Genetically
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8 October 2000

Table of Contents

US Senate Testimony: "The Future of Food: Biotech. and Consumer Confidence"
European Company Will Buy Entire Crop of Corn in Recall
Evidence of harm to human subjects in GE experiments
Monsanto scientists go for growth with luminous lawn
Disastrous Bayer vaccin appears to be GE.
Genetically Modified Jelly Bellies
GE Foods FDA Lawsuit
Judge Upholds F.D.A. Policy on Genetically Altered Foods
Genetically engineered crops allowed in US food supply
Suspect pro-GM mole on anti-biotech list
US: Greenpeace Issues 'Shopping List' of Biofoods
US – Alliance for Bio-Integrity statement on GM Court case
UK: Three Cases of Human `Mad Cow' Disease Found in UK Children
JUDGE Colleen Kollar-Kotelly to also rule in Monsanto suit?
US-BIO: Recommending approval of ALL GE crops for human consuption
Imminent FDA Rulemaking on Genetically Engineered Foods

Top NextFront Page

Date: 29 Sep 2000 17:23:34 +0100
From: Jason Boehk jasonab@fiam.net

US Senate Testimony: "The Future of Food: Biotech. and Consumer Confidence"

http://www.senate.gov/~labor/hearings/sept00hrg/092600wit/09260jm....

Comment: there's no fundamental challenge issued here to the wisdom or necessity of the venture to genetically engineer food, even though the speaker is from a "sustainable ag" center.

These comments are also noteworthy in my opinion:

Some people argue that foods made from transgenic crops are not safe and should therefore be labeled. That is not my area of expertise and I can only assume that FDA has done its job and their determination that such foods are safe is based on sound science and sufficient data.

Concerns about the ecological consequences of transgenic crops centers on nontarget organism effects. To what extent can plant pollen from transgenic crops confer traits to their weedy relatives? While some crops lack wild relatives, such as corn, others, such as strawberry, canola, and cucurbits have the potential to transfer genes to weedy relatives over distances that depend on wind and insect pollination patterns.

At least in Mexico, corn in fact has wild relatives (teosinte, Zea mays ssp. parviglumis), which might be capable of cross-pollinating GE varieties.

Can someone in the list confirm or elaborate?

In searching for an answer to my own question, I found this RAFI communique from 10/30/1991: Genetic Engineering of Maize: A Report on Work in Progress which is a partly prophetic time capsule from almost ten years ago. found at:

http://64.4.69.14/web/allpub-one.shtml?dfl=allpub.db&tfl=allpub-o....

I also found a superb article about the biology and history of Maize at:

http://www.ag.iastate.edu/departments/agronomy/maizearticle.html

Jason


Top PreviousNextFront Page

Date: 30 Sep 2000 11:01:22 +0100
From: jim@niall7.demon.co.uk

Guess, where you will find that recalled GE Maize?

"Dextrose, also called "corn sugar", is derived synthetically from starch."

http://www.nexusmagazine.com/SugarBlues.html

... and many more products!

European Company Will Buy Entire Crop of Corn in Recall

By ANDREW POLLACK
http://www.nytimes.com/2000/09/30/business/30CORN.html

The company that makes the genetically modified corn linked to the recent recall of taco shells agreed with the government yesterday to buy back this year's entire crop to prevent the grain from getting into the food supply.

The Agriculture Department and the Environmental Protection Agency announced the deal in a joint statement after negotiating with Aventis CropScience, part of Aventis S.A., a big European drug company. The Agriculture Department estimated the entire crop would cost about $90 million to $100 million.

The Aventis corn, known as StarLink, is approved for use as animal feed but not for human consumption because questions about whether it could cause allergies cannot be definitively answered. Recently, biotechnology opponents reported discovering the StarLink corn in Taco Bell brand taco shells made by Kraft Foods, a subsidiary of Philip Morris. When Kraft confirmed the findings, it recalled millions of the shells, and the Taco Bell restaurant chain also began replacing its shells.

Susan McAvoy, a spokeswoman for the Agriculture Department, said buying an entire crop was rare but not unprecedented. A cranberry crop found to have illegal chemical residue was purchased in the 1950's to keep the berries out of circulation.

Aventis earlier this week said it would suspend sales of StarLink seeds, which means that StarLink will not be grown next year. Yesterday's action seeks to take care of the StarLink corn that is now growing and being harvested. StarLink is grown on about 315,000 acres, or less than 0.5 percent of the nation's corn acreage, making it one of the least popular of the nation's genetically engineered crops.

Under the plan, the Agriculture Department will actually buy the corn from farmers and then take direct control of the corn's storage and distribution. The corn will not be destroyed but will be sold under government supervision to animal feed lots or for industrial uses such as making ethanol, a gasoline additive.

Aventis CropScience will reimburse the Agriculture Department but will be able to keep the proceeds from the sale of the corn. So it is unclear what the financial impact will be on Aventis. A spokesman for Aventis CropScience declined to comment on the program's costs.

The E.P.A. and the Agriculture Department called the plan "a prudent and responsible step."


Top PreviousNextFront Page

Date: 3 Oct 2000 05:45:59 +0100
From: RBBAX@aol.com
From: Vera Hassner Sharav veracare@erols.com

Evidence of harm to human subjects in GE experiments

Sections:
Comment
Article from The Scientist
Research autority withdrawn
Checking Tray Tables?
Need for Oversight
Value of an Advisory Committee

Comment

CIRCARE: Citizens for Responsible Care & Research,
A Human Rights Organization
Tel. 212-595-8974 FAX: 212-595-9086
veracare@erols.com

The Scientist article (below) does not focus on ethical and legal violations which increase risks of harm to human subjects of research. It focuses rather on reaction of some researchers to the inconvenience of regulatory oversight and temporary shut downs: "The suspensions hobbled the expensive, demanding, and complex business of conducting research with human subjects." Norman Fost of the Univ of Wisconsin calls OPRR's greater oversight a "reign of terror!"

