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How It Happened That We Don't Regulate Biotech

by Donella Meadows
Tide Pool
August 18, 2000

Back in the 1970s the awesome news that scientists had learned how to redesign genes started a regulatory flurry. Distinguished panels met to ask imponderable questions. Could some human-created form of life carry self-multiplying havoc into the world? How can we prevent such a disaster?

Back then genetic escapes were considered so likely that gene-splicing research was carried out in sealed labs. The citizens of Cambridge, Massachusetts, home of Harvard and MIT, forbade such labs within their city limits. Congress debated dozens of bills to regulate genetic engineering.

Then, suddenly, the concern disappeared. Genetic engineering became routine in academia and a hot field of competition in business. Nowadays scientists and corporations create gene-spliced organisms and release them into nature with astounding little oversight.

I always wondered how that happened. It's not as if the serious questions about "genetic pollution" were ever answered. Our ignorance of the health and ecological and evolutionary impacts of gene-spliced crops and other products is still enormous. But somehow the biotech enterprise got a social and regulatory green light. No questions asked. Full speed ahead.

Why? How? When?

A partial answer to that question has appeared in the July issue of "Gene Watch," the bulletin of the Council for Responsible Genetics. Susan Wright, a science historian at the University of Michigan, writes about an MIT archive in which she found the transcript of a fateful meeting that took place in 1976 at the National Institutes of Health.

Then, as now, the greatest area of concern was microbes. Higher organisms carry their DNA around in discrete packages inside cell nuclei. They release genes into the world only under relatively controlled acts of reproduction. Bacteria and viruses, on the other hand, slosh genes around in a shockingly messy way.

They pick them up and drop them off, shuffle them, trade them, insert them into the supposedly organized genomes of higher forms of life. That's how viruses infect us. It's also one of the ways geneticists paste genes from one kind of critter into another. First they insert a snipped-out gene, from a flounder, say, into a virus or bacterium. Then they use the microbe to smuggle the flounder gene into, say, a salmon or a tomato.

The problem is that once the gene has been loosened from the organized flounder into the disorganized microbial world, there's no telling where it might end up. One single-celled creature could pass it to another. For all we know, it could end up in a minnow or a whale or in our own guts.

In 1976 an august committee of NIH virologists was asked to test this danger. They were to snip out from a virus a gene that causes tumors when the virus infects mice. They were to paste that gene into bacteria and then see whether the bacteria could cause tumors in other animals. If so, it would not only be evidence that some kinds of gene-splicing might turn cancer into a communicable disease, it would also be evidence that genes unleashed into microbes could spread beyond anyone's recall.

The committee debated what kind of bacteria to use in the test. Scientifically the answer was obvious; you seek out the worst case. You use bacteria likely to thrive and infect the test animals. But the virologists had more than science in mind. They worried about politics, about public controversy, about their own work being regulated. So they chose to use weakened bacteria that were unlikely to do harm.

In short, they fudged the test. Here are some of the things they said, recorded in the transcript of the meeting. "By using known pathogens, it seems to me we go politically in the wrong direction even though scientifically it does make more sense." "If we want to get these experiments done so we can go about our work quickly, maybe one shouldn't introduce problems of this level." "It's molecular politics, not molecular biology, and I think we have to consider both, because a lot of science is at stake."

They wanted "a slick New York Times kind of experiment." But even the weakened bacteria they ended up using did infect some test animals with tumors. That result, says Wright, "had the NIH campus buzzing at the time."

So they fudged again. The disturbing results were never published in a major journal. To the contrary, a 1979 NIH press conference announced that "this form of research is perfectly safe." The New York Times reported that "the risks are considerably less than had been feared." All through the 1980s and 90s, this study was cited as evidence that bioengineering poses no threats. Only in 1988, at a meeting of federal regulators, did one of them honestly articulate our government's actual policy: "If the American public wants progress, they will have to be guinea pigs."

Next time you hear a scientist asserting that gene splicing is safe, remind yourself that there is no scientific evidence for that statement. We are profoundly ignorant about what we are doing to the code that generates all life. And unfortunately some scientists, including those entrusted with public safety, are willing to lie.

