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Date:

July 19, 2006

Subject:

Aussies Wise Up; Sequencing Cassava; Diabetes-Friendly Safflower; Biotech Biofuel; Regulatory Slowdown; Enviro Hypocrisy

 

Today in AgBioView from http://www.agbioworld.org - July 19, 2006

* Australian Farm Group Rethinks GM Crops Ban Support
* ... NSW Farmers Support Commercial Release of GM crops
* Danforth Center to Sequence Cassava
* Calgary Firm Turns Safflower Into Insulin
* Biofuel Research Reaches Fever Pitch
* Regulatory Slowdown on GM Crop Decisions
* Do Cisgenic Plants Warrant Less Stringent Oversight?
* Crops Could Make Their Own Fertilizer
* Why do Enviros Embrace Science to Save Nature but Reject GM?
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Australian Farm Group Rethinks GM Crops Ban Support

- ABC TV, July 19, 2006 http://au.news.yahoo.com/060719/21/ztzc.html

The New South Wales Farmers Association has withdrawn its support for a ban on genetically modified (GM) crops. The association has passed a motion asking for the immediate lifting of the state's moratorium on GM crops.

Grain producer Michael Matthews says it is a victory for progressive farmers.

"This is a technology that we have to have to be able to compete on the world stage. Without this technology we're going to be sinking further and further behind," he said.

"This technology is all about producing greener crops, cleaner crops, healthier crops, crops grown with 70 per cent less herbicide and are more friendly to our environment.

"If we're not producing these crops, we're not going to be winning our spot on the supermarket shelves."

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New South Wales Farmers' Association Supports Commercial Release of GM crops

- SeedQuest, July 18, 2006 http://www.seedquest.com/

The New South Wales Farmers' Association has voted to support the commercial release of Genetically Modified (GM) crops following a vote at the Annual Conference in Sydney.

Chairman of the New South Wales Farmers' Association Grains Committee, Angus McLaren says the vote demonstrates that farmers in New South Wales want the State Government moratorium lifted immediately.
"Members at Annual Conference believe the benefits of GM crops outweigh the marketing risks and want the ability to adopt the technology," Mr McLaren said.

"GM crops increases grower profitability through significantly less herbicide use," Mr McLaren said. "This is the first time this organisation has supported the move for the commercial release of GM crops since the debate started.

"The technology has been rapidly embraced in major grain and oilseed exporting countries in the United States, Argentina and Canada, accounting for 85 percent of all GM production in 2004," Mr McLaren said.

The New South Wales Farmers' Association also voted to lobby the Primary Industries Ministerial Council (PIMC) to set adventitious presence levels for all crops rather than for just canola as is currently the case.
Farmers also want practical, objective and inexpensive "on-farm" GM detection tests as well as an education program in conjunction with lifting the moratorium.

"Lifting the moratorium will put New South Wales farmers on a level playing field with some of our biggest international competitors," Mr McLaren concluded. The Association will be pursuing the GM issue with Minister for Primary Industries Ian Macdonald. At this stage, the moratorium is set to expire in 2008.

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Danforth Center Spearheads Effort to Sequence Cassava at National Research Center

- Press Release, July 18, 2006; Donald Danforth Plant Science Center, www.danforthcenter.org

"U.S. Department of energy joint genome institute to initiate genome sequencing that will influence development of breeding and biotech tools"

The U.S. Department of Energy Joint Genome Institute (DOE JGI) recently announced that it selected a proposal organized by the Donald Danforth Plant Science Center to conduct genome sequencing of the cassava plant (Manihot esculenta). Dr. Claude M. Fauquet, principal investigator from the Danforth Center, led a consortium comprised of over a dozen scientists from 11 institutions that submitted the proposal to the DOE JGI.

"Sequencing the cassava genome will help bring this important crop to the forefront of modern science and generate new possibilities for agronomic and nutritional improvement," said Dr. Norman Borlaug, Nobel laureate, father of the "Green Revolution," and Distinguished Professor of International Agriculture, Texas A&M University. "It is a most welcome development, especially for millions of the world's poor who depend upon cassava for their sustenance."

"This new cassava project builds on the past participation of the Danforth Center in the maize and soybean genome sequencing programs to now focus on a crop for the developing-world," Danforth President Dr. Roger N. Beachy explained. "Dr. Claude M. Fauquet is a recognized leader in cassava biology and biotechnology, co-chair of the Global Cassava Partnership, and he will collaborate with Dr. Brad Barbazuk, a bioinformatics specialist at the Danforth Center, and with genomics experts from TIGR and Broad Institute, to apply the project's data in future work to enhance cassava."