The Scientist article fails to mention evidence of harm to human subjects of research –ncluding preventable deaths. The fact that neither the FDA nor OPRR conduct audits of the patient-subject medical records –s part of their oversight responsibilities –as effectively buried the casualties and blocked any independent evaluation of these subjects' outcomes. Indeed, David Korn (AAMC) acknowledges: "We don't have the right outcomes measures."

Indeed, if the circumstances of Jesse Gelsinger's death had not been exposed to the public by the press –irst by two local Tuscon Arizona newspapers, then by the Washington Post –is death would have remained unacknowledged just as the deaths of other human subjects remain secret.

The Scientist article fails to mention how the president of the University of Oklahoma –ormer Senator David Boren –ook action when presented with OHRP's damaging findings (in June 2000). Boren did what a CEO in every other industry would be expected to do:

First, he terminated those responsible at the top –he principle investigator, the medical dean, the director of research, and the chair of the IRB.

Second, he introduced a plan of action for overseeing clinical research to prevent violations in the future. That plan includes an independent research compliance office, unannounced spot checks of research, mandatory education, a requirement that researchers must sign conduct contracts, and he instituted a hotline for reporting potential violations anonymously.

Self-regulation (i.e., peer review by Institutional Review Boards) has been in effect for 22 years. The evidence demonstrates that such an insular system failed to protect vulnerable patients from researchers who put greater value on science & $$ than on protecting the welfare of individual subjects.

Vera Hassner Sharav, President CIRCARE: Citizens for Responsible Care & Research, A Human Rights Organization Tel. 212-595-8974 FAX: 212-595-9086 veracare@erols.com

Article from The Scientist

By Harvey Black, The Scientist 14[19]:1, Oct. 2, 2000
http://www.the-scientist.com/yr2000/oct/black_p1_001002.html

Research autority withdrawn

Research and Human Subjects Recent temporary suspensions, regulation initiatives inject uncertainty into study management

Times are difficult for researchers using human subjects. Over the past few years the federal Office for the Prevention of Research Risk has temporarily lifted the authority of a number of prestigious institutions to do such research. They included, according to the Office of Human Research Protection, OPRR's successor agency, Duke University Medical Center, Virginia Commonwealth University, the University of Alabama at Birmingham, Rush Presbyterian St. Luke's Medical Center in Chicago, and the University of Illinois-Chicago. The suspensions hobbled the expensive, demanding, and complex business of conducting research with human subjects.

"We had some people who were flying in from foreign countries to start on a trial. They arrived and all of a sudden couldn't start on the trial. That has an adverse effect. We also had human subjects and patients who wanted to start on new experimental drugs and couldn't do it because that protocol was closed down," says Russell Kaufman, vice dean for education and academic affairs at Duke University Medical Center. However, both Kaufman and OPRR agreed that Duke's transgressions did not threaten the lives of any human subjects. The errors were failure of the Medical Center's Institutional Review Board (IRB), which approves human subject research protocols, to properly document its actions on these protocols. The system had become "lax," says one source familiar with OPRR's operations and the Duke situation, and those weaknesses "at least theoretically could put subjects in danger," the source says.

At Duke, which has since resumed its research, OPRR required the IRB to re-review clinical research protocols. "As far as OPRR and most federal agencies are concerned, if you didn't document it you didn't do it," Kaufman , who was not involved in the IRB when research was suspended, notes. The IRB now reports to Kaufman.

Checking Tray Tables?

But the level of documentation OPRR requires riles Norman Fost, professor of pediatrics at the University of Wisconsin-Madison, who witheringly brands OPRR's actions a "reign of terror." "OPRR is faulting IRBs for failing to comply with procedures and paperwork, "which in my view are only remotely related to protection of subjects," says Fost, who chairs the University's Health Sciences Human Subjects Committee. As one example, he cites the requirement of annual IRB re-review of already approved protocols. Standard practice for IRBs, he says, is for a subcommittee to conduct these re-reviews. That's because "in 99-plus percent of the cases," nothing has changed, so there is no need to take what he regards as valuable committee time to do this. Where the subcommittee finds new information or adverse effects, then the full committee can discuss the issue.

Fost likens the OPRR requirement for complete committee review of all protocols to a campaign by the Federal Aviation Administration, in an effort to reduce fatalities, to have airline pilots, not flight attendants, document that each tray table is in its "upright and locked position" before take-off, and complete paperwork specifying this.

"I have no reason to disagree with Norm on this at all," says Richard Krugman, dean of the University of Colorado Medical School. The school's human subjects' research was suspended by the Food and Drug Administration in September 1999 for all FDA-regulated protocols. Krugman says the Medical School then voluntarily suspended all human subjects' research. The FDA, he says, cited no "patient issues." The FDA's concerns focused on revamping the IRB's administration. As at Duke, the IRB re-reviewed human subjects' protocols. A private IRB also reviewed a number of protocols. By Christmas 1999, after establishing a new IRB structure, re-writing rules for review of protocols, and re-re-review of protocols, "FDA lifted the sanctions," says Krugman.

Fost and Krugman are hardly alone in the complaints, says Alta Charo, a professor of law at UW-Madison and a member of the National Advisory Commission on Bioethics, which is examining the entire issue of human subjects' research. "The commission has heard a lot of testimony from people who are IRB members, are investigators or are IRB staff, who have said that they are drowning in the workload, and a good part of that workload is the process of documentation. And it includes minutes of the meetings, records of the votes, evidence that the committee has worked its way down a checklist of considerations that go into whether or not we can assume that consent was really voluntary and informed," she says. Charo says the commission, which anticipates having a draft report on its deliberations has as a goal a system that is "more manageable" but still retains oversight over human subjects' research. "We endorse oversight mechanisms that protect research subjects to the maximum degree possible," writes Ralph Synderman, chancellor for Health Affairs at Duke, and Edward Holmes, dean of the Duke University School of Medicine. "Nonetheless it is our view that regulatory mechanisms are overly complex, difficult to interpret, and at times, redundant or inefficient."1

Need for Oversight

But the views of Fost and others are not universally accepted. Cynthia Dunn, director of clinical research at the University of Rochester, has nothing but praise for OPRR. In its 1996 investigation of the death of a human subject in an NIH- sponsored study at the university, the agency backed the university's own investigation that left the IRB blameless. But OPRR said, "there were some research administrative issues we really should be looking at," says Dunn. These included the staffing and training of the IRB. "They helped us become a leader nationally in this area," she says. Among the steps the university took as a result of its dealings with OPRR was to require that researchers get training of investigators who do research with human subjects that "constitutes greater than minimal risk" and pass an exam on ethics and regulations governing human subject research. (Beginning this month, all researchers applying for NIH grants will have to have such training.)

