7 January 2003

FDA MISSED OBVIOUS ERRORS WITH HARMFUL GM COMPOUNDS/CONFIDENCE IN US FOOD CHAIN NEARS MELTDOWN

Even for its staunchest supporters it's becoming increasingly impossible to believe that the U.S. has either a safe or sustainable food supply, as is clear from the items below.

With GM animals due to enter the food chain next year despite no standards having been established for testing their safety (item 3) and with pharma crops having already been grown at 300 secret sites often in food crops, even normally pro-GM groups like the Center for Science in the Public Interest (items 1-3) and the Grocery Manufacturers of America are starting to hit the panic button (5-6).

In fact, CSPI is hammering even the existing system for GM food approval in the U.S.:

"CSPI reviewers studied about a quarter of all the cases where gene-altered plants have come before the FDA for review. In many instances, the report said, the FDA requested information on the nutritional composition of a plant that industry failed to provide. In three of 14 cases, CSPI reviewers found "obvious errors" in FDA analyses of certain food crops.

"Certain scientific papers - cited to prove that human exposure to a particular foreign protein in gene-altered tomatoes and cantaloupes is safe - do not prove anything of the sort, the center said."

"...the group said the FDA's procedures are so full of holes that continued safety cannot be ensured as companies press to bring many more genetically engineered plants to market." (item 2)

This has major implications for importers of U.S. food. Even where an extensive testing system has been put in place to try and save US exports by stopping Starlink contamination getting through, the system has failed, apparently inexplicably. (item 4)

1.FDA Policies for Gene-Altered Foods Faulted in Report
2.FDA missed 'errors' in reviewing possibly harmful GM compounds - consumer body
3.Safety of transgenic animals doubted
4.Japan to Boost StarLink Testing
5.Biopharming touted as good idea for Iowa; some fear big risks
6.Puzzling Industry Response to Prodigene Fiasco
7.GM crops to kill glyphosate use in US as land values drop?

***

1.FDA Policies for Gene-Altered Foods Faulted in Report

By Justin Gillis
Washington Post Staff Writer
Tuesday, January 7, 2003; Page A05
http://www.washingtonpost.com/wp-dyn/articles/A19370-2003Jan6.html

Excessive levels of harmful compounds could show up in genetically engineered foods because the government has failed to put strong safeguards in place to catch them, a consumer group says in a report scheduled for release today.

The Center for Science in the Public Interest (CSPI), a Washington group known for a moderate stance on the use of genetic engineering to alter food plants, contends that the Food and Drug Administration, the primary federal agency responsible for food safety, missed "obvious errors" in reviewing some gene-altered crops. Although crops now on the market appear to be safe to eat, the group said the FDA's procedures are so full of holes that continued safety cannot be ensured as companies press to bring many more genetically engineered plants to market.

"The companies don't provide enough data to prove these foods are safe," said Gregory A. Jaffe, director of biotechnology issues at the center. "And FDA's review process doesn't give you a lot of comfort that they've looked at it closely and challenged the companies."

Laura Tarantino, deputy director of food-additive safety at the FDA, rejected the group's contentions, saying companies have provided all the data on their crops that the agency deemed important. She said FDA staffers were well aware of the possibility that genetic engineering could increase levels of harmful compounds in food. She called this a "very hypothetical risk" and said she did not believe it had happened with any crop now on the market. She added, however, that the FDA was studying whether it should make changes in the way it reviews such foods as more move toward commercialization.

The food-processing industry also rejected the report's conclusions, saying the current regulatory setup gives the FDA maximum "flexibility" to ensure that foods are safe.

The center's report is designed to influence an unfolding public debate about the way the nation regulates genetically altered crops. At the request of the FDA and other federal agencies, a panel of the National Academy of Sciences, meeting today in Washington, is studying whether such crops could have unintended consequences for human nutrition.

Much of the concern centers on "anti-nutrients," or harmful compounds common in many food crops. Typically such compounds are present only at minuscule levels. But when crops are genetically altered there is at least a theoretical risk that the level of anti-nutrients could increase, making consumption of that plant more harmful. The FDA has failed to establish firm procedures requiring companies to test for such harmful changes, the report said.

