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Date:

October 2, 2001

Subject:

WHO Chief on GM; US v. EU; German Senate; Africa ; Bt

 


Today's Topics in AgBioView.

* WHO Chief: GM Food Products Can Save Lives
* German Senate Approval of Transgenic Crops
* US, EU Prepare For Further Biotech Food Dispute
* GM Food Could 'Set Africa Free'
* Biotech Cotton
* Book Review -- First Fruit: Flavr Savr Tomato and the Birth of Biotech Food
* Dirty Birds - Organic Chickens Have More Food-poison Bacteria
* Ag Biotech Research: Congressional Testimony by Charles J Arntzen and Cathy Ives
* Genetically-Modified Convenience


WHO Chief: GM Food Products Can Save Lives

- Gro Harlem Brundtland, Director General, World Health Organization

Genetic manipulation of food products provokes strong emotions whenever the subject is discussed. So far, this discussion has mainly taken place in Europe and North America, and for too long it has been portrayed as a conflict between commercial interests and consumer interests.

But those who argue for or against genetically modified foods are being left behind by developments on the farm as well as in the laboratories.

GM foods are already here, and research on genetic manipulation of food is taking place in thousands of universities and private companies not only in the industrialized world, but also in a number of other developing nations.

Genetic manipulation: Seen from a farm in Africa and China, the issues look considerably different from the perspective of Western supermarket aisles. Many poor farmers who hear that the GM seeds can increase yields, withstand drought or protect crops, from insects, only ask: "When can we get our hands on these new varieties?"

GM foods have the potential to bring with them the largest change in food production, since the green revolution of the 1960s. We may see vitamin A and iron deficiencies being drastically reduced through GM crops that are rich in such substances.

Iron deficiency might affect four to five billion people worldwide, constituting a public health condition of epidemic proportions. Vitamin A deficiency affects between 100 and 400 million children in the world, leaving 250,000 to 500,000 blind every year, half of them dying within 12 months of losing their sight. Adding nutrients to food products is not a new idea. Most countries in the world have added iodine to salt for decades to avoid goiter and mental disabilities that are caused by iodine deficiency. Many of the breakfast cereals and other foods on our table have vitamins added to them.

Bio-pharmaceuticals: What is new is that, in this case, scientists are not adding substances - they move genes so the plants produce their own. Down the road, some suggest we may even see "bio-pharmaceuticals" - food products such as fruits that contain vaccines against diseases. In countries that struggle with low immunization rates, such products may become major lifesavers.

However, such claims from the investors will not be taken at face value. The efficiency of foods to combat vitamin A deficiency, and produce other positive health effects, needs to be compared to other existing methods to promote health. We may also encounter serious negative effects. If GM products are more expensive than existing ones, they may not reach the poor. If they are not properly tested, they may have dangerous and unexpected side effects.

Safety concerns: Safety is a key issue, but we may also answer questions about whether genetically modified food is beneficial and for whom? Since they are more resistant to insects, the new varieties use less insecticides and therefore are more environmentally friendly.

All in all, the scope of any future evaluation should be broad and include safety, nutritional and environmental aspects as well as efficiency, socio-economic and ethical considerations. Such considerations will be developed with other World Health Organization (WHO) partners, including such intergovernmental organizations as the United Nations (UN) Food and Agriculture Organization, UN Environmental Program, Organization for Economic Cooperation and Development, the World Bank and non-governmental organizations.

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German Senate Approval of Transgenic Crops

(From: "Mieschendahl Dr., Martin" ) "Neuerscheinungen, August 2001".
Statement of the Senate Commission on Genetic Research, January 24th, 2001; Genetic Engineering and Food

The complete text at http://www.dfg.de/aktuell/publikationen.html

Conclusions and recommendations

- The Commission confirms its statement of 1996, in which it recommends to emphasize promotion of the responsible development of genetic engineering in plant breeding and food-related microbiology to the benefit of humans and the environ-ment.

- Rules and regulations of Genetic Engineering Law and Food Law have largely stood the test of assessment of health safety of genetically modified crop plants and foods. Rather, a call for action seems appropriate for the substantiation and consistent implementation of national and European regulations. Supple-mentary regulations (threshold limits for contamination, label-ling) are needed for seeds to be used for the production of feeding stuff and foods.

- The assessment principle of "Substantial Equivalence", which is based on a comparison of genetically modified and traditional foods is still valid. Novel scientific findings are to be taken into account.

- Technical realization of open-field experiments with genetically modified plants does not require any modification. Previous safety research should be extended by including cultivation-linked ecological aspects. For this purpose, it is necessary to develop suitable approaches. Risk assessment should be carried out on the basis of single-case evaluation by careful assessment of chances and risks in consideration of current agricultural practice.

- With respect to safeguarding world nutrition and protection of natural resources, it is necessary to develop and promote intensive and environmentally friendly production processes. The principle of sustained development in agriculture and the food sector must be observed.

- Since advanced technologies increasingly determine global economic development, industrialized and developing countries should make use of possibilities offered to them within the framework of the Convention on Biological Diversity and participate in this development. In particular, developing countries should be enabled to utilize novel technologies to their advantage and to prioritize research, development and applications according to their own needs.

- Increasing privatization of research (private companies are responsible for approximately 80 per cent of research invest-ments in agricultural biotechnology) necessitates a fundamen-tal reconsideration of the modes of co-operation between pub-licly and privately funded research. The increasing activity of biotechnology companies in research, development, and production of seeds, their legitimate request for industrial property rights (patents and/or protection of cultivar and varieties), as well as the emerging market concentration in this area should put no strains on co-operation with developing countries. Rather, this should lead to improved plant breeding and cultivation in these countries.