Donella H. Meadows is an adjunct professor of environmental studies at Dartmouth College.


Comments prepared by Steven M. Druker,
Executive Director [Alliance for Bio-Integrity]

2 May 2001
[Docket No. 00N-1396]
Dockets Management Branch [HFA-305]
Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852

To Whom It May Concern:

The Alliance for Bio-Integrity (ABI) provides the following comments in response to the Department of Health and Human Services, Food and Drug Administration's ("FDA") "Premarket Notice Concerning Bioengineered Foods" 66 Fed. Reg. 4706 (January 18, 2001).


If it looks like corn and tastes like corn  . . . what's the problem???

In submitting these comments, the Alliance for Bio-Integrity incorporates by reference all documents submitted to the District Court and the FDA (including the complaint, legal briefs, and declarations) and all the assertions made therein, as well as the administrative record provided by the FDA, in the case of Alliance for Bio-Integrity, et al, v. Shalala, et al, Docket No. 98-1300 (CKK) (filed May 27, 1998).

More specifically, ABI finds the new FDA proposal to be not only inadequate and contrary to the best scientific knowledge, but (a) contrary to the clear intent of U.S. law and (b) based on misrepresentation. Further, ABI maintains that a full consideration of the evidence makes it difficult to believe that these misrepresentations are innocent mistakes but instead strongly indicates they are fraudulent and are part of a calculated, systematic endeavor to deceive Congress and the American people about the potential health hazards of bioengineered foods (commonly referred to as "genetically engineered" or "GE" foods). This statement is not made lightly but is based on thorough knowledge of the facts, and it is prompted by a belief that such behavior on the part of the agency entrusted with assuring the safety of the nation's food must be clearly categorized as wrong, directly confronted, and promptly corrected.

The following paragraphs explain in detail why the FDA's behavior in permitting the marketing of bioengineered foods is so unscientific, unethical, and unacceptable - and why the proposed regulations must be withdrawn and every bioengineered food withheld from the market until proper testing has confirmed it is safe according to the standard required by law.

I. FDA's Claim That GE Foods Are Generally Recognized As Safe is False and Fraudulent

A. The Required Level of Consensus is Very High

As the FDA's regulations prescribe and the federal courts have decreed, general recognition of safety can only be imputed if there is an overwhelming consensus in the community of qualified experts. While unanimity is not required, a significant disagreement prevents a determination that consensus exists. (62 Fed. Reg. At 18939.) Further, it takes only a few experts to provide the requisite level of disagreement. For instance, in United States v. Seven Cartons . . . Ferro-Lac, 293 F. Supp. 660, 664 (N.D. Il. 1968) the court agreed with the FDA that there was not general recognition of safety, based solely on the affidavits of two scientists who said that they were not aware of any studies in the pharmacological-toxicological literature on the intended use of the substance.

B. There Was Sufficient Doubt About the Safety of GE Foods Within the FDA's Own Scientific Staff to Nullify GRAS Status

Prior to the FDA's issuance of its May 1992 policy statement presuming that GE foods are generally recognized as safe (GRAS), its own experts had expressed concerns about the unique potential health hazards of these new foods in numerous memos to agency decision-makers. The pervasiveness of the concerns within the scientific staff is attested by a memo from an FDA official stating: "The processes of genetic engineering and traditional breeding are different, and according to the technical experts in the agency, they lead to different risks." (FDA Administrative Record (hereinafter "A.R.") at 18,953.) Quotations from many of the FDA scientists are in the briefs we submitted to the court in the previously mentioned lawsuit. The FDA has the original memos in its possession, and photocopies of over twenty key ones are on our website http// Further, although the District Court upheld the FDA on narrow technical grounds in the lawsuit, it acknowledged that concerns had been raised by the FDA experts, and it did not state that the required level of disagreement was lacking. Rather, the court ruled that the upper level administrators had discretion to disregard their experts in making a GRAS determination. Even if this ruling is correct (which is highly dubious), it is still the case that the overwhelming opinion of the FDA experts was that no GE food can be presumed safe unless it has been confirmed so through rigorous toxicological feeding studies.

