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July 28, 2004


AGBIOVIEW: US Science Panel OKs GM; French "Frankenfood" Farce; GM - Its Just A Matter of Time; Biotech's Crazed Critics; Europe is Losing Its Scientific Elite; GM Sheep Lightens Up


Today in AgBioView from www.agbioworld.org: July 28, 2004

* Science Panel Sees No Unique Risk From Genetic Engineering
* ... Science Panel Urges Closer Look at Biotech Crop
* Republicans Have More Respect for Science than Democrats
* Farmers in Australia Have Nothing to Fear from GM
* The Skeptic: French "Frankenfood" Farce Could Be Ending
* Seeds of Discontent
* The Institute of Food Science & Tech Supports GM
* GM: Its Just A Matter of Time
* Genes, Torts Converge in ASU Law Program
* Biotech's Crazed Critics
* Europe is Losing Its Scientific Elite
* GM Sheep Producing Light-Bulb Filaments Startles Environmentalists

Panel Sees No Unique Risk From Genetic Engineering

- Andrew Pollack, New York Times, July 28, 2004

Genetically engineered crops do not pose health risks that cannot also arise from crops created by other techniques, including conventional breeding, the National Academy of Sciences said in a report issued yesterday. The conclusion backs the basic approach now underlying government oversight of biotech foods, that special food safety regulations are not needed just because foods are genetically engineered.

Nevertheless, the report said that genetic engineering and other techniques used to create novel crops could result in unintended, harmful changes to the composition of food, and that scrutiny of such crops should be tightened before they go to market. "The most important message from this report is that it's the product that matters, not the system you are using to produce it," Jennifer Hillard, a consumer advocate from Canada who was on the committee that wrote the report, said in a telephone news conference. Committee members said the genetically engineered foods already on the market are safe.

The study, "Safety of Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects," is somewhat vague on how regulations should change, but rather deals more with the science needed to determine whether food from genetically engineered crops and animals might be harmful.

It does not, for instance, explicitly recommend mandatory reviews of new genetically engineered foods by the Food and Drug Administration. It says that assessments should be made on a case-by-case basis. Right now, companies that create such crops voluntarily consult with the F.D.A.

The report suggests that in some cases, surveillance might be needed after a food gets to the market to check for possible health effects, something not done now. It also calls for some information on the composition of genetically modified foods to be made public rather than kept proprietary.

Both sides in the polarized debate about genetically engineered foods found things to like and not like in the report. "They've clearly identified that there are significant problems with our technological ability to both identify changes that might happen in G.E. crops as well as to evaluate what those changes might mean," said Doug Gurian-Sherman, a senior scientist at the Center for Food Safety in Washington, which opposes biotech crops.

But backers of biotech were heartened by the report's determination that the risks of biotech foods are not unique. Michael Phillips, vice president of agricultural science and regulatory policy of the Biotechnology Industry Organization, said in a statement that the report "should lay to rest the few naysayers who continue to question the safety of these crops."

The report was commissioned by the three agencies that regulate genetically engineered crops: the F.D.A, the Department of Agriculture and the Environmental Protection Agency. It was produced by a committee of mostly academic scientists led by Bettie Sue Masters, of the department of biochemistry at the University of Texas Health Science Center in San Antonio.

Genetic engineering involves the transfer of a specific gene from one organism to another. Cross-breeding, by contrast, involves the mixing of thousands of genes, most unknown. Another breeding technique is to bombard plants with radiation or expose them to chemicals to induce hundreds of random mutations in hopes of finding one that will confer a desirable trait.

The report said that genetic engineering was more likely to cause unintended effects than the other techniques used to develop plants except for the mutation-inducing technique. Right now, crops produced by techniques other than genetic engineering go through virtually no regulatory scrutiny.


Science Panel Urges Closer Look at Biotech Crops

- Associated Press, July 28, 2004

U.S. government regulators should look more closely at the potential health effects of some genetically modified plants before they can be grown as commercial crops, a scientific advisory panel said Tuesday.

It also said regulators should check for potential food safety problems after people eat the products. The report by a committee of the National Research Council and Institute of Medicine said regulators should target tighter scrutiny at genetically engineered varieties that have greater levels of biological differences from current plants.

The analyses also should look more closely at conventionally developed plants if there are indications naturally occurring chemicals in the conventional plants could have unintended health effects, the report said. Some chemicals in plants can create allergic reactions or otherwise make some people sick. To prevent such problems, the study recommended a case-by-case approach to the applications based on compounds in conventional, as well as biotech plants, rather than the current focus on biotech varieties. The report said, however, biotech plants would probably have greater risk.

The compounds to be examined could be new ones not normally in the plants, as well as naturally occurring ones that are above or below healthful levels, the report said. To help regulators make their approval decisions, a database should be developed to list the levels of certain compounds, including healthful substances such as proteins and dangerous ones such as allergens, the report said.

The report also said the government should develop better ways to see if genetically modified foods cause health problems. Among these could be systems to trace foods with greatly altered levels of those compounds through the food supply and to check populations to see if there are health problems among people who eat the foods.