- The application of genetic engineering to the benefit of mankind and the environment requires the consent of the broad public. The public debate about this topic therefore must be carried on as a constructive dialogue, i.e. in an atmosphere of mutual understanding between the scientific community and the public. The information of consumers by open and perspicuous presentation of complex scientific facts, a meaningful la-belling of genetically modified foods, as well as the transparency of research and approval procedures must be guaranteed.

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US, EU Prepare For Further Biotech Food Dispute

- Jeffrey L Fox, Nature Biotechnology, October 2001 Vol 19 No 10 p 897

The European Commission (EC) adopted new agriculture-related proposals on genetically modified organisms (GMOs) late in July. With the ink on those proposals barely dry, a broad coalition drawn from the US food and agriculture industries began imploring US officials to join battle against the specifics of those proposals and, more generally, to develop a wider challenge against both current and pending European Union (EU) restrictions on imports from the United States of biotechnology-derived food and agricultural products.

Following a recent pattern of confrontation rather than assuagement on matters of international dispute, top Bush administration officials appear ready to go for broke here, too, hinting that a contest over agbiotech products before the World Trade Organization (WTO; Geneva) would not be out of the question. Of course, mounting a WTO-level challenge would not be appropriate until the most recent EC proposals are actually implemented. But, as those proposals are now framed, members of the agriculture and food producer coalition find plenty to criticize.

The EC proposals contain new provisions for tracing and labeling all food and feed consisting of, containing, or produced from, GMOs (Nat. Biotechnol. 19, 795, 2001). For instance, the proposed rules call for the ability to trace such ag products through all stages of production and distribution, with the express purpose of monitoring any effects that they might have on human health and the environment. Moreover, the food-labeling proposals go beyond current standards by requiring labels for all foods produced by GMOs regardless of whether detectable DNA or protein is in those products. "Certainly there is a cost ... but what is at stake is our ability to build public confidence," says EU Environment Commissioner Margot Wallstrom, referring to the recent proposals. "European consumers will only be able to seize the opportunities provided by biotechnology if this confidence is established."

In a separate development early in September, the commission proposed to tighten labeling rules for allergens in foods. The new proposal would abolish the current rule that says producers are not obliged to indicate allergenic ingredients unless they make up 25% or more of intentionally added materials in a food product. The new rules call for noting all such ingredients that are intentionally added to foodstuffs. One major concern revolving around biotech foods is that gene splicing may inadvertently introduce novel allergens.

A proposal having to do with another type of threshold in the July GMO-related proposals is provoking criticisms from other parties to the GMO debate. In those provisions, the EC would set a threshold of 1% for the "adventitious" presence of GMOs in food and feeds, below which products would not need to carry special labels indicating their presence. Biotech critics at Greenpeace immediately blasted this provision, saying it risks "opening a hole in the dike, allowing ...unauthorized GMOs into the EU market." In calling this provision "the wrong reaction" to pressures from the US administration and industry, Greenpeace European Unit political advisor Brigid Gavin urges the EU instead to set "clear and uncompromising safety standards" for GMOs in foods and warns against "opening loopholes" that would enable industry to "continue...sneaking unwanted and dangerous GMOs into our food chain."

Meanwhile, many other July EC proposals are provoking oppositely aimed but equally blistering criticisms from the US industry coalition, whose members repeatedlyóand sympatheticallyómade their case to top-level Bush administration officials during the past months. "This is a major deal for the Bush administration," says one insider. "There is extensive high-level attention at the cabinet and subcabinet level. They are engaged in the debate, and looking at the WTO as a potential remedy."

Behind the scenes, members of the administration are working closely with members of an industry and producer coalition that includes more than two dozen associations of farmers, specialty crop producers, processors, grain handlers, grocery manufacturers, and food exporters. In a recent letter from the coalition addressed to Secretary of Agriculture Ann Veneman, for example, coalition members called the proposed EU food labeling regulations "onerous, unworkable, and internally inconsistent" and said that, if implemented, they would be a "serious trade impediment" for essentially all foods produced with biotechnology-derived materials.
These critics also specifically object to the proposed GMO "traceability" provisions, saying they fall short of meeting the EC's stated three major goals of facilitating product recall, monitoring potential human health or environmental effects, and verifying labeling claims. Whether developed through documentation procedures or by direct testing, heeding these provisions would pose "serious questions of cost, risk, and feasibility," these critics assert. They also consider the proposed threshold provisions "not sufficient to provide ...confidence that [their implementation] will allow corn exports to ... resume." And they object to other provisions that extend the EU approval process to animal feeds, saying this expansion further "threatens hundreds of millions of dollars of US feed exports."

Underlying this forceful critique of the July proposals is smoldering unhappiness among US food producers over what amounts to a three-year moratorium on approving US biotechnology-derived products for import into EU markets. Although some of the affected products have moved through the premarket scientific review phase of approvals, critics say, political decisions about them are still pendingóa situation that now costs US food producers at least $200 million per year and could go up, particularly because of the new provisions that extend restrictions to food oils and to animal feeds. "The new proposals could escalate tensions between the US and Europe," says a critic who represents US food producers. "They can't be challenged at the WTO until they're implemented, but we are doing the analysis now and using the WTO threat as a way of motivating the Europeans."

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GM Food Could 'Set Africa Free'

- Nico van Burick
http://news.24.com/News24/Technology/Science_Nature/0,1113,2-13-46_1086769,00.html

Pretoria - Genetic manipulation to improve agricultural products in South Africa, is here to stay and the government is likely to have a national strategy for biotechnology in place within the next six months. This was the message to emerge from a two-day conference over biotechnology attended in Sandton by 35 speakers from the US, Europe and Africa.