C. The FDA Knows There Has Never Been Expert Consensus About the Safety of GE Foods

In 1992, when the FDA issued its formal presumption that GE foods are GRAS, it was well aware that not only were they not recognized as safe by its own experts but that there was in fact no consensus in the scientific community at large. This lack of consensus was clearly acknowledged by Dr. James Maryanski, FDA's Biotechnology Coordinator, in a letter to a Canadian official on October 23, 1991. (A.R. at 22925)

Moreover, the FDA is also well aware that substantial disagreement in the scientific community about the safety of GE foods not only continues but is broadening and intensifying - and that it is more than enough to prevent these products from qualifying as GRAS. The mere fact that nine well-credentialed experts joined our lawsuit as plaintiffs and asserted they viewed GE foods as inherently more hazardous than their conventional counterparts was in itself sufficient evidence that the legally required level of consensus does not exist. The District Court clearly acknowledged the lack of consensus by stating: "Plaintiffs have produced several documents showing significant disagreements among scientific experts." However, it said that because it was specifically reviewing FDA's policy decision of 1992, it was restricted to consider only the information the FDA had before it at that time.

However, even if the court was correct in concluding that all evidence since May 1992 was irrelevant for purposes of that particular legal action (a conclusion that appears seriously flawed), it in no way told the FDA it had license to ignore such evidence in making its decisions after that date. But that is precisely what the FDA persists in doing. It systematically disregards the extensive evidence demonstrating the existence of significant expert disagreement about the safety of GE foods that has been presented to it by our lawsuit, at the series of public meetings it held in 1999, and through other formal channels; it pretends that this evidence is somehow nonexistent; and it gives the false impression in its public pronouncements that there is overwhelming consensus about safety.

D. The FDA Has Made Fraudulent Claims About (a) the Existence of Scientific Consensus and (b) the Safety of GE Foods

Accordingly, it is obvious that the FDA's claims (issued in May, 1992 and repeated up to the present) that there is general recognition of safety are not only false but fraudulent. Moreover, the agency has flatly denied having any information showing that GE foods differ in any meaningful way from other foods, even though its own files are replete with such information, much of it from its own experts. One of the most blatant examples of such fraudulent misrepresentation is the following assertion in the agency's formal policy statement of May 29, 1992: "The agency is not aware of any information showing that foods derived by these new methods differ from other foods in any meaningful or uniform way..." It is difficult for a reasonable man or woman to regard this statement as anything other than a calculated attempt to deceive the public and evade the law.

II. The Technical Evidence Required for GRAS Status Does Not Exist

As the FDA's own regulations make clear, in addition to overwhelming consensus about safety, GRAS status requires that this consensus be based on technical evidence that clearly demonstrates safety. The court acknowledged this requirement, stating that to qualify as GRAS, a substance "must have technical evidence of safety, usually in published scientific studies ." (Citing 21 C.F.R. Sec. 170.30 (a-b); 62 Fed. Reg. 18940.) This means, in the words of FDA's own regulations, that the tests must demonstrate "a reasonable certainty ... that the substance is not harmful under its intended conditions of use." (21 CFR Sec. 170.3(i)). Therefore, even if there were scientific consensus about the safety of bioengineered foods, the law clearly requires that their safety still must be established through standard scientific tests.

The evidence presented in our lawsuit made it clear that such technical evidence of safety does not currently exist for any GE food. Interestingly, although we plaintiffs emphasized this point in our legal briefs, and although the court acknowledged a requirement for technical evidence in its opinion, the opinion then drops the subject completely and never addresses the issue of whether such evidence actually exists in the case of GE foods. Consequently, there has yet to be an actual judicial ruling on this particular issue, and the FDA is not justified in claiming that such technical evidence exists.