"The successful lobbying of the DOE JGI by the Danforth Center to sequence the cassava genome validates its importance as a high starch producing crop. The acquisition of the cassava genome sequence will facilitate our understanding of this crop and its relatives within the relatively under explored Euphorbiaceae family," Dr. Fauquet announced. "These tools will link genes to genetic and physical maps to accelerate breeding programs, identify cassava gene targets for biotechnology development, and provide a platform to explore the vast biodiversity within cassava wild species. Ultimately these activities will improve food security for developing countries by increasing cassava crop yield and its nutritional quality, and will position cassava as a valuable source of renewable bio-energy."

"Cassava is a root crop that accumulates large quantities of starch with an unrivaled efficiency, and represents an important source of calories within many developing countries. The cassava genome sequence will enable scientists to apply the knowledge gained from the current collections of plant genomic, proteomic and metabolomic data to cassava, thus enabling a better understanding of the molecular basis of cassava development, morphology and physiology," said Dr. Barbazuk.

The DOE JGI chose to sequence cassava because it is an excellent energy source. Its roots contain 20-40% starch that costs 15-30% less to produce per hectare than starch from corn, making it an attractive and strategic source of renewable energy. Cassava grows in diverse environments, from very dry to extremely humid, from acidic to alkaline soils, from sea level to high altitudes, and in nutrient-poor soil. Moreover, it is grown worldwide as a source of food for approximately 1 billion people, raising the possibility that it could be used globally to alleviate dependence on fossil fuels. The effort to sequence the cassava genome will be aided by alignments to the genomes of poplar and castor bean, plants closely related to cassava, and available cassava BAC libraries and EST and cDNA sequences will facilitate annotation. This project will elucidate the genetic machinery required for efficient energy production in a range of environments, and the information it yields will enable improvement to a wide range of crops important for the U.S. biofuel supply.

In addition to the Danforth Center, the consortium includes the United States Department of Agriculture, Washington University in St Louis, the University of Chicago, The Institute for Genomic Research, the Missouri Botanical Garden, the Broad Institute, Ohio State University, the International Center for Tropical Agriculture, and the Smithsonian Institution.

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Calgary Firm Turns Safflower Into Insulin

- Leonard Zehr, Globe and Mail, July 19, 2006

In a breakthrough that could rival the discovery of insulin by Canadians Frederick Banting and Charles Best in 1921, a Calgary biotech company claims to have produced commercial quantities of human insulin from genetically modified safflower plants, a move that could change the economics of the diabetes market.

"We believe that when we're successful, people in the developing world, who otherwise wouldn't get insulin because there isn't enough supply or they can't afford it, will get it," said Andrew Baum, president and chief executive officer of SemBioSys Genetics Inc.

Currently, pharmaceutical companies use genetically engineered bacteria and yeast to produce synthetic insulin in large steel vats. SemBioSys genetically manipulates plant-seed oils to create proteins that can be used to produce drugs and non-drug products. By inserting a human insulin gene into a safflower plant, for example, the technology has led to the recovery of human insulin as the plant grows and seeds develop, the company says.

Mr. Baum said the company's next goal is to demonstrate, by the end of the year, that its product works as well as insulin currently on the market to control blood glucose levels. That would set the stage for a request to the U.S. Food and Drug Administration for approval to begin human clinical testing at the end of 2007, which would also likely draw the interest of a major pharmaceutical company to take part in the clinical trials. SemBioSys says it can make more than one kilogram of human insulin per acre of safflower production.

That amount could treat 2,500 diabetic patients for one year and, in turn, meet the world's total projected insulin demand in 2010 with less than 16,000 acres of safflower production. Worldwide demand for insulin is forecast to soar to 16,000 kg by 2010, from an estimated 4,000 to 5,000 kg last year, because more people are developing the disease and are being diagnosed earlier in their lives, and because of the development of new products such has inhaled insulin, which requires five to 10 times the amount of injected insulin, Mr. Baum said.

Mr. Baum, a 50-year-old industrial engineer by training, founded Calgene Inc. of Davis, Calif., in 1981, which went on to develop a genetically engineered "flavour saver tomato" that could be harvested and delivered ripe to grocery stores. Monsanto Co., the world's biggest developer of genetically modified crops, acquired Calgene in 1997 for $240-million (U.S.).