Arts, Culture, Science and Technology Department director-general Dr Rob Adams encouraged role players to contribute "constructively and enthusiastically" to retain biotechnology on the national agenda. He added that a national strategy, requiring an annual budget of R182 million, is aimed at promoting human health, safe food and environmental conservation.

The proposed strategy is currently available for comment. Adams affirmed that an important aspect of the strategy is to establish regional centres to boost innovation and biotechnology. Priorities earmarked for the next five years include development of vaccines against human diseases such as HIV/Aids, tuberculosis and malaria, vaccines against animal diseases such as Newcastle disease among poultry, insect and pest control for crops and to try and improve drought and flood resistant crops.

South Africa is the only African country where GM products are cultivated on a commercial basis. In order to improve cotton production, a gene was incorporated in the cotton seed which effectively eradicates boll-worm. AfricaBio director Dr Wynand van der Walt said GM is here to stay and that both opponents and supporters should be accommodated.

Democratic Republic of Congo ambassador Bene MíPoko said a country unable to feed its people will never be free. "Biotechnology could help Africa rid itself of poverty and famine for good." Dr Florence Wambugu a biotechnologist from Kenya said population increases stand at 3.5 percent while food production increased by only 2.5 percent. Biotechnology could prove to be a deliverance.

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Biotech Cotton

- Philip Brasher, Associated Press, October 2, 2001

WASHINGTON -- The U.S. government has, according to this story, decided against requiring farmers to cut back on planting cotton that is genetically engineered to produce its own pesticide.

The Environmental Protection Agency was cited as saying Monday there is no evidence that resistance to the Bt is developing, and that requiring farmers to reduce their use of the crop "would result in unacceptable economic losses" and lead to more use of chemical insecticides.

EPA gave approval for the biotech crop to be grown for another five years, renewing a registration that was to have expired on Monday. The crop is known as Bt cotton for a bacterium gene that is inserted into the plant to produce the insect toxin.

The story explains that to prevent resistant insects from developing, EPA requires farmers to plant sections of conventional cotton along with the Bt varieties. Insects in the conventional fields will mate with insects from the biotech fields and ensure that successive generations of bugs are still susceptible to the Bt poison.

Randy Deaton, a spokesman for Monsanto, was quoted as saying, "This renewed registration assures that cotton growers can continue to use this valuable technology to protect against insect pests while reducing the use of chemical pesticides."

Jane Rissler, a biotechnology critic with the Union of Concerned Scientists, was cited as saying that EPA should have increased the size of the conventional cotton fields, known as "refuges" adding, "I don't see how we are going to significantly delay resistance with these small refuges." EPA will require an independent firm to monitor farmers' compliance with the refuge limits. EPA was further cited as saying that the popularity of Bt cotton has led to a two-thirds reduction in the spraying of insecticides that are most toxic to birds and fish, and a one-third cut in the use of chemicals most dangerous to people. EPA: http://www.epa.gov/pesticides/biopesticides/reds/brad--bt--pip.htm

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Book Review -- First Fruit: The Creation of the Flavr Savr Tomato and the Birth of Biotech Food

Reviewed by Alan McHughen* Nature Biotechnology, October 2001 Volume 19 Number 10 p 909
*Alan McHughen is a professor and senior research scientist at the University of Saskatchewan (e-mail: mchughen@duke.usask.ca). His book, Pandora's Picnic Basket: The Potential and Hazards of Genetically Modified Foods, was published by Oxford University Press in 2000.

First Fruit: The Creation of the Flavr Savr Tomato and the Birth of Biotech Food
by Belinda Martineau; McGraw Hill; $24.95, 269 pp, hardcover; ISBN 0071360565, 2001

Belinda Martineau is a scientist, a writer, and a citizen concerned about health and the state of the environment. In First Fruit, Martineau, as a staff scientist working for the biotechnology startup Calgene (Davis, CA), provides an inside view of the development of the Flavr Savr tomato, the first genetically engineered whole food to reach the US marketplace. There are several stories intertwined through the pages, each one interesting in its own way.

The story of the rise and fall of Calgene is a major strand, and Martineau keeps our attention with a series of interesting vignettes. Venture capital elicited not with a product, but with the mere concept of a potential commercial product. Unrealistic technical and production schedules. Intellectual property turf battles. Regulatory approvals. Laboratory and field trials. Scaleup and marketing. Consumer demand exceeding production capacity. And then the boom falls as Monsanto (St. Louis, MO) closes in.

Martineau maintains a lively flow of the ups and downs faced by Calgene (and likely by most small biotech startups) in their attempt to create a product and put it on the market. These include not only the scientific hurdles, like cloning the gene and inserting it into the plant, or figuring out a satisfactory method to measure fruit firmness, but also the exciting race to the patent office. For scientists, one of the most alien (but important) threads is the coverage of the several patent disputes and reliance on laboratory notes to establish priority. Any laboratory supervisor having trouble convincing workers to keep detailed logbooks (minus personal grocery lists and doodles) will assign First Fruit as required reading.

Many readers will want to know why Flavr Savr failed, but Martineau begs the question. She emphasizes that it was not due to any reluctance on the part of consumers to eat the genetically engineered fruit. Indeed, she notes, from the initial rollout, demand exceeded supply, even with the premium-priced tomatoes well marked as genetically engineered. Benefiting from the clear vision of hindsight, Martineau does provide many examples of mismanagement, both on the commercial and, less frequently, the technical side. No doubt these contributed to the ultimate demise. But the major reason, apparent to many in the plant breeding and food production industry, was missed.