However, the primary focus should be on the preapproval process, "and we would hope that, for the most part, there wouldn't be a great deal of postmarket tracking," said the committee chairwoman, Bettie Sue Masters, a professor of chemistry at the University of Texas Health Science Center in San Antonio.

The report said genetic engineering of food crops, although relatively new, appears to be a safe technology and there is no evidence it has harmed health. Committee members emphasized current biotech crops have gone through extensive safety checks.

Current biotech crops do not need the tracing or re-examination, said Dean DellaPenna, a professor of biochemistry and molecular biology at Michigan State University. The committee's job was to evaluate what could be done for new applications, he said. "What we are talking about is from this point going forward," he said.

The committee did not intend for researchers to identify every one of the thousands of compounds in plants but to focus on the "handful" that might cause problems, DellaPenna said. The committee did not consider the cost of implementing its recommendations, DellaPenna said. "We are proposing what we think would be ideal recommendations and it is certainly up to the agencies and Congress to determine how they go forward."

The report was done for the Food and Drug Administration, the Agriculture Department and the Environmental Protection Agency, which oversee biotech crop applications. Michael Phillips, vice-president of agricultural science and regulatory policy at the Biotechnology Industry Organization, a biotech trade group, said the report should "lay to rest the few naysayers who continue to question the safety of these crops."

Consumer advocates said the report also supported their positions. "The report clearly and correctly states that biotech foods could have unintended consequences," said Gregory Jaffe, biotechnology project director of the Center for Science in the Public Interest.

The National Research Council and the Institute of Medicine are arms of the National Academy of Sciences, a private, congressionally chartered organization that advises the government on scientific and technical matters.


Republicans Have More Respect for Science than Democrats

- Gordon Couger"

While I believe that my statement that republicans including G.W. Bush have more respect for science in their decision making than democrats that hardly is good enough to be a ringing endorsement.

Both parties are dismal failures when it comes to consulting science to make sound political decisions. All we have to do is look at the utter failure of almost every environmental program implemented by either party to see that. The EPA is littered with fraudulent conclusions that are not rescinded and our birth control policy hog tied by no reference to condoms or abortion. DDT effectively banned from the third world once the first world no longer had use for it. Rules that ban lead paint from every where but government use. Billions were spent on asbestos abatement that posed almost no risk to anyone if properly painted or coated by people wearing the proper protective equipment.

On the right we ham string cloning and on the left our envoy to Kyoto signs the accord knowing that there is no way on earth that it can get 5% of the votes needed to pass the senate but it looks good for his gene image.

We inspect beef, chickens and pork to the tune of millions of dollars and I can go out on the bank and set up a commercial fishing operation with a $25 commercial fishing license and never see an inspector and sell the fish interstate.

I think that politics and science don't mix too well no matter what the party. Democrats spend more money on grants for science and let politicians do most of the regulating and republican spend less on research and block projects that morally offend them, and there are a lot but let scientist make more decisions about regulations. We don't get a very good deal either way. Like the rest of the country science is becoming polarized like everything else that has been touched by politics.

- Gordon Couger Stillwater, OK www.couger.com/gcouger

> Suicide by Pseudoscience - Bruce Sterling, Wired, Issue 12.06, June 2004 http://www.wired.com/wired/archive/12.06/view.html?pg=4

> The Union of Concerned Scientists in a February report pointed out something the science press has known for years: The Bush administration has no respect for science. Ideologues prefer to make up the laws of nature as they go.


Farmers in Australia Have Nothing to Fear from GM

- Gordon Couger, gcc@couger.com, Stillwater, OK, www.couger.com/gcouger

The farmers in Oz are still a large enough part of the population to put fear in the hearts of their politicians. It is time you guys got your act to greater and let them know the positive benefits that GM crops have for the land of Oz in reduced erosion, salt intrusion, better weed control with safer herbicides and improved boll worm control with drastic reductions in insecticide use in cotton and corn. Making the country cleaner and safer for every one not just more profitable for farmers.

We have conceded the high ground to our enemies when in most cases it is ours in almost ever case. There are very very few areas the GM crops and production method are not kinder to mother earth than any other method in use today. We need to quit hiding behind our desks and in our fields and get out and tell people the truth about the situation and quit capitulating to the lies and misdirection of those
that use the misguided soles that have taken up the green agenda and warped it to fit their needs of anti business and anti globalization interest.

Gordon is an land owner and retired farmer and researcher with land in 3 counties in Oklahoma and 2 in Texas. Ranging from range land that has been in the family since 1873 to drip irrigated cotton that was installed last year on the on the south head quarters of the XIT Ranch in Texas.

> Australia: Complaints from Fear - Brown; Country News, July 26 2004


The Skeptic: French "Frankenfood" Farce Could Be Ending

- Matthew Curtin, Dow Jones International News, July 26, 2004

PARIS (Dow Jones)--It was another one of those farcical events for which France is often unfairly lampooned. Several hundred anti-globalization activists intent on protecting us all from the supposed menace of genetically-modified crops trampled over patch of transgenic corn being grown in a field in southwest France.

