieties are developed and grown. The US process is seen as sorely inadequate in comparison to the new guidelines; in fact, the US Food and Drug Administration (FDA) does not have its own detailed safety standard or testing guidelines.

Several studies of US safety assessments have been carried out, most recently by the Center for Science in the Public Interest. Their recent report, Holes in the Biotech Safety Net, demonstrates that United States’ review of genetically engineered foods by the FDA does not assure the safety of those foods. We hope that the new Codex guidelines can begin to redress these regulatory inadequacies in the United States.

Premarket safety assessments are essential

One of the most important decisions made by Codex, and contained in the Principles for Risk Analysis of Foods Derived from Modern Biotechnology, is that “(a) pre-market safety assessment should be undertaken … and should be of a quality and, as appropriate, of quantity that would withstand scientific peer review.” It is well known that there is no mandatory pre-market safety assessment for GE foods in the United States. Companies are required to “consult” with the Food and Drug Administration, but the amount of testing done on the foods is entirely up to the company. The Food and Drug Administration does not “approve” foods for placing on the market. Instead the letter resulting from the consultation reads similar to the following quote from an actual FDA letter to Monsanto:

Two more points are worth noting about the differences between what Codex says and what the United States requires.

Unintended effects. The United States FDA does not require companies to carry out a thorough assessment of unintended effects. “Unintended effects” include those effects resulting from: disruption or silencing of existing genes, activation of silent genes, modifications in the expression of existing genes, or formation of new or changed patterns of metabolites. In order to carry out such an assessment, a company or government agency would need to look beyond the basic variables analyzed in a US food safety assessment: composition, toxicants, and anti-nutrients.

According to the new Codex guidelines, unintended effects are defined as predictable or unpredictable. Alteration in the basic variables for assessment in the United States - composition, toxicants, anti-nutrients - would be considered predictable unintended effects, and might be detected in a safety review (but see endnote 6 for exceptions to this). Codex guidelines stipulate that assessment should also be concerned with unpredictable unintended effects. There is nothing in US procedures that would encourage companies to undertake studies to detect unpredictable changes that might have adverse effects on human health.

Missing pieces of US food safety assessment. The Draft Codex Guideline lists a number of relevant factors that should make up a food safety assessment, including evaluation of toxicity of expressed substances, compositional analyses of key components, evaluation of metabolites, food processing, and nutritional modification. The FDA has been criticized for not making the companies look carefully at the toxicity of expressed proteins and compositional analysis of key components, including toxicants and anti-nutrients. US safety evaluations fail to address metabolites and food processing in any comprehensive way. New or altered metabolites, or altered concentrations of existing metabolites, could have adverse effects on human health. To date, the FDA has not paid attention to this potential food safety problem, despite numerous mentions in the scientific literature.

Potential human health effects of GE foods under different food processing treatments is an understudied area. The lack of scientific information in this area has been highlighted by recent contamination of Mexican maize and by the controversies over US dumping of GE food aid in developing countries. GE maize in the United States is primarily consumed by animals, or by humans in highly processed forms in small quantities, e.g., corn syrup, corn starch, corn flakes and corn chips. However, maize is consumed in Mexico and southern Africa in a very unprocessed form and in large quantities several times during the day. The FDA and company assessments of GE maize have not taken into consideration these differences in food processing treatments.

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