Flavr Savr failed because Calgene management lost sight of the objective; they chose their product based on technical and regulatory expediency, not on developing and marketing a superior product. Too bad they didn't include tomato breeders and production experts in their decision-making and production processes. They might have learned, for example, that Calgene need not have discarded all the good tomatoes carrying multiple inserts, as breeders can (and usually do) deal with several genes and loci at a time. Yes, it entails a bit more work, both in the field and at the regulatory agencies, but the effort might have provided a better, more market-viable tomato. By excluding all tomatoes not fitting the simplest genetic model, Calgene might have been throwing away the best parts. Nevertheless, Martineau provides an inside view of the sometimes-infelicitous decisions of Calgene's management.

Because this is not a science book, Martineau's story of the technical development of the new genetically engineered tomato is necessarily superficial. Many in the scientific community were, and remain, curious about the more general effects of antisense polygalacturonase in tomato. Does it really prolong shelf-life (and thus provide consumer appeal)? Does it maintain fruit firmness beyond the ripening point (thus facilitating harvest and distribution)? Does it really maintain vine-ripe flavor? Unfortunately, Calgene did not generate enough antisense polygalacturonase tomatoes of enough different genotypes to conduct the requisite measurements to fully answer these questions. The explanations of genetic transformation, antisense technology, and other scientific aspects are too scant to satisfy scientists or interested nonscientists, and yet not so detailed as to scare off those readers more interested in the other stories. Those expecting a full description of the technology behind Flavr Savr will be disapp

The most novel and moving story, however, is the personal account of an idealistic young scientist hired into a small, energetic startup company, intent on using modern science to derive useful knowledge and products. Reality sets in gradually, as the inevitable winner in the conflicts between science to derive knowledge versus science to derive a commercial product becomes more and more apparent. Martineau shares with us the frustrations of being reassigned from working on a scientifically interesting project to one conducted solely to meet regulatory compliance or commercially expedient goals.

An important contribution is Martineau's treatment of scientists as human beings. The frequent popular image of a scientist, especially a corporate scientist, is of a two-dimensional faceless boffin, perhaps brilliant at conducting experiments in an ivory tower or secret commercial laboratory, but too naive to realize the results are being coerced to conform to a corporate agenda. Martineau effectively paints her colleagues as people who party, support football teams, coach their kids' soccer teams, and argue politics in addition to conducting science. Of course, she has her biases, but she's entitled to them; this is her book and her perspective.

Perhaps this will inspire other scientists, both corporate and academic, to take the time to document, for a nontechnical audience, their own perspectives and experiences, good and bad. Perhaps then society will shift its stereotypic view of scientists to one showing us to be humans after all.

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Dirty Birds

- New Scientist 1 October, 2001 ; Journal ref: Letters in Applied Microb (Vol 33, p269).
(Forwarded by "Andrew Apel" )

Organic broiler chickens are three times as likely as conventionally-bred poultry to be contaminated with a bacterium that causes food-poisoning, say Danish vets. The team at the Danish Veterinary Laboratory in Aarhus found that all 22 organic broiler flocks they investigated were infected with Campylobacter - the most common cause of food poisoning in the UK. Only one third of 79 conventional broilerhouses were infected.

The organic movement is sound, but this is unwelcome news, says Karl Pedersen, who supervised the project. He says the result is not entirely surprising, since organic birds are allowed to roam outside and are more likely to be exposed to food and water contaminated with infected faeces from wild animals. But it turns out that the difference was far higher than we expected, he says.

Peter Bradnock, chief executive of the British Poultry Council, says he was also unsurprised by the results. 'We're starting to see some of the organic myths about food safety debunked,' he says.

The UK Soil Association, which promotes organic farming, was unavailable for comment.

Unhygienic handling: It takes just 10 to 50 bacteria to pass on the infection, and faeces can contain a billion bacteria per gram . The amount in faeces is extremely high, so one bird can infect many others, Pedersen says.

Conventionally-bred birds are slaughtered after around 38 days, whereas organic birds live twice as long, and so are more likely to pick up infections. And in most European countries, conventional broiler farmers grow and slaughter all their chickens at the same time, so empty broilerhouses can be thoroughly disinfected before the next batch of day-old chicks arrives.

Campylobacter is the most common cause of food poisoning in Britain. Although infections have levelled out over the past few years, cases have doubled since 1986, from 25,000 to 54,000 in 2000. In a survey published last month, Britainís Food Standards Agency found that half of all chickens sampled were contaminated with campylobacter.

Pedersen says that there is little that can be done to prevent infection if birds roam freely outside. He says the bacteria will not survive cooking, but could spread to other food items if contaminated carcasses are unhygienically handled in the kitchen.

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Agricultural Biotechnology Research

- Charles J Arntzen , Congressional Testimony 25 Sep 2001

Statement of Charles J. Arntzen, Ph.D. Florence Ely Nelson Presidential Chair, and Founding Director, Arizona Biomedical Institute Arizona State University Tempe, Arizona Presented to House of Representatives Committee on Science; Subcommittee on Research

Thank you Mr. Chairman, for the invitation to appear today before the Subcommittee on Research. My name is Charles Arntzen. I am the Founding Director of the Arizona Biomedical Institute (AzBio) at Arizona State University. I am also the president emeritus of the nation`s largest not-for-profit research institute devoted to the study of plants and associated organisms -- the Boyce Thompson Institute for Plant Research, which is located on the campus of Cornell University.

