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Date:

August 24, 2007

Subject:

Japan Approves Agrisure; Biorefining of corn; Activists Hit Portugal Farm

 

* Japan Approves Agrisure RW
* Growers Have New Tech Responsibility
* Agency to control GM foods
* Biorefining of corn
* Transgenic rabbit-milk drug results
* Map Of The Bovine Genome
* GM crops vandalised in Silves

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Syngenta's Agrisure RW Corn Rootworm Biotech Trait Obtains Full Regulatory Approval in Japan

- Grain Journal, August 23, 2007

http://www.grainnet.com/articles/Japan_Approves_Syngenta_s_Agrisure_RW_Corn_Rootworm_Biotech_Trait_-47535.html

Golden Valley, MN--Syngenta announced on Aug 23 that it has obtained full regulatory approval in Japan for Agrisure® RW, its corn rootworm insect control corn seed.

Agrisure RW now has full approval in the United States, Canada, and Japan, and import approval in Australia and New Zealand.

Syngenta's innovation in genetics and traits such as Agrisure RW is helping growers meet the rapidly expanding demand for corn.

The Agrisure brand spans a wide range of products bringing new choices to growers including Agrisure CB/LL, Agrisure GT, Agrisure RW, Agrisure GT/RW, Agrisure GT/CB/LL, Agrisure CB/LL/RW and Agrisure 3000GT.

In this introductory year, Agrisure RW growers participated in a comprehensive stewardship program to ensure their grain would remain in domestic markets.

With this approval, Agrisure RW grain can now be accepted by elevators exporting grain to Japan.

However, Syngenta is committed to and will continue to implement the grain stewardship program with growers through the end of 2007.

In 2008, Agrisure RW will be part of the seed industry's Market Choices grain direction program.

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Corn Growers Remind Growers About New Corn Tech Responsibility

American Agriculturist, August 24, 2007

http://americanagriculturist.com/index.aspx?ascxid=fpStory&fpsid=29668&fpstid=1

When a new crop technology becomes available it often brings along requirements and responsibilities for the grower. For example, recent biotech advancements require farmers to use the Market Choices grain channel to make sure products don't end up in countries that have not approved the biotech trait.

Thursday's announcement from Syngenta that Japan has approved the biotech trait Agrisure RW was good news for corn growers, according to a press statement from the National Corn Growers Association. But the group also warns that farmers need to adhere to the stewardship agreements they signed when they planted this new-tech grain.

NCGA had a part in helping address issues the Japanese had with the new trait. The regulatory process is time-consuming, says Martin Barbre, chairman of NCGA's Biotechnology Working Group. "NCGA and other members of the industry have worked together to address all questions the Japanese had," he says. "We appreciate the close cooperation and open communication that resulted in resolving all the issues surrounding Agrisure RW's approval, and look forward to continuing a close working relationship with the Japanese."

Notes Ken McCauley, NCGA president: "One of the real wins in this is that U.S. corn can continue to flow freely to our major export market, and there will be no new testing procedures for our markets or our growers."

McCauley notes that growers need to "take every precaution to make sure our products are sold to the appropriate markets. That means growers should contact their buyers to ensure they are accepting grain from Agrisure RW hybrids."

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Agency to control distribution of GM foods

- Zulkifli abd Rahman, The Star (Malaysia), August 24, 2007

http://thestar.com.my/news/story.asp?file=/2007/8/24/nation/20070824172518&sec=nation

SERDANG: An agency will be formed to control the distribution of genetically-modified (GM) foods and enforce the mandatory labelling of such products sold in the market.

Agriculture and Agro-Based Industry Minister Tan Sri Muhyiddin Yassin said the labelling requirement, which was stated in the Biosafety Bill 2006, will allow consumers to choose whether they want to consume or reject GM foodstuff.

"The regulations will allow people to be aware of the presence of GM foods as it will be stated on the labels pasted on the packaging," he told reporters after presenting excellent service awards to 253 agriculture department staff at the Serdang Agricultural Institute here Friday.

(GM foods contain ingredients that have been modified through genetic engineering.)

Muhyiddin said, unlike some countries where producers can voluntarily label GM foods they export, Malaysia had decided through the Bill that consumers must be informed about the manufacturing process of GM foodstuff and choose whether they want to buy them based on the information they read on the packaging.

On another matter, Muhyiddin said his ministry had not received any report about the shortage in the supply of agricultural products due to bad weather.

He added that his officers would be informed by a committee led by the Domestic Trade and Consumer Affairs Ministry on the demand for fish, meat, vegetables and fruit before the start of the festive season.

"We will import if there is a supply shortage. However, it's difficult to predict on the weather fluctuations, which will affect the food supply.

"Hopefully, last year's major floods, which affected the farmers and caused food shortage, will not recur," he added.