The protesters stomped about under the watchful gaze of the police, whose efforts to prevent the destruction of private property - the field's owned by Pioneer Hi-Bred (PNB.XX) - went only as far as photographing the miscreants for possible future prosecution.

According to a report in Le Figaro, the organizers of the protest suddenly panicked when it dawned on them that they might inadvertently be encouraging the propagation of the corn - the plants' pollen was now all over their shoes and boots.

Meanwhile, France's Justice Minister Dominique Perben said the perpetrators would be swiftly brought to justice. They probably aren't quaking in their dusty shoes, though their number includes France's most famous activist Jose Bove, who has done a brief spell in jail for attacking a McDonald's (MCD) and whose anti-GMO group organized the crop-trampling, just one of several over recent years.

Other notables included Noel Mamere, a French Green Party deputy and mayor of a suburb in Bordeaux, as well as Green Euro MP Gerard Onesta, who said he was acting on behalf of the "80% of the European population that don't trust GMOs."

Of course, in a poll conducted not long ago, half of Europeans questioned thought the difference between genetically-modified food and ordinary food was that the first had genes added, while the second was gene-free.

All these GMO-related antics would be funnier if it weren't for the fact that French and other European politicians have been keen in the past to pander to the anti-GMO lobby, delaying the introduction of new crops which are no more than the result of a more-advanced form of plant breeding that, over the centuries, has steadily helped feed more and more people round the globe. One promise, of course, is that the bounty can be brought to the many millions who, despite the progress, remain undernourished throughout the world.

In that light, the latest study published by the French government agency responsible for food security is a timely contribution to a saner debate in Europe. The Agence Francaise de Securite Sanitaire des Aliments enjoys a high standing in France, not least for its efforts that helped ensure France was relatively untouched by BSE and escaped contagion from the British foot-and-mouth outbreak a couple of years ago.

The report, carried out by a 20-strong panel of experts, finds that the environmental and health risks posed by genetically-modified cotton, corn, sugarbeet, and rice are small, if not negligible, while the benefits, particularly in the reduction of the amount of pesticides farmers have to use, are significant - in terms of protecting the environment and people from toxins or growing crops more cheaply. At the same, AFSSA acknowledges that some benefits, particularly that of vitamin-enhanced "golden rice," aren't yet clear.

But AFSSA is adamant that real and potential benefits of GMOs have clearly been identified. But the risks aren't, and can't be, because "to this day, no health problem, whether it's a question of toxicity or allergens, can be specifically attributed to a GMO on the market."

For politicians in France, and elsewhere, seeking to prioritize policy and what to spend taxpayers' money on, that sort of verdict should help focus the minds on what they should be worrying about - and it ain't GMOs.


Seeds of Discontent

- Editorial, The Wall Street Journal Europe

While antiglobalization-farmer extraordinaire Jose Bove was out mowing down genetically modified crops this weekend, the French food-safety agency was issuing a report testifying to the advantages of genetically modified food.

Mr. Bove, who justified the action by saying those who would see GM crops introduced in France are "deaf," should listen up. We don't hold out much hope that France's most famous professional provocateur will change his stripes, but maybe some of those in France who look so admiringly on his publicity stunts will get the message.

The food-safety agency, known by its French acronym Afssa, made headlines in France mostly by pointing out the obvious; pest-resistant GM crops such as BT corn and cotton reduce pesticide use, helping the environment -- and farmers too, Mr. Bove. The report was less certain about the health advantages of pesticide-resistant crops, since that often means one pesticide is traded for another.

But it went on to say that no problems, either in terms of allergic reaction or toxicity had ever been traced to GM crops. Bowing to the absurdist precautionary principle, it noted that this, however, did not exclude the possibility that there were such risks, as yet undetected. But given that none had ever been found, the risks were said to be impossible to quantify.

Of course, we do not expect the Mowing Brigade to be moved by such testimony. It is precisely to prevent the scientific study of the effects of genetic modifications that Mr. Bove and his followers have taken to destroying the few test crops planted around France. But scientific progress has a way of leaving Luddites behind. Mr. Bove could face up to five years in prison if convicted in his latest act of sabotage. If his luck runs out and he goes away for awhile, his country may have time to learn the benefits of modern biotech science. The Afssa assessment is a good start.


The Institute of Food Science & Technology Supports Genetic Modification


Says Genetic modification has the potential to offer very significant improvements in the quantity, quality and acceptability of the world's food supply.

27/07/2004 The Institute of Food Science & Technology, through its Public Affairs and Technical & Legislative Committees, has authorised the following Information Statement, dated 27 July 2004, replacing the Statement of 2 September 1999 and any previous version.

Genetic modification (GM) has the potential to offer very significant improvements in the quantity, quality and acceptability of the world's food supply.

Food scientists and technologists can support the responsible introduction of GM techniques provided that issues of product safety, environmental concerns, information and ethics are satisfactorily addressed. IFST considers that they are being addressed, and need even more intensively to continue to be so addressed. Only in this way may the benefits that this technology can confer become available, not least to help feed the world's escalating population in the coming decades.