I will try to make three major points in my testimony:

1. Application of recombinant DNA technology (genetic engineering) to plants has the potential to create many new products that are designed to improve human health.
2. In addition to American producers and consumers, people in the developing world will be major beneficiaries of many of the new biotechnology-derived products.
3. The human health benefit of new plant biotechnology products may be delayed because advancement from prototype to product for new plant-based pharmaceuticals is hindered by two factors: an incomplete information base relating to regulation of gene expression and cellular accumulation/stability of foreign proteins in commercially viable crops (i.e., not model organisms), and an emerging but as yet inadequate regulatory framework for new product introduction that must be accompanied by public education efforts (including companion efforts of relevance to countries outside the US).

The opinions I provide are based upon my background experience. I was born on a family farm in Minnesota at a time when my father still planted some crops using horses rather than mechanized equipment. I grew up when new technology was greatly increasing crop yields and farm profitability. My college education was at land grant universities, which are historically centers of technological innovation related to plant biology and related outreach education (extension programs). My employment with USDA, academia and industry (DuPont) has been related to plant biology and biotechnology. I want to express my appreciation to the Committee for its support of scientific research that has given my colleagues and I in the plant sciences the ability to make discoveries leading to new crops of wide benefit to humankind.

In the last two-to-three decades, scientific research has spawned a new wave of technology that is having a global impact in both medicine and agriculture. Highly sophisticated methods are now available to analyze DNA sequences, which are the basis of all genetic traits, and the regulation of DNA expression in different cells and tissues. The results are dramatically influencing our understanding of basic principles of biological development and of factors which define the differences between healthy and diseased conditions in plants, animals and humans. And, they are creating opportunities for novel product development.

To a large extent, our genetic research tools for plant biology are derived from medical research. The human genome project is one striking example. The needs for increased speed of DNA sequencing of human genes have lead to remarkably rapid, and increasingly simple methods for analyzing DNA and the functioning of genes in all organisms -- from man to maize. There are already dramatic results from application of these new analytic tools to crop improvement research. Regional crop breeding stations, which previously lacked sophisticated biological style laboratories, are now adding DNA diagnostic tools that are adapted from those being introduced into hospital laboratories. Crop geneticists now use DNA marker-assisted breeding methods to speed the creation of new varieties with superior traits. The speed at which new basic scientific research findings are translated into improved varieties of crops is increasingly rapid, and is a key factor to maintaining United States competitiveness in global agriculture.

A very important aspect of our current plant biotechnology is the fact that it is now possible to move genes among different species. Nearly twenty years ago, a few pioneers in crop genetics began experimenting with recombinant DNA technology. In 1983, the first success in DNA transfer into plants was reported, and a new technique was added to the crop breeder`s ``tool box``. The concept of moving DNA was first developed by microbiologists for transfer of DNA (genes) into bacteria. The approach rapidly gained importance as a tool for pharmaceutical development and was a driving force for creation of American dominance in the biotechnology industry.

As was documented in the background materials for this hearing, the creation of transgenic plants (genetically modified or GM crops) increasingly have an important impact on agricultural profitability for commodity crops in the U.S. It is important to note what factors were the most important determinants of the agricultural research agenda in the U.S. in the early 1980`s as recombinant DNA techniques were being developed for crop breeding. It was a period of increasing crop subsidy costs and public concern about excessive pesticide use and cropland degradation and erosion. It is therefore not surprising that the first agricultural products of recombinant DNA technology were insect-resistance seeds (Bt-corn, Bt-cotton as examples that provide farmers a means to reduce use of chemical insecticides), and crops tolerant to post emergence herbicides (which aide farmers in conservation tillage; Round-up Ready Soybeans, for example). These products have at least partially met their objectives if we judge by farm

Because there are long periods of research and development that precede the introduction of any new crop involving genetic improvement, it is of value to examine the current 'pipeline'to estimate the value and impact of new products, and to determine if they will enter commercial distribution in a timely manner. It seems certain that significant improvements in ``production traits'(insect, herbicide, disease, and drought tolerance) will be available over the next decade. Background information for this committee hearing has discussed some of these traits and their importance; this is a very significant justification for expanded government investment in basic studies of plant genomics. Because the background information is already before you, I will focus my testimony on the dramatic potential of plant genetic engineering in areas other than production traits. Specifically, I will focus specifically on genetically modified crops, which are designed to directly be used as human pharmaceuticals. The discussio

Vaccines are one of the great success stories of modern medicine. Ten of millions of lives have been saved by the successful eradication of smallpox from the globe, the nearly complete eradication of polio, and the great reduction in some other infectious diseases. At least forty new vaccines are under currently under evaluation by US regulatory authorities; nearly all of these have resulted from the use of new tools of biotechnology. However, the likely success of immunologists in identifying new vaccine candidates has posed a problem for public health officials in the World Health Organization (WHO). They are concerned about the potential cost of 'high-tech recombinant DNA 'vaccines, their availability to developing countries where infectious diseases are the greatest threat, and availability of the vaccines in a convenient form for universal use. With respect to the latter issue, there has been a general call for more oral vaccines and new products that do not need costly refrigeration.