The center said the FDA's review process is an outgrowth of the nation's lax approach to dealing with genetically altered crops. Congress has never passed a law to regulate plants or animals created through genetic engineering, and, as a result, federal agencies have had to stretch old laws, written for other purposes, to create a patchwork system of rules.

Some gene-altered food plants, particularly if they contain foreign genes to help them fight bugs, fall under regulations requiring their creators to get mandatory approval from the Environmental Protection Agency before going to market. But others fall solely under the FDA's food-safety jurisdiction, and that agency has adopted only voluntary procedures for companies to follow in assuring the public their products are safe.

The food industry likes this voluntary system. Environmental groups, suspicious of all genetic manipulation of plants or animals, have long decried it. CSPI is one of the few consumer-oriented groups that supports genetic manipulation in principle but argues that the voluntary system must be scrapped.

For the report, CSPI reviewers studied about a quarter of all the cases where gene-altered plants have come before the FDA for review. In many instances, the report said, the FDA requested information on the nutritional composition of a plant that industry failed to provide. In three of 14 cases, CSPI reviewers found "obvious errors" in FDA analyses of certain food crops. For instance, certain scientific papers -- cited to prove that human exposure to a particular foreign protein in gene-altered tomatoes and cantaloupes was safe -- don't actually prove anything of the sort, the center said. "Had FDA conducted thorough reviews, the errors would have been easily detected," the report said.

Tarantino of the FDA said she had not seen the CSPI report and could not respond to the claim. But there is routine give-and-take between the FDA and companies about the quality of scientific evidence, she added, and the agency will not bless crops for commercialization until it is satisfied.

CSPI called for a tighter system involving mandatory review of new products and a detailed statistical analysis of risks -- in essence, a version of the rigorous drug-approval process for which the FDA is widely respected.

Timothy Willard, a spokesman for the National Food Processors Association, said the food industry would support some changes, including making some type of FDA review mandatory. But he noted that no company has opted out of the current voluntary process, which has worked to date.

***

2.FDA missed 'errors' in reviewing possibly harmful GM compounds - consumer body

AFX Asia (Eng)
Tuesday, January 07, 2003  16:13

WASHINGTON (AFX) - Excessive levels of harmful compounds could show up in genetically engineered foods because the government has failed to put sufficiently strong safeguards in place to catch them, the Washington Post reported, quoting findings by a consumer protection group.

In a report scheduled for release today, the Center for Science in the Public Interest (CSPI), contends that the Food and Drug Administration missed "obvious errors" in reviewing some genetically modified crops, the newspaper reported.
 
Although crops now on the market appear to be safe to eat, the group said the FDA's procedures are so full of holes that continued safety cannot be ensured as companies press to bring many more genetically engineered plants to market.

"The companies don't provide enough data to prove these foods are safe," the Post quoted Gregory A. Jaffe, director of biotechnology issues at the center, as saying.

Much of the concern centers on "anti-nutrients," or harmful compounds commo n in many foods. Typically such compounds are present only at minuscule levels. But when crops are genetically altered there is at least a theoretical risk that the level of anti-nutrients could increase.
 
The FDA has failed to establish firm procedures requiring companies to test for such harmful changes, the report said.      CSPI reviewers studied about a quarter of all the cases where gene-altered plants have come before the FDA for review. In many instances, the report said, the FDA requested information on the nutritional composition of a plant that industry failed to provide. In three of 14 cases, CSPI reviewers found "obvious errors" in FDA analyses of certain food crops.
 
Certain scientific papers - cited to prove that human exposure to a particular foreign protein in gene-altered tomatoes and cantaloupes is safe - do not prove anything of the sort, the center said.
 
Laura Tarantino, deputy director of food-additive safety at the FDA, rejected the CSPI's contentions, saying companies have provided all the data on their crops that the agency deemed important.
 
The food-processing industry also rejected the report's conclusions.

***

3.Safety of transgenic animals doubted

By Steve Mitchell
UPI Medical Correspondent
http://washingtontimes.com/upi-breaking/20030106-041351-4771r.htm
WASHINGTON, Jan. 6 (UPI) -- Genetically engineered animals -- which could be in food markets by next year -- could pose hazards to human health and the environment, experts told United Press International Monday.