Food biotechnology is the application of biological techniques to food crops, animals and micro-organisms to improve the quality, quantity, safety, ease of processing and production economics of food. It thus includes the traditional food manufacturing processes used for bread, beer, cheese and various fermented milk products.

A relatively more recent (i.e. starting about 25 years ago) application of biotechnology to food is genetic modification (GM), also known as genetic engineering, genetic manipulation, gene technology and/or recombinant DNA technology. The collective term "Genetically Modified Organisms" or GMOs is used frequently in regulatory documents and in the scientific literature to describe plants, animals and micro-organisms which have had DNA introduced into them by means other than by combination of an egg and a sperm or by natural bacterial conjugation.

Advantages and potential benefits of genetic modification For the development of improved food materials, GM has the following advantages over traditional selective breeding:

- Allows a much wider selection of traits for improvement: e.g. not only pest, disease and herbicide resistance (as achieved to date in plants) but also potentially drought resistance, improved nutritional content and improved sensory properties
- It is faster and lower in cost
- Desired change can be achieved in very few generations
- Allows greater precision in selecting characteristics
- Reduces risk of random occurrence of undesirable traits.

These advantages could, in turn, lead to a number of potential benefits, especially in the longer-term, for the consumer, industry, agriculture and the environment:
- Improved agricultural performance (yields) with less labour input and less cost input
- Benefits to the soil of “no-till” farming practice
- Reduced usage of pesticides and herbicides
- Ability to grow crops in previously inhospitable environments (e.g. via increased ability of plants to grow in conditions of drought, soil salinity, extremes of temperature, consequences of global warming, etc.) leading to improved ability to feed an increasing world population at a reduced environmental cost
- Improved sensory attributes of food (e.g. flavour, texture, etc.)


GM: Its Just A Matter of Time

- The Grocer (UK), July 26, 2004

Greenpeace, Friends of the Earth et al would have everyone believe theres not a cats hope in hell that GMOs will hold a stake on British supermarket shelves, especially now that US GM pioneer Monsanto has pulled out of the European seed cereal business and closed a research centre near Cambridge.

Yet at Monsantos HQ in St Louis, scientists are quietly confident that the vilified food science will eventually spread worldwide, as The Grocer discovered during an exclusive interview with Hugh Grant, Monsantos chairman, president and chief executive officer, last week.

Speak to any Monsanto executive, and you'll soon be inundated with statistics. Did you know, for instance, that: 18 nations plant biotech crops, and the 2003 acreage grew by 15% over the previous year; or that seven million farmers worldwide grew GM last year, six million of them in developing countries; how about the fact that half the worlds population live in countries that grew the crops during 2003; and 90% of the massive US soya bean crop this year will be biotech.

In the UK, these are the sort of statistics that strike fear into the heart. But in the US, they are used to supporting the companys case. In truth, many in the US food and farming community are amazed that UK protestors have created lingering, nagging doubt in the minds of millions of consumers. As one pro-GM scientist put it to me: Britain has become the islands of introspection on this issue.

Typical of the opinions expressed in the US are those of prominent soya bean and corn farmer Greg Guenther, a former national director of the US Corn Growers Association. Standing in a cornfield in his 850 acres in Belleville, Illinois, he says: Prince Charles, by opposing genetic modification, has not done his country any favours.

My message to EU agriculturalists is that if you all want to go 100% organic, instead of taking up GM, be my guest. We will pick up the markets that you miss, but don't come crying to us when you lose money. US farmers are laughing at the way people across the pond are being manipulated by Greenpeace. Genetic modification gives us a technological advantage in world commodity markets.

Grant, who has just returned from a tour of several European states, including the UK, is just as confident the sceptics will eventually be won over. Recalling The Grocers visit to St Louis in 2000, he says: Four years ago, the GM debate was transatlantic. But it has been broadened considerably in recent times to become a global discussion. He feels encouraged that a large chunk of GMs growth in recent years has come from Asia, notably India, China, Indonesia and the Philippines, where more small farmers and low input agriculture have embraced the technology.

Globally, the first GM soya beans went into the ground in 1996, and now the total planted is over half a billion acres. Yet, argues Grant: Despite that growth, the sky has not fallen in on GM worldwide. None of the terrible things that were predicted for consumers who ate GM food have occurred. And in the US it is estimated that 50m worth of pesticides were not needed last year, as GM plantings spread. More and more North American farmers are embracing the technology because they can see that it works.

Grant believes the global debate on GM has moved from theory to delivery. After extolling the benefits of GMOs in the agronomic field, the biotech industry is moving into the next generation, offering products with direct benefits for the healthy food revolution. Monsanto has been working on developing plants that contain what some dub as the worlds best healthy heart ingredient Omega 3 fatty acids usually found in cold water, deep-sea wild fish. Fish make Omega 3 as a result of eating algae from the ocean and Monsanto scientists are taking the Omega 3 gene from the algae and transferring it to soya beans and oil seed rape. Last year, harvests from field trials showed that 20% of the oil from the crops consisted of Omega 3.