I have documented the need for improved vaccines in an article published in the journal Nature Medicine ('Pharmaceutical foodstuffs - Oral immunization with transgenic plants', Nature Medicine, Vol. 4, pages 502-503; Vaccine Supplement issue.) In this article, I document the need to develop vaccines for enteric diseases, recognizing that each year diarrhea kills about two and one-half million children under the age of five. Most of these deaths are in the developing world. Since these children and their parents are at the low end of the economic scale, little industrial research has targeted new vaccines for this public health segment. To respond to this unmet need, my colleagues and I have designed a new approach to the creation of modern, oral vaccines. We have genetically modified plants in a way that each cell of the new plants has the capacity to accumulate '`subunit vaccines' to prevent diarrheal disease. (Subunit vaccines are comprised of only one or a few proteins of the pathogen that causes disease

Since 1997, my colleagues and I have collaborated with two leading U.S. medical schools to determine if our plant-based vaccines are effective in humans. We requested and received approval from the U.S. Food and Drug Administration (FDA) to conduct human clinical trials in which volunteers consumed our genetically engineered vaccine-containing food. The results of three studies are now in hand. In every case, we have found a human immune response when volunteers simply ate raw potatoes that were engineered to contain a vaccine. We recognize that our results are, as yet, preliminary and that further studies with human volunteers are needed to determine proper dosages of plant-based vaccines. In particular, we know we must work out protocols by which subunit vaccines can be produced in edible parts of plant species that are amenable to cost-effective processing to yield a processed end product. We need such material to deal with issues such as packaging for uniform dose delivery, storage for shipment (especia

I have frequently been asked when a plant-based, oral vaccine will be available from doctors or pharmacists. (The questions are often accompanied by a statement such as 'my kids can't wait for an alternative to needles'or 'this would be wonderful for immunizing children in poor countries.') I have to respond that the situation is complex. First, our work to date has used uncooked potatoes as the vaccine delivery tool. Second, we recognize that vaccines must be regulated medical products and we need to make define ways in which plant materials meet existing product standards. Lastly, I acknowledge that some members of the general public (especially in Europe) have demonstrated resistance to GM-crops (Genetically Modified crops). Vociferous members of this critical community do not differentiate between any classes of plants, and I recognized that these groups could interfere with the introduction of plants that would serve as vaccine ``manufacturing systems'and thereby add an unknown period of delay in the i

We know that raw spuds won`t be accepted by infants in Asia (or anywhere else, probably), and are not the vaccine delivery system of choice. But, we chose potatoes as an experimental system since it is an edible food in a commercial crop species, and since there was an adequate science information base on ways to cause foreign proteins to accumulate in tubers. In addition, it was ``fast,'meaning that we could put a new gene into a potato cell and regenerate plants that would yield a pot full of potatoes in about four months, and be conducting pre-clinical or clinical trials a few weeks later. When a scientist such as myself is doing research with government funding on a 'three year grant' we need to get data in a timely manner!

We have also explored the potential use of other crops for vaccine delivery. Bananas, for example, have great potential for developing countries. They are grown in almost all tropical or subtropical countries, the fruit is eaten uncooked by infants and adults (avoiding vaccine destruction by heating), and the fruit can easily be processed into a puree (baby food) or dried 'chips' for delivery of uniform doses. >From a grant-getting standpoint, however, bananas are difficult since it takes at three-four years from the time a gene is inserted into a banana cell until the genetically modified fruit can be harvested (T.R. Ganapathi, N.S. Higgs, P.J. Balint-Kurti, C.J. Arntzen, G.D May, J.M. Van Eck. 2001. Plant Cell Reports 20: 157-162). And, even more importantly, there has been almost no genomic research or analyses of genetic regulation of protein accumulation in this crop (largely because it is not grown by farmers in the developed world but not in the 'first world').

To date, there has been understandable hesitancy by established vaccine manufacturers to explore the use of genetically engineered plants as a 'manufacturing/delivery' system for a new class of oral vaccines. Several factors lie behind this hesitancy, including: differences between the importance of vaccine manufacturing and delivery costs in the developed vs. the developing world (with costs being much more important in the developing world), an uncertain regulatory environment related to pharmaceuticals produced in plants, and evidence of public uncertainty related to ``genetically modified food stuffs that creates the perception of risk by potential investors in new technology. In addition, there is an inadequate information base related to fundamental aspects of plant cell biology and gene expression in the commercial cultivars of crops (as opposed to model 'laboratory varieties') that create uncertainties in our ability to project the cost to develop additional, new plant-based vaccine candidates. All

In conclusion, I would like to emphasize several key points. Molecular genetics using recombinant DNA is a new and powerful tool for plant biologists and crop improvement specialists, but new products created with this tool take many years to progress from the research bench through periods of extensive testing before product introduction. The very few products now available, known to the public as genetically modified organisms, represent only a fraction of the potential pipeline. The next generation of products will increasingly have immediate uses that relate to human therapeutics, vaccines and other macromolecular drugs. This is a new area of fundamental science in the U.S. and the world, and a new area of commercial opportunity in which the U.S. can extend its dominance in biotechnology while providing great benefit to health programs on a global basis. However, the new area is not yet embedded in existing corporate structures and needs to be cultivated to succeed in a timely manner. There is an urgent

The National Academy of Sciences offers many features upon which a new research effort can flourish to ensure the success of plant-based production of new health care products. The NSF has been successful in creating 'Centers' that promote multidisciplinary research, which is needed to link scientists in plant biology to immunology to product development. The NSF has the process to conduct per review of scientific proposals to identify 'Centers' that are based upon very sound science. And, the NSF has experience in educational programs that are essential for the success of an emerging area of plant-based macromolecular drug production, involving international dimensions, bioethics, and education of the general public about the importance of this new technology for a global community.