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Biorefining of corn brings gelatin production into the 21st century

- American Chemical Society (press release), August 22, 2007

http://www.eurekalert.org/pub_releases/2007-08/acs-boc081007.php

BOSTON - Scientists are reporting an advance toward turning corn plants into natural factories for producing gelatin to replace animal-sourced gelatin widely used by the pharmaceutical industry for manufacturing capsules and tablets. The advance, described today at the 234th national meeting of the American Chemical Society, may lead to a safe, inexpensive source of this protein for manufacturers who now rely on material obtained as a by-product of meat production.

Today, production of gelatin, a jelly-like substance, relies on the same fundamental methodology employed since commercial production began in the 17th century: Gelatin is derived from the break-down of collagen, which is a component of skin, tendon, bone, cartilage and connective tissue of animals. While there are no naturally occurring plant sources of gelatin, scientists have successfully modified plants, such as corn, to have a gene that results in the production of "recombinant" gelatin.

About 55,000 tons of animal-sourced gelatin are used every year to produce capsules and tablets for medicinal purposes. Plant-derived recombinant gelatin would address concerns about the possible presence of infectious agents in animal by-products and the lack of traceability of the source of the raw materials currently used to make gelatin. However, finding ways to recover and purify recombinant gelatin from plants has remained a challenge because only very low levels accumulate at the early stages of the development process.

Now, scientists at Iowa State University in Ames and FibroGen, Inc., in South San Francisco say they have developed a purification process to recover these small quantities of recombinant gelatin present in the early generations of transgenic corn. The method uses a four-step recovery system to separate the recombinant protein from other corn proteins with sufficient purity that its structure and composition can be verified, says Charles Glatz, Ph.D., a chemical engineer at Iowa State University who directed the work.

"Protein production from transgenic plants is a challenging process, with potential pitfalls all along the way," Glatz says. "It is important to develop methods in the early stages of the development program to purify gelatin to demonstrate that it can be produced properly."

The studies establish transgenic corn as a viable way to produce gelatin and potentially other products, Glatz says. In time, researchers may also be able to develop a variety of "designer" gelatins, with specific molecular weights and properties tailored to suit various needs of products containing gelatin.

"Corn is an ideal production unit, because it can handle high volumes at a low cost," he says. In addition the recombinant gelatin is free from the safety concerns of using meat byproducts.

The purification process relies on chromatographic and filtration techniques, building upon methods developed by FibroGen to recover recombinant gelatin produced in yeast.

Glatz says ultrafiltration allowed the group to take advantage of the size difference between the recombinant protein and other corn proteins.

"This step greatly reduced the process volume for later chromatographic steps, and was crucial to achieving a high purification factor."

The group is now working to refine the method and boost the overall recombinant protein yields in corn, he says. Though the procedure requires more testing, Glatz says the technique could someday be used to produce high-grade gelatin in a safe and inexpensive manner.

Overall costs could be further reduced by combining the production of gelatin in corn with the extraction of non-protein parts of the grain - such as oils and starches - that are now grown and harvested for biodiesel and ethanol production, he adds.

"Corn wouldn't be planted for its gelatin alone, but those products could help off-set the cost of biorefineries that use corn to produce other products," he says.

Cheng Zhang, a doctoral student at Iowa State University, presented details of the new purification process at the American Chemical Society meeting.

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Latest transgenic rabbit-milk drug results 'positive'

- Kirsty Barnes, BioPharmaReporter, August 22, 2007

http://us-pharmatechnologist.com/news/ng.asp?n=79169-pharming-transgenic-rabbit-milking

Positive interim Phase III trial results for an experimental new transgenic rabbit-milk anti-inflammatory drug has prompted its developers to halt the placebo arm and treat all patients with this promising new therapy.

The drug, Rhucin (recombinant human C1 esterase inhibitor), is a human protein being to treat acute attacks of hereditary angioedema (HAE), a rare disease characterised by painful swelling of soft tissue.

Rhucin is fairly unique in that it is developed from a therapeutic protein produced in the milk of rabbits which have been engineered to carry and express the gene of interest in the mammary glands. The protein is collected using the proprietary technology of its developers, Dutch biotech company Pharming.

Only one such transgenic animal-derived drug is currently available on the market, GTC Biotherapeutics' goat-derived ATryn - which was approved last year as an anticoagulant to treat a rare congenital disease - and these latest trial results will bolster Pharming's bid to make its drug the second on the market.

Pharming announced this week that early results in a European placebo-controlled study designed to evaluate the efficacy and safety of Rhucin, showed that none of the patients taking the drug suffered a relapse of their HAE attack, nor any treatment-related adverse events.

These results reflect those from earlier studies, said the firm, who will be presenting the data in detail on August 30th at an analyst meeting in London.

