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Date:

September 3, 2004

Subject:

Orphans at the Window; Catagena Protocol; Heart-Healthy Soy; Brazil Cotton Growers' Lament; Biopharmaceuticals; Public Understanding; Horizontal Transfer

 

Today in AgBioView at www.agbioworld.org ; September 4, 2004

* Orphans at the Window
* Meetings of the Catagena Protocol on Biosafety
* Monsanto Launches New "Heart-Healthy" Soybean Seed
* Readers Respond to "New Bully At Western Farm Press"
* Brazil Cotton Growers Lament GMO Straightjacket
* Plant-Made Pharmaceuticals Might Grow on Wall Street
* Tobacco Promising "Factory" for Biopharmaceuticals
* Issues of Dignity Focus of U.S.-Vatican Ties
* Factors Determining the Public Understanding of GM Technologies
* NAS Issues Mixed Message on Unintended Effects of GM
* 'Informative' Horizontal Gene Transfer
* Problems in Monitoring Horizontal Gene Transfer in Field Trials of Transgenic Plants
* Environment/ Predator Protected Structure

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Orphans at the Window

- Editorial, Nature Biotechnology, v.22, 1055 (September, 2004). www.nature.com ; Reprinted in AgBioView with the permission of the editor.

Genetically modified crops, some in Europe would argue, are already orphans. They were deserted long ago by their parents--first the supermarkets, then the food processors, then the politicians and lawmakers, and now the agrochemical and seed companies. The decision by agrochemical company Syngenta to cease its operations in the UK this summer is just another indicator of the malaise. But now, with the first proper EU-wide approvals of GM crops and a celebratory conference--ABIC's 'Agbiotech goes Europe' meeting--due to be held in Cologne this month, the European window for GM crops is perhaps opening again. To jamb that window open, agbiotech companies and European regulators must make sure that the next generation of GM crops has a marketplace. And that means that they should avoid mainstream, bulk-buy products and instead focus on niche markets and what we propose calling 'orphan crops.'

Things went awry very early on for agbiotech in Europe. And the problems didn't start with genetically manipulated seeds; they started with manipulated milk. With 20/20 hindsight, it was an absolutely batty first promotion. Let's offer people something really enticing from agbiotech's promised chimeric cornucopia (drum roll): milk from cows injected with growth hormones made in bacteria. It is hard to conceive of a worse way to introduce yourself to Europe's suspicious, cancer and chemical conscious consumers. And recombinant bovine somatotropin (BST) is clearly just what European dairy farmers, who are paid to underproduce, were crying like babies to obtain.

Like BST-boosted cows, herbicide-resistant corn and canola and various pest-resistant crops also shared the failing that they were what could be produced (because they were technically facile) rather than what the market demanded. They conveyed palpable advantages not to Joe Consumer, but to agricultural producers. They represented foods and food ingredients that were an anathema to technophobic European gourmands: not only were they foodstuffs, but they were foodstuffs that were ubiquitous and largely inseparable and undistinguishable from their 'conventional' equivalents. And perhaps most damningly, they were perceived as the weapons of Satanic big business (largely from the US) looking to monopolize world markets opened up by the Global Agreement on Tariffs and Trade.

What kind of industrial strategist--and we must assume there was strategy at some point--would try to stealthily bring to market products that no one needs but everyone has to consume, that the most industry-friendly politician would have difficulty justifying and whose only apparent redeeming feature is to improve the market positioning of the companies that make them? It didn't help that corrupted environmental pressure groups became obsessed with nonenvironmental agendas and misrepresented the balance of risks in environmental releases. Nor did it help that internecine fighting within the European Commission and nationalistic tendencies in the European Council created a regulatory system that made inaudible the voices of science and common sense. But the truth is that the agbiotech industry doomed itself from the get-go because it chose products that made it easy, if not inevitable, for European public opinion to be mobilized against GM.

That would change if the industry simply changed focus to orphan crops. Such products would be, conceptually, diametrically opposite to anything agbiotech has produced up to now. By direct analogy with orphan drugs, orphan crops would address unmet needs in narrow markets, such as the specialist nutrition market. Cow's milk for the lactose-intolerant, for example, or peanuts purged of life-threatening allergens. Exotic GM wheats for those with celiac disease (a particularly European problem). Low-phenylalanine foodstuffs for people with phenylketonuria. With more than 20 years of recombinant plant development now behind us, these types of products ought to be possible.

The markets would be relatively small: celiac disease affects around 1 in 250 Europeans, and is 20 times rarer in the United States; phenylketonuria occurs in 1 in 10,000 or 1 in 25,000 people, depending on geography. But rarity is a good thing in the context of GM food. It would be good PR if GM crops were aimed only at a fraction of needful consumers rather than the entire population; Europeans would be less likely to feel that GM staples were being surreptitiously foisted on them. And it would be difficult for activists to turn public opinion against such products because they would be fighting against the interests of disadvantaged individuals with dietary problems.