At Calgene, Mr. Baum worked with Maurice Moloney, a renowned plant molecular biologist who developed genetically modified canola. Mr. Moloney, now 53, left the company in 1987 to become the first chairman of the biotechnology department at the University of Calgary, which was making a big push in the sector. At the university, he pursued his research and developed the technology that led to the creation of SemBioSys, a university spin-off.

"Morris called me out of the blue after the Monsanto deal and offered me a job as CEO of what was largely an academic project at the time that he wanted to take to the next level," Mr. Baum recalled. The company went public at the end of 2004.

In outlining the benefits of the technology, Mr. Baum said safflower-produced insulin could reduce capital costs by 70 per cent and product costs by 40 per cent, compared with traditional insulin manufacturing.
Mr. Moloney, who is SemBioSys's chief scientific officer, said scientists in the past have tried to make insulin from plants, but commercial quantities were never achieved.

SemBioSys believes its product would require about $80-million in capital investment to make 1,000 kg of insulin, compared with $250-million per 1,000 kg for traditional insulin. "This company exists because it has the production and manufacturing capacity that suggests they can beat everybody on price," said Brian Bapty, an analyst with Raymond James in Vancouver. "If you can be the lowest cost producer in an expanding market, you stand to get the bulk of the business."

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Biofuel Research Reaches Fever Pitch

- Toronto Star, July 17, 2006

Researchers gathered at a global biotechnology conference in Toronto yesterday to explore better methods of making biofuels out of everything from corn stalks to orange peels.

With oil prices above $76 (U.S.) a barrel, research and development into ethanol and biodiesel is reaching a feverish pitch in North America. The search is on to find higher yielding crops and improved sugar extracting enzymes -- both necessary for making biofuel production more economical and less disruptive to food and livestock feed markets.

"There would be a lot fewer of us here if it weren't for the situation regarding oil," said Anna Halpern-Lande, founder of renewable energy consultancy Cyrnel LLC, one of dozens of panellists at the third annual World Congress on Industrial Biotechnology and BioProcessing.

The U.S. government recently set a goal of displacing 30 per cent of its transportation fuel consumption with biofuels by 2030. Last week, the U.S. Department of Energy followed up with a research road map aimed at reaching that target through advances in biotechnology. It also wants to see biofuel production cost competitive with oil by 2012. Ottawa, meanwhile, may soon require that all gasoline and diesel fuel contain a minimum of 5 per cent of ethanol or biodiesel by 2010, following in the footsteps of more aggressive targets in Ontario.

Biofuels such as ethanol are generally considered a cleaner alternative to oil because they release fewer pollutants. They're also net-zero emitters of carbon dioxide, meaning plant materials used to produce ethanol absorb about as much C02 as released when the fuel is burned.

Tim Haig, chairman of the Canadian Renewable Fuels Association and chief executive of Biox Corp., the Oakville-based producer of biodiesel, attended the conference and said it's encouraging to see the biotech community tackling market challenges.

"If we are going to be something more than just a fringe part of the fuel pool, these kinds of things have to be discussed," said Haig, adding that Canada is far behind the United States when it comes to policy. "That's because the U.S. have policies that are driven by energy security, and our policies aren't."

Some critics of biofuels say government funding and incentives related to corn-based ethanol, for example, amount to a subsidy for farmers and that turning corn into ethanol takes more energy than the biofuel produces.

Others warn that using dedicated crops, particularly food crops, to produce fuel will hurt global food supply, inflate feed prices for livestock, and deplete nutrients in soil. Questions also remain over whether there is enough feedstock available to make a serious dent in oil consumption.

Concern over these issues has focused attention on improving how much ethanol can be produced from a given piece of land, and on ways to make ethanol from waste materials, such as forest slash, municipal organic waste and various agricultural residues.

Thousand Oaks, Calif.-based Ceres Inc., a biotech firm focusing on plant genomics, is trying to map the genome of energy-rich switchgrass and other dedicated biofuel feedstocks to help improve crop yields per acre. A major focus is on producing hardier strains that can grow on previously unusable land. Such achievements not only improve the economic proposition for farmers, but ethanol plants can lower transportation costs by keeping a higher density of the feedstock closer to operations.

"For those people who think high-yield, dedicated biomass crops are a distant thing, I'm here to tell you you're wrong," said Anna Rath, director of business development at Ceres. She estimated that such crops would begin emerging as early a 2008.