Dunn also takes strong exception to Fost's view on the matter of documentation and counters with her own airline analogy. "How would you feel if there were no records being kept as to certain maintenance being done on a plane you were to be flying but no plane had crashed yet?" she says. "There would be people, who likely would say such planes should be grounded until there was proof of inspection. In many respects, this whole area is no different," she adds. The grounding analogy, of course, refers to the suspension of research.

And Jane Henney, commissioner of the FDA, which is also involved in regulating human subjects' research, asserts strongly the need for strict adherence to rules and regulations governing the use of human subjects. "We all need to do all that we should to make sure we've got patients protected and studies being done in a way that we can stand behind this research enterprise," she says. (A spokesperson for the new Office of Human Research Protection declined to offer comment for this article. He referred The Scientist to FDA Commissioner Henney. The new head of OHRP, Greg Koski, did not return a message asking for comment left on his answering machine.) A major problem, says Henney, is "how well these IRBs have been supported at the local level, and whether or not they have been given the time and the resources to do the needed work that is required."

While acknowledging that work on an IRB is a significant addition to a faculty member's workload, Henney insists that the requirement of annual re-review by the entire IRB of ongoing research protocols is vital. "The fact is when sometimes you don't have a third party like an IRB regularly involved with work they've approved, you set up the scenario for not good things happening," she says.

Some who have been sanctioned by OPRR do sound as though they are better for the experience, as difficult as it was. While not directly saying whether the shutdown of research, re-review of protocols, and remedying of the deficiencies pointed out by OPRR has enhanced or hindered the IRB's work, Kaufman does say, "We have much greater participation on the IRB members in the review [of protocols process]. I think what we are most proud of is we protect human subjects better than we did before." Says Krugman, "I believe that we are now in a far better position to respond to questions on protocols." But he also adds, "I don't know there is any difference with regard to the subjects themselves."

All this increased effort comes at a cost, says Kaufman, noting that yearly human subject protection now costs "well over $1 million," more than four times what it did. At Colorado the IRB budget is $650,000 a year also a fourfold increase.

Value of an Advisory Committee

David Korn, senior vice president for biomedical and health sciences research at the Association of American Medical Colleges, views the actual value of the "processes and procedures" imposed by federal agencies as a necessary evil because the actual can't be verified. "We don't have the right outcomes measures. Probably if a bunch of reasonable people sat down in a non-emotional atmosphere, they might be able to agree on outcome measurements that are more satisfying than what we have now," he asserts. Krugman asserts there is a need for "outcomes research" to assess the value of the rules and regulations to see if they do what they are supposed to: protect human subjects.

As part of the plan replacing OPRR with the Office of Human Research Protection, there will be a 12-member committee to advise OHRP on human subject issues. Korn says that the AAMC proposed this idea, because human subject regulations have never gone through any kind of notice and comment process. "We felt that having an advisory council, with thoughtful people, would serve as an opportunity to think about some of these issues in advance and get feedback before issuing some of these pronouncements that you have to follow," he says.

How this committee will actually function remains uncertain and many eyes in the research community will be on it, as they will be on Koski to see how he handles this highly charged and thorny area.

Harvey Black is a freelance science writer in Madison, Wis.

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Top PreviousNextFront Page

Date: 3 Oct 2000 13:48:02 +0100
From: Jason Boehk jasonab@fiam.net

Monsanto scientists go for growth with luminous lawn

by David Wastell in Washington, UK Telegraph October 1, 2000

link:

http://www.telegraph.co.uk:80/et?ac=003100565149417&rtmo=QxO3OkOR....


Top PreviousNextFront Page

Date: 3 Oct 2000 15:20:24 +0100
From: geno@zap.a2000.nl

Disastrous Bayer vaccin appears to be GE.

From wytze

An incredible case of fraud.

A vaccin used to prevent cows from getting influenza (IBR) was introduced two years ago. Vaccination was made obligatory but from the very first day it went wrong. Thousands of cows died and got severely ill within very short time after getting the IBR vaccin.

The producer, Bayer Pharmaceutical company, claimed that in only a handful of cases it admitted a mistake and that it involved a viral contaminated batch of the vaccin, and was willing to pay some recompensation. In all the other cases Bayer said: proof that the problems were caused by the vaccin.

After the problems became too big the vaccination programme got suspended. About 1000 farmers are until now not getting any compensation for the death or disease of their animals. ID-DLO claims that now a synthetic version by a company Intervet should have solved the problem. Restart on a for now voluntary basis of the vaccination is now beginning but immediately the first new deaths are also being reported.

The vaccin was developed by a Dutch Institute: ID-DLO in Lelystad. ID-DLO has the patent on the vaccin and Bayer pays royalties to the Institute.

Guess who was asked to evaluate the problems with the vaccin and see if the vaccin had been the cause? Right, ID-DLO. A Parliamentarian committee has judged that the review was "impartial".

Bayer had always denied that GE had been involved. When asked they answered that it concerned a "natural mutant". However, today, at a GE congress in Lelystad a courageous farmer revealed that in a pr-folder of Bayer from 1996 (2 years before introduction) Bayer stated that a gene from the donororganism had been deleted. This pr-folder was however quickly withdrawn.

Why courageous? A journalist who was investigating the whole issue had received several anonymous and serious threats. This amazing fuck up and cover up is fortunately finally exposed but it will take a lot more work to get it all on the table.

It appears that the same killing vaccin is now also used in Canada and Germany and possibly also other countries and death reports are coming in. Severe problems seem to be happening with at least 3% (but possibly more) of the animals that get vaccinated. to be continued.