The comments came as a panel of scientists convened by the government kicked off a three-day meeting to discuss the health risks of genetically modified plants and animals.      "We don't know as much as we'd like to about potential unexpected changes that can occur in animals with genetic engineering," said Douglas Gurian-Sherman, science director for the biotechnology project at the Center for Science in the Public Interest in Washington.

A panel convened by the National Academy of Sciences began their second meeting Monday to discuss methods for identifying unintended health effects of genetically engineered foods.      The panel will address issues related to both genetically modified plants and animals. The first meeting was held in September and panelists expect to issue a report on their conclusions in 2004 to help the Food and Drug Administration and other agencies determine how to regulate these products.      FDA representatives will make a presentation at the NAS meeting, in which they will report the agency has decided to classify genetically engineered or transgenic animals as drugs for regulatory purposes. This has the benefit of requiring a mandatory safety review for these animals -- for genetically modified plants, the safety review is voluntary.      "But the problem is the process is completely secret," Gurian-Sherman said. "It doesn't allow public input or comment" and the public will not be told which transgenic animals the agency is reviewing.

A report issued by a different NAS panel in August concluded transgenic animals probably were safe to eat but recommended further research before finally declaring them totally safe for humans.      Although no genetically engineered animals have been approved by the FDA for human consumption in the United States, several are being developed. In addition, Cuba has approved a strain of tilapia fish genetically engineered to grow rapidly and a genetically engineered carp might be approved in China.      The species closest to market in America is a salmon that has been genetically modified to produce more growth hormone, which causes it to grow more rapidly than non-modified fish. The salmon producer, Aqua Bounty Farms of Waltham, Mass., said it currently is completing safety studies and the fish appears to be no different than normal salmon.      "We have no reason to believe there is anything unusual occurring in these fish," Aqua Bounty spokesman Joe McGonigle told UPI. He noted all the safety studies "will eventually ... go up on our Web site, among other places" to make them available to the public. The company plans to file for FDA approval in the latter half of this year, which could make the transgenic salmon available to consumers in 2004.

Robert Schwartz, a cell biologist at the Baylor College of Medicine and co-founder of Advisys, a company in The Woodlands, Texas, that is involved in improving the growth of livestock, agreed transgenic animals are safe for consumption.      "There's no evidence of toxicity" of genetically engineered animals, said Schwartz, who will also make a presentation at the NAS meeting.      However, he noted there are no standards for testing the safety of these animals. The FDA should establish criteria for how these tests should be conducted, which would help assure the public these animals are safe, he said.

Schwartz's company is working on a pig with a gene for a protein called insulin-like growth factor that increases the animal's weight. Other transgenic animals being developed include cattle with antibacterial genes to make their milk safer.      "It is highly doubtful" that any of these animals are toxic to humans "but there would have to be testing, some sort of standards ... to prove it," Schwartz said, adding better education of what these products can do and informing consumers on packaging the product comes from a genetically modified animal also would be helpful.      The Center for Food Safety in Washington, which filed a legal petition with the FDA and other governmental agencies to keep the transgenic fish from coming to market, also has concerns about the health risks posed to humans consuming the fish. The FDA needs to establish "a real process of looking at the human health impacts of the fish," said Joseph Mendelson, the center's legal director.      Elevated levels of growth hormones could create risks or unintended effects, such as allergies in some people, Mendelson said. There are also humane issues to consider because the fish are being created merely to improve industry efficiency, he said.

So far the FDA has not responded to the legal petition, which the Center filed along with 75 other environmental and consumer groups, Mendelson said, but they have received 50,000 public comments in support of the petition.      Another problem is the environmental impact of transgenic animals, Gurian-Sherman said. Indeed, the NAS report in August concluded the impact of these animals escaping into the environment was the most worrisome because there was no way to predict what might happen or to reverse such a situation if it turns out to have disastrous consequences.      "Studies show that potentially a genetically engineered salmon, if it escapes, could cause extinction of endangered salmon species," Gurian-Sherman said.