Yet, in practice, the FDA does try to give the impression that there has been scientific demonstration of safety. For instance, on May 3, 2000, the FDA Commissioner declared: "FDA's scientific review continues to show that all bioengineered foods sold here in the United States today are as safe as their non-bioengineered counterparts." Yet the year before, the FDA clearly acknowledged it does not perform substantial reviews of GE foods, stating: "FDA has not found it necessary to conduct comprehensive scientific reviews of foods derived from bioengineered plants Š consistent with its 1992 policy." (Reported in The Lancet, May 29, 1999) Moreover, according to the FDA's own experts, the most extensive test it did review (on the Flavr Savr tomato) raised an unresolved safety issue. (A.R. 004258-60; 005092-95; 005117-19)

III. FDA's Proposed Regulations Are Based on Assumptions That Are Scientifically Unsound

As noted above, FDA's proposed regulations do not rest on solid evidence. Rather, besides the agency's fraudulent claims about GRAS status, its regulations rest on an unfounded assumption - the assumption that producing new varieties of food-yielding organisms through recombinant DNA technology ("genetic engineering") is inherently no more hazardous than doing so through traditional breeding. Not only is this assumption empirically unsubstantiated, the weight of the evidence is against it. The FDA has already been extensively informed about the unique potential for GE foods to contain unexpected and harmful substances. (e.g. Center for Food Safety Comments of April 10, 2001) Recent evidence provides added justification for concern about unexpected side effects.

First, the discoveries of the human genome project released in early 2001 (a) confirm that the foundational assumptions of genetic engineering are overly simplistic and seriously unsound and (b) indicate that recombinant DNA techniques entail greater potential for unpredictable hazards than was previously suspected even by experts advocating a more precautionary approach.

Second, there is mounting evidence of GE plants with substantial - and unexpected - alterations in chemical composition. For instance, Aventis's data revealed statistically significant differences between T25 herbicide-resistant maize and its conventional counterpart in terms of carbohydrate, amino acid and fatty acid composition.

Research at the Rowett Institute on two lines of GE potatoes found several statistically significant compositional differences between each one and the nonGE parental line. Further, there was even statistically significant difference between the two GE lines, although they were derived from the same line using the same foreign gene - indicating that the effects of an inserted gene vary with its position. Moreover, the Public Health Association of Australia (PHAA) analyzed Monsanto's data on three GE plants (herbicide resistant maize and canola, and pesticide-producing maize) and in all three cases discovered several statistically significant differences in chemical composition from the nonGE counterpart. The PHAA report (October 2000) states that the differences cannot be attributed solely to the known products of the inserted genes and cautions that these plants may contain unexpected - and to date unidentified - new substances that could be harmful to humans. (This report is attached.)

Third, research at UK's John Innes Centre confirms that the viral promoter used in almost all GE plants can facilitate various abnormal genetic recombinations. This could lead to serious disruptions or to generation of new and hazardous chemicals. Additionally, experts warn that parts of existing viruses could recombine into novel and more dangerous viruses.

IV. Recognizing the Extent to Which FDA's Behavior is Wrong and Reprehensible

Based on all the evidence, it is difficult for any rational and morally aware individual to condone the FDA's behavior; and it is high time that those responsible for this ongoing behavior be confronted with the fact that what they are doing is deeply wrong and reprehensible. The FDA's behavior is more than irresponsible and even more than unconscionable. It is criminal. It is clearly criminal for officials entrusted with ensuring the safety of the nation's food to be allowing a flood of new products on the market when they have been adequately informed by their own and other experts that these products entail unique human health hazards. And it is yet more criminal for these officials to repeatedly lie about the facts to the public and its elected officials.

Those FDA officials who have knowingly perpetrated or facilitated such fraud must realize that someday soon they may well be prosecuted and imprisoned - especially if some GE foods cause widespread death and disability. Their misdeeds are fully documented and they cannot long escape a formal reckoning.

For now, the only way the agency can even begin to atone for its crimes is to openly acknowledge the facts and promptly ban every GE food unless and until it is established safe in the rigorous manner prescribed by law. Anything less is legally and morally unacceptable.

