2 news stories on GMO's.

[Guest guest]

Regulators fine biotech companies for mishandling crops

 

PAUL ELIAS

Associated Press

 

SAN FRANCISCO - Federal regulators fined two biotechnology companies for

alleged mishandling of genetically engineered corn planted outside.

 

Mycogen Seeds, a unit of Dow AgroSciences LLC, and Pioneer Hi-Bred

International agreed to pay a combined $18,700 to settle charges they

failed to adequately protect their experimental crops in Hawaii from

contaminating other crops growing nearby. Neither company admitted or

denied wrongdoing.

 

Neither company was accused of actually contaminating unmodifed crops.

But Pioneer Hi-Bred must perform tests on unmodified corn growing in

adjacent fields to ensure none of those crops was contaminated.

 

An increasing number of consumers are concerned about the health

consequences of genetically engineered food, even though not a single

sickness has been reported.

 

The government and biotech industry are under pressure by food

processors and biotech foes to toughen rules for growing pharmaceutical

and industrial crops. The Grocery Manufacturers of America, for example,

wants biotech companies to stop using corn and soybeans - which are

widely used for food - as vehicles for growing biotech products that

humans and animals are not supposed to eat.

 

" There are so many unknown impacts of genetically modified organisms, "

said Doreen Stravlinsky, a Greenpeace scientific adviser.

 

Last week, another biotechnology company, Prodigene Inc., agreed to pay

the U.S. Department of Agriculture more than $3 million in penalties for

mixing genetically engineered corn containing an animal vaccine with

soybeans meant for humans.

 

Pioneer and Mycogen are experimenting with corn engineered with a

bacterium's genetic material. The corn is designed to be resistant to

the rootworm pest and the genetic modification allows the corn to

produce its own pesticide, reducing reliance on traditional chemical

sprays.

 

Neither company's corn modified for rootworm has been approved for human

consumption. Each had to agree to rigorous pollen containment. The

alleged violations on the islands of Molokai and Kauai were uncovered by

EPA inspectors in March.

 

The EPA said Dow's Mycogen did not properly surround the experimental

corn with trees and unmodified corn to serve as a " windblock " to inhibit

pollen spread. Dow said Thursday the alleged violations were the results

of administrative errors and that the food supply was never threatened.

The company agreed to pay $8,800 in penalties.

 

" We are disappointed with our performance in this instance, " said Dow

vice president Pete Siggelko. " We're convinced that what we did provided

for improved protection of the environment. But it wasn't consistent

with what we said we were going to do. That's a significant

administrative oversight, and we're taking steps to ensure that it does

not happen again. "

 

The EPA accused Pioneer of planting its genetically modified corn too

close to other crops and at an unapproved location in Hawaii. The

company agreed to pay a $9,900 fine.

 

A Pioneer spokesman didn't immediately return a telephone call.

 

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The Three Mile Island of Biotech?

by JOHN NICHOLS

 

The Nation

[from the December 30, 2002 issue]

http://www.thenation.com/doc.mhtml?i=20021230 & s=nichols

 

Hamilton County, Nebraska, is where food comes from. You can visit the

Plainsman Museum on Highway 14 to learn about " farm life from the 1880s

to the 1950s, " or you can just drive on up the highway and learn about

farm life in 2002 at any of the dozens of family farms that still grow

corn and soybeans on fields that some families have worked since their

ancestors homesteaded here just after the Civil War. For more than a

century, farmers in this fertile stretch of a state where folks still

refer to themselves as " cornhuskers " have planted food crops each spring

and trucked the harvest in the fall to towering grain elevators on the

edge of the bustling Great Plains town of Aurora. Those grains become

the cereals, the breads, the cake mixes and the soy patties that feed

America and the world.

 

This fall, however, the predictable patterns of Hamilton County and

American food production took on the characteristics of a dystopian

science-fiction story. An area farmer, who a year earlier had

supplemented his income by quietly planting a test plot with seed corn

genetically modified to produce proteins containing powerful drugs for

treatment of diarrhea in pigs, this year harvested soybeans for human

consumption from the same field. He trucked them off to the Aurora

Co-op, where they were mixed with soybeans from other fields throughout

the county in preparation for production as food. Just as the soybeans

were about to begin their journey to the nation's dinner plates, a

routine inspection of the test field by US Department of Agriculture

inspectors revealed that corn plants that should have been completely

removed were still growing in the field from which the soybeans had been

harvested--raising the prospect that the pharmaceutical crop had mingled

with the food crop.