Top PreviousNextFront Page

Date: 3 Oct 2000 19:02:06 +0100
From: marcus@myrealbox.com

Genetically Modified Jelly Bellies

A large number of US products are no longer exported to the rest of the world because of their GM soya or maize (corn) content, which must now be labelled in many countries worldwide. US companies are losing out on exports because the "biotechnology" companies, such as Monsanto, forced the mixing of GM soya and maize crops with conventional crops on the way from the farm to the consumer.

Jelly Bellies are one of the few US exports which openly declare themselves to contain GM maize and one of very few products in the EU still to be seen containing GM maize. The safety of GM maize is unknown as it has never been independently tested. GM maize is intended to kill the corn borer insect, but also kills other "non target" species, including the Monarch butterfly.

For more info and contact details of Herman Goelitz, the company which products the FrankenJellyBellies, see here :

http://www.gmfoodnews.com/gmjelly.html

I'm sure Herman Goelitz will be pleased to hear from people with their views on GM maize...

regards
Marcus Williamson http://www.gmfoodnews.com


Top PreviousNextFront Page

Date: 4 Oct 2000 11:01:39 +0100
From: Jason Boehk jasonab@fiam.net

The text below comes from a Center for Food Safety press release dated October 3, 2000. Please note that it may not be the final word with regard to an appeal. Following, today's New York Times story about the lawsuit's dismissal.

--Jason Boehk

GE Foods FDA Lawsuit dismissed

For Immediate Release:

Contact: Andrew Kimbrell 202/547-9359

October 3, 2000
Joseph Mendelson

Federal Court Holds that FDA Currently has No Regulations on Genetically Engineered Foods

Current FDA Policy Held to be "non -binding" on Producers of Biotech Foods

Court Refuses to Judge Safety of Foods Currently on the Market

Washington D.C.-- On Monday, October 2, 2000, a federal court held that the Food and Drug Administration's (FDA) current, 1992 policy on genetically engineered foods "does not have a binding effect" on GE food producers. In dismissing a May 1998 lawsuit on the FDA's 1992 policy, the court equated the current policy to agency "inaction" and therefore found it immune from challenge under a number of statutes. FDA has announced that it will publish new rules on the testing and labeling of GE foods this fall.

The Court also refused to judge the current controversy over the safety and labeling of GE foods declaring that the agency's 1992 policy can only be

assessed with the information that was available at that time. While acknowledging plaintiffs have produced information "showing significant disagreement among scientific experts" concerning the safety of such food, the court stated it could not consider such information because it has been presented after 1992. The ruling leaves questions regarding the creation of actual regulations addressing the safety, environmental review and labeling of genetically foods unresolved.

Commenting on today's decision, Center for Food Safety Executive Director Andrew Kimbrell stated, "This court decision means that for almost a decade these novel foods have gone virtually unregulated in the United States. American consumers have been used as unknowing guinea pigs for the safety of these foods."

As a result of the court assessing only issues concerning GE foods prior to 1992, the ruling will have no effect on the safety and environmental issues concerning GE foods that have come to light since the issuance of the policy. On May 3, 2000, the FDA announced plans to substantially modify its 1992 policy rendering the court's determination irrelevant to the agency's expected new regulations.

The Center for Food Safety and 53 environmental, farming, and consumer organizations legally petitioned the FDA earlier this year detailing the new science that supports mandatory pre-market safety testing, environmental review and labeling of all GE foods. The FDA has not formally answered the coalition's legal petition as of yesterday's court ruling.

"We can only hope that FDA's response to our petition and the new regulations scheduled to be released this fall ensure adequate pre-market testing and mandatory labeling for all GE foods," stated Joseph Mendelson, Center for Food Safety Legal Director and attorney in the case.

"Clearly another legal battle may be in the offing should the FDA's new regulations fail to protect consumers and the environment," Mendelson continued.


Top PreviousNextFront Page

Date: 4 Oct 2000 11:01:39 +0100
From: Jason Boehk jasonab@fiam.net

Judge Upholds F.D.A. Policy on Genetically Altered Foods

By Andrew Pollack, New York Times, October 4, 2000

A federal judge has upheld the Food and Drug Administration's policy on genetically modified food, throwing out a lawsuit by biotechnology opponents that sought to require that such foods be labeled and tested for safety.

The decision represents a victory for the F.D.A. at a time when the agency is under fire from biotechnology critics for not regulating bio- engineered foods strictly enough. That criticism has increased in the last two weeks after environmental groups discovered a genetically engineered corn that was not approved for human consumption in taco shells.

In the taco case, meanwhile, a man who said he developed severe hives and stomach problems after eating the shells filed a lawsuit, the first known formal claim that anyone had actually been hurt by the corn.

The dismissed lawsuit was not directly related to the taco shell incident. It was filed in 1998 challenging the F.D.A.'s fundamental policy on genetically engineered foods.

In its policy statement, issued in 1992, the agency said genetically modified foods were generally recognized as safe and would not be regulated as food additives. It set up voluntary, not mandatory, consultations for

companies wanting to market such foods. It also said labeling was not required because genetic engineering did not change food in a "material" way.

The lawsuit, filed by the Alliance for Bio-Integrity and by some scientists and clergy members, said that lack of labeling and mandatory safety testing violated food safety laws. The suit also asserted that the F.D.A. had not allowed for proper public comment or filed an environmental impact statement on the new policy. And it said the lack of labeling violated the religious rights of people who did not want to eat such foods on moral grounds.

But Judge Colleen Kollar-Kotelly of the United States District Court in Washington granted summary judgment to the F.D.A., ruling that the agency "was not arbitrary and capricious in its finding that genetically modified foods need not be labeled because they do not differ `materially' from nonmodified foods." The decision was issued Friday but the parties involved did not receive copies until late Monday.

Judge Kollar-Kotelly also said that the government did not have to follow procedures for public notice and comment or file an environmental impact statement because the 1992 announcement was a policy statement, not a formal regulation.