To avoid 'contamination' of conventional foods, these specialist products would have entirely separate production and processing chains. There are already separate distribution channels for them: those with special nutritional needs buy their food at the pharmacy, not the supermarket. Contained production in greenhouses or in isolated locations could also allay concerns over environmental impact and outcrossing.

The rarity of the indications would mean both that production volumes would be low and that the finished products would have a premium, rather than a discounted, value. The small market size, despite a genuine consumer demand, would also make product development unattractive to large producers, which in turn would create a real opportunity for small firms—firms that might indeed look somewhat like the pioneering agbiotech companies of the 1980s and early 1990s—except that now, through orphan crops, they might stand a chance of establishing a real presence in the market (as Genentech and Biogen and Amgen brought interferons and growth hormones and erythropoietin to patients as orphan drugs).

There is one obvious caveat: making orphan crops a reality would require orphan legislation to prevent the market rewards for pioneering firms being eroded by fast follower copycats. But adding more GM-specific rules to European regulations might not be necessary: existing legislation applies to orphan medicinal 'products' and even mentions 'active substances of herbal origin.' Perhaps such rules could encompass medically relevant orphan foods. Failing that, adapting legislation to facilitate the development of treatments based on orphan foods ought to be an easier political challenge than trying to uphold the case for BST, GM canola or GM corn.

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Meetings of the Catagena Protocol on Biosafety

- Paul Christensen

The next meetings of the Cartagena Protocol on Biosafety are: 4 - 6 October 2004 - Geneva, Switzerland: Coordination meeting for representatives of academic institutions actively involved in education and training programmes in biosafety,  http://www.biodiv.org/meetings/default.aspx?thm=CPB&yr=%

18 - 20 October 2004 - Montreal, Canada: Technical Group of Experts on Liability and Redress: http://www.biodiv.org/doc/meeting.aspx?mtg=BSTELR-01

Willy De Greef has pointed out the imbalance between representatives of the scientific community and those of NGO opposing biotechnology at these meetings (see article that was highlighted earlier in AgBioView at: http://www.nature.com/cgi-taf/Dynapage.taf?file=/nbt/journal/v22/n7/full/nbt0704-811.html).

The fundamental roles for the scientific community in the safety discussion are:

1. Providing information on individual technical issues in food and environmental safety

Discussion of and support for the role of science based risk assessment. The Achilles heal of risk assessment is that any particular model can be biased.  Risk assessment differs from the scientific method in that it is not entirely empirical. The ability of the public to trust risk assessment can be reinforced if we in the scientific community show that the other aspects of the scientific method (skepticism and universality) allow the discussion of risk models to converge over time to unbiased results, especially if skeptical criticism leads to focused data collection that allows the whole scientific method to be applied to critical components of risk assessment models.  On the negative side, more scientists should recognize that the firmer interpretations of the precautionary principle are inherently anti-rational, because they do not allow for relative comparison of risks, and are not compatible with rational evaluation and choice between of courses of action.   

2.  Quantify, using methodology that can be widely accepted, the benefits and negative impacts of use and rejection of biotechnology on individuals and communities.

The big issue that goes beyond safety, biology, and the physical world is freedom of choice.  Does the individual (or an individual nation) have an ethical right to positions that are not based on science based information? Does he (or a nation) have the right to such positions when the position will harm others?  
As supporters of democracy, we probably recognize rights of this sort, but also hope that the average citizen will not choose to use them. Unbiased credible information is crucial.

3. Clarification of the impact of the regulatory process on results. 

Are enough representatives of the scientific community, scientific societies or university associations, planning to attend the next meetings as observers?
---
Paul Christensen, Seed Science Center, Iowa State University, Ames, Iowa 50011-3228

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Monsanto Launches New "Heart-Healthy" Soybean Seed

- Channel Newsasia International, September 1, 2004 http://www.channelnewsasia.com/stories/afp_world_business/view/104454/1/.html

Monsanto Company on Wednesday said it has begun marketing a new low-linolenic soybean crop that, once processed, will yield an enhanced oil that is low in trans fats. The new soybean crop is one of a raft of new heart-healthy products that Monsanto has in development, which it plans to market under the brand name Vistive.

The biotech giant has spent 10 years developing this soybean crop, using conventional breeding methods to reduce the content of linolenic acid, and hence the need for hydrogenation during the processing phase.

Trans fats are a byproduct of the partial hydrogenation process, which is used to increase shelf life and flavor stability in fried foods, baked goods, snacks and other processed foods. But the medical community has raised the red flag on trans fats, citing their link to heart disease, because of their function in lowering the levels of HDL, or "good," cholesterol while raising LDL, or "bad," cholesterol levels.

The US Food and Drug Administration has mandated the publication of trans fat content on food labels beginning in 2006, and has taken the position that "intake of trans fats should be as low as possible." The agency has refused to set a maximum recommended daily allowance for trans fats, because the only safe level is zero.

"Vistive soybeans contain less than three percent linolenic acid, compared to eight percent for traditional soybeans, resulting in a more stable soybean oil with a better flavor profile and less need for hydrogenation," Monsanto said in a statement.