 

Suddenly, as they say in Aurora, all kinds of hell broke loose. In

November, USDA investigators swooped into town to order the lockdown of

a warehouse filled with 500,000 bushels of food-grade soybeans that had

been contaminated by contact with the beans containing remnants of the

pharmaceutical corn. Aurora Co-op managers quietly secured the soybeans.

But when word of the incident leaked out, Greenpeace campaigners climbed

a tall white elevator to unfurl a banner that read: " This Is Your Food

on Drugs! " Agitated officials of the Grocery Manufacturers of America

expressed " concerns about the possible adulteration of the US food

supply. " Consumer groups made unfavorable comparisons between the

incident in Hamilton County and the last great genetically engineered

food debacle, which occurred two years ago when GE StarLink corn that

had been approved solely for animal feed turned up in taco shells, chips

and other food products.

 

Biotech industry groups and the government agencies with which they have

worked closely to promote the increased use of genetically modified

organisms in food crops rushed to assure consumers that all was well.

Anthony Laos, CEO of ProdiGene, the Texas biotech company that has made

Aurora ground zero for experiments in putting drugs into food, and that

faced a possible $500,000 fine and the loss of its testing permit,

promised to cover the $2.8 million cost of the contaminated crops. Jim

Rogers, a spokesman for the USDA's Animal and Plant Health Inspection

Service--which has been criticized for lax oversight of pharmaceutical

crop experiments, commonly known as " biopharming " --said, " It's isolated,

it's in one location, it's not being moved. " That same week, however, it

was revealed that ProdiGene had been ordered, just two months earlier,

to burn 155 acres of corn from an Iowa field where stray biotech plants

had " jumped the fence " and contaminated conventional corn crops.

 

But there is no two-strikes-and-you're-out rule at the USDA. ProdiGene

got off with a $250,000 fine and a promise to follow regulations better.

The company kept its permit to plant experimental crops, and biotech

promoters continue to push for policies that could allow as much as 10

percent of US corn production to be devoted to pharmaceutical crops by

2010. " The future of biopharmaceuticals has simply never been brighter, "

said Laos. Farm and food activists worry that the events of fall 2002

will be little more than a bump in the road to the brave new world of

biopharming.

 

" This is the Three Mile Island of biotech, " says Mark Ritchie, president

of the Institute for Agriculture and Trade Policy, comparing this fall's

incidents to the near-meltdown of the Pennsylvania nuclear power plant,

which led to a dramatic shift in public attitudes about expansion of

that industry. " The biotech industry says that because some soybeans

were quarantined at the last minute, no one should worry. Well, at Three

Mile Island, they contained things. But that didn't mean it wasn't a

crisis, and it certainly didn't mean that people should have said, 'Oh,

everything's fine now. Let's just let these guys get back to business as

usual.' "

 

Richie says it's crucial to seize the moment--this is possibly the last

chance to prevent the disasters that are all but certain to occur if

biotech corporations are allowed to continue on their current course.

" This is not the point to back off; this is the point to move very

aggressively to get a handle on what is happening, and to control it, "

he says. " We're at the earliest stage of the attempt to genetically

engineer corn plants to make them factories for producing powerful and

potentially dangerous drugs, and already we have examples of

contamination of food crops. This is scary stuff. " [see Mark Schapiro,

" Sowing Disaster? " October 28.]

 

How scary? Britain's Royal Society has expressed concerns about allergic

reactions that could result from ingesting, inhaling or even touching

biotech crops, while a new study by GE Food Alert, a coalition of

health, consumer and environmental groups, details scientists' concerns

about the prospect that eating crops containing biopharmaceuticals could

weaken the immune system.