The plaintiffs snatched some measure of victory from that reasoning. "It's a court ruling that there hasn't been any regulation on genetic engineering from the F.D.A.," said Joseph Mendelson III, a lawyer for the International Center for Technology Assessment, a Washington public interest group that was one of the plaintiffs. An F.D.A. spokeswoman said only that the agency was pleased by the decision.

Mr. Mendelson said the plaintiffs would not appeal because the F.D.A. is now changing its regulations. Those new regulations, while tougher, do not go far enough and could be the subject of a new lawsuit, he said.

In the taco shell incident, meanwhile, the F.D.A. said it had confirmed that StarLink corn was in the Taco Bell brand taco shells and had instituted a formal recall, although Kraft Foods, a unit of Philip Morris, which sold the shells, has already voluntarily recalled them. The F.D.A. also said it would now test other processed corn products.

Wallace Wasson of Chicago stated in a lawsuit that he suffered a severe stomachache, diarrhea, headache and hives after eating the Kraft taco shells. Mr. Wasson joined a class- action suit yesterday that had been filed last week against Kraft and Azteca Milling, which made the corn flour used in the shells.

StarLink was not approved for human consumption because of concerns that it could cause allergies. But there is no proof that it actually does cause allergies and some experts have said the chances of this are small.

The environmental groups that first detected the StarLink in the taco shells said they had received numerous calls from people believing they had suffered reactions to the shells. But even these biotechnology opponents

said that many of the claims were dubious and that none had been confirmed. An F.D.A. spokeswoman said the agency had received a few complaints of adverse reactions and was investigating them.

According to the complaint filed in Illinois state court in Chicago, Mr. Wasson ate some taco shells on the evening of Sept. 20 and awoke in pain at 3 a.m. the next morning. On Sept. 22, hearing the news about the tainted

taco shells, he called the toll-free number listed on the taco shell box and was referred to a doctor, who assured him the shells were safe


Top PreviousNextFront Page

Date: 5 Oct 2000 00:29:24 +0100
From: Ericka doodles@netins.net

Revised March 2000
UNION OF CONCERNED SCIENTISTS
2 Brattle Square, Cambridge, MA 02238
617-547-5552    ucs@ucsusa.org

Sources: webpages of
USDA http://www.aphis.usda.gov/bbep/bp/index.html
EPA http://www.epa.gov/oppbppd1/biopesticide
FDA http://vm.cfsan.fda.gov/~lrd/biocon.html

Genetically engineered crops allowed in US food supply

Foods on the Market

DateCropCompanyGE'd forAgainstTreatment
Date unknownCanolaMonsantoResist glyphosate herbicide to control weeds Arabidopsis, bacteria, virusRoundup Ready
1999CanolaMonsantoAltered oil (high lauric acid) to use on soap and food products Calif bay, turnip rape, bacteria, virusLaurical
1995CanolaAventisResist glufosinate herbicide to control weeds Bacteria, virusName unknown
2000Chicory (radicchio)Bejo ZadenMale sterile to facilitate hybridization BacteriaSeed Link
1997CornMonsantoBt toxin to control insect pests (European corn borer) BacteriaYieldGard
1995CornAventis Resist glufosinate herbicide to control weeds / male sterile to facilitate hybridizationBacteria, virusSeedLink
Date unknown Corn Aventis Resist glufosinate herbicide to control weeds Bacteria, virus LibertyLink
Date unknown Corn Dow / Mycogen Bt toxin to control insect pests (European corn borer) Corn, bacteria, virus NatureGard
1995 Corn Monsanto / DeKalb Bt toxin to control insect pests (European corn borer) Bacteria Bt-Xtra
1997 Corn DuPont / Pioneer Hi-Bred Male sterile to facilitate hybridization Potato, corn, bacteria, virus Name unknown
1998 Corn Monsanto Resist glyphosate herbicide to control weeds / Bt toxin to control insect pests (European corn borer) Arabidopsis, bacteria, virus Name unknown
1998 Corn Monsanto / DeKalb Resist glufosinate herbicide to control weeds Bacteria, virus Name unknown
Date unknown Corn Aventis Resist glufosinate herbicide to control weeds / Bt toxin to control insect pests (European corn borer) Bacteria, virus Star Link
1998 Corn Monsanto Resist glyphosate herbicide to control weeds Arabidopsis, bacteria, virus Roundup Ready
1998 Corn Novartis Bt toxin to control insect pests (European corn borer) Bacteria Bt11
1996 Corn Novartis Bt toxin to control insect pests (European corn borer) Corn, bacteria, virus Knock Out
1995 Corn (pop) Novartis Bt toxin to control insect pests (European corn borer) Corn, bacteria, virus Knock Out
1998 Corn (sweet) Novartis Bt toxin to control insect pests (European corn borer) Bacteria Bt11
1998 Cotton Monsanto / Rhone-Poulenc Resist bromoxynil herbicide to control weeds / Bt toxin to control insect pests (cotton bollworms and tobacco budworm) Bacteria Name unknown
1998 Cotton Monsanto Bt toxin to control insect pests (cotton bollworms and tobacco budworm) Bacteria Bollgard
1995 Cotton Monsanto Resist glyphosate herbicide to control weeds Arabidopsis, bacteria, virus Roundup Ready
1996 Cotton DuPont Resist sulfonylurea herbicide to control weeds Tobacco, bacteria Name unknown
Date unknown Cotton Monsanto / Rhone-Poulenc Resist bromoxynil herbicide to control weeds Bacteria, virus BXN Cotton
1995 Flax Univ Saskatchewan Resist sulfonylurea herbicide to grow in soils with herbicide residues Arabidopsis, bacteria CDC Triffid
1999 Papaya Cornell Univ / Univ Hawaii Resist papaya ringspot virus Bacteria, virus Sunup, Rainbow
1997 Potato Monsanto Bt toxin to control insect pests (Colorado potato beetle) Bacteria NewLeaf
1995 Potato Monsanto Bt toxin to control insect pests (Colorado potato beetle) / resist potato virus Y Bacteria, virus NewLeaf Y
1999 Potato Monsanto Bt toxin to control insect pests (Colorado potato beetle) / resist potato leafroll virus Bacteria, virus NewLeaf Plus
1998 Soybean DuPont Altered oil (high oleic acid) to increase stability, reduce polyunsaturated fatty acids Soybean, bean, bacteria, virus Name unknown
1997 Soybean Aventis Resist glufosinate herbicide to control weeds Bacteria, virus Name unknown
1998 Soybean Monsanto Resist glyphosate herbicide to control weeds Petunia, soybean, bacteria, virus Roundup Ready
1995 Squash Seminis Vegetable Seed Resist watermelon mosaic 2 and zucchini yellow mosaic viruses Bacteria, virus Freedom II
1995 Squash Seminis Vegetable Seed Resist watermelon mosaic 2, zucchini yellow mosaic, cucumber mosaic viruses Bacteria, virus Name unknown
1997 Sugarbeet Monsanto / Novartis Resist glyphosate herbicide to control weeds Bacteria, virus Name unknown
1999 Sugarbeet Aventis Resist glufosinate herbicide to control weeds Bacteria, virus Name unknown
2000 Tomato DNA Plant Technology Altered ripening to enhance fresh market value Tomato, bacteria, virus Endless Summer
1995 Tomato Monsanto Altered ripening to enhance fresh market value Bacteria Name unknown
1995 Tomato Zeneca / PetoSeed Thicker skin and altered pectin to enhance processing value Tomato, bacteria, virus Name unknown
1995 Tomato Monsanto / Calgene Altered ripening to enhance fresh market value Tomato, bacteria, virus FlavrSavr
1994 Tomato (cherry) Agritope Altered ripening to enhance fresh market value Bacteria Name unknown