The crop is being marketed to Iowa farmers and growers for 2005, a Monsanto spokesman said. The company hopes to have 100,000 acres (40,000 hectares) under cultivation next year. The US population consumes more than 18 billion pounds (eight billion kilos) of soybean oil annually, according to Monsanto.

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> Meet the New Bully At Western Farm Press

> Harry Cline, Western Farm Press, August 27, 2004
> http://westernfarmpress.com/news/8-27-04-column-new-bully/

Letters To The Editor, Western Farm Press, September 4, 2004

> Harry: I was dismayed to see your commentary on the GMO ban issue today. Please provide your readers with substantiation of your claims or inferences that:

> GMO crops have found worldwide acceptance. There are close to 1,000 similar bans in effect.

(Editor: In 2003, the global area of transgenic crops continued to grow for the seventh consecutive year at a sustained double digit growth rate of 15 percent, according to the International Service3 for the Acquisition of Agri-Biotech Applications. Estimated global area of GM crops is 67.7 million hectares by 7 million farmers in 18 countries. That sure sounds like acceptance.)

> GMO's have been subjected to a high level of scientific scrutiny- "exhaustive testing and evaluation by several government agencies." The is a deliberate false statement.

(Editor: The U.S. Government agencies responsible for oversight of the products of agricultural modern biotechnology are the U.S. Department of Agriculture's Animal and Plant Health Inspection Service (USDA-APHIS), the U.S. Environmental Protection Agency (EPA), and the Department of Health and Human Services' Food and Drug Administration.)

> GMO crops pose no risk of cross pollination to California agriculture - organic farmers who continually face the threat of contamination of their crops and resulting losses.

(Editor: Due to claims by anti-GMO activists, many public university scientists have evaluated pollen transport between convention and biotech corn. Generally, the cross pollination effect has been less than 2 percent and that was only when GMO and conventional crops of the same species were within less than 200 feet. Bottom line: the cross pollination issue is an insignificant issue.)

> Technology is bringing cheaper and safer food than ever before. Show me the numbers.

(Editor: One example: Arizona cotton growers now spray their cotton to controls damaging pests an average of once per year. Before advent of Bt cotton, and other new pest management technology and products, it was not uncommon for growers to treat 7 and 8 times per year with pesticides to control pink bollworm and other pests. Scientific research has repeatedly proven that growing herbicide-resistant and pest-resistant crops dramatically reduces the cost of farm and the use of pesticides. If you do not belAieve that, call the major chemical companies - as you call them "biotech bullies" and ask them how their pesticide sales have been impacted by biotech crops.)

> The campaign in Mendocino County was unusually vicious, wineries opposed to the ban were threatened with violence, intimidation, etc.

(Editor: My sources tell me there were organic producers opposed the Mendocino GMO ban, yet, they were coerced into not voicing that opposition. Many mainstream organic producers are embarrassed by this radical anti-GMO movement. I know for a fact the staff of one organization opposed to the Mendocino GMO ban initiative was so fearful for their safety by the hate mail received in its office that the president of the organization cut short a business trip to return to the office because of the fear for his Astaff.)

> The bottom line, Harry, is that agriculture cannot continue indefinitely externalizing the cost of all the genetic pollution and environmental damage brought about by high technology. That is why organic food is the fastest growing sector in our economy - in spite of having a bare minimum of 'scientific' research funded and less than 1 percent of land grant college research acreage.

(Editor: Organic food is the one of the fastest growing sectors in our economy because traditional agriculture is producing healthy affordable, organic products on vast acreages in California and elsewhere. It is the very same agriculture you say is "externalizing the cost of all the genetic pollution and environmental damage.")

> It is true that there is substantial disunity in agriculture, including the Farm Bureau. That is largely due to the heavy handed ('bullying' is an accurate term) promotion of biotechnology. But it is also a product of the lack of concern for the loss of income, jobs, and declining quality of agricultural life implicit in publications such as yours. Can you rise above the blame game and address those concerns in an accurate and objective manner exemplary of your journalistic skill?

(Editor: Skillful journalist? Your fellow anti-GMO advocate David Kupfer says I am not a journalist - only "an industry hack and a pawn" bought and paid for by Western Farm Press advertisers. You guys need to get your story straight as to what I am.) George Stevens
-------

Harry: I'm proud of you?great responses! These guys can be likened to the terrorists in their attitudes. Unbelievable!
- Gene Lundquist Bakersfield, Calif.
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Seems to me that the anti-biotech attitude is due mostly to stupidity and hatred of large corporations. I have a brother who follows the same logic. I remind him that he gets to eat daily due to biotechnology and some large corporations as well as large and small farmers. Maybe my brother and Mr. Hayward would like to starve and eat poor quality foods.
- Tom Gaschler Imperial, Neb.
------

Perhaps this man (Jack Hayward II) was more strongly opposed to industry/big business than he was to biotechnology. What I would say is that some of the people who are against biotechnology are very knowledgeable and make some strong arguments. This person made no arguments and this seems to be by design.