 

No one, not even the top scientists with the USDA, the Food and Drug

Administration or the Environmental Protection Agency, can say with

absolute certainty that the Iowa and Nebraska incidents are the only

cases in which experimental pharmaceutical crops have jumped the fence

from test plots and mixed with food crops. An expert committee of the

National Academy of Sciences this year came to the conclusion that just

as residue from more traditional GE cornfields has contaminated

neighboring organic fields, so " it is possible that crops transformed to

produce pharmaceutical or other industrial compounds might mate with

plantations grown for human consumption, with the unanticipated result

of novel chemicals in the human food supply. "

 

The potential public health threat creates another threat--the health of

American agriculture. Says Iowa State University agriculture professor

Neil Harl, " If consumers take on the belief that corn products are being

contaminated with products designed for vastly different uses--like HIV

vaccines or hepatitis B vaccines or any of a variety of other things

that are being discussed--and if they think this contamination poses a

threat to them, that's going to create the risk of a negative reaction

to corn grown in the United States. And consumers are kings. If

consumers start to have doubts about US corn, farm-state economies are

going to be in very serious trouble. "

 

That prospect frightens Keith Dittrich, a corn farmer from north of

Aurora who has shied away from offers to plant biopharm test plots.

" This is being sold to farmers as a new specialty crop that could make

them a lot of money, " says Dittrich, the president of the American Corn

Growers Association. " But if these experiments end up costing farmers

markets in Europe or the United States, we could be looking at a

short-term profit that turns into a long-term disaster. " According to

research by the ACGA, US corn farmers have already lost more than $814

million in foreign sales over the past five years as a result of

restrictions on genetically modified food imports imposed by Europe,

Japan and other countries.

 

" When it comes to what is being proposed, and what is actually happening

with regard to genetic modification of food crops, we're absolutely

navigating uncharted waters at a high rate of speed. And we're being

pushed to speed up by people with dollar signs in their eyes and no

concern whatsoever for farmers or consumers, " says Nebraska Farmers

Union president John Hansen. " There may be a television program here or

an article there about what's happening, but I don't think most

Americans have any idea of the extent to which things have been pushed

forward without the kind of research and precautions that ordinary

common sense would demand. "

 

Biopharming represents the new frontier of biotechnology, where

agribusiness meets the pharmaceutical industry to explore a once

unimaginable prospect: manipulating the genetic code of plants to induce

them to generate AIDS vaccines, blood-clotting agents, digestive enzymes

and industrial adhesives. If their initiative works, the corporate

promoters of biopharming predict, expensive laboratories and factories

will by the end of this decade be replaced by hundreds of thousands of

acres growing pharmaceutical corn and soybeans that will allow consumers

to realize ProdiGene's promise that you can " Have Your Vaccine and Eat

It, Too! " And those corporations will yield huge returns--ProdiGene

predicts billion-dollar markets for products it has patented.

 

The dream of a biopharmed future is still presented as the noble cousin

of GE cash-crop schemes. To the extent that Americans discuss genetic

engineering, they usually refer to the process by which genes and

segments of DNA that do not naturally occur in a particular food crop

are added to it in order to make it easier, cheaper and more profitable

to raise--such as the splicing of an antifreeze gene from flounder to

produce a cold-resistant tomato. Biopharming pushes the limits of

genetic engineering to a new plateau, where scientists re-engineer crops

to produce drugs that can be extracted from kernels and beans far more

cheaply than they can be produced in factories.

 

In their race to patent and market pharmaceutical crops, ProdiGene,

Monsanto, Dow Chemical and various universities have quietly obtained

permission from the USDA to have farmers plant open-air test plots

across the United States; on these plots, the corporations are

attempting--with some success--to turn corn, soybeans, rice and even

tobacco into " plant pharmacies " that can provide edible vaccines for

everything from hepatitis B to diabetes. Though biopharming is still in

the experimental stage, the experiment has already seen twenty

corporations and universities conduct more than 315 open-air field

trials in undisclosed locations. These plots have brought thousands of

acres--virtually all of them in the vicinity of fields growing

traditional food crops--into biopharm production.

 

The race to the fields has sped up in recent years, in part because the

biotech industry has many allies in the Bush Administration and a

Republican Congress that prefers " voluntary regulation " by industry to

real regulation by the government. And these firms are actively

recruited by state officials and university chancellors who believe that

a biotech boom could turn Wisconsin or Iowa into a version of Silicon

Valley. (ProdiGene was recruited to Texas during George W. Bush's

governorship.) As a result, calls for limits on biopharming are often

met with cries of " no way " from farm-state politicians.