The FDA review process requires companies to assess the environmental impact these animals could have, but there are some barriers to putting that into practice, Gurian-Sherman said. "It is not clear how much authority the FDA has to do a thorough environmental analysis and there is also a lot of concern that they don't have the expertise because they don't usually do that kind of analysis," he said.      Aqua Bounty's McGonigle said his company still is working with the FDA to determine how to do an environmental impact assessment of the salmon. That study has not yet begun, he said.      The FDA did not return repeated phone calls from UPI seeking comment by presstime.

***

4.Japan to Boost StarLink Testing

1/6/2003, Edited by Willie Vogt, E-Content Director, Farm Progress

Over the weekend Japanese officials announced they would be boosting the StarLink testing they'll be doing on corn coming from the United States. According to a report by OsterDowJones, an official from Japan's Ministry of Health, Labor and Welfare confirmed that 1,200 metric tons of corn in a 19,234-ton shipment was found to contain traces of StarLink but the remainder of the load tested negative.

That positive test, however, means officials will ramp up their StarLink testing for 2003, the wire service reports. The Japanese have been conducting random testing of corn imports for two years, since StarLink content was first discovered in food products in the country.

OsterDowJones reports that the shipment of corn came from Harvest States, a division of CHS Cooperatives. Mitsui & Co., Ltd. was the buyer. The cooperative told the wire service that the load was tested extensively for StarLink before being shipped to Japan.

The discovery of StarLink content was announced Dec. 27, but the new year closing of government offices has kept U.S. reaction to the incident quiet. We'll keep you posted as more information becomes available.

***

5.Biopharming touted as good idea for Iowa; some fear big risks

By James Q. Lynch
The Gazette
Monday, January 06, 2003
http://www.crgazette.com/go_article/0,1336,48933%252D1,00.html?cks=0

Hoping to make Iowa's "Fields of Opportunity" a reality, Iowa lawmakers are likely to consider legislation to help farmers earn better profits by turning their fields into living factories. Crops planted would produce chemicals for industrial use and drugs that offer better treatments, perhaps even cures for a variety of diseases. Gov. Tom Vilsack and some legislative leaders are touting "biopharming" -- the production of corn and soybean plants genetically engineered to contain pharmaceuticals and industrial chemicals -- as an opportunity for farmers and Iowa to tap a lucrative market. That, they say, could smooth the bumpy farm economy and keep farmers on their land and out of bankruptcy court.

The price could be steep if it comes at the cost of Iowa's traditional crops, as well as organics and crops Iowa farmers raise for specialty markets, others warn. They are calling for regulations that will protect both the genetically modified crops and Iowa's bread-and-butter corn and soybeans.

"I think farmers understand this is a big step up from regular GMOs (genetically-modified organisms) like Bt beans," said corn and soybean farmer Sen. Jerry Behn, R-Boone, who will chair the Senate Agriculture Committee when the Legislature convenes Jan. 13. "They think we need better protection.

"However," he added, "farmers think that if we're not careful, we'll let this golden opportunity slip through our fingers."

Mount Vernon seed corn producer Laura Krouse hopes Iowa farmers cash in on "biopharming" opportunities, but she doesn't have to look far to see problems associated with genetically modified crops.

In 2001, transgenic pollen from genetically modified crops near her once-organic corn caused the loss of half her seed corn sales for the 2002 crop.

"I'm just trying to keep going," Krouse said. "I've lost about half of my customers, so I have to create a new market."

Like Krouse, who teaches biology at Cornell College and understands the promise of biopharming, Democratic Rep. Mark Kuhn, a Charles City farmer, worries that turning plants into drug factories could threaten food supply safety.

"If we are going to feed the world, then we have to ensure the safety of the food supply and ensure the world that we can prevent contamination," Kuhn said. "The perception is that you could have drugs in your cornflakes."

Contamination problems brought to light by the Aventis StarLink and ProdiGene cases confirmed Krouse's worries that federal guidelines don't offer adequate protection.

So Krouse is working with a group of Iowans to draft legislation creating an indemnity fund to reimburse farmers for losses caused by biopharming.