This person may just be someone who wants to create havoc. At least that would be my take on it. Corporate America, especially biotechnology, just happens to be the avenue he is using. Perhaps because it is one of the few arenas where he can scare people, without "decency," and some people will see it as legitimate.
- Hal Hoelzer (No address)

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I just finished reading your column in the ag news weekly e-mail I received. This is a very disturbing issue the needs to be addressed now. I grow bio-crops. Roundup Ready soybeans and Bt Corn are the best thing that could happen to crop production this century. These radicals like Hayward need to be stopped in their tracks.

I hope people like you can help do that. I would like to see you send your article with Hayward's e-mails to every paper and magazine. Bio-crops are a wonderful thing from powdery mildew resistant grapes to whatever else they try to genetically modify. But these crops need to be used as a tool.
----
Stan Dunk Crop and Livestock farmer Lewistown, Penn.

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Brazil Cotton Growers Lament GMO Straightjacket

- Elizabeth Johnson, Dowjones, Commodity Wire, August 31, 2004

Sao Paulo -- Alvaro Salles reckons he would save $525,000 per year if he could use genetically modified technology on his 3,500-hectare cotton farm in Campo Verde, at the heart of Brazil's fast expanding cotton belt.

Brazilian farmers have done well without GMOs, which are banned here but used in all other major producing countries. After years as a cotton importer, Brazil overhauled its industry in the mid-90s to become a major exporter. But producers are concerned the GMO ban could stymie efforts to climb the ladder of top cotton-producing nations. "Brazil could easily become the world's largest exporter of cotton in four or five years," said Miguel Biegai, a cotton analyst from Safras e Mercados.

Brazilian cotton production has grown threefold since 1996 and is seen reaching around 1.3 million metric tons in 2005, with exports expected to increase 42% to 510,000 tons. The turn-around is due to Brazil's world-beating yields, which are about 50% higher than U.S. levels. Brazil averages 1,200 to 1,300 kilos of cotton per hectare versus 815 kilos per ha in the U.S., while production costs are on par with those of U.S. growers, roughly $1,200 per hectare.

But Brazil's competitive advantages are cut away once the cotton leaves the farm gates due to astronomical freight costs, which are five times higher than in the U.S., according to Salles. "We are always on the edge," he said. "When international prices are good, we make money. But it's uncomfortable."

Brazilian cotton producers believe that GMO technologies would give them the advantage they need to have a competitive edge internationally. "We expect to save a minimum of $150 per hectare by using GMO cotton varieties," said Helio Tollini, the executive director of Brazil's Cotton Producers Association, Abrapa.

While environmentalists see GMO technology as a potential threat to the environment and human health, farmers say conventional cotton is one of the hardest crops on the environment. Producers in Brazil are now required to apply herbicides up to 15 times each year, according to Joao Luiz Ribas Pessa, the head of the Cotton Producer's Association of Mato Grosso, or AMPA.

"With GMO technology, we could reduce the number of agrochemical applications to two or three per crop," he said.

In the wake of Brazil's favorable ruling by the World Trade Organization, WTO, against U.S. cotton subsidies, growers here believe they need to act quickly, fearing that if they aren't prepared to fill the gap left by U.S. producers, other countries will.

As the sector awaits an indication of how the U.S. will react to the WTO decision and resolution of Brazil's GMO issue, further expansion of the industry has been placed on hold. For the upcoming season, it is unlikely that Brazil will increase the area under cultivation, said Djalma Aquino, a cotton specialist at government supply corporation Conab.

In the future, Brazil could expand cotton production into several areas, but farmers are just waiting for the right market conditions. "The Iuiu river valley in western Bahia has ideal conditions for cotton and could very well become the next frontier," Safras' Biegai said.

Likewise, farmers easily could expand into the roughly five million hectares of degraded pasture in eastern of Mato Grosso, under the right conditions. "Without a government decision on the GMO issue, Brazil is going to continue to import subsidized GMO cotton from the U.S.," Biegai said.

The government's own crop research agency, Embrapa, is in the process of developing several GMO cotton varieties, including one genetically engineered to kill the cotton boll weevil anthonomus grandis, which Brazilians spend hundreds of millions of dollars to combat every year, said Luiz Paulo Carvalho, the head of research at Embrapa's Paraiba cotton center.

But even the government's own research could be jeopardized because of lack of legislation for biotechnology. While the government has submitted a bill that would regulate biotechnology in Brazil, producers are concerned that the bill will not pass in time for the upcoming planting season, which begins later this year. "We want to guarantee the use of GMO cotton in the upcoming harvest," AMPA's Pessa said.

But GMO cotton is advancing despite the government ban. Earlier this month, Brazilian officials discovered illegal GMO cotton on a number of farms in the top-producer Mato Grosso state, prompting concern that a black market will quickly grow beyond government control, as the country's GMO soybean crop has over the past six years.