Modified on other grounds, 424 F.2d 136 (7th Cir. 1970)

Alliance For Bio-Integrity
Preserving the Safety of Our Food, the Health of Our Environment,
and the Harmony of Our Relationship with Nature
406 West Depot Avenue, Fairfield, Iowa 52556
(641) 472-5554


USDA Says Yes to Terminator

RAFI  (Rural Advancement Foundation International) (now
News Release
3 August 2001

It's official. The US Department of Agriculture announced this week that it has concluded negotiations to license the notorious Terminator technology to its seed industry partner, Delta & Pine Land (D&PL). As a result of joint research, the USDA and D&PL are co-owners of three patents on the controversial technology that genetically modifies plants to produce sterile seeds, preventing farmers from re-using harvested seed. A licensing agreement establishes the terms and conditions under which a party can use a patented technology. Although many of the Gene Giants hold patents on Terminator technology, D&PL is the only company that has publicly declared its intention to commercialize Terminator seeds. (for details, see '2001: A Seed Odyssey' RAFI Communique, January/February 2001,

'USDA's decision to license Terminator flies in the face of international public opinion and betrays the public trust,' said Hope Shand, Research Director of RAFI. 'Terminator technology has been universally condemned by civil society; banned by international agricultural research institutes, censured by United Nations bodies, even shunned by Monsanto, and yet the US government has officially sanctioned commercialization of the technology by licensing it to one of the world's largest seed companies,' explains Shand.

'USDA's role in developing Terminator seeds is a disgraceful example of corporate welfare involving a technology that is bad for farmers, dangerous for the environment and disastrous for world food security,' adds Silvia Ribeiro of RAFI. Terminator has been universally opposed as an immoral technology because over 1.4 billion people, primarily poor farmers, depend on farm-saved seeds as their primary seed source.

Michael Schechtman, Executive Secretary to USDA's Advisory Committee on Agricultural Biotechnology, made the official announcement regarding the licensing of Terminator at the Committee's August 1 meeting. The 38-member Advisory Committee, established during the Clinton administration, was created to advise the Secretary of Agriculture on issues related to growing public controversy over GM technology. Because of overwhelming public opposition to USDA's involvement with Terminator, the issue became a top priority for the Advisory Committee. USDA officials admitted last year that the Agency had the option of abandoning patents on Terminator, but chose not to do so. Although many members of the Biotech Advisory Committee urged the USDA to abandon its patents and forsake all further research on genetic seed sterilization, the USDA steadfastly declined. The official statement released by USDA this week states that the Agency 'had a legal obligation' to license the technology to D&PL.

In a lackluster attempt to quell its critics, the USDA pledged to negotiate licensing restrictions on how the Terminator technology could be deployed by Delta & Pine Land. 'In the end, the restrictions negotiated by USDA are meaningless,' concludes Michael Sligh, RAFI-USA's Director of Sustainable Agriculture, and member of the Biotech Advisory Committee. According to Sligh, 'USDA's promotion of Terminator technology puts private profits above public good and the rights of farmers everywhere.' Sligh spearheaded efforts amongst Advisory Board members who urged the USDA to abandon Terminator.

USDA places the following conditions on D&PL's deployment of Terminator:

  • The licensed Terminator technology will not be used in any heirloom varieties of garden flowers and vegetables and it will not be used in any variety of plant available in the marketplace before January 1, 2003. (RAFI's comment: In other words, Terminator will not be commercialized, at the earliest, until 2003 - only 17 months from now. To suggest that USDA is protecting heirloom varieties from genetic seed sterilization technology is ludicrous. There's no money to be made on genetic modification of heirloom vegetables and flowers. The seed industry aims to engineer seed sterility in major crop commodities - especially those crops that have not been successfully hybridized on a commercial scale such as soybeans, rice and wheat.)

  • USDA scientists will be involved in safety testing of new varieties incorporating the GM trait for seed sterility, and a full and public process of safety evaluation must be completed prior to regulatory sign-off by USDA.(RAFI's comment: Can USDA play a role in both developing and regulating this technology? Is it a blatant conflict of interest for the agency to conduct a biosafety review of a product in which it holds a financial interest?)

  • All royalties accruing to USDA from the use of Terminator will be earmarked to technology transfer efforts for USDA's Agricultural Research Service innovations that will be made widely available to the public. (RAFI's comment: 'Technology transfer' is a very broad concept. Terminator seeds in every foreign aid package? More paper clips for ARS patent lawyers?)

