Banished biotech corn not gone yet

Traces raise health, other key issues

December 1
San Jose Mercury News

Three years after a genetically engineered corn banned from human consumption turned up in taco shells and was pulled from the market, contaminated grain is still showing up in the nation's corn supply.

A federal testing program found traces of the banished grain, called StarLink, in more than 1 percent of samples submitted by growers and grain handlers in the past 12 months, government records show.

The corn variety, engineered to produce its own pesticide, was supposed to be limited to animal feed and industrial use out of fear it might cause severe allergic reactions.

While the health effects of StarLink are still unsettled, many worry that the government remains unprepared to deal with unexpected health problems from genetically engineered crops, especially those now being field-tested to mass-produce medicines, vaccines or industrial chemicals.

It is still unclear how StarLink became mixed with the vast stream of corn headed for human consumption. Some growers may have sold their corn without identifying it as StarLink. Because corn kernels move in and out of grain elevators and shipping containers like a liquid, even small amounts can contaminate large stores of grain.

As the continued StarLink contamination shows, it is very difficult to eliminate all traces of any type of grain once it's been mixed in with others.

``It's hard to put the toothpaste back in the tube,'' says Iowa Assistant Attorney General Steve Moline, who helped negotiate a 17-state settlement with StarLink producer Aventis CropScience.

``The StarLink lesson is that contamination is to some extent irreversible,'' said Doreen Stabinsky, a scientific adviser to Greenpeace, who has a Ph.D. in genetics. ``Years later, you could still see it turning up in the food supply and the grain supply.''

However, the biotech industry regards StarLink as a unique case. Despite dozens of claims from individuals who say they suffered allergic reactions after eating corn products, officials say the contamination caused no proven health effects. And they say this kind of contamination is unlikely to be repeated with other genetically engineered plants.

``It's been a non-trivial black eye, a self-inflicted wound we didn't need,'' said Val Giddings, vice president for food and agriculture for the Biotechnology Industry Organization, a trade and lobbying group. But ``not only don't we have dead bodies, we don't have headaches or a single sniffle.''

When StarLink seed was approved for planting in 1998, the manufacturer, a division of the company now called Aventis, agreed to have growers sign contracts requiring them to keep the grain out of the human food supply.

But in September 2000, a coalition of environmental groups announced that they had found StarLink residues in taco shells, chips and muffin mixes pulled from supermarket shelves.

``The response to StarLink in the human food supply was swift: to make sure more of it didn't get there and anything out there didn't reach consumers,'' recalled William Jordan, a senior policy adviser for the EPA's pesticide programs.

The company lost its approval to sell the seed, but was not fined. `If you don't pass your driver's test, you don't get a fine -- you don't get a driver's license,'' Jordan said.

Food manufacturers pulled their products from supermarket shelves and Aventis agreed to buy up the StarLink crop and track down any seeds still unplanted. In a settlement with attorneys general in 17 corn-growing states, the company agreed to reimburse farmers and grain handlers for their losses.

This year, Aventis agreed to pay $110 million to settle claims from corn growers who did not grow StarLink but were hurt by the declining market for U.S. corn because of the contamination.

Aventis, a French drug company that sold off its crop seed subsidiary, will not comment on how much it has spent on the StarLink recall and its aftermath. Neil E. Harl, a professor of economics at Iowa State University, estimates that the company has paid out more than $500 million to farmers, food processors and grain handlers.

Over the past three years, the amount of StarLink detected by the U.S. Agriculture Department's voluntary testing program has dropped steadily -- and so has the number of samples tested.

In the first year after the corn was withdrawn from the market, USDA reported 8.6 percent of samples tested were positive for the Starlink protein that acts like a pesticide. The contaminated proportion had dropped to 1.2 percent in the 12 months ending Sept. 30.

``We don't believe that it reflects the overall corn supply,'' said John B. Pitchford, director of international affairs for the USDA's Grain Inspection, Packers and Stockyards Administration, which runs the testing program. ``We think our data is skewed on the high side.''

Growers and grain handlers, however, are free to conduct their own tests without revealing their results to the government.

Following federal guidelines, the mills that process corn and other grains for cereal and other dry products test every load of corn brought to their facilities for StarLink. About one out of every thousand samples tested postive this year -- down from one out of a hundred two years ago, said Jim Bair, vice president of the North American Millers' Association.