Grant says: The beautiful thing about this is that the oil crushed from those seeds does not taste of fish. It also means oil that a food manufacturer can put into a yogurt, a salad dressing, and a health bar, or even in corn flakes, and offer shoppers a daily requirement of Omega 3 without harvesting fish for that purpose. Therefore, its good news from a food point of view because it is a cheaper, more sustainable source. Monsanto expects the products, subject to regulatory approval, to be available by 2009. The company is also contributing to a development in the Philippines to produce vitamin A enhanced GM rice, and other healthy products are understood to be in the pipeline.

But what about claims from UK activists that even some members of the US public have begun to question the safety and viability of GM? At the annual International Convention of the Biotechnology Industry Organisation in San Francisco recently, a gaggle of protestors in Grim Reaper and Frankenstein costumes loudly made their views known.

Grant, however, is adamant. Market research and anecdotal evidence tells me that such a discussion is not on US shoppers radar screens. And that is mainly because of the combination of the US Department of Agriculture and the Food and Drug Administration a combined regulatory system that consumers trust.

He also cites the GM evolution in India. Four years ago there was government concern about GM and field trials were being destroyed. Today, biotech cotton, approved by the Indian authorities, is being planted and small companies are preparing to do research.

But given the events worldwide, he must surely be disappointed by the lack of support for GM foods in Britain? I am very encouraged by the Food Standards Agency, he says. And while things cannot happen overnight, the FSA is giving balance to the GM debate in Britain. And that is real progress. In addition, a general European regulatory system, that took way too long to appear, has started working.

As Asia expanded into GM, Europe went backwards. But now things are moving in Europe, where some 25 GM products have been awaiting Brussels approval. In the last six months we have seen the machinery restart and the GM debate is being re-ignited on a scientific level.

Back in his adopted country of the US, Grant says that compared with four years ago, the group is receiving more calls from food manufacturers interested in using GM raw materials. Given the debate about nutrition and obesity in the US, suddenly our products are regarded as potential solutions, he says.

So is it time for Monsanto to turn up the publicity machine in the UK to promote GM against the continuing barrage from the activists? Grant nods cautiously, but adds: I am not a fan of empty rhetoric. I prefer to see new products and technologies have a part in the dialogue.

However, given that we are close to the stage when we can be talking about Omega 3 in soya, or even a formulation that can be worked in yogurt or salad dressing, it takes us from an abstract to an absolute. And that makes for an easier conversation with food companies rather than simply appearing a visionary.

While Grant believes Monsanto can help in the discussion about GM in the UK, he does not think the group should be leading it. I am not presumptuous enough to think that an American technology company should lead that discussion with the British consumer. Clearly, that is something that should be led by retailers, food manufacturers and British scientists. We have a part to play. But the mistake that we made in 1997 was that we arrogantly believed that we could and should lead it. It is OK to make a mistake once, but unacceptable to make it twice.

The European debate about GM will be played out country by country, believes Grant. The discussion in the UK is a different one to that in France or Holland. But I believe that it is an easier conversation in Britain now that the FSA exists where there was a vacuum. In truth, we have never really stopped talking to the agencies and authorities in the UK, but recently it has been more low key, and more practicably based.

Second, compared with four years ago, more people are engaged in the discussion, and it helps our cause when big retailers cross their traditional borders through store expansion. Also, we are no longer the spear-catcher for this issue, and that is kind of nice. Finally, Grant says he is encouraged by the recent growing support from the UK farming community.

Having said that, farmers are not vocal. They are genuinely conservative, so I am not holding my breath on them storming Whitehall. But the opinion among those that I have met in the UK countryside is that there is more willingness to at least try GM when they are able to.

Is it realistic to believe that the organic system in the UK could ever live harmoniously alongside GM food on supermarket shelves? Grants answer is an emphatic yes. He adds: There will always be a small percentage of consumers who will be prepared to pay significant premiums for organic. And I am fine with that. But there will also always be a big piece of supermarket shelf space that focuses the consumer on price and quality and the last decade has shown that GM technology has a part to play in driving price and quality.

The fact that the EU is allowing imports of a genetically engineered sweetcorn, developed by Swiss firm Syngenta, thus ending a six-year moratorium on the approval of biotech food, suggests that attitudes may already be changing in Europe. Grant says, The challenge is to introduce consumer choice to the debate so when shoppers walk into supermarkets they get a chance to select something that is clearly labelled as GM or produced in an alternative system.

That is where the frustration lies, because if the price were right I think British consumers would happily buy GM products.


Genes, Torts Converge in ASU Law Program

- Josh Kelley, The Arizona Republic, July 28, 2004 http://www.azcentral.com/

Guy Cardineau takes it personally when his wife buys organic milk, unaltered by scientists like himself, or when an environmentalist bashes insect-resistant corn, with genes changed by scientists like himself.

For the past 20 years, Cardineau has worked at the cutting edge of research on genetically modified crops. But worse than personal insults can be the legal fallout from innovative but controversial scientific research. That's one lesson among many he'll be teaching lawyers next year at Arizona State University in the country's first program offering an advanced legal degree in biotechnology and genomics.