In an effort to bring Brazil's fast-growing black market in GMO soybeans under control, the government granted amnesty to illegal crop growers for the 2003-04 season as a temporary measure until Congress could pass legislation regulating biotechnology.

But farmers fear that the bill, which was submitted in late 2003 and has been stuck in the Senate for months, will not be passed in time. "The government's inaction regarding GMOs has been catastrophic for agribusiness," Biegai said.
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Plant-Made Pharmaceuticals Might Grow on Wall Street

- Brian O'Connell BioPharm International Aug 1, 2004; Full story at http://www.biopharminternational.com/biopharm/article/articleDetail.jsp?id=114975

'Companies that create new products often discover that the largest market for said products was not the market the "experts" thought it would be.

Take Alfred Nobel. When the fabled scientist was in the process of developing dynamite, he was trying to discover a better explosive device for the US military. As it turned out, dynamite proved to be too explosive for even the armed forces. The big guns in Washington decided that dynamite was too unpredictable and too dangerous for soldiers to be carting around.

Chagrined, Nobel wasn't sure where to turn when representatives from the mining, railroad, and construction industries contacted him. Waving checkbooks at Nobel, it was clear that they immediately saw the productivity potential for dynamite in their respective fields of work. Hello, rock-busting explosive device. Good-bye, pick and shovel.

So it goes with the biopharmaceutical industry and one of its promising, if nascent, technologies -- plant-made pharmaceuticals (PMPs).

A $20 BILLION MARKET
What are PMPs, and why should Wall Street types get to know them? According to a white paper on the topic released by BIO, PMPs use biotechnology-fueled plants to produce uber-proteins that might be used by doctors to battle life-threatening illnesses. According to the BIO paper, "in this process, plants themselves become 'factories' that manufacture therapeutic proteins. These proteins are then extracted, refined and used in pharmaceutical production."

A $20 billion market, PMP tools and technologies are very much a work in progress, with most projects in either the field trial or clinical trial stages, according to SeedWorld magazine, which covers the latest advances in plant breeding and development, biotechnology, marketing, testing, and international trade. According to BIO, the United States Department of Agriculture reports that only 20 permits were issued to conduct PMP trials in 2002, and only nine more in 2003. To date, only a handful of farming-friendly states (Arizona, California, Florida, Iowa, Texas, and Nebraska among them) have been issued permits to conduct PMP trials by the USDA. According to BIO, "it is estimated that it will be at least three to five years before full commercialization of the first PMP is reached. Plant-made pharmaceuticals are strictly regulated by United States regulatory agencies and differ from traditional commodity agriculture on many fronts."

I won't bore you with my limited knowledge of the scientific side of PMPs -- in other words, how PMPS are produced, what kinds of plants are used, and the ins and outs of the harvesting process (there's more than enough good information on that elsewhere in this issue of BioPharm International). Suffice it to say that the idea of pharmaceutical plants becoming quasi agri-factories where therapeutic proteins can be produced faster, easier, and cheaper has a great deal of potential to investors.

TAKING A SWING AT PMPS
Contrast the potential of PMPs with conventional production methods, and you begin to see why the technology could save substantial amounts of time and money, enable easily scaleable production, and produce complex proteins that current systems cannot produce. What also interests me -- and hopefully the readers of this column -- is the kinds of diseases that potentially can be treated with the technology. After all, it's the "trigger effect" of treating such diseases that will demonstrate the technology's potential to generate fat profits and reward shareholders that pour money into a technology that may or may not pay off.

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Tobacco Promising "Factory" for Biopharmaceuticals

- Biotech Law Weekly, September 3, 2004

The economics of producing biopharmaceuticals from transgenic plants such as tobacco is still a roadblock to producing large quantities of urgently needed medicines, especially for people in underdeveloped nations.

Chenming (Mike) Zhang is testing a variety of ways to economically recover recombinant proteins from transgenic tobacco using different protein separation techniques. Zhang, an assistant professor in the department of biological systems engineering (BSE) in the College of Engineering at Virginia Tech, is working with a team of three PhD students to develop transgenic tobacco plants able to express recombinant proteins economically. Recombinant proteins are potential therapeutic agents for treating human and animal diseases and creating new vaccines. Plant-made vaccines are especially beneficial because plants are free of human diseases, reducing the cost to screen for viruses and bacterial toxins.

"Recombinant protein production from transgenic plants is challenging, not just from the molecular biology aspect of creating high-expression plant lines, but also from the engineering aspect of recovering and purifying the proteins economically - the importance of which cannot be overlooked," Zhang said.

Recombinant proteins are proteins expressed by a host other than their native hosts. For example, if the gene for human growth hormone is inserted into the genetic code of yeast (gene recombination), then the corresponding protein expressed in the yeast is called recombinant human growth hormone.

Zhang's research starts with introducing the genes of interest into tobacco plants and then developing economical processes for recovering and purifying the expressed proteins. Relaxin, one of the proteins his team is studying, could potentially benefit patients with asthma, hay fever and even cardiovascular disease.