This Distinguished Committee is providing a valuable service to the public by inviting independent scientists who conduct research using biotechnology to provide information that could assist the Committee and the general public in making informed decisions related to the value of new research programs and new products, including those involving recombinant DNA technology. This information will allow enlightened risk-benefit analyses. I hope I have conveyed to you today the excitement I feel for increased NSF funding to create ' Centers' that will ensure the progression of basic plant biology to human and animal health products of global importance!

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Agricultural Biotechnology Research

- Catherine L Ives, Congressional Testimony, 25-Sep-2001

Testimony of Catherine L. Ives, Ph.D. Director, Agricultural Biotechnology Support Project Michigan State University East Lansing, MI 48824 Good afternoon Congressman Smith, Congresswoman Johnson, and other members of the committee. My name is Catherine Ives, and I am the Director of the Agricultural Biotechnology Support Project (ABSP) at Michigan State University. Thank you for asking me here today to testify on HR 2051, a bill to establish regional plant genome and gene expression research and development centers, and HR 2912, a bill to establish a grant program for partnerships between U.S. research organizations and those in developing countries. I commend the committee for proposing these two initiatives. They will contribute, through advancement in basic and applied plant research, to increased food security and economic growth in our country and abroad.

One may ask why should the U.S. research community invest in programs to elucidate fundamental mechanisms of plant production? First and foremost because history has shown us that technological innovation is essential for human progress. From the domestication of animals and the advent of agriculture to today`s advances in biotechnology, people have developed tools for improving public health and nutrition, as well as raising productivity and facilitating learning and communication. However, despite these improvements, there are still today almost a billion people living in absolute poverty and suffering from persistent hunger. Seventy percent of these individuals are farmers - men, women and children - who eke out a living from small plots of poor soils, mainly in tropical environments that are increasingly prone to drought, flood, bushfires, and hurricanes. Crop yields in these areas are stagnant and livestock suffer from chronic parasitic diseases.

While many around the world are still locked in a vicious cycle of hunger and poverty, a revolution in biotechnology is improving the health, well-being and lifestyle of those of us in the developed world. What must be done to harness this revolution to address the food and nutrition needs of the poor? Technological innovations today have a global reach - a breakthrough in one country can be used around the world (the elucidation of the rice genome, for example, is of benefit to the USA and China alike). More public funding, to be spent on creating new partnerships among public institutions, private industry and non-profit organizations, is needed to solve problems of particular interest to the poor. Advances in basic and applied research on orphan commodities (defined as subsistence food commodities or commodities of little interest to the private sector) will contribute to improved lives.

So what are the main challenges in addressing international research and development efforts? There are many including:
A lack of understanding regarding the importance of agricultural biotechnology amongst policy makers in many countries;
Mistrust and/or inexperience in working with the private sector;
Inexperience in intellectual property and the management of new technologies;
Non-existent or poor regulatory systems;
Poor laboratory and communications infrastructure and;
A small number of trained scientists.

These two bills would, I think, most directly address the last two challenges - improving communication, infrastructure, and networking, and increasing the number of trained scientists through these research partnerships. The small number of trained personnel in developing countries makes the work of the ABSP especially difficult. The development and deployment of biotechnology-derived crops in these countries depends, in part, upon those countries having the appropriate national policies and regulatory structures. Scientists in those countries are called upon to provide technical input into legislation or regulations and are often unprepared or unqualified to do so. The ability of a country`s scientists to independently assess new biotechnology-derived crops is vital to the food security and economic prosperity of that country. Developing an increased knowledge of, and experience with, the techniques of modern biotechnology would greatly assist countries in the formulation of scientifically sound policies,

However, I would like to stress that all the challenges I mentioned earlier would benefit, even indirectly, from support to the basic plant sciences and development of new partnerships between scientists from different parts of the world. Fundamental knowledge and understanding of plants, and cooperative research strategies, are the foundation for addressing food production and nutrition problems. Increased basic knowledge about orphan crops, such as cassava and bananas, will require the investment of the public sector and the US should be at the forefront of this effort, given the strength of its research community. These programs would contribute to that effort.

I believe these programs fill an important funding gap in the current research environment. While the U.S. Department of Agriculture (USDA) funds basic research, that effort is primarily focused on crops of national interest. The U.S. Agency for International Development (USAID), on the other hand, is mandated to assist developing countries and provides technical assistance in many areas. However, they do not have a basic research mandate. These programs, aimed at expanding genomics research and applying that knowledge to crops in the developing world, will directly assist the work conducted under the ABSP.

The ABSP, a consortium of public and private sector institutions in the US and around the world, is funded by the USAID, and has worked for the last 10 years to assist developing countries - and developing country scientists - in accessing biotechnology to develop crops that are resistant to insects and disease. This is a comprehensive program that focuses not only on technical training and applied research, but also on helping countries develop national and institutional policies that will permit access to, and deployment of, agricultural biotechnology. Permit me to give two examples of how we have worked to assist countries in improving their agricultural production and increase the health of their citizens. I should note that all of our projects are ongoing, as development of a new cultivated plant, especially one created through the use of modern agricultural biotechnology, takes time as well as government structures that are often lacking in developing countries.