Cardineau, a professor at ASU, is one of a few scientists using genetically altered plants to manufacture vaccines and antibodies eventually intended for human consumption and even national defense against bioterrorism. With his personal success also comes the need for patents to protect intellectual property and the inevitable string of lawsuits from people claiming to be sick from genetically altered foods.

An expert in molecular and cellular biology, Cardineau, 54, has seen firsthand the host of legal issues that genetic research can entail. He has been deposed 14 times, taken the witness stand in court and collaborated on legal strategies for a biotech company. In fall 2005, Cardineau will take his practical experience into the classroom when he begins teaching lawyers enrolled in the new advanced legal degree program. Lawyers will earn a master's degree after one year of study from the College of Law at ASU. Cardineau plans to jointly teach a class called Biotechnology and the Law, with Douglas Sylvester, a law professor.

Cardineau spends most of his time with ASU's Biodesign Institute, which, at least in part, has spurred the creation of the new law program that will form a "symbiotic relationship" with the institute, said Gary Marchant. Marchant is the executive director of the College of Law's Center for Law, Science and Technology that will support the new program.

The Biodesign Institute's new 172,000-square-foot building that cost $73 million is scheduled to open this fall. Another building, similar in size and cost, is under construction. The institute's master plan calls for two more buildings and a conference center in the future. The new law program has already attracted a wide variety of people worldwide, including Arizona state Appeals Court Judge Susan Ehrlich, who is itching to apply. "I'm very excited about the possibility," Ehrlich said. "I really hope I'm accepted in the first class."

Ehrlich has three versions of the human genome map in her office and says she has loved science since she was a little girl. But besides satisfying her curiosity, enrolling in the program will likely provide Ehrlich with important legal and scientific training.

"These issues are increasingly confronting the courts," said Ehrlich, who has also reviewed U.S. Department of Defense grant applications to analyze their ethical and legal implications. "I expect that the number of issues will grow exponentially," she said.

That's a sentiment echoed by Marchant. He says he has been overwhelmed by the global response to the new program from lawyers in countries including Great Britain, South Korea, Kenya, Germany, France, Brazil and Mexico.


Biotech's Crazed Critics

- Henry I. Miller, TechCentral Station, July 28, 2004 http://www.techcentralstation.com/072804D.html

It's hard to top some of the loony things that have been said about the new biotechnology. Technophobe Jeremy Rifkin claimed, for example, that genetically engineered bacteria might disrupt weather patterns, and that biotechnology threatens "a form of annihilation every bit as deadly as nuclear holocaust." And at one of the six public meetings convened by the British government to discuss biotechnology, there was conjecture about whether the SARS virus originated in gene-spliced cotton in China.

But in a recent article, anti-biotechnology activist Steven Druker came up with a real doozy. The gist of his argument is that by filing a complaint at the World Trade Organization against the EU's regulatory practices toward biotech-derived crops and foods, the United States "has been bullying the EU to abandon a principle that is the cornerstone of its own food safety law." As evidence, Druker cites U.S. food safety regulation that "places the burden of proof on the manufacturer and requires that foods containing new additives be presumed unsafe until proven safe."

The principle that Druker alludes to is the extreme "precautionary principle," much beloved in Europe, which holds that while a product, technology or activity has not yet been proven to be absolutely safe, it should be prohibited.

Not only is the basic premise of Druker's argument absurd, but the example he invokes to prove his case -- the requirement in U.S. law for the review of food additives before they are sold -- in fact proves exactly the opposite. He appears not to understand what a food additive is.

Under American law, a new food or food ingredient is either "generally recognized as safe" (GRAS) or it is a food additive and requires government review and approval. The maker of the product gets to determine whether or not the product is GRAS.

Conceptually, the objective of pre-marketing regulation (as opposed to post-marketing policing of the marketplace for products that cause problems) generally is to circumscribe for review potentially high-risk categories of products, such as food additives (which are, by definition, not generally recognized as safe), pesticides, prescription drugs and nuclear power plants.

In contrast, all of the gene-spliced, or "genetically modified" (GM), plants now on the market are widely recognized to be a negligible- or very-low risk category, as are the vast majority of the varieties being tested or contemplated. No one should find this surprising. The U.S. National Research Council observed fifteen years ago, "With classical techniques of gene transfer, a variable number of genes can be transferred, the number depending on the mechanism of transfer; but predicting the precise number or the traits that have been transferred is difficult, and we cannot always predict the [traits] that will result. With organisms modified by molecular methods, we are in a better, if not perfect, position to predict the [traits]."

More recently, even EU Commissioner for Health and Consumer Protection David Byrne acknowledged that Europe's precautionary labeling and traceability rules have nothing to do with protecting consumer health or the natural environment. And an analysis by the EU that summarizes the conclusions of 81 different EU-funded research projects spanning 15 years concluded that because gene-spliced plants and foods are made with highly precise and predictable scientific techniques, they are at least as safe, and often safer, than their conventional counterparts.