To use agricultural residue, finding the right mix of enzymes is another challenge. Plant and wood biomass contain a fibrous material called cellulose, which requires enzymes -- derived from fungi or termite guts, for example -- to liberate sugars from the material.

A different "cocktail" of enzymes is needed depending on the feedstock, requiring a lot of mixing and matching to come up with a formula to extract the most sugar. Jupiter, Fla.-based Dyadic International Inc. is one company trying to build a library of enzyme cocktails that are best suited for a range of different feedstock. But for now, the main ingredient for ethanol is corn. Suncor Energy Products Inc., which just began operation of Canada's largest ethanol plant, in Sarnia, still relies on corn and doesn't expect that to change for at least 10 years.

"We've chosen corn because it's tried and true," said André Boucher, general manager of the plant. He's convinced that new processes for so-called cellulosic ethanol, as pioneered by Ottawa-based Iogen Corp., won't be economical on a commercial scale for another decade.

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Regulatory Slowdown on GM Crop Decisions

- Greg Jaffe, Nature Biotechnology, Vol. 24 No. 7, 748 July 2006. http://www.nature.com/naturebiotechnology Reproduced in AgBioView with the permission of the editor

To the editor: The speed of regulatory decision-making is an important constraint on the ability of industry to innovate and bring new products to market.

To determine whether the US federal government’s regulation of biotech crops has become more or less efficient and effective over time, I have analyzed eleven years of information from the US Food and Drug Administration (FDA) and the Animal and Plant Health Inspection Service (APHIS) of the US Department of Agriculture about genetically modified (GM) crops that have passed the mandatory or voluntary regulatory hurdles required before a crop can be commercialized in the United States.

The analysis shows that the time it took each agency to reach a regulatory decision more than doubled in the past five years for no explainable reason (see Table 1). That trend should worry those who believe that genetic engineering can be used safely and can benefit farmers, consumers and the environment in the United States, other developed countries and developing countries. Public discourse is needed to understand what factors account for the trends and whether and how they can be reversed.

Three federal agencies--APHIS, FDA and the US Environmental Protection Agency (EPA)--regulate GM crops using existing statutes that govern health, safety and environmental impacts of similar products produced by traditional methods1. I do not consider the EPA registration process here because that regulatory process only covers a small percentage of GM crops, whereas all GM crops go through APHIS and FDA.

From information publicly available from FDA and APHIS, one can calculate the period of time from the official submission of a regulatory package by a developer to the final agency decision allowing that product to be commercialized. For submissions to FDA under its voluntary consultation process, FDA provides on its website the date when a particular submission is received by the agency and the date when it sends a letter to the developer stating that the consultation is completed.

For the APHIS petition for nonregulated status, its website (http://www.aphis.usda.gov/brs/ informational_resources.html) provides both the date when a petition has been received by the agency as well as the date when the petition for nonregulated status was approved. Thus, one can calculate the length of time that each agency took to decide on a particular submission to determine whether the length of time has increased, decreased or remained the same. For both agencies, the number of months was counted from the submission date to the agency decision document, rounding off the time periods to the nearest month.

For the 67 voluntary consultation reviews conducted by FDA between 1994 and 2005, the time from official submission to receipt of the FDA letter ranged from one month (in 1995) to 35 months (in 1995), with an average of 8.5 months per consultation (see Supplementary Table 1 online). For submissions from 1995 through 2000, the average completion time was 6.5 months. However, for submissions from 2001 to 2005, the average completion time was 15.2 months. Thus, it took FDA 2.3 times as long to review GM crops for food safety from 2001 to 2005 than it did from 1995 to 2000. For the 70 petitions for nonregulated status ruled upon by APHIS between 1994 and 2005, the decision time ranged from one month (in 1995 and 1996) to 29 months (in 1994), with an average of 8.6 months (see Supplementary Table 2 online). For submissions from 1994 through 2000, the average completion time was 6.1 months; for submissions from 2001 to 2005, however, the average completion time was 15.4 months.

Thus, the review time at APHIS increased 2.5-fold for the period from 2001 to 2005. The publicly available information from FDA and USDA also allows one to compare the review time for similar products with similar risk profiles. For example, in September 1994, St. Louis-based Monsanto submitted to FDA its consultation data package for its soybean containing the enolpyruvylshikimate-3-phosphate synthase (EPSPS) gene for tolerance to the herbicide glyphosate and received the conclusion letter from FDA five months later (Biotechnology Notification File (BNF) no. 1). Monsanto also submitted consultation packages in the 1990s for placing that same EPSPS gene into cotton, corn and sugar beets, with the review time for those applications taking five months (BNF no. 26), six months (BNF no. 51) and five months (BNF no. 56), respectively.