USDA concludes that Terminator 'is a valuable technology.' Ironically, the agency promotes Terminator as a 'green' technology that will prevent gene flow from transgenic plants.

'We reject the notion that Terminator is a biosafety bandage for GM crops with leaky genes, but even if it were, biosafety at the expense of food security is unacceptable,' concludes RAFI's Silvia Ribeiro.

Last year the FAO's Panel of Eminent Experts on Ethics in Food and Agriculture concluded that Terminator seeds are unethical. When heads of state meet at FAO's World Food Summit Five Years Later in Rome, 9-15 November, they will have the opportunity to re-affirm that finding, and recommend that member nations ban the technology. In keeping with its image as a rogue, isolationist state in international treaty negotiations on global warming and biological weapons, the US also appears to stand alone on Terminator.


Delta & Pine Land (Mississippi, USA) is the world's 9th largest seed corporation, with revenues of $301 million in 2000. The company has joint ventures and/or subsidiaries in North America, Brazil, Argentina, China, Mexico, Paraguay, South Africa, Australia, and China.

RAFI is an international civil society organization based in Canada. We are dedicated to the conservation and sustainable use of biodiversity and to the socially responsible development of technologies useful to rural societies.

For further information on this news release:

Hope Shand, RAFI: 919 960-5223
Michael Sligh, RAFI-USA (member of USDA's Ag Biotech Advisory Committee) (919) 542-1396


EPA Rejects Biotech Corn As Human Food

by Marc Kaufman
Washington Post
July 28, 2001

Federal Tests Do Not Eliminate Possibility That It Could Cause Allergic Reactions, Agency Told

The federal government's investigation into whether StarLink corn causes allergic reactions failed to establish that the genetically engineered corn was safe to eat, according to an expert panel convened by the Environmental Protection Agency.

While the panel did not conclude the modified corn causes allergies, it said that months of study by federal agencies "do not eliminate the possibility of such a reaction."

Based on the panel's recommendations, the EPA yesterday announced that it would continue its policy against permitting even trace amounts of StarLink in foods -- turning down a request to change that position from Aventis CropSciences, which developed the corn.

The unapproved presence of Starlink has required hundreds of food recalls and costly international trade problems, and food industry officials said yesterday they were disappointed in the EPA's refusal. But critics of biotechnology said they were pleased by the decision, which they said vindicated their concerns about the potential risks of some genetically modified products.

Stephen Johnson, of the EPA's Office of Prevention, Pesticides and Toxic Substances, said the agency had no choice but to turn down the Aventis application. "Some of the world's leading experts on allergenicity and food safety told us there was not enough data to conclude with reasonable certainty that there was an acceptable level of [StarLink corn] that people could eat," he said. "That leaves us no room" to allow StarLink.

The EPA approved StarLink as animal feed in 1998, but did not allow it for human use because of concerns that it contained a protein that broke down slowly and could cause dangerous allergic reactions. A public interest group found StarLink's genetically modified protein in taco shells last fall, and it has been at the center of the often contentious international debate over crop biotechnology ever since.

Johnson said the agency was studying how it might respond to the panel's recommendation that it expand its study of possible allergic reactions to StarLink. The panel said the federal government should ask specialists to report suspicious reactions to corn -- which is not a common cause of allergic reactions -- and should expand research into the entire field of genetically improved crops and food allergies.

In addition, the panel said that "every attempt" should be made to further test two people who reported severe reactions and who have offered to undergo skin testing and to eat StarLink products under medical supervision.

One of the two, Florida optometrist Keith Finger, told the panel that he sought out StarLink corn after his initial reaction last fall, and had received some anonymously in the mail. After running a test that showed it was in fact StarLink, he ate some and went to a local hospital several hours later with itchy rashes over his body and fast-rising blood pressure.

During two days of testimony in mid-July, Food and Drug Administration officials said that blood tests on 17 people who reported possible allergic reactions to StarLink, including Finger, did not show any signs of an actual physical reaction.

But the expert panelists raised questions about the validity of the testing process and the size of the sample. They said that the tests decreased the probability that people had suffered allergic reactions to StarLink, but did not rule it out.