Because most recombinant proteins are for therapeutic uses, they need to be highly purified to be safe for human use. Thus, once a protein is expressed, whether by transgenic tobacco or bacteria, the protein first needs to be recovered into liquid solutions before purification. "Because of the high purity required, the purification is rigorous and not surprisingly, very expensive. Therefore, development of more economical techniques for protein purification is always an engineering challenge in order to lower the cost of therapeutic proteins or biopharmaceuticals," Zhang said.

Zhang uses tobacco in his research because it is a nonfood crop and is well suited as a "factory" for recombinant protein production. The leafy green tobacco plant is relatively easy to alter genetically and produces thousands of seeds and a great deal of biomass. As a nonfood crop, genetically manipulated tobacco will not pose a safety threat to products consumed by humans. "Since tobacco is neither a food nor a feed-crop, transgenic tobacco will not enter our food chain," Zhang

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Issues of Dignity Focus of U.S.-Vatican Ties

- Rocky Mountain News September 2, 2004. Excerpts below. Full Interview at http://www.rockymountainnews.com/drmn/opinion/article/0,1299,DRMN_38_3155316,00.html

..... Jim Nicholson, was sworn in as U.S. ambassador to the Holy See on Aug. 10, 2001. Prior to his stint as a diplomat, Nicholson was chairman of the Republican National Committee. He was in Denver recently and spoke with the Rocky Mountain News. The interview has been edited for length and clarity.

News: You mention poverty as one of the issues the United States and Vatican have a joint interest in alleviating. But what is the Vatican's understanding, as you see it, of the causes of poverty? The Bush administration might argue that the best way to relieve poverty in the Third World is to enact political and economic reforms that promote freedom and allow people to develop their own wealth. In contrast, historically, the church has seen poverty as primarily a matter requiring the redistribution of wealth. Do you think the Vatican hierarchy understands the necessity of ethical, hospitable capitalism?

Nicholson: This is a holistic issue that is evolving within the church. The pope has said globalization is here to stay and that we have to make it work for everybody. A major focus of the church is, of course, justice. They define it quite broadly, which can include such things as debt forgiveness to help countries attain a certain level of self-sufficiency and independence. In general, however, the church always returns to the dignity issues. Food, for example, is a huge concern we both share. The Food and Agricultural Organization in Rome has concluded that there are about 800 million people worldwide with a food deficit that can range from undernourishment to starvation. Feeding these people is a major piece of the Vatican's portfolio because having enough to eat is a key aspect of leading a dignified life.

News: The Vatican has a problem with genetically modified food.

Nicholson: We don't have convergence of this issue, though I'm working to try to persuade them otherwise. About 80 percent of our corn and soy beans are the product of genetically modified seed, which is tremendous because yields are heavier, it's better for the environment, uses less water, herbicides and pesticides, and it's easier to cultivate in harsher climates. There's no science that supports any claim of deleterious health effects. But the Vatican has basically sat idly by while the European community protects its growers from foreign competition and makes what are largely bogus claims about food security. The big problem is the effect on Africa, where millions are starving. The odd thing is the argument the Europeans have been able to sell to the African nations, which is that if you ever allow genetically modified food into your countries some people are going to grow it but you'll never be able to export it to Europe. And this is said to countries with whole populations under duress.

Unfortunately, some of the African bishops have bought into this. There have been a few incidents in which aid groups have been forced to take back supplies of GM food stocked in warehouses. This is just unbelievable. The Vatican can't sit on the sidelines forever. If the pope were to weigh in with his tremendous moral authority I think European opposition would eventually fade away and we could go into Africa and not only feed people but help put them on a path of sustainable development.

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Factors Determining the Public Understanding of GM Technologies

- Lesley Hunt, AgBiotechNet, http://www.agbiotechnet.com/ (Agribusiness and Economics Research Unit, PO Box 84, Lincoln University, Canterbury, New Zealand)

Abstract: GM technologies challenge our understanding of what it means to be human, and of what role we play in the natural world. These technologies arise out of particular contexts. Our experiences and understanding of events in our own lives and of events observed and reported in other places around the world, inform our understanding, giving rise to fears about the risk of genetic modification.

What could their impact be in the long-term? What are the possible problems? What information about them can be trusted? What choice do I have? Who benefits and who would bear the brunt of any problems? This article presents some of the findings of social scientists about the many interrelated factors that underlie the public's response to GM technologies.

The challenges these technologies present can contribute to increased feelings of uncertainty because the world as we know it is changing, alienation because of our lack of control over the development and use of many GM technologies, and ambivalence as we appreciate their benefits but worry about their possible negative impacts. Overall our attitudes to GM technologies reflect the issues associated with living in the contemporary world.

1. Introduction: Where do I fit in the natural world? Am I part of nature or apart from nature? What power do I actually have over what I eat and what happens to the environment? How can we really tell whether something will have good consequences or bad? Who knows? How can we choose when we know that some technology has enormous potential to help human kind but also could put us at great risk? All these questions and more are raised when we consider the place of GM technologies in our lives and in the world.