The relevant U.S. government policies that govern gene-spliced foods lie primarily not in the food additive regulations but in two others. The first, a 1992 announcement from the White House Office of Science and Technology Policy, articulates "a risk-based, scientifically sound approach" to the oversight of biotech products generally, according to which neither oversight nor the degree of regulatory scrutiny should "turn on the fact that an organism has been modified by a particular process or technique."

The second, also published in 1992, describes specifically the FDA's official policy toward foods derived from "new plant varieties." This announcement, intended to clarify the FDA's position on the regulation of gene-splicing and gene-spliced plants, explained that the "regulatory status of a food, irrespective of the method by which it is developed, is dependent upon objective characteristics of the food and the intended use." This genuinely risk-based approach treats gene-spliced and other foods no differently and requires case-by-case review by regulators only when the products raise specific safety concerns.

In short, official U.S. policy dictates unequivocally that merely the use of gene-splicing techniques is not an appropriate trigger for case-by-case review, or "precautionary" regulation, of foods. The FDA's approach is, thus, consistent with the consensus of the scientific community.

Therein lie the fundamental differences between the U.S. and European approaches to the precautionary principle. Many, if not most, countries impose extra scrutiny on higher risk categories of activities, technologies, or products. But out of ignorance, caprice or protectionism, Europe has chosen to vastly over-regulate gene-splicing, a negligible-risk, proven, beneficial technology.

What are the effects of this disparity? Since 1998, 61 percent of the private-sector institutions surveyed by the European Commission's Joint Research Center have canceled research projects that involve gene-splicing technology, and there has been a near-meltdown of field trials of gene-spliced organisms. From an unimpressive peak level of 264 field trials in Europe in 1997, there were only 35 in 2002. By contrast, U.S. plant biologists and plant breeders perform thousands of field trials annually, and last year more than 45 million hectares of commercial gene-spliced crops were planted.

But there is more to this story. Druker's op-ed goes on to grind one of his favorite axes -- one that's so old it's showing rust: He bashes the FDA's twelve-year-old risk-based policy of treating gene-spliced foods no differently from conventional foods except as scientific factors may dictate, and he accuses the FDA of "cover[ing] up the warnings of their own scientific experts about the unique risks of" gene-spliced foods. He bases that accusation on documents that supposedly show that several of the hundreds of FDA staffers who were involved in the formation and promulgation of agency biotech policy were more conservatively inclined, because they pointed out that even small genetic alterations in an organism can cause many changes.

Cover-up? Unique risks? Neither claim stands up to scrutiny. I headed the FDA's Office of Biotechnology at the time, and I was astonished at the virtual unanimity, both inside and outside the agency, of opinion toward the FDA's risk-based approach to regulation, which was consistent with the widespread scientific consensus about the high degree of precision and predictability of gene-splicing techniques.

But the proof of the pudding is in the eating, and over the past twelve years, the FDA's policy has worked flawlessly for tens of thousands of food products containing gene-spliced ingredients -- of which to date Americans have consumed more than a trillion servings.

Druker's risible accusations about FDA cover-ups and U.S. government actions "cloaked in hypocrisy and driven by deception" shed a great deal more light on his own paranoia than on public policy.

Henry I. Miller, a fellow at the Hoover Institution and the Competitive Enterprise Institute, headed the FDA's Office of Biotechnology from 1989-1993. His latest book," The Frankenfood Myth: How Protest and Politics Threaten the Biotech Revolution," will be published next month by Praeger Publishers. 


Europe is Losing Its Scientific Elite

- Ann Mettler, Financial Times (UK), July 14 2004; Via Vivian Moses

Few issues have caused as much controversy during the run-up to thisyear's US election as the complex and elusive phenomenon known as"offshoring". In the US, the practice is deemed unjust, even unpatriotic.

But imagine the political outcry if, in addition to the loss of so manyjobs, nearly half a million of America's scientists had already left thecountry, claiming that working conditions there were so poor they couldnot do their job properly. Imagine, too, if companies were moving theirstate-of-the-art scientific research overseas, believing the cutting-edgeinnovations were more likely to be discovered elsewhere.

Welcome to Europe, where this scenario is not a fantasy but a grimeconomic reality. Each year, thousands of Europeans go to study in the USand the vast majority - more than 70 per cent - will not bring theeducation they receive there back home. Most will stay in the US,preferring to pursue their career in an environment that nurtures theirtalents and rewards their ingenuity. As a result, nearly 40 per cent ofthe scientists working in the US today were born in Europe.

Companies looking for markets that welcome innovation are following suit:only last month, Syngenta joined Monsanto, DuPont and Bayer CropScience inrelocating its genetically modified crop research operations from Europeto the US - a move that is currently also being contemplated byGermany-based BASF, the world's largest chemical company.

Yet these facts are being completely overlooked in the contemporary debate on Europe's economic future. Politicians and trades unions are watching companies move jobs overseas, responding logically to Europe's high-wage,low-flexibility work environment. But rather than striving to change the business climate here, they are denouncing companies that move jobs overseas as "unpatriotic".