NOTES

Regulation and product names:

  1. All crops listed above required a determination from the US Department of Agriculture (USDA) that they were not plant pests under the Federal Plant Pest Act.

  2. Bt crops, in addition to USDA regulation, were approved by the Environmental Protection Agency (EPA) under the Federal Insecticide, Fungicide, and Rodenticide Act and the Federal Food, Drug, and Cosmetic Act.

  3. Before most of the herbicide-resistant crops could enter the food supply, EPA registered the herbicide for use on the new crop. Sulfonylurea-resistant flax is the exception because the herbicide is not to be sprayed on the crop. Sulfonylurea-resistant flax is to be planted only in soils containing sulfonylurea residues.

  4. Although not required, all products were the subject of voluntary consultations with the Food and Drug Administration (FDA) about food safety. FDA required labeling of two productsacanola and soybean with altered oilsabecause the agency considered the oils to be significantly different from nonengineered canola and soy oil. The required labels do not divulge that the oils were obtained from genetically engineered crops.

  5. To the extent they are known, the chart lists trade names or company designations for crops at the time they finished the regulatory process. Once a crop is commercialized and licensed to other companies, it may be sold under many other names.
communications with agency staff and company representatives; Federal Register notices and agency documents on individual crops.

Revised March 2000

UNION OF CONCERNED SCIENTISTS
2 Brattle Square, Cambridge, MA 02238
617-547-5552
Contact us at ucs@ucsusa.org


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Date: 5 Oct 2000 11:20:14 +0100
From: RBBAX@aol.com

Suspect pro-GM mole on anti-biotech list

Would the real Simon Howell please stand up?

-------------

Dear All,

As you will see from the following e-mail correspondence, a certain Simon Howell appears to have been posing as an anti-GM campaigner on one of the main anti-biotech e-mail lists – perhaps in order to try and influence the GM debate at grass roots level.

A few campaigners recently decided to check Simon out because of his rigid pro-biotech views (see enclosed e-mails) – and after some investigation it was suggested that Mr Howell is actually Professor Simon Howell, Head of Biomedical Sciences at Kings College, the Strand, London. (Check out this link for info and pic of Prof. Simon Howell): http://www.kcl.ac.uk/depsta/biomedical/errg/errgshowell.htm

I have twice put it to Mr Howell that he is actually Professor Howell, but I've received no response (see enclosed e-mail). And when an anti-GM campaigner recently contacted Mr Howell to enquire where he worked, Mr Howell claimed he was a student in the USA (see enclosed e-mail). And when it was put to Mr Howell that his e-mail address was actually European-based, again he clammed up.

So, by remaining silent Simon Howell appears to guilty by default. Perhaps therefore he should be paraded outside Monsanto's UK headquarters and pelted with mushy GM fruit and vegetables – if such things exist!.

Pro-biotech moles may like to take note: GM fruit and veg is bad for your health, and your complexion!

Ron Baxter


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Date: 6 Oct 2000 03:19:29 +0100
From: jim@niall7.demon.co.uk

The Greenpeace list was posted on the Internet at http://www.truefoodnow.org

US: Greenpeace Issues 'Shopping List' of Biofoods

Wednesday October 4 7:56 PM ET
http://dailynews.yahoo.com/h/nm/20001004/sc/biotech_list_dc_1.htm....

WASHINGTON (Reuters) – The anti-biotech group Greenpeace issued a on Wednesday outlining thousands of brand-name cereals, snacks, frozen dinners and other foods that contain genetically-altered corn, soybeans and other ingredients.

The activist group said it published the list on its web site, along with a list of foods that do not contain gene-spliced ingredients, to give consumers a choice at the grocery store. While food companies have eliminated genetically engineered ingredients in Europe, the shopping list is the only way American consumers can avoid genetically engineered contaminated said Charles Margulis, a Greenpeace food spokesman.

Japan, Australia, Italy, Britain and a dozen other nations now require labels on foods containing genetically-altered ingredients.

U.S. regulators have rejected pressure from activist groups for similar labelling requirements, saying the foods are no different from those grown with conventional crops.

Labelling has been thrust into the spotlight with the Food and Drug Administration (news – web sites)'s current investigation into how a biotech corn variety ended up in taco shells, even though it wasn't approved for human food. The taco shells were recalled because of concern that some people could be allergic to the corn.

The FDA is expected to soon issue voluntary guidelines for U.S. companies that want to add a label saying a food does or does not include biotech ingredients.