"Based on the results and after consulting with the independent data monitoring committee, the Company has decided to discontinue further randomised treatments within the clinical study for methodological and ethical reasons...All investigators have been informed", Pharming said in a statement.

The company is pushing to have Rhucin approved and launched in Europe by the end of this year and said it has now included this latest analysis in its dossier submitted to the European Medicines Agency (EMEA) to further support its request for marketing authorisation.

While Pharming awaits a decision from the European regulator, it is also preparing to apply for US Food and Drug Administration approval (FDA) for Rhucin. An additional trial is required for the US application, which is currently ongoing but expected to be finished within the next few months, with the application to be submitted later this year. Pharmaing said it has now also submitted data from this latest analysis to the FDA to help its case.

Meanwhile, in July Pharming was advised that its five facilities used in the manufacture of Rhucin complied with the standards of good manufacturing practices (GMP), following inspections by the EMEA. The GMP approval was the first in the world for a transgenic rabbit facility.

Pharming chief commercial officer Rein Strijker told in-PharmaTechnologist.com at the time that the GMP success indicated a change in thinking and showed there was a move towards greater acceptance of transgenic animal-derived drugs.

"Many people in the past have questioned whether we can use animals to make drugs and often said we could not get to the stage where authorities would approve to GMP standards. This is proof that the authorities are satisfied with our production using animals. This is quite an achievement."

A new area in the drug world, transgenic drug-producing animals have been wrought with controversy and ethical debate, but according to Strijker the technology is more cost effective than conventional protein-producing mechanisms and has a lot of potential in the biopharmaceutical industry.

"Milk is very rich in proteins and mammary glands are good at producing high amounts in a high quality."

The transgenic rabbits are able to produce between 10 and 12 grams of protein per litre of milk, he said. This is compared to highly optimised cell cultures that can typically generate 0.2 to 1 grams of protein per litre of culture medium.

The high protein levels were achieved by including an extra bovine milk-specific promoter sequence (alpha-S1 casein) functionally linked to the gene encoding human C1 inhibitor. Rabbits can produce up to 10 litres of milk a year. Scaling up was an easy process, said Strijker.

Meanwhile, other companies active in the transgenic arena include US firm Hematech, owned by Japan's Kirin Brewery, which is focusing on human antibody-producing cows that will be used for the development of large quantities of polyclonal antibodies, while US-based Avigenics is pursuing avian transgenesis for treatments in oncology, infectious disease and autoimmune disease.

The use of animals in the production of biopharmaceuticals is clearly an exciting and emerging new field being explored by many cutting-edge firms - could breakthrough drugs using such technologies be the milky way forward?

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Physical Map Of The Bovine Genome Revealed

- Medical News Today, August 22, 2007

http://www.medicalnewstoday.com/articles/80257.php

The recent publication of a paper in Genome Biology describing a physical map of the bovine genome provides cattle researchers with a tool to aid their search to improve cattle production and health and decrease the environmental footprint of the industry. The physical map is like a framework of a house in that it allows all the fine details to be positioned and placed in order. This framework underpins most current and future cattle research, including the genome sequencing project currently underway and new DNA based methods to improve cattle genetics.

The international bovine BAC mapping consortium consisted of contributions from over 20 groups based in 8 countries: Australia, Brazil, Canada, France, Italy, New Zealand, Scotland, and the USA. Lead author, Warren Snelling based at USMARC at Clay Centre Nebraska, said "It is very gratifying to see this project completed as this resource will aid research for all grazing species including cattle, sheep and goats. "These species have the unique ability to convert pasture from extensive uncultivable regions into high quality protein in a low cost energy efficient manner."

One of the challenges of such a large project extending over more than a five year period has been its coordination. Steve Kappes of USDA Agricultural Research Service (ARS) who chaired the consortium was particularly pleased with the way the information was made available rapidly to the community: "As the information became available it was placed into the public domain promptly, it would be fair to say that a lot of the cattle genomics research conducted over the past 5 years has relied on the information provided by this project."

The project serves, also, as an example of how a motivated international group can combine their limited resources to obtain an outcome for the benefit of all. Kellye Eversole from the Alliance for Animal Genome Research is pleased with the progress achieved. "We have advocated for a coordinated, international effort and it is rewarding to see both the end of this step and its success."

The project commenced with the construction of a high quality BAC library with DNA obtained from a linebred Hereford bull bred at the USDA-ARS research station near Miles City, Montana. The BAC library contains random segments of genomic DNA placed inside bacterial cells and propagated. These acted as the resource for the majority of the subsequent work. This work included mapping the genome in 4 different ways. The DNA segments were fragmented into unique patterns using enzymes that cleave at certain short sequences and then the patterns compared to merge the segments into larger units Using information gained by reading or sequencing the actual base pairs for short regions on the ends of the BACs, the size of these units was increased. The sequences were then used to create probes for 2 different types of mapping, one based on inheritance of variants through cattle pedigrees and another based on close physical distance. The combination of methods, each with its own strengths, allowed for the maps to be cross checked against each other and a combined or consensus map created. The map also integrates and builds upon bovine maps created over the last decade. The final version consists of 422,000 end sequences, 291,000 digests and 17,000 markers. It is available at http://www.bovinegenome.org.