Thus, the average time for FDA to review crops transformed only with the EPSPS gene in the 1990s was 5.25 months. Monsanto also submitted voluntary consultation packages for engineering creeping bentgrass, wheat, alfalfa, sugar beet and cotton with the EPSPS gene from 2001 to 2005. In those cases, the FDA review time was 12 months for creeping bentgrass (BNF no. 79), 25 months for wheat (BNF no. 80), 14 months for alfalfa (BNF no. 84), 16 months for sugar beet (BNF no. 90) and 9 months for cotton (BNF no. 98), for an average of 15.2 months. Although the crops are different and each product has a unique transformation event, one would expect the food safety risk analysis of those crops to overlap tremendously, making subsequent reviews quicker. Each crop has the same introduced gene producing the same gene product and two of the major potential food-safety risks one assesses for engineered crops--allergenicity and toxicity--are specific to the gene and gene product, and unrelated to the specific crop. Thus, it seems unlikely that the food-safety risk profile of the particular engineered crops between 2001 and 2005 could explain the almost three times longer review process.

A similar analysis was performed on the publicly available APHIS information to see if engineered crops with similar risk profiles had similar agency review times before and after 2001. For the potential agricultural and environmental risks that are the primary risk issues addressed in USDA’s petition for nonregulated status regulatory process, the crop and its phenotype play a determinative role in the engineered crop’s risk profile. Thus, if one looks at corn engineered with a phenotype that is both lepidopteran resistant and herbicide tolerant, two such applications were submitted to APHIS in the 1990s, one by Berlin-based AgrEvo (now part of Aventis CropScience) that was decided by APHIS in eight months (97-265-01) and one by Monsanto that was decided in six months (96-317-01), for an average review time of seven months. Two applications for corn engineered with that phenotype were also submitted after 2001, one by Mycogen (San Diego), Dow AgroSciences (Indianapolis, IN, USA) and Pioneer Hi-Bred (Des Moines, IA, USA) that was decided by APHIS in 13 months (00-136-01) and one by Dow that was decided by APHIS in 16 months (03- 181-01), for an average time of 14.5 months. Thus, as with the FDA’s review process for Monsanto’s herbicide-tolerant products, APHIS took significantly longer reviewing corn products with similar risk profiles after 2001.

Data from submissions to APHIS involving cotton engineered with a phenotype to be herbicide tolerant also supports the conclusion that the increased length of the review time is not due solely to the potential risks of the product. Three petitions for nonregulated status for herbicide-tolerant cotton were submitted in the 1990s and the APHIS’s granting of those petitions took seven months (Calgene (Davis, CA, USA; now part of Monsanto) no. 93-196-01), five months (Monsanto no. 95-045-01) and four months (DuPont (Wilmington, DE, USA) 95-256-01), for an average review time of 5.3 months. For the two petitions for similar products after 2000, the APHIS review time was 13 months (Aventis no. 02-042-01) and 9 months (Monsanto no. 04-086-01) for an average review time of 11 months.

Thus, although the US government tells the American public and the rest of the world that its biosafety regulatory system is fair, efficient and science based, in reality that system has become surprisingly slow at making decisions. One would expect that the regulatory pathway for biotech crops in the 21st century would be quicker and easier than in the 1990s for four reasons: first, regulators have become more experienced with products of this new technology; second, there has been no evidence of risks from any of the existing products; third, with fewer products to review between 2001 and 2005 (75% of all GM crops submitted to FDA and APHIS were concluded by 2000)2,3, there should be more agency resources for each product; and fourth, many of the recent products have similar risk profiles to products reviewed in the 1990s.

Even so, the time needed to make a regulatory decision has more than doubled at both APHIS and FDA in the past five years. In fact, this slower approach at APHIS has occurred during a time when APHIS consolidated its resources to regulate GM crops more efficiently and effectively4. APHIS announced almost two years ago that it might be revising its regulatory system for GM crops, but APHIS has not released the proposal to the public5.

Revising APHIS’s regulatory process to make its case-by-case assessment of individual crops a more risk-based system with different regulatory pathways for different potential products would be a start toward making the US biosafety regulatory system more efficient and effective. Both FDA and APHIS need to ensure that all future products receive an efficient review that is proportionate to the potential risks posed by a particular application. GM crops that are not novel and have been engineered with genes already used in previous applications should receive streamlined reviews commensurate with their lower risk so that scarce agency resources could be targeted to novel applications.