 

" Nature is not a pharmaceutical factory. It was never meant to be. But

we have reached the point where it may be possible to make it that, and

that prospect excites politicians and corporate executives who see this

as a new way to make money, " says Bill Freese, a policy analyst with

Friends of the Earth who wrote GE Food Alert's groundbreaking report on

the dangers of manufacturing drugs and chemicals in traditional food

crops. " They talk a great deal about the benefits for society. But it's

really the economics that attract them. They think they can grow drugs

more cheaply and have lower production costs than if they were produced

in factories. Also, if a drug goes well, they can just scale up the

acres involved in production. If the drug is a bust, they can just fire

the farmers. "

 

ProdiGene press releases describe the firm as being " well positioned to

capitalize on the opportunities in the large and expanding recombinant

protein markets. " ProdiGene promotes itself as " the first...company to

produce and market a recombinant protein product from transgenic

plants, " and it maintains a portfolio of ninety current and pending

patents--including one to use plants to develop vaccines that can be

eaten rather than injected. As a seed company and pharmaceutical

industry executive, ProdiGene CEO Laos has for decades preached the

bio-utopian " future of farming " gospel. To a greater extent than other

biopharmers, he is determined to continue using corn as his company's

preferred pharmaceutical plant. " We have looked at many different

alternatives, and the best system available today for this technology is

corn, " he says.

 

And ProdiGene is getting lots of help. Its research on an edible AIDS

drug is funded by the National Institutes of Health, and it recently

developed a partnership with Eli Lilly. ProdiGene has collected more

permits to initiate biopharm field trials than any other corporation in

the United States--eighty-five, while the next most active experimenter,

Monsanto, has just forty-four. Half of ProdiGene's permits are for

fields in Iowa and Nebraska--the state that, according to the USDA, has

been the site of the largest number of open-air field trials. And many

of those fields are in Hamilton County, where Laos lived before taking

charge of ProdiGene.

 

Laos has allies in the Corn Belt. In December, after the Nebraska and

Iowa incidents, the Biotechnology Industry Organization (BIO) backed off

a proposal to temporarily stop growing GE drug- and chemical-producing

crops in major corn-growing states after the plan encountered noisy

opposition from Iowa's Democratic Governor, Tom Vilsack, and other

farm-state politicians, who still see biopharming as a boon. Many

farmers in Hamilton County have planted test fields at the behest of

seed salesmen associated with Laos and ProdiGene. The salesmen offer

small premiums--$600 for planting an acre of experimental corn and

another $300 for managing it in the year after the experiment is

done--along with the promise of bigger bonuses when the biotech train

leaves the station. " They tell you: 'Once this gets going, the farmers

who are in on it are going to make a lot of money growing these crops,' "

says Mike Alberts, an Aurora-area farmer who this year turned down an

opportunity to grow a ProdiGene test plot. " Farmers around here have had

it hard for a long time, and a lot of them don't want to miss out on

something they're calling the future of farming. "

 

Critics of the biotech industry say that the federal agencies that

should be strictly regulating burgeoning biopharm experimentation--the

USDA, the Food and Drug Administration and the Environmental Protection

Agency--are still too busy promoting GE crops as the cure for what ails

American agriculture to recognize that they could turn into a curse. The

USDA continues to hail GE crops as a boon for farmers, gleefully

promoting biopharming with a website that features such headers as:

" Animal Urine--A New Source of 'Pharmed' Medicine? " Even now, the agency

allows agribusiness firms to withhold details about the nature of their

experimental crops and the locations of test plots from the

public--including neighboring food farmers--by declaring the data

" Confidential Business Information. "

 

" The regulatory system isn't working. It looks like we've got

pharmaceutical chaos in the fields, " says former North Dakota

Agriculture Commissioner Sarah Vogel. " I'm not sure that some of these

people in Washington or the corporate boardrooms quite understand the

threat these incidents tell us are being created for food safety and the

future of American agriculture. " Part of the problem, according to Jean

Halloran, who directs Consumers Union's Consumer Policy Institute, is

that technological advances have outpaced not just regulations but basic

questions of whether biopharming should be allowed at all. " What's

infuriating is that there has been no public debate on whether we should

be proceeding to this technology. They just went ahead and did it, "