American food companies, which oppose mandatory labels, said the new Greenpeace shopping list failed to tell consumers that regulators have found all the foods safe. These products are safe and adhere to science-based federal food regulations already on the said Karil Kochenderfer, a trade official with the Grocery Manufacturers of America. Activist opponents of food biotechnology need to do their homework on the studies done by the National Academy of Sciences and other authoritative bodies on products derived through he added.

The U.S. biotech industry contends gene-spliced foods are just as safe as conventional ones, and have been subjected to more safety and environmental tests.

The National Academy of Sciences issued a report earlier this year that cautiously endorsed the safety of biofoods but called for more study into long-term health and environmental effects.

The Greenpeace list was posted on the Internet at http://www.truefoodnow.org


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Date: 6 Oct 2000 08:51:25 +0100
From: RBBAX@aol.com
By way of: nlpwessex@bigfoot.com (NLP Wessex)

Please note: The following release provides new information and perspective on the recent decision in the lawsuit against FDA policy on genetically engineered food.

Posted at the Alliance for Bio-Integrity website http://www.biointegrity.org

US – Alliance for Bio-Integrity statement on GM Court case

For Immediate Release

Alliance for Bio-Integrity
October 4, 2000
Contact: Steven Druker (641) 472-8008

U.S. COURT CONFIRMS THAT BIOENGINEERED FOODS ARE UNREGULATED

FINDS FDA "INACTION" IS TECHNICALLY LEGAL DESPITE "SIGNIFICANT" SCIENTIFIC DISPUTE ABOUT SAFETY

SAYS POLITICAL APPOINTEES HAD LEEWAY TO IGNORE WARNINGS OF STAFF SCIENTISTS ABOUT UNIQUE HEALTH HAZARDS

Although acknowledging that "significant" scientific dispute exists about the safety of genetically engineered (GE) foods, a federal court has ruled that the U.S. Food and Drug Administration's decision not to regulate them is technically legal. On October 2, the U.S. District Court for the District of Columbia delivered a ruling that the policy of "inaction" adopted in 1992 is entitled to stand, despite the fact that scientists currently disagree about the safety of these new foods and that the FDA's own experts had repeatedly warned about their unique health hazards. Accordingly, it dismissed a lawsuit filed against the FDA in May, 1998 by a coalition of public interest groups, eminent scientists, and religious leaders. Doing so, it affirmed FDA policy does "not impose any ... obligations" on the biotech industry.

The suit challenged the FDA's presumption that GE foods are safe and its refusal to require they be safety tested and labeled. In an unprecedented step, nine well-credentialed scientists joined the suit as plaintiffs to emphasize the extent to which FDA's presumption of safety is scientifically unsound. While noting that plaintiffs had introduced many statements from experts explaining that genetic engineering is "inherently risky" and that "genetically modified plants could have high levels of toxins," the court said it could only consider evidence within the FDA's written record when the agency made its policy decision in 1992.

Further, although the court recognized there were numerous statements in the relevant record from the FDA's own scientists "warning" about unintended harmful side effects and "criticizing" the lack of scientific basis for the FDA's policy, it held that the agency's political appointees were legally entitled to disregard such expert input.

"The court's decision is based on technical aspects of U.S. administrative law and in no way rules that GE foods are safe," states Steven Druker, executive director of the Alliance for Bio-Integrity, the public interest organization that coordinated the suit and is the lead plaintiff. "Rather, the court has said that FDA's 1992 policy to allow unregulated marketing of GE foods is entitled to judicial deference even though there is major scientific disagreement about their safety. Moreover, the court appears to indicate that if the FDA were trying to institute such a policy decision today, it could not sustain a presumption that these foods are generally recognized as safe among scientists."

Druker continues: "The decision only upheld FDA policy by failing to address key facts emphasized by the plaintiffs.

First, shortly before the FDA issued its policy statement claiming that GE foods are generally recognized as safe, its biotechnology coordinator wrote to a Canadian health official that there was no scientific consensus about safety.

Second, the political appointees did not just ignore their experts' input, they lied about it. They claimed they were 'not aware of any information showing that foods derived by these new methods differ from other foods in any meaningful or uniform way.'

Third, as the court recognized, the law requires that each GE food be demonstrated safe through 'technical evidence'; but there is no such evidence for any of the GE foods on the market."

Druker concludes: "This decision is clearly unsound. The Alliance for Bio-Integrity intends to appeal it, reverse it, and reinstate reason and responsibility in FDA policy."

Note: Summaries of the statements from FDA scientists, along with photocopies of the original documents, are posted at the Alliance for Bio-Integrity website http://www.biointegrity.org

quote:

"All policymakers must be vigilant to the possibility of research data being manipulated by corporate bodies and of scientific colleagues being seduced by the material charms of industry. Trust is no defence against an aggressively deceptive corporate sector,"

THE LANCET, April 2000


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Date: 6 Oct 2000 11:12:05 +0100
From: Vegetarian Resource Center vrc@tiac.net

UK: Three Cases of Human `Mad Cow' Disease Found in UK Children

Bloomberg News, October 6 2000 12:01AM , London, October 6 (Bloomberg)
http://my.aol.com/news/story.tmpl?table=n&cat=0110&id=00100612015....

An aggressive campaign to detect the human version of "mad cow" disease in U.K. children has uncovered three cases in the past three years.

Since May 1997, a surveillance unit in Cambridge has sent cards to U.K. pediatricians every month asking about children with signs of intellectual or neurological deterioration. Because the disease, called variant Creutzfeldt-Jakob disease or vCJD, can be hard to detect in children, the researchers requested information on any signs of neurological progressive disease.

A team of experts reviewed hundreds of reports, confirming two cases and identifying a suspected case in 1999. The youngest patient was 12 years old when symptoms appeared.

"That active prospective surveillance for three years has not discovered a large number of cases of vCJD in children is reassuring," the researchers said.

Still, three years is a short time to identify any trends and no one knows how long it takes for symptoms to appear, they said.

"There is still the possibility that an increasing number of cases will be diagnosed in children," they concluded. Their findings will appear in tomorrow's edition of the medical journal Lancet.