On the basis of the analysis in this paper, the US government needs to explain to the public why its ‘science-based’ regulatory system is taking longer to come to decisions about the safety of GM crops. The public wants assurances that federal regulators are ensuring the safety of products and are not considering nonscientific issues in regulatory decisions, which potentially could result in consumers losing confidence in the regulatory process. Similarly, unnecessary regulatory delay hurts developers by increasing uncertainty about the regulatory decision-making process and by increasing the cost of getting a product to market.

It has been 11 years since the first commercialized GM crops, and yet only a small fraction of the potential benefits from this powerful technology have been realized. The trends outlined here need to be analyzed and addressed if future benefits are to be realized. Only with a regulatory system that is efficient, transparent and protective of human health and the environment will the US public garner the benefits (and be protected from the risks) of GM crops.

Note: Supplementary information is available on the Nature Biotechnology website.

- Gregory Jaffe, Biotechnology Project, Center for Science in the= Public Interest, 1875 Connecticut Ave., NW #300, Washington, DC 20009, USA. e-mail: gjaffe.at.cspinet.org=
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Table 1 Average number of months for US government review and decision on GM crops Time period- Average number of months USDA took to approve GM crop petitions for nonregulated status - Average number of months FDA took to complete voluntary consultations for GM crops

1994–2005 8.6 8.55

1994–2000 6.1 6.5

2001–2005 15.4 15.2
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1. Office of Science and Technology Policy (OSTP) Coordinated framework for regulation of biotechnology products. Fed Register 51, 23302 (1986). 2. http://www.isb.vt.edu/cfdocs/biopetitions1.cfm 3. http://www.cfsan.fda.gov/~Ird/biocon.html 4. United States Department of Agriculture (USDA). Statement: USDA Creates New Biotechnology Unit (http://www.aphis.usda.gov/lpa/news/2002/08/bioreorg. html) August 2, 2002. 5. United States Department of Agriculture (USDA). Animal and Plant Health Inspection Service (APHIS). Fed Register 69, 3271–3272 (2004).

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Do Cisgenic Plants Warrant Less Stringent Oversight?

- Nature Biotechnology, Vol. 24 No. 7, July 2006. http://www.nature.com/naturebiotechnology ; Reproduced in AgBioView with the permission of the editor

To the editor: While the debate continues on the appropriate level of regulatory oversight for transgenic plants, we believe there are strong reasons for legislators to differentiate cisgenic from transgenic plants.

A cisgenic plant is a crop plant that has been genetically modified with one or more genes (containing introns and flanking regions such as native promoter and terminator regions in a sense orientation) isolated from a crossable donor plant. In contrast, transgenic plants contain genes from noncrossable organisms (e.g., a selection marker gene originating from a microorganism), synthetic genes or artificial combinations of a coding gene with regulatory sequences, such as a promoter, from another gene.

To date, the majority of established regulations on genetically modified organisms (GMOs) worldwide have not discriminated cisgenic from transgenic plants. This may be because until now cisgenic plants have been almost absent in applications for approval of deliberate release of transgenic plants into the environment. Only in Canada, which has a product-based regulation rather than a process-based regulation, might cisgenic plants be treated less stringently than transgenic plants.

In our view, cisgenic plants are fundamentally different from transgenic plants. In the case of transgenesis, a foreign gene is introduced into a plant. A transgenic plant may have a phenotypic trait that did not occur before in that species and its crossable relatives. Such a novel trait can affect fitness in ways new to the species. Gene flow to wild relatives could potentially extend this fitness effect. This may lead to increased invasiveness of the transgenic crop or its relatives. In contrast, for cisgenesis, the introduced gene of interest with its native promoter has already been present in the species or in crossable relatives for centuries.

Therefore, cisgenesis does not add an extra trait. It does not invoke a fitness change that could not also occur through traditional breeding or in nature. The same holds true for other environmental risks, such as effects on nontarget organisms or soil ecosystems, and for usage in food or feed. As a result, deliberate release of cisgenic plants into the environment is as safe as the deliberate release of traditionally bred plants.