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NAS Issues Mixed Message on Unintended Effects of GM

- Jeffrey L. Fox, Nature Biotechnology, v. 22, 1062; (September, 2004). www.nature.com ; Reprinted in AgBioView with the permission of the editor.

A National Academy of Science report recognizes that genetically modified food may have potentially unanticipated effects. Activists have welcomed a report published by the National Academy of Science because it recognized that food may have potentially unanticipated effects.

A report released on July 28 by a 13-member committee of the Institute of Medicine within the National Academy of Sciences (NAS) in Washington, DC, proposes to extend voluntary testing to all new foods that have been modified, regardless of the technique used to create the modification. Although encouraging on the narrow, genetically modified (GM) food front, the report reveals a shift of attitude that could yet prove expensive for agbiotech companies, particularly if the report's recommended expansive regulatory and data-gathering practices were made mandatory.

The NAS report, "Safety of Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects," was commissioned jointly by the Food and Drug Administration (FDA), the US Depart-ment of Agriculture (USDA), and the Environmental Protection Agency (EPA), all of which share responsibilities for regulating GM organisms and foods derived from them. This commission is part of the response by the agencies to a NAS report published four years ago that called on them "to better coordinate their work and to expand public access to the regulatory process" in this arena (Nat. Biotechnol. 18, 486, 2000).

Adverse health effects from consuming GM foods "have not been documented in the human population, but the technique is new and concerns about its safety remain," according to the report, which also notes that "even traditional methods such as cross-breeding can cause unexpected changes." Thus, the NAS committee recommends extending voluntary testing from new types of GM foods to testing foods that are developed by traditional breeding such as hybridization.

To assist in the process, the report urges industry and regulatory officials to build and to integrate databases that would include food sources that are subject to conventional breeding and newer cloning methods, instead of limiting special scrutiny to GM food sources alone, as federal agencies have been doing for more than a decade. NAS committee member and former FDA official Sanford Miller, now of the Polytechnic Institute and State University in Alexandria, Virginia, says: "We fully recognize that this is very expensive, but there are a lot of reasons for using public and private funds to set up a central depository of information."

Until now, companies have been carrying out voluntary and proprietary testing—focusing on compositional changes rather than health testing--of GM crops that mostly are used in feed rather than in foods for humans. Although the report stands as a "guide for federal agencies to select the route of safety assessment," it does not fully specify what compositional changes would trigger such tests. Nor does it spell out how to improve epidemiological and survey tools to detect any "changes in the population's health that may be caused by these foods."

Instead, that challenge is left "to the agencies and industry," noting that they stand to benefit from using those tools to pick up what committee member Lynn Goldman of the Johns Hopkins University School of Public Health in Baltimore, MD, and a former EPA official refers to as "truly unanticipated consequences."

The NAS committee recommends extending voluntary testing from new types of GM food to testing food that are developed by traditional breeding methods such as hybridization. 

Immediate reactions to the NAS report are proving it to be delphic. For instance, Michael Phillips, vice president of agricultural science and regulatory policy of the Biotechnology Industry Organization (BIO) in Washington, DC, cites the report as another "milestone in consumer acceptance of agricultural biotechnology." Thus, it "should lay to rest the few naysayers who continue to question the safety of these crops."

Perhaps not. For example, biotech critic Doug Gurian-Sherman, senior scientist at the Center for Food Safety, an activist think tank, in Washington, views the report as renewing warnings about "potentially harmful GM foods that we don't know much about." Furthermore, he says, "there are substantial gaps in our ability to identify unintended changes in biotech foods or to determine the human health impacts of those changes, and we need much more rigorous pre-market testing and post-market surveillance."

Gurian-Sherman and others continue to call for a mandatory pre-market approval process for GM foods as well as mandatory labeling, like in the European Union. To reach this end, Democratic Senator Richard Durbin of Illinois introduced legislation (S.2546) on June 17 that seeks to establish a mandatory approval process for such foods.

However, the report, stops well short of recommending mandatory assessments, while potentially greatly expanding the scope of testing which is now done strictly on a voluntary basis by product sponsors. And the NAS committee leaves decisions about what foodstuffs would be reviewed to federal officials. For each case, officials and company representatives are "to determine whether and how much further evaluation is needed," explains NAS committee chair Bettie Sue Masters, a chemist from the University of Texas Health Science Center in San Antonio.

The NAS committee also urges the FDA, USDA and EPA to improve their ability to detect consumer trends in purchasing GM foods and to enable the traceability of such foods. "What they're asking for seems to be excessive. They don't give recommendations on how this would be done or who pays for it," says Lisa Dry of BIO. "And in balance with no apparent risk, it seems unnecessary."

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'Informative' Horizontal Gene Transfer

- Harry J Gilbert, Anthony G O'Donnell & John C Mathers, Nature Biotechnology  22, 1076, September, 2004). www.nature.com ; Reprinted in AgBioView with the permission of the editor.