Bair complains that the test for StarLink is so sensitive that it can detect as little as five parts per billion in a contaminated sample, an amount that is vanishingly small. That's one one-thousandth of the Food and Drug Adminstration standard for a peanut protein known to cause serious, sometimes deadly allergic reactions.

Bair and others, however, are troubled by an incident last year, when ProdiGene, a Texas biotech company, was found to have contaminated 500,000 bushels of soybeans with corn engineered to produce an experimental pig vaccine. The company paid a $250,000 fine and agreed to reimburse the Department of Agriculture for the $3 million cost of destroying the contaminated soybeans.

Officials with the Biotechnology Industry Organization say the incident proved that the regulatory system works and that unlike StarLink, these non-food test crops are grown on smaller acreage and are carefully monitored by regulators.

But Iowa State's Harl worries that the way farmers store, ship and handle grain makes it difficult to keep such contaminants out of the food supply. And he adds, ``If there is a significant, serious health problem with one of these, this becomes a serious public health issue.''

English wild plant variety wanes

December 1
BBC

Some of England's rich variety of wild plants is disappearing in the face of an onslaught by pollution and invading competitors, the UK Government says.

A survey of English biodiversity found plants in trouble in and near fields, along river banks and in woodlands.

But river quality is improving and more of England is being farmed in a way that also respects the environment.

In the UK as a whole, the wild bird population has risen by 5% over the last 10 years, the government says.

The survey report, Measuring Progress: Baseline Assessment, is published by the Department for Environment, Food and Rural Affairs (Defra) as part of its strategy for improving biodiversity in England.

Depending on plants
It notes two negative trends: an increase in nutrient levels (especially phosphates) in rivers, and a decline in wild plant diversity in fields and field margins, river banks and stream sides, and woodlands.

The report says the decline has been most severe in infertile grassland and hedge bottoms. Plants are important food sources for many birds and insects.

Defra scientists say there are several reasons for the plants' plight, including fertiliser use which enriches the soil, and the nutrient enrichment of the rivers. Both can encourage the growth of species which overwhelm less chemical-tolerant plants.

The Environment Minister, Elliot Morley, said: "The key issue for plants is light. If you get invasive species like nettles which shade out the natives, they'll die."

He said one plant, the starry breck lichen which grew in eastern England, appeared to have become extinct in 2002, probably because of airborne pollution.

The chief executive of the Natural Environment Research Council (Nerc), Professor John Lawton, underlined the dangers of this sort of pollution last September.

Hopes raised
He said: "There is as much nitrogen falling out of the air from car exhausts now as farmers put on the land with fertilisers in the 1950s. That is the scale of the problem."

The report says the number of wild birds in England has begun to stabilise after a 20-year decline, with water and wetland birds increasing by 7% since 1975.

Farmland birds seem to have stabilised since the mid-1990s, and nine species of town and garden birds have increased by 10% since 1979, though sparrow and starling populations have fallen by 60%.

The Royal Society for the Protection of Birds said if the government delivered on the reforms of the European Union's common agricultural policy, the future for birds could be good.

But if it gave the go-ahead to genetically modified (GM) crops, that would be "another kick to farmland birds".

GM trials 'limited'
Last month Lord May, president of the UK's Royal Society, said both opponents and supporters of GM technology had misrepresented the results of the recent trials of their effects on farmland biodiversity, the field scale evaluations (FSEs).

He said: "To generalise and declare 'all GM is bad' or 'all GM is good' for the environment as a result of these experiments is a gross over-simplification, but statements from both sides in the GM propaganda war have claimed 'victory' based on these findings."

Mr Morley told BBC News Online: "I think there's some truth in that. People on both sides tried to read more into the FSEs than was there.

"The key finding was what they showed about the impact of chemical management. It was the chemicals that were used on the trial crops that affected the biodiversity, not the GM traits themselves."

Stubborn decline
Across the UK, Defra says, "the population status of 106 bird species is 13% higher than it was in 1970, although there has been a small increase compared to 2000".

But farmland bird numbers remain at below 60% of their 1970 level, and woodland birds about 20% lower.

The survey was compiled in conjunction with the Royal Society for the Protection of Birds and the British Trust for Ornithology.

Safety of food from clones under debate

FDA retracted its OK of meat and milk from replications of animals when an advisory panel challenged the scientific basis of the decision

December 1
Chicago Tribune

WASHINGTON -- The U.S. Food and Drug Administration is in a quandary over cloned animals.