Halloran says of an industry that, for the most part, is policed only

with vague guidelines and threats of action if, as in the case of

ProdiGene's plots, something goes really wrong. " We're in the middle of

an official comment period on a set of guidelines--not regulations, just

guidelines--at the same time that we are learning that we've got these

problems with the testing. Doesn't that sound like we've missed a step? "

 

After the near-disaster in Hamilton County, there may be some scaling

back of the explosive growth in the number of biopharm test plots in

corn-growing states. ProdiGene and USDA officials talk of " isolating "

the firm's open-air test fields, just beyond the edge of the cornbelt in

Nebraska's Sand Hills or perhaps in the Southwest. But independent

observers who know about farming and food safety are skeptical about

this kind of self-regulation. They note that roughly 20 percent of the

nation's corn production--including that of much of Nebraska--occurs

outside the " drug-free zone " that BIO advanced and then abandoned. More

significant, they argue that open-air test plots are not necessarily

" isolated " by distance from traditional food crops.

 

Iowa State's Harl explains that even an isolated field can be hit with a

tornado or heavy winds that will drop a kernel of corn far from the test

plot. " Birds, deer, runoff from fields into rivers--it's hard to list

all the ways that seeds and kernels can be carried substantial

distances, " says Harl, who adds that because of consumer confidence and

liability concerns, " ultimately, I think we are going to conclude that

we have to produce a zero-contamination rule. That requires us to

control the total environment--and that means in a greenhouse. "

 

Federal regulators have begun to feel pressure to tighten regulation of

biopharm experiments and production, and not just from environmental,

consumer and grocery industry groups, which have long been troubled by

the prospect of drug crops contaminating food crops. In November Senate

majority leader Tom Daschle and Agriculture Committee chair Tom Harkin

wrote Agriculture Secretary Ann Veneman to ask " whether existing

procedures and safeguards are sufficient to ensure that similar

incidents do not occur in the future. " A more energetic push came from

the National Food Processors Association, whose president, John Cady,

said the USDA and the FDA " should impose a stringent and mandatory

regulatory framework to ensure protection of the US food supply and US

food exports from any inadvertent or even intentional contamination by

plant-made materials that have not been approved for human food and

animal feed purposes. " At the same time, however, farm groups allied

with agribusiness--chief among them the American Farm Bureau

Federation--issued a statement reaffirming their faith in biotech crops

and essentially asking federal officials to continue encouraging

biopharming.

 

Harl, who has served on the USDA's Advisory Committee on Agricultural

Biotechnology, says federal agencies are going to have to fundamentally

alter their approach to biopharming. " This is part of a broader

regulatory phenomenon that has not been faced yet. If we are going to

allow this type of production, then we have to ramp up the regulatory

regimen, " he says. The USDA, the FDA and the EPA must resolve turf wars

over which agency is in charge of regulating not just test plots but,

potentially, wide-scale production of pharmaceutical crops. That will

require development of a regulatory regimen that makes public the

details about where biopharm fields are planted and where biopharm

products are being processed, and that insures regular testing through

all the steps of food processing to assure that pharmaceutical crops are

not being mixed with food crops. " We won't have discipline until we have

testing at every point of commingling, " Harl says. " We have some tests,

but they are not what they must be: fast, easy and cheap. "

 

Before any of these steps occur, however, Jean Halloran of Consumers

Union suggests a more fundamental move. " We should ask whether

pharmaceutical products should be engineered into food plants in the

first place, " she says. " Our view is that the answer to the question

should be no. " She notes that the drugs that biopharming promises to

deliver can be gotten through other means. " The practical aspects of

trying to keep these pharmaceutical plants separate from the regular

food plants is an insurmountable problem, " she says. " It just can't be

done. It can't be done because of the fallibility of human beings. It

can't be done because you can't control pollen flow. It can't be done

because you can't control mother nature that way. And if you can't

control mother nature and fallible human beings, we've come to the

conclusion that you shouldn't try. "