We have worked extensively with scientists at the Agricultural Genetic Engineering Research Institute (AGERI) outside of Cairo, Egypt. Researchers at MSU and AGERI have developed a specific variety of potato, used by small farmers for domestic consumption, with resistance to Potato Tuber Moth, an important insect pest worldwide, primarily in tropical and subtropical areas (although there have been outbreaks in California, Texas and New Mexico). The current method of controlling the insect relies primarily on multiple applications of insecticides in the field, and 3-5 direct spraying of insecticide on the potatoes during storage. Without insecticide, losses can be up to 100% of stored potatoes. ABSP has tested these new types of potatoes in field trials in the US and Egypt, and will shortly be testing them in South Africa. Initial results have demonstrated greatly increased moth resistance in the field, and in storage for 2-3 months. We are currently working with Egyptian regulatory authorities to gather the

However, as mentioned, the ABSP is an integrated development program, and it is not enough to expect that research results will magically transport themselves onto a small farmer`s field. National and institutional policies have to be amended, government and/or private sectors engaged, and farmers and consumers adequately informed. With these objectives, the ABSP has given assistance for the development of intellectual property policies at the institutional and national level. We have trained scientists in the new field of intellectual property management, and linked scientists and legislators together. We also recognize that the regulatory structures in many developing countries are lacking. Therefore, in Egypt, we have and are continuing to provide training in the development of biosafety systems, including assistance in drafting national guidelines.

Another ABSP initiative that has recently begun is a collaboration with the TATA Energy Research Institute (TERI) of India and Monsanto Company to develop and adopt enhanced oil from mustard seed. This collaboration, known as the ``golden mustard'project, has the potential of helping hundreds of thousands of children suffering from vitamin A deficiencies, particularly in northern and eastern India, where mustard oil is commonly used for food preparation and cooking. Recent estimates reveal that more than 18% of the children in India suffer some level of vitamin A deficiency. The World Health Organization estimates approximately 250 million people suffer significant illnesses, including vision impairment, inability to absorb proteins and nutrients, and reduced immune function because of vitamin A deficiency.

Monsanto has been working since the mid-1990s to enhance the carotenoid levels of oilseed crops with a focus on the accumulation of beta-carotene - the precursor to Vitamin A - in the seed of canola (also known as oilseed rape). As a result, researchers have been able to achieve concentrations of beta-carotene in oil from crushed canola seed greater than currently available in any other oil or vegetable. In March 1999, Monsanto announced it would share at no cost this gene transfer technology to developing countries. While this collaborative project is less than a year old, the basic research conducted by Monsanto to elucidate the biochemical pathway of carotenoid biosynthesis was crucial to adapting this technology for use in a crop of importance to a developing country.

As I mentioned earlier, we should not expect that funding research programs alone would result in improved technologies available to the poor in developing countries. It will be important for NSF to develop strong linkages and information sharing procedures with USAID and USDA`s Foreign Agricultural Service to prevent duplication of effort and instead provide synergies with existing projects and programs. Perhaps this would involve joint meetings, participation in review panels, and joint priority setting. Progress made in one area of research and development should be available to build upon by other funding agencies whose role is adaptive research and technology transfer. It should not be NSF`s role to support the development and transfer of specific technologies, but rather to promote the generation of knowledge and innovation. That said, these programs would fill an important gap in the federal research system, and provide those agencies and organizations mandated to transfer technology with new tools i

Let me conclude by saying that the National Science Foundation, through its support of basic research in plant biotechnology, plays a critical role in helping ALL countries increase food production and improve food quality, and in promoting a knowledge-based economy. Research centers, and partnerships between scientists, will improve our understanding of more complex plants, and strengthen the capability of developing countries in producing and distributing new, more productive and nutritious crops. That concludes my remarks and I`d be happy to answer any questions. Thank you.

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Genetically-Modified Convenience

- Martina Watts, Letter, UK Newsquest Regional Press , 27 Sep 2001

I wish I had been genetically modified. A bit of Claudia Schiffer here and a bit of Jennifer Lopez there would be ideal. Vain perhaps, but it's only natural to want a perfect body and it's only human to want to eat perfect food such as potatoes with built-in insect repellents, straw-berries with more flavour, faster-growing salmon and leaner pigs.

So, what's the big deal about genetically-modified foods? Genetic modification involves the transfer of genetic material within species or from one species to another (e.g. fish to plant, bacteria to pig, or human to sheep). Those who oppose it argue that the natural process of evolution is bypassed and the consequences irreversible. By inserting foreign genes at random, we may alter the host's expression of its own genes with unpredictable, possibly disastrous results. Some GM crops have built-in pesticides which either kill pests or force them to develop stronger resistance, giving rise to "superbugs".

Biologists worry that lady-birds, birds and bees could be adversely affected. Crops are genetically engineered to tolerate weed-killers and could breed with wild relatives to create superweeds therefore, more pesticides would subsequently be needed to control them. GM foods are thought to suppress our immune system. Genetically-modified soya milk, for instance, may trigger herpes-related viruses in humans. Some strains of GM maize contain an antibiotic resistance gene but, if disease-causing bacteria pick it up, antibiotics become completely ineffective. Various engineered foods are known to trigger allergic reactions and, for those with allergies, mealtimes become a hazardous game of Russian roulette. One suspects that our bodies are just a tad confused when confronted with the new "Frankenfoods". Is it a tomato or is it a frog? Or neither of the above? Nobody has any idea whether GM products are safe, so why not stick to food as nature intended what is so wrong with non-GM food? Unlike organic products, t

Proponents of GM food accuse the media of inciting mass hysteria and that GM crops are needed to increase productivity in developing countries. But haven't they forgot-ten? Our track record of foisting our dietary habits on to the Third World hasn't always been all that favourable. And although we have the knowledge to meddle with DNA, it is debatable whether we have the wisdom to use it. Who is going to give us the bigger picture? The politicians haven't a clue and the British Medical Association is rather laid-back, saying we should wait and see whether GM food is safe or not. As an estimated 70 per cent of processed food may now contain GM ingredients, the BMA may not have to wait long. Meanwhile, read food labels and buy organic, non-processed food if you are unwilling to take any risks.