As the process of genetic modification itself may lead to mutations and rearrangements, cisgenic plants should be screened for unwanted changes in a similar way as plants derived from mutagenesis are screened and selected. Mutation breeding has led over the past 70 years worldwide to more than 2,250 plant varieties, derived either as direct mutants or from their progenies1. Mutagenesis has led to undirected mutations and translocations. Release of mutation-derived varieties does not require molecular characterization of the mutations involved. Although these numerous mutation-derived plant varieties have been produced and used for food, feed or as ornamentals in more than 30 countries for several decennia1, we are not aware of indications that the underlying but unknown mutations, after selection of the variety, have caused damage to the environment or have caused adverse effects on consumers or livestock2. This provides circumstantial evidence that the phenotypic screening and selection, which are the rule in plant breeding programs, in combination with other conventional selection procedures before introduction of varieties onto the market, have been sufficient to reduce risks of unknown mutations in plants to an acceptable low level. The same process of screening and selection will be the rule for development of cisgenic varieties.

Considering the equivalence of products resulting from cisgenesis and traditional breeding including mutation breeding, we propose that cisgenic plants should be excluded from GMO regulations. Cisgenic plants should in our view be handled at the regulatory level like traditionally bred plants (that is, those created via long-standing cross breeding, in vitro fertilization, polyploidy induction, protoplast fusion between crossable species and mutagenesis with chemicals or irradiation). Given that an increasing number of functional genes from crops and their crossable wild relatives are being isolated and can readily be used to create cisgenic plants, the time to act is now.

- Henk J. Schouten1, Frans A. Krens1 & Evert Jacobsen1,2
1Plant Research International, Wageningen University and Research Centre, P.O. Box 16, 6700 AA Wageningen, The Netherlands. 2Laboratory of Plant Breeding, Wageningen University and Research Centre, P.O. Box 386, 6700 AJ Wageningen, The Netherlands. e-mail: henk.schouten.at.wur.nl

1. Ahloowalia, B.S., Maluszynski, M. &
Nichterlein, K. Euphytica 135, 187-204 (2004). 2. Harten, A.M. van Mutation Breeding: Theory and Practical Applications. (Cambridge University Press, Cambridge, UK, 1998).

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Crops Could Make Their Own Fertilizer

- Michael Hopkin, Nature, June 28, 2006 http://www.nature.com/news/2006/060626/full/060626-7.html

'Plants that build homes for bacteria could do without chemical nitrogen.

Plant geneticists have induced plants to form 'fertilizer factories' without the aid of bacteria that are normally crucial to the process. If the technology can be transferred to plants such as wheat or rice, industrial fertilization of these crops could be reduced or even abolished.

When bacteria known as rhizobia enter the roots of a leguminous plant, such as a pea or bean, the plant develops lumps, or nodules, on its roots to house the microbes. The bacteria take nitrogen from the air and turn it into ammonia that feeds the plant.

Two research groups have now made legumes that produce nodules in the absence of rhizobia, potentially paving the way for crops that would not need to be treated with nitrogen fertilizer, but instead would rely on nitrogen-processing bacteria that are omnipresent in the soil to colonize their nodules.

Feed me
Fertilizing crops is inefficient and environmentally damaging, says Giles Oldroyd of the John Innes Centre in Norwich, UK, who led one of the research teams. Besides polluting waterways, chemical fertilizer production accounts for an estimated half of the fossil fuels burnt by agriculture.

Nitrogen-fixing bacteria are a better way for plants to gain their nitrogen, Oldroyd adds. Many farmers and gardeners alternate legumes such as broad beans or clover with their other crops. Traditional Latin American farmers plant beans alongside their maize.

"Cereals have a huge nitrogen demand. But legumes not only provide nitrogen for themselves, but also for other plants," says Oldroyd. He and his colleagues are attempting to genetically engineer related plants such as tobacco and tomato to produce root nodules.

Self help
Nodule production is normally initiated when nitrogen-processing bacteria enter a plant's root cells. The plant senses the bacteria and its root cells grow to form a nodule.

But the two research groups, Oldroyd's team and a group led by Jens Stougaard of the University of Aarhus, Denmark, found that by mutating a gene that produces a cellular messenger called CCaMK, root cells can be converted into nodule-forming cells, even without the bacteria. They report their discovery in this week's Nature1,2.

The idea that a self-fertilizing facility could be set up in other crop plants has not yet been tested, although Oldroyd says that his work on tobacco and tomato should reveal whether this occurs.

There is no theoretical reason why it shouldn't work, says Oldroyd. "We can make empty nodules, but the plant has to allow the bacteria to invade," he says. "But if legumes can do it, others should be able to as well."