This is not the final step for the bovine genome project as the community at large is awaiting eagerly the next assembly and annotation of the bovine genome being done by the Baylor Genome Sequencing Centre. Resources from the physical mapping project were provided to the Baylor team to improve the quality of the assembly. Expected within a year, the next assembly and annotation of the bovine genome will permit the identification of many of the genetic differences that distinguish grazing animals or ruminants from other mammals unable to digest forages containing cellulose.

The project was funded by United States Department of Agriculture, the Alberta Science and Research Authority, Agriculture and Agri-Foods Canada, the Biotechnology and Biological Sciences Research Council, The European Commission, the Commonwealth Scientific and Industrial Research Organization of Australia, AgResearch Ltd, New Zealand Foundation for Research, Science and Technology, EMBRAPA Brazil, CNPq (National Council for Scientific and Technological Development) Brazil, the Roslin Institute Scotland, INRA (the French National Institute for Agricultural Research), AGENAE, Genoscope, the Texas Agricultural Experiment Station, and the Alliance for Animal Genome Research.

The paper in Genome Biology is freely available at: http://genomebiology.com/content/pdf/gb-2007-8-8-r165.pdf

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GM crops vandalised in Silves

- Eloise Walton, The Resident (Portugal), August 23, 2007

http://www.portugalresident.com/portugalresident/showstory.asp?ID=20827

AROUND 100 anti-GM protesters destroyed more than a hectare of genetically modified corn at the Herdade da Lameira farm in Silves while the owner tried desperately to stop them before the GNR arrived. The President of Portugal and the Minister of Agriculture have condemned the acts of vandalism.

João Menezes, the 56-year-old farmer, was surprised on August 17 by a group of around 100 protesters who destroyed part of his 51 hectare farm of genetically modified (GM) corn. By the time the GNR arrived on the scene to escort the protesters off the premises, they had already destroyed one hectare of the crop.

During the protest, the activists had their faces covered to protect themselves against the pollen. After being identified and escorted off the land by the authorities, the protesters continued their rally against genetically modified products as they marched with banners into the village of Poço Barreto.

This action was promoted and supported by two environmental groups, the newly created Verde Eufémia and the Algarve based Almargem as well as some of the local population and organic farmers who disagree with GM crops.

Mr Menezes said that his farm is completely legalised and has been inspected by the Ministry of Agriculture. "This is what my family live on; it is our only means of income," said Mr Menezes, adding: "If they destroy this corn, I will die of hunger. Someone has to pay for the damages."

Luis Grifo, the technical engineer responsible for the corn crop at the Herdade da Lameira, said: "It is only known that GM corn is planted here because all of the regulations have been adhered to and all of the neighbours have been informed. Portugal only produces corn for three months of the year; during the rest of the year, corn is imported, of which 90 per cent is genetically modified."

Since the incident, the environmental group Almargem has asked the Portuguese government to destroy the GM crop at the Herdade da Lameira. A spokesman said: "We are asking for the immediate application of the emergency measures outlined in article 25° of the law decree n° 72/2003 of April 10."

This law regulates the deliberate release of genetically modified organisms into the environment, as well as the placement of these products on the market, conforming to the principle of precaution, taking into account the protection of human health and the environment.

"The presence of GM crops in the Algarve could have a catastrophic impact on the region's main industry, tourism, with unpredictable social consequences," said the spokesman.

Castelão Rodrigues, regional director of Agricultura do Algarve, said: "The farm is legal and I cannot see why Almargem is invoking that particular law".

Mr Menezes has decided to press charges against the protesters responsible for the damages caused, and who were identified by the GNR, which could lead to a prison sentence of up to three years.

During visits to the Algarveon Monday, President Cavaco Silva and Jaime Silva, Minister of Agriculture, condemned the acts of vandalism at the Herdade da Lameira.

Cavaco Silva appealed to the authorities during a speech in Albufeira for an investigation to be carried out on the vandalism of genetically modified crops in Silves. "There can be no doubt that the law in Portugal is to be obeyed and those who have the power to make it be obeyed must not let this happen," said the President.

Jaime Silva visited farmer José Menezes to offer him legal support, saying: "Those responsible for the damages caused will pay, have no doubts.

"If it (GM crop) does not cause problems to public health, if it generates more income and is an environmentally friendly corn, as it does not need pesticides, why should we not plant it?," said Jaime Silva.

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*by Andrew Apel, guest editor, andrewapel+at+wildblue.net