The human disease is widely believed to be linked to an outbreak of mad cow disease in the U.K. in the late 1980s.

As of Sept. 4, there have been 82 definite or confirmed cases of the disease in adults, up from 68 cases in April. It's believed they contracted vCJD from eating infected beef.


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Date: 6 Oct 2000 14:29:45 +0100
From: Sprinkraft@aol.com

How long do we still have to believe that judges are "right" and "unbiased"?

JUDGE Colleen Kollar-Kotelly to also rule in Monsanto suit?

The same judge that ruled on the FDA/Bio-integrity suit is apparently going to also rule on this suit filed after the FDA suit..........

Genetically Modified Food COMPLAINT alleging antitrust and safety violations under U.S. and international law filed against Monsanto

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

CLASS ACTION COMPLAINT

(JURY TRIAL DEMANDED)

CASE NUMBER 1:99CV03337

JUDGE: Colleen Kollar-Kotelly

DECK TYPE: Antitrust

DATE STAMP: 12/14/1999

on behalf of themselves and all others similarly situated,

Plaintiffs,

v.

MONSANTO COMPANY 800 North Lindbergh Boulevard St. Louis, Missouri 63617

Defendant.


Top PreviousNextFront Page

Date: 7 Oct 2000 15:47:00 +0100
From: jim@niall7.demon.co.uk

US-BIO: Recommending approval of ALL GE crops for human consuption

Quote from this article:

"The recall spurred both Kraft Foods and the Biotechnology Industry Organization (BIO) to recommend that all biotech crops planted be approved for human consumption and .... "

Biotech Corn Leads To Series Of Recalls

By Matthew Herper, Forbes, Tuesday October 3
http://biz.yahoo.com/fo/001003/mu3562.html

It may sound like a silly science fiction movie. But that's how Lisa Dry, a spokeswoman for the Biotechnology Industry Organization, referred to a very real crisis for biotech crops designed to be insect resistant.

StarLink is a brand of genetically engineered corn sold by France's Aventis (NYSE: AVE – news). It was approved only for use in animal feed, but an environmental group called Friends of the Earth discovered it in taco shells sold under the brand name Taco Bell Home Originals by Kraft Foods, a subsidiary of Philip Morris (NYSE: MO – news). On Sept. 22, Kraft became the first company to pull a product from American shelves because it contained genetically altered corn.

That spurred Aventis, which had 1999 revenues of about $11 billion, to take the corn seed off the market. Because that still left seed in the hands of growers, Aventis announced on Monday that it would pay for a government buyback program that could reportedly cost as much as $70 million.

How will this string of events affect Aventis and other companies that sell genetically altered crops?

The recall spurred both Kraft Foods and the Biotechnology Industry Organization (BIO) to recommend that all biotech crops planted be approved for human consumption and that tests for validating grain be put in place.

One member of BIO is Monsanto, a division of drug giant Pharmacia (NYSE: PHA – news) that is expected to go We think [these recommendations] are all reasonable and, frankly, are says Monsanto spokeswoman Scarlett Lee Foster.

As an animal-only biotech crop, StarLink is an anomaly. Of the 40 genetically modified crops on the market, only StarLink was not approved for human consumption. That's why Friends of the Earth tested consumer products for StarLink corn in the first place, according to Larry Bohlen, a spokesman for the group.

It's not clear that the recalled taco shells posed any danger to consumers. The insect-killing protein in StarLink, CRY9C, is distinct from the insect-resistance compounds in the other seven types of biotech corn on the market. Because CRY9C was not immediately digested after being eaten, the Food and Drug Administration wanted proof that it was not an allergen before approving it for human consumption.

But according to a letter sent through BIO by Steve Taylor, a professor at the University of Nebraska-Lincoln, most allergenic proteins are present in foods at levels from 1% to 40%. CRY9C was present in StarLink at a concentration of 0.3%, and all involved with the case acknowledge that StarLink was only a small fraction of the corn present in the recalled taco shells.

That doesn't quiet advocates who say that the StarLink incident is proof that regulation of biotech crops is insufficient. This should be a wake-up call to folks that the federal government has says Foster.

Among those most worried may be organic farmers, who often can't sell crops that have been mixed with genetically modified pollen blown by the wind onto their fields. The organic products sector is worth an estimated $6 billion, according to Mark Lipson, policy program director for the Organic Farming Research Foundation. There are markets that are very highly sensitive about the presence of recombinant DNA, and virtually any detectable Lipson says. As an example, he points to organic tortilla chip maker Terra Prima, which had to recall 87,000 bags of its chips after tests by a Netherlands-based distributor found that they contained genetically modified corn.

Go to www.forbes.com to see all of our latest stories.


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Date: 7 Oct 2000 15:56:54 +0100
From: jim@niall7.demon.co.uk

Imminent FDA Rulemaking on Genetically Engineered Foods

October 5, 2000
http://www.gefoodalert.org/html/fdamemo.htm

PRESS MEMO

To:Reporters and Editors
From:Richard Caplan, U.S. Public Interest Research Group, 202-546-9707

Re: Imminent FDA Rulemaking on Genetically Engineered Foods

The recent news about Kraft's recall of Taco Bell taco shells has significantly raised the profile of the genetic engineering debate in the United States. In addition to the Food and Drug Administration's announcement on Wednesday, October 4 that the recall was Class II, meaning the illegal adulterant is a potential health hazard, the agency also disclosed they would be testing other products for thepresence of the genetically engineered corn. With additional action by the agency expected in the next few weeks, this is a crucial time to examine FDA's regulations.

The Food and Drug Administration has never properly regulated geneticallyengineered foods. The agency has resisted both scientific need and overwhelming public support for mandatory labeling.

FDA's new initiatives would do very little to change the current system. The pending regulations will merely act as a band-aid on a badly flawed policy. The following background paper details shortcomings in FDA's current policy, and why the agency's new proposals are wholly inadequate to protect public health or meet the needs of the public.

FDA's proposals fall far short of what consumer, environmental, and food safety groups have petitioned the agency for, including mandatory labeling for all genetically engineered foods, full environmental review, and a comprehensive pre-market food safety review.