The agency tentatively concluded in late October that meat and milk from cloned animals is safe to eat, elating farmers who are developing clones of cows and other creatures. But almost immediately, one of the FDA's advisory committees sharply questioned the conclusion and the science behind it.

Now the FDA must figure out how to respond to the panel's findings and its request for more data, despite the small amount of available research from the cash-strapped cloning industry. The initial FDA report contained no studies that analyzed meat from clones, and only one small study examining milk from clones.

The agency is facing strong pressure to write rules for a new, controversial, potentially exciting industry while simultaneously dealing with an unusual lack of science in the field. It is an almost unprecedented situation for the FDA, and the official in charge of the cloning review acknowledged it is struggling to come up with an answer.

"Most of the things we evaluate for safety, we can identify what the hazard might be," said Stephen Sundlof, director of the FDA's Center for Veterinary Medicine. "When you're talking about cloning, it's very different because we have not been able to identify a particular hazard.

"Trying to ask for particular studies when you don't have a specified hazard to drill down on and evaluate, it becomes very hard for the agency to say what they would be looking for," Sundlof said.

The FDA plans to release a more detailed report in the spring to address the concerns of its advisory panel.

Critics contend that the FDA, responding to pressure from the food industry, relied on the flimsiest of science to rush cloned animals into the human food supply and should require more extensive tests before it moves forward with the approval process.

In evaluating food from cloned animals, the agency outlined two approaches in October.

One approach, it said, compared clones at different stages of life to healthy conventional animals to determine whether they appear the same. The second and more rigorous approach could involve tests on the meat and milk of clones.

When the FDA concluded that cloned animals appeared to be safe to eat, critics noted that the agency seemed to rely almost exclusively on the first approach.

Joseph Mendelson, legal director for the non-profit Center for Food Safety, called the FDA's draft report "bizarre" for its lack of research.

"Healthy animals equal safe food. I agree with that on some level," Mendelson said. "But we don't know if these animals are healthy. What if they appear healthy, and there's some metabolic difference that's caused by a genetic defect? They don't have those studies."

How much science?
At the heart of the debate is the question of how much science is required to determine whether cloned animals or their progeny are safe for humans to eat. As the backers of genetically engineered plants and bovine growth hormone can attest, it's a question that may have as much to do with public attitudes about new technologies as it does about science.

"You really need to have a higher bar on this one," said Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania. "Forget about what is required from a regulatory point of view. From a practical point of view, if you are not persuasive about the safety of cloned animals, you are going to be leaving the door open for critics."

The FDA's regulatory efforts come as the tiny cloning industry is struggling to deliver on its initial promise and as the public remains overwhelmingly uneasy about the process of cloning animals, let alone eating cloned ones. A 2002 Gallup poll found that 66 percent of consumers considered it morally wrong to clone animals.

In the years since Dolly the sheep became the first cloned mammal in 1996, researchers have successfully cloned cattle, mice, goats and pigs, though the process remains costly because so many clones die in utero or shortly after birth.

Still, a small number of biotech companies have cloned cows and pigs in the hopes of replicating animals that produce the best meat and milk, preserving rare and endangered species and creating research herds for pharmaceutical experiments.

FDA pulls permission
The FDA has imposed a voluntary moratorium on allowing cloned animals into the food supply while it creates regulations.

Greg Wiles, a dairy farmer in western Maryland, paid about $60,000 in 2000 to have two clones made of Zit, a champion Holstein that produced more than 30,000 gallons of milk a year, rich in butter fat.

"Right now, there's no benefit to us," said Wiles, referring to the clones, named Genesis Z and Cigar Z. "We are dumping the milk twice a day. Basically we're losing money. . . . Our problem will be, by the time the FDA makes its decision, our two clones will probably have passed their potential."

The FDA's decision has been complicated not only by the complexity of cloning but also by questions about whether the agency has the authority to regulate cloning. The FDA does not regulate animal reproductive technologies, such as in-vitro fertilization, but it would regulate cloning if regulators decide that the process introduces something new into the food supply that can be classified as a food additive or a new animal drug.

The FDA's draft report found that animals that lived to adulthood appear to be safe to eat. The report also noted that there was little science to review about the safety of eating cloned animals.

The report said the only risks that could arise from clones "would be from an incomplete or inappropriate reprogramming of the genetic information" that would allow a clone to appear healthy but harbor subtle anomalies that could be hazardous.