To the Editor: The Perspective of Nielsen and Townsend on p. 1110 presents an interesting analysis of current studies on horizontal gene transfer from transgenic plants into microbial ecosystems. With respect to their analysis of our work on gene transfer from transgenic plants into human intestinal microbes (Nat. Biotechnol. 22, 204–209, 2004), we would like to clarify some of the issues raised.

Nielsen and Townsend comment on the limitations imposed by the multiple rounds of subculturing, indicating that our analysis is "uninformative." It was not the intention of our work to quantify the frequency of bacterial transformants in the intestinal microflora, but to seek evidence of their existence. We believe, therefore, that the identification of these microbes using an enrichment and PCR strategy is highly informative.

We also wish to point out that as the small intestinal bacterial population numbers are relatively low (106 organisms/g), and our PCR methodology will analyze 106 genomes per reaction, we have interrogated a significant proportion of the bacterial population. We also believe that as the level of the PCR product did not significantly vary throughout the seven subcultures, our media did not specifically select (positively or negatively) the transgene-containing bacteria.

We think that maybe the crucial point made by Nielsen and Townsend is that one can never be sure that gene transfer events have not occurred as it could take a protracted time for the transformant(s) to be sufficiently abundant within a bacterial population to be detected. Thus, the authors are correct in suggesting that although we did not find evidence for additional gene transfer events subsequent to consumption of the GM meal, current methodology may not have detected the transformants if transfer were an extremely rare event.

In their concluding remarks, Nielsen and Townsend identify the importance of more focus on the bacterial genetic composition and environmental conditions that facilitate positive selection of bacterial transformants. Although substantial manipulation of the environmental conditions of the human small intestine is clearly impractical, we agree that analysis of the genomes of the bacterial transformants, both with respect to identifying the organisms and the site and mechanism of transgene integration, is likely to advance understanding of the risks associated with gene transfer from transgenic plants to the human intestinal flora. Indeed, we intend to characterize the genomic context of transgenic plant-derived recombinant genes in the bacterial transformants. This will provide insight into both the identity of these organisms and the mechanism of transgene chromosomal (or episomal) integration.

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> Problems in Monitoring Horizontal Gene Transfer in Field Trials of Transgenic Plants
> Jack A Heinemannn & Terje Traavik, Nature Biotechnology (September, 2004). www.nature.com ; Reprinted in AgBioView with the permission of the editor.

Transgenic crops are approved for release in some countries, while many more countries are wrestling with the issue of how to conduct risk assessments. Controls on field trials often include monitoring of horizontal gene transfer (HGT) from crops to surrounding soil microorganisms.

Our analysis of antibiotic-resistant bacteria and of the sensitivity of current techniques for monitoring HGT from transgenic plants to soil microorganisms has two major implications for field trial assessments of transgenic crops: first, HGT from transgenic plants to microbes could still have an environmental impact at a frequency approximately a trillion times lower than the current risk assessment literature estimates the frequency to be; and second, current methods of environmental sampling to capture genes or traits in a recombinant are too insensitive for monitoring evolution by HGT.

A model for HGT involving iterative short-patch events explains how HGT can occur at high frequencies but be detected at extremely low frequencies.

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Environment/ Predator Protected Structure

- Timur Hyat-khan, Pakistan
Dear All: I have been working on an Low-Cost Environment/ Predator Protected Structure for the past several years. My reasons for doing so are as follows:

1. Uncertain weather patterns affect crop yield negatively.
2. Out of season vegetables command better price.
3. Small Animals and birds curtail produce.
4. High cost "Mother Plants" need protection.
5. With no crop insurance, subsistence farmers cannot afford risks related to open air farming.

I started out with the Geodesic Dome structure from Permaculture, here locally available raw materials such as light poles are abundant after the Monsoons (Paper Mulberry, Eucalyptus etc.). This is just before the advent of winter, which is a logical start point for a protection structure. A total of 65 poles around 4 ft in length, configured into 6 polygons, gives me a tough dome structure that can be encircled with mesh and covered with plastic or polyproplene. I called it The Wah (Wow) Garden after my ansectral village and use it for Kitchen Gardens, Food Security, Income/ Nutrition Enhancement for poverty reduction. However, there is a restriction of space as I got a maximum of 500 sq ft.

To overcome this problem I used six sided panels (septagon?) and configured them into square or rectangular shapes that can be extended almost infinitely. I have called this low cost and readily fabricated structure The Timuriya Garden after my own name.

The greatest problem faced by Biotech is the objection to wild card genes drifting to contaminate other plants. With the Timuriya Garden this objection is removed. The structure is low in cost, light weight yet durable, the materials are readily available, the structure is modular and can be erected/ removed in little time. Low cost protection can be afforded with a little ingenuity (using inner and/ or outer covers of used fertilizer bags and other recyclable materials.

If anyone is interested I can detail this development that is a practical alternate to medium and high Tunnels and is a much better and stronger alternate with the added advantage of reduced costs. Will this help the cause of Biotech and also Poverty eradication.

Best Regards, Sardar Taimur Hyat-Khan

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