This is sheer demagoguery. Europe's politicians know that the loss of many low-cost manufacturing jobs should be considered a natural progression -an act of "creative destruction", to borrow the economist Joseph Schumpeter's phrase - as Europe moves from an industrial to a networked and knowledge-based economy. Paul Krugman, the US economist, once noted that, had you told a farmer in the 1830s that less than 5 per cent of the population would work on the land in 150 years' time, he would have shuddered at the prospect, not knowing that manpower-intensive agrarian jobs would soon be replaced by better-paid, less volatile employment opportunities.

The same is true today: jobs in manufacturing will and should go to locations that can provide these services more cheaply and efficiently.European leaders must acknowledge this fact and begin tackling the real problem - the shortage of highly qualified people, especially in the sciences, who will be needed to keep Europe's economy at the forefront of21st-century developments.

The truth is, Europe's leaders are the ones who are unpatriotic; they consistently promulgate policies aimed at the next election, not the next generation. How else can one explain that they choose to spend almost half of the European Union budget on agricultural subsidies while funding per student for tertiary education is more than a third lower in Europe thanin the US? How can they find the money to subsidise economic activities that are pre-industrial in nature while watching Europe's best and brightest leave in droves, taking invaluable intellectual capital and corporate investment with them?

The debate about offshoring is deeply distorted and highly populist. The fact is that offshoring has been occurring for many years, if not decades.The bad news is not that Europe is losing its manufacturing jobs but thatit has already lost a good chunk of its intellectual elite. The silent departure of more than 400,000 scientists - the number now based in the US- may not be as threatening to politicians as loud and disruptive street demonstrations, but it deserves to be seen as a form of protestnonetheless. gThe number of Europe's "educational refugees" may be toosmall to be felt at the polls, but their absence will be felt in future prosperity and social cohesion.

It is time for Europe's leaders to put their money where their mouths are.If they want more scientists, more research, more entrepreneurship and more innovation it is their responsibility to provide a political and economic climate capable of producing the jobs of the 21st century.The writer is executive director of the Lisbon Council, a Brussels-based pressure group



'Environmentalists, Animal Rights Activists Can't Decide What to Think about New Sheep'

Watley Review, Vol. 2, Issue 29, July 27, 2004


The first research of its type in Australia has concluded that genetically modified sheep are capable of growing specialized wool which can serve as light bulb filaments. However, the findings have provoked a furious muddle among activists who can't decide on what grounds, if any, to condemn the project.

The Commonwealth Scientific & Industrial Research Organization (CSIRO) conducted a five-year experiment in which they determined that Merino sheep with a particular genetic modification could, when fed the right diet, produce wool with a high enough tungsten content to function as the filament in an incandescent light bulb. In a typical 60-watt bulb, the tungsten filament is about 6.5 feet (2 meters) long but only one-hundredth of an inch thick. Tungsten is a metal not normally found in wool.

"The potential benefits and limitations of this technology need to be properly evaluated, taking into account scientific data and community concerns," said project leader Norm Adams at a press conference. "However, it is our hope that these animals, which we have dubbed "Edison Sheep," may do mankind a service by providing an environmentally safe and cheap alternative to traditional tungsten production methods."

On the one hand, this project raises ethical questions comparable to those in any experiment involving genetically modified animals. Gene Thompson, a spokesman for the group "Friends of the Earth," which has long campaigned against genetically modified food, said "Genetically modifying animals so they become factories raises serious ethical questions. Where will this stop? Will the sheep be growing entire light bulbs next? What kind of a life would that be, to walk around growing glass bulbs on your back?"

On the other hand, widespread production of the Edison sheep could radically transform the tungsten production business, reducing pollutants by millions of tons annually and preventing mining-related health problems for thousands of people, not to mention saving an estimated $150 million in costs.

"Man, this is a real head-scratcher," said Greenpeace activist Robert Pendrake. "I must admit that the elimination of an entire mining industry is a very attractive prospect. And - not that I'm for genetically modified animals - but if they could create sheep that grow wool containing coal, or other products, they could really make a difference. Why couldn't they have made it simpler for us by making the sheep grow guns or something. I could take a position on that."

Further complicating the matter, however, is the fact that incandescent light bulbs are not as energy-efficient as fluorescent equivalents.

"Compact fluorescent bulbs use a quarter the energy of regular bulbs," said Sylvia Gerstan of the group Energy Responsibility Now. "We've been working for years to convince consumers to spend a little more up front on fluorescents. I think making regular bulbs cheaper like this is utterly irresponsible. Why can't they make the sheep grow fluorescent tubes instead?"

And still more complicated is the potential impact on workers currently employed in the tungsten production business. "I can tell you this," said John Barker of the United Mine Workers of America. "Those sheep put even one miner out of a job, we'll make mutton pie out of 'em."

With such a maelstrom of conflicting public opinion making it difficult to gauge public reaction to the news, the White House declined to comment on the Edison sheep.

"Are you kidding?" said White House Spokesman Scott McClellan. "Ask me an easier one, like something about war crimes or the economy or something."