Johnson said yesterday it "would require many months or years of continued scientific evaluation to answer the question of allergenicity."

An Aventis official said that the company was not surprised by the panel conclusions and the EPA decision. She also said that there is no way to conclusively determine if the Cry9C protein in StarLink -- which protects the corn against the European corn borer -- can cause allergic reactions.

In a statement, the company emphasized its commitment to directing all corn with the StarLink Cry9C protein to livestock and industrial uses. "We will continue to support the grain handlers and millers with their testing programs," the company said. "We are proud of the progress we have made in containing StarLink corn."

In its report, the expert panel concluded that the amount of StarLink in the food supply was significantly less than predicted in the fall, and that there is a "low probability of allergenicity" in the population based on levels of StarLink in the U.S. diet. Aventis has been buying back StarLink corn, and corn commingled with StarLink, and virtually all is expected to be out of the food supply after the fall harvest.

During the panel meeting, officials from the Agriculture Department reported the agency will spend between $13 million and $17 million to also buy back seed for growing corn that had been contaminated with StarLink.

The modified corn, which was planted on only 320,000 acres last year but has spread well beyond that, has created problems for U.S. corn exporters because some foreign buyers avoided all U.S. corn. The grain and food industries have supported the Aventis request for allowing trace amounts of the corn, saying low levels of many genetically modifed proteins can be found in virtually all corn.

"The food industry is disappointed by the EPA decision today on StarLink," said Gene Grabowski of the Grocery Manufacturers of America. "It means continued uncertainty and anxiety in the food market . . . and eventually will result in price increases. It's a situation that should not be allowed to continue."

But Bill Freese of Friends of the Earth, an environmental group, said the panel report "shows that the EPA and FDA need to begin more seriously regulating genetically engineered foods to protect public health."


OTA Timetable on GMOs

1992 - OTA's 1992 Guidelines for The Organic Foods Industry included a prohibition on recombinant DNA materials:

"BIOTECHNOLOGY-The industry recognizes that biotechnology issues need to be addressed and that further review is necessary. Recombinant gene splicing is one issue to be addressed and is part of an industry-wide discussion. Recombinant gene splicing is prohibited until further review."

OTA works to educate the industry by including viewpoints on biotechnology in the December 1992 OFPANA Reports, its quarterly newsletter.

1993 - OTA position written May 1994: "The Board of Directors agrees that Recombinant DNA technology is a synthetic process. The Board of Directors is of the opinion that such technology is not compatible with organic production."

1995 - OTA prepared a White Paper outlining the issues surrounding genetic engineering and possible impact on organic agriculture.

1997 - OTA member meeting in September 1997 included a discussion on OTA's draft position on genetically engineered products. As reported in the November 1997 issue of The Organic Report, this draft resolution stated:

"All products of genetic engineering are considered synthetic materials. No products, seed and plant varieties, or animals resulting from transgenic techniques may be used at any time in organic production."

March 13, 1999 - OTA forms a GMO Task Force.

Oct. 1, 1999 - Language on GMOS in Draft 3 of the American Organic Standards: Principles: 3.10. Genetically engineered/modified organisms (GEO/GMO's), or products produced by or through the use of such organisms, are not compatible with the principles of organic production (either the growing, manufacturing, or processing) and are not permitted under these standards.

3.11. Organic standards do not allow the use of prohibited materials such as synthetic fertilizers, pesticides, and genetically engineered organisms, but cannot ensure that organic products are completely free of such residues or contaminants, due to background levels of environmental pollutants."

OTA adopted the American Organic Standards on Oct. 20, 1999.

Nov. 30, 1999 - OTA submitted testimony to the U.S. Food and Drug Administration (FDA) urging FDA to label foods containing genetically engineered organisms or their products.

Dec. 30, 1999 - OTA submitted testimony to the U.S. Environmental Protection Agency that Bt plants are harmful to organic agriculture. OTA urged EPA to 1) review and revise its policy regarding buffer zones, 2) incorporate independent ecological field studies into its consideration, and 3) insist on the creation of buffer zones around Bt crops as part of the requirement for the use of Bt corn.