As proposed, the fund would collect a fraction of a cent on every bushel of corn and beans sold in Iowa to raise about $5 million a year, Krouse said. Producers of identity-preserved crops who suffer losses caused by pollen drift or other problems could be reimbursed. They could get up to 90 percent of the difference between the price they could have received for the identity-preserved crop and the price they receive after the damage.

"It would be open to the people raising the biopharm crops, too," Krouse said.

Kuhn has some reservations with that approach.

"The obvious problem," Kuhn said, "is why should farmers pay for a problem they didn't create? Where is the industry in this?"

Although the issue "really is on the front-burner right now," Rep. Jack Drake, R-Lewis, who will chair the House Agriculture Committee, favors waiting for federal standards.

"We don't want to preclude farmers from making more money with new crops, but we want to keep our food supply safe," he said.

Those rules haven't worked, according to Kuhn, because they are full of "shoulds" rather than mandates.

He agrees with Krouse that for most farmers, profit opportunity has been overstated.

"There's a lot of money to be made by the companies which invent" the specialty crops, Krouse said. "But I don't see how very many farmers could handle growing those crops. That's not most farmers."

"There will be very few farmers growing these crops on very few acres and they will be selected by the companies who hold the patents."

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6.Puzzling Industry Response to Prodigene Fiasco

Jeffrey L. Fox, Nature Biotechnology, January 2003 Vol. 21 No.1 pp3-4;
www.nature.com
 
In December, officials from the US Department of Agriculture (USDA; Washington, DC), working with the Food and Drug Administration (FDA; Rockville, MD), imposed a $250,000 fine against ProdiGene (College Park, TX) for violations of the Plant Protection Act. Meanwhile, the US Biotechnology Industry Organization (Washington, DC) caved in to intense political pressure and revised a previous statement calling for outcrossing biopharmaceutical crops not to be planted in the US corn belt. These awkward developments come at a delicate moment for companies working to develop plants that produce pharmaceutical or industrial products. Food producers are calling for stronger regulations that will keep pharmaceutical crops not meant for human consumption entirely separate from the food supply.

Federal officials are penalizing ProdiGene for two similar incidents involving its test plots of GM corn being raised under contract by local growers, one farm in Nebraska and another in Iowa. In the Nebraska case, officials realized that some 500,000 bushels of harvested soybeans were contaminated with small amounts of GM corn, which had been grown during 2001 on the same plot, because the farmer did not weed "volunteer" plants from the field in which the soy was grown. In Iowa, federal officials required a local producer to destroy some 155 acres of corn because it could have been cross-pollinated by ProdiGene's engineered corn being raised in a nearby field.

Without admitting to those violations, ProdiGene agreed to post a $1 million bond and also to reimburse the USDA for the costs, which could be several million dollars, involved in disposing of the contaminated crops. "We have learned some valuable lessons," says Anthony Laos, the company's president and chief executive officer. "We expect the enhanced compliance program we are developing in close cooperation with USDA to set the benchmark for regulating the entire industry."

"We have to ensure enforcement of biotech regulations in order to maintain confidence in the systems and the new technologies," says USDA Secretary Ann Veneman. "And so, when companies don't adhere to those rules, we will take action as we did ... with...ProdiGene. We are continuing to work very closely with FDA to ensure regulatory requirements are clear and that monitoring of licensees that are issued is effective and efficient.... We also don't want to stifle growth, but we have to have strong and credible regulatory systems."

Shortly before the US midterm elections BIO and several member companies announced support for strong regulatory oversight for biopharming and agreed to voluntary safeguards intended to keep such bioengineered plants apart from the food supply. BIO emphasized that, in this early phase of the development of biopharming, member companies would be better off by voluntarily refraining from growing test plots of, for instance, engineered corn plants in the corn belt.

However, relentless political heat, particularly from Senator Charles Grassley (R-IA), led BIO to retreat from this position by early December. In a letter to Sen. Grassley, BIO president Carl Feldbaum agreed that its "position statement...requires revision in order to more accurately and clearly express our views on stewardship of plants that produce pharmaceutical and industrial products." In backing away from its earlier call to limit growth of experimental crops in "major areas of production of that crop's food/feed counterparts," BIO now is saying that it will "encourage and invite alternative approaches...that would deliver at least equivalent assurances for the integrity of the food supply and export markets."