The technology is in its infancy: "A number of key steps need to be achieved," Stougaard warns. But he hopes that it could be used to make self-fertilizing versions of the world's main food staples: maize, wheat, barley and rice.

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Why do Enviros Embrace Science to Save Nature but Reject Genetically-Modified Advances?

- Pete Geddes, New West Environment, July 18, 2006; http://www.newwest.net/

A betrayal of science and reason..

The 21st Century will be the century of biology. Breakthroughs in rDNA technologies allow the precise manipulation of genetic material. This holds great promise for human and ecological well-being. Applying these molecular tools builds on the oldest and most widespread of human inventions -- traditional selective breeding. It is through this method that we created our domestic animals and crops, e.g., dogs, cows, rice, seedless grapes, tomatoes, and corn.

Advances in biotechnology deliver compelling benefits. For example, bioengineered human insulin has reduced the discomfort and inconvenience of diabetes. The Human Genome Project has increased our knowledge of the causes of many genetically based diseases. And drought- and disease-resistant crops have dramatically improved yields and reduced the need for fertilizers, pesticides, and cropland. (Last year, 8.5 million farmers in 21 countries grew biotech crops on 222 million acres, an 11 percent increase over the previous year.) Continued progress in this arena will be especially important as we adapt to a changing climate.

Despite this potential, the genetic manipulation of food crops engenders passionate opposition from radical Greens. Their angst is a mix of neo-Luddism, Marxism, and ascetic environmentalism. This is a profoundly conservative worldview.

It's not an accident that opponents look to Mary Shelley's Frankenstein for inspiration in their attack campaign against genetically engineered foods, labeling them "Frankenfoods." Frankenstein was published in 1818 during the Industrial Revolution, a time of dramatic scientific and social change. Shelley's tale warns against technological hubris. Frankenstein's monster sends a clear message: morally irresponsible scientific advances can destroy humanity.

These folks believe that civilization in general, and technology in particular, alienates us from nature and fosters environmental harm. This belief is rooted in Rousseau's myth of the Noble Savage, i.e., that before the modern age humans lived in ecological harmony. The Unabomber's manifesto and the writings of Al Gore are modern examples in this tradition. Below are quotes from each. Can you guess the authors? I identify them in the online version of my column on FREE's web site, www.free-eco.org.

"Among the abnormal conditions present in modern industrial society are excessive density of population, isolation of man from nature, excessive rapidity of social change and the breakdown of natural small-scale communities such as the extended family, the village or the tribe." (Al Gore___ Unabomber___)

"Modern industrial civilization, as presently organized, is colliding violently with our planet's ecological system. The ferocity of its assault on the Earth is breathtaking, and the horrific consequences are occurring so quickly as to defy our capacity to recognize them, comprehend their global implications, and organize an appropriate and timely response." (Al Gore___ Unabomber___)

Only wealthy, comfortable people, whose survival and physical comfort are taken for granted, can afford the luxury of such delusions.

We know that until very recently human life was characterized by violence, pain, hunger, disease, and suffering. Today, the average citizen of an industrialized country lives a prosperous material life, with good nutrition, ample leisure, and recreation that were luxuries just a century ago.

Consider this incomplete list of the diseases from which technology and modern science have liberated us: polio, cholera, typhoid fever, viral hepatitis, salmonella, whooping cough, diphtheria, parasitic worms, intestinal parasites, malaria, chickenpox, smallpox, measles, mumps, influenza (25 million killed in 1918), plague (which killed a third of the population of Europe in the 14th century), and tuberculosis.

This progress is the result of centuries of open intellectual inquiry and accumulated knowledge. Our Western tradition of empirical inquiry demands theories of reality be amenable to observation, prediction, and falsification. This is a triumph of reason over superstition, allowing us to dismiss claims of all sorts of quackery, from fortune tellers to the existence of unicorns, ghosts, and UFOs.

Since Neolithic times, people have harnessed technology to improve agricultural crops. Genetic modification at the molecular level is the latest step in our desire and ability to improve human welfare.

There are no silver bullets. Every scientific advance risks unintended consequences. And technology can, of course, be used for ill. The real question, however, is do the benefits of technology outweigh those consequences?

I'm disturbed that anti-scientific attitudes have infected large segments of the environmental movement. Rejecting the fruits of science is not the path to progress.

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Mr. Geddes is executive vice president of the Foundation for Research on Economics and the Environment in Bozeman, a thinktank that promotes Libertarian and market-oriented solutions to environmental problems.

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