Jan. 7, 2000 - OTA submitted written comments to FDA concerning labeling genetically engineered foods and food ingredients. In this document, OTA wrote: "OTA requests that FDA require the labeling of foods containing genetically engineered organisms or their products."

Jan. 14, 2000 - OTA issues a press release calling for a moratorium on the use of genetically modified organisms in all agricultural production.

February-March 2000 - The feature article in the February/March issue of What's News in Organic, an OTA informational flier geared to the media and D.C. legislators, was "GMOS cause organic industry concern."

March 2000 - The Organic Report, OTA's quarterly member news magazine, features an article entitled "GMOs: Moratorium needed in all agricultural production," as well highlights from a perspective from the chair of OTA's GMO Task Force.

March 21, 2000 - In a 12-page document, OTA's GMO Task Force released a second report and outlined recommendations to OTA's Quality Assurance Committee. Appendix A of the report included OTA's Public Statement on GMOs that had been approved by OTA's Executive Committee:

Why are GMOs not allowed in organic food production?

The use of GMOs (genetically modified organisms) in agriculture is new technology which works by moving DNA between species in ways that are not possible in nature. This technology has the potential to cause unintended effects on the environment and on human health. Organic certification organizations prohibit the use of GMO seeds or other products of GMOs in organic production.

The Organic Trade Association supports the consumer's right to know, and to choose foods based on environmental personal health, religious, dietary or other preferences. Labeling of GMO products or products containing GMOs is necessary to making these choices at this time.

Doesn't 'Certified Organic' mean no-GMOs?

Although the certified organic label means GMOs are not used, some organic foods could contain small amounts of GMO material from exposure to pollen from GMO crops in the field or incidental GMO ingredients in processing. Minor ingredients made from corn or soy, in particular, must be carefully sourced to avoid GMO by-products. For this reason in order to safeguard organic integrity, it is necessary that all GMO seed, ingredients, and agricultural products be labeled.

What needs to be done about GMOs?

More independent research and regulation are necessary before any more GMOs are allowed in the food system. As long as GMO continue to be allowed, organic producers are at risk from background levels of GMOs. Because of the impact on organic production, the Organic Trade Association supports a moratorium on the use of GMOs in all agricultural production."

Nov. 20, 2000 - OTA urged EPA to deny any expansion of the use of Bt crops, including denying the petition for the continued production of StarLink. "Not only are there health concerns, there are not sufficient controls over the product to significantly reduce the risk of genetic contamination of organic corn," OTA wrote, adding, "It is this rush to prepare for insect resistance to other forms of Bt biopesticides that has resulted in an untested and potentially unsafe food becoming entwined with the human food chain. We can only hope that the contamination of the food supply by this gene is not permanent. OTA requests EPA to reject the application to allow the presence of this gene in the food supply and further requests that EPA assess the damage to organic agriculture by Bt biopesticides."

Feb. 28, 2001 - OTA submitted comments to the U.S. Department of Agriculture in response to USDA's call for comments concerning the marketing of crops derived from biotechnology. In its five-page comment, OTA urged USDA to avoid favoring biotechnology over organic, and thus the value of any marketing by USDA of crops derived from biotechnology be equal In value to the marketing by USDA of organic products. OTA urged USDA to "support vigorously all voluntary segregation practices, at least until segregation becomes mandated by law, and should develop programs to train agricultural handlers in segregating grains and produce. In addition, USDA should financially support testing for GMOs so that identity preservation can be achieved." OTA also wrote that it "considers the lack of labeling of biotechnology-derived products-which leaves the provenance of the non-protein derivatives of such products unknown-a very serious obstacle to the effective marketing of organic products."

March 2001 - OTA lends support to Congressman Dennis Kucinich's bill to label genetically engineered food.

May 3, 2001 - OTA submitted comments to FDA concerning the structure of the consultation process for bioengineered foods. OTA urged making this consultation mandatory. OTA also encouraged "FDA to act in the public interest by engaging in inter-agency consultation with EPA and USDA"

Holly Givens
Communications Director
Organic Trade Association
phone: 413/774-7511, ext. 18
fax: 413/774-6432
general e-mail:

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