"Iowa producers have a strong, scientific case for being involved in this new agricultural opportunity," says Sen. Grassley, who envisions biotechnology becoming a multimillion dollar industry in his state. "It's good to see that BIO has realized that they are putting unscientific restraints on Iowa and many other states."

However, while Sen. Grassley and other politicians are pressuring the biotechnology industry to stay active locally, many food producers are sounding a different message about biopharming. For example, officials of the Grocery Manufacturers of America (GMA; Washington, DC) are urging USDA to mandate the use of "non-food crops" in biopharming R&D efforts.

Similarly, John R. Cady, CEO and president of the National Food Processors Association (Washington, DC), referring to the ProdiGene episode, calls it "nothing short of alarming to know that at the earliest stages of the development of crops for plant-made pharmaceuticals, the most basic preventive measures were not faithfully observed. This apparent violation of rules...very nearly placed the integrity of the food supply in jeopardy."

Last November the GMA and representatives from member companies met with Secretary Veneman and other USDA officials. Participants discussed using non-food crops and several other options for strengthening USDA regulations such as dedicating fields for growing of experimental biopharm plants only, specifying periods during which such fields lie fallow, and marking experimental crops.

"In our meeting with Secretary Veneman and her staff, GMA expressed its concerns about the possible adulteration of the US food supply and the need for strong bio-pharmaceutical regulations," says Manly Molpus, CEO and president of the GMA. "While GMA and its member companies are supportive of biotechnology's current and future benefits, we must have stronger regulations that will keep pharmaceutical crops not meant for human consumption entirely separate from the US food supply."

Some activist groups are calling for still stronger actions. For instance, the Genetic Engineering FoodAlert (Washington, DC), a coalition of health, consumer, and environmental groups, announced in November plans to petition the USDA for an "immediate halt to all biopharms." Its members also are criticizing federal officials for "not revealing pertinent information on the contamination incidents" involving ProdiGene's experimental plots in Iowa and Nebraska.

"We warned the USDA earlier this year this was going to happen," says Larry Bohlen of Friends of the Earth (Washington, DC), a member of the coalition. "If the USDA continues to allow biopharm food crops to be planted, someone is going to get prescription drugs or industrial chemicals in their corn flakes."

***

7.GM crops to kill glyphosate use in US as land values drop?

NLP Wessex

If you can't continue doing something, then by definition it is not sustainable.  Here's what's now happening to the technology that claims to be transforming global agriculture:

"... A symposium on glyphosate-resistant weeds attracted an overflow crowd on Thursday morning to hear updates on glyphosate-resistant marestail in the DelMarVa area, west Tennessee, Kentucky, southern Indiana and southern Ohio..... Monsanto is making recommendations for resistance management in areas where glyphosate-resistant marestail has already been found as well as in the surrounding area. Monsanto has submitted a supplemental label to the EPA with modified requirements for using 2,4-D tankmixes for burndowns in the area surrounding the locations with known resistance.

Syngenta is taking a more aggressive resistance management approach based on herbicide rotations. In corn or soybean-based rotations, they recommend no more than two applications of glyphosate in a field over any two-year period. They recommend rotating Roundup Ready crops with conventional crops, and using full rates of glyphosate to minimize tolerant weed escapes.

Iowa State University weed scientist Mike Owen questioned whether proactive resistance management is economically feasable in the short run. He expects growers to continue to use low-cost, effective weed control tools such as glyphosate until they are forced to switch to alternative programs.

With few, if any, new blockbuster chemicals in the pipeline, the question may become whether there will be alternative programs to switch to if glyphosate loses its effectiveness."
'Glyphosate resistance dominates weed science meetings'
Mike Holmberg
Farm Chemicals Editor
Successful Farming
December 6, 2002
http://www.biotech-info.net/dominating.html

So bad has this situation become that Syngenta have now built a web site entirely devoted to this problem:
http://www.farmassist.com/resistance/

The web site reassuringly asks: "As weeds resistant to glyphosate rise and land values are predicted lower, what options do growers have?... Land managers and rural appraisers say more weed resistance on land means less rent or overall value."

And for some reason the British Prime Minister thinks this is 'progress'.