To determine whether such hazards posed food safety risks, the agency relied on an approach that divided the animal's life into five stages and compared development to other types of artificial reproduction. The approach "is based on the hypothesis that a healthy animal is likely to produce safe food products."

In addition, the FDA said a "compositional analysis" of food products from healthy clones could determine whether it was different from conventional meat. But because cloned animals are so expensive, the FDA said none are likely to be slaughtered for meat, so information on the composition of clone meat is very limited.

The FDA used an analysis of milk from 17 cloned cows that found their milk was similar to that of conventional cows. Differences between the two were attributed to differences between breeds and the cows' diets.

The FDA also relied on a new study from Cyagra, the company that cloned Wiles' cow, which reviewed medical records from 134 cloned cows and found "healthy clones of the oldest [6-18 months] cohort evaluated are virtually indistinguishable from their comparators."

The information provided the FDA with "a high degree of confidence in judgments regarding the health of [and likely food safety of edible products derived from] bovine clones," the report said.

Likely, not absolute
" In all likelihood, the products from cloned animals are perfectly safe," said John McGlone, a member of the FDA advisory panel and a professor of animal science at Texas Tech University. "We just don't have any evidence of that. . . . There's no data to say that it's unsafe. And there is not enough data to say it's safe."

On Wiles' Futuraland 2020 farm, the dairy farmer wonders why the FDA hasn't tested the blood or milk from his animals. Wiles has done some research on his own, though.

"I've actually drank the milk from our clones," said Wiles, who reports no noticeable ill affects. "It tastes just the same as regular milk."

EU food agency to give first verdict on GMO safety

December 1
Crop Decisions

Europe's top food agency will give its first verdict on the safety of genetically modified food next week, days before the EU debates lifting a five-year ban on new GMO crops and foods.

The low-profile European Food Safety Authority (EFSA) has assessed the safety of a type of GM maize used in feed and marketed by U.S. biotech giant Monsanto. EFSA reached its conclusion but will stay silent until December 4.

A few days after the EFSA verdict, a specialist EU committee will discuss European Commission plans to authorise imports of a GM sweetcorn, Bt-11 maize, manufactured by Switzerland's Syngenta.

This committee, comprising officials from the EU's 15 member states, will meet on December 8. Bt-11 already received the required positive scientific opinion in early 2002 from another EU committee, several months before EFSA came into existence.

If Bt-11 imports are approved, the EU's unofficial ban on GMOs would effectively end, to the delight of countries such as the United States and Canada which have already started action against the EU's biotech policy at the World Trade Organisation.

It will be the second time in under a month that the committee will debate the Bt-11 maize application: last time, an informal show of hands showed there was clearly not yet enough support to endorse the Commission proposal.

While the product that EFSA has analysed is different to the one that will form the focus of the committee's debate, the scientists' views could still shape the tone of the debate as they represent non-political independent opinion -- not that of a committee made up of officials from the EU's member states.

The applications for both Bt-11 and the Monsanto product, a field corn known as NK603, relate to import and industrial processing, not for planting in Europe's fields.

The Commission is keen for a committee meeting in early February that could possibly agree to authorise NK603 maize. However, diplomats say the acid test for judging whether the EU's ban is really over will be when member states agree to approve a live GMO, for planting and harvesting.

EU procedure allows for member states to lodge objections on environmental or human health grounds against proposed new GMO authorisations. If these objections are not withdrawn by the end of a specified period, EFSA is asked for a risk assessment.

If it receives such a request, EFSA must give its scientific opinion within 90 days and the Commission also has to wait for EFSA's opinion before proceeding with new GMO applications.

The Commission has asked EFSA to assess other GMOs, all from Monsanto. These applications are for import and processing, not growing. EFSA is expected to deliver its views in early 2004.

The products are Monsanto's GT73 herbicide-resistant oilseed rape, its maize line MON 863 and maize hybrid MON 863/MON 810. The maize products are designed to resist certain insect pests.

EFSA hit the headlines in July with its first scientific opinion, again requested by Commission, its main customer -- which relates directly to the politically-charged GM debate.

It ruled that Austria had not given enough evidence to justify one of its regions outlawing all GM organisms for three years. The Commission then followed EFSA's opinion and rejected the Austrian request for a GM-free zone -- while the region itself, Upper Austria, said it would take its case to court.