Summary

Monsanto and other companies producing or using GE food continue to hide behind the public and financial community's misperception that government regulators have tested these products and declared them safe. What the FDA has done is approved GE crop commercialization based on Monsanto's assurance that the products are safe.

A few exceptions, such as Bt protein - but not the entire Bt plant - have been declared safe (in this case by the EPA), which provides an example of how different sides can hide behind the ambiguity of the "tested" vs. "not tested" argument.  And while shareholders recognize that regulatory agencies review certain aspects of these products, it is clear is that the FDA does no testing and relies on an inadequate process of voluntary consulting; and that the EPA and USDA require test only for very narrow impacts based on a set of guidelines that were not originally developed for GE technology. It is also clear that (like Vioxx) no agency is responsible for monitoring GE plants after they have been commercialized.

Every governmental and independent study on the GE crop approval process has found significant gaps in the regulatory process and testing procedures. These studies, combined with a growing body of science challenging the safety of these products and a proven track record of environmental contamination, requires a greater level of transparency and accountability from Monsanto.  In the end, Monsanto is entirely responsible for its commercialized products and all financial risks and liabilities are those of Monsanto and its shareholders.

 

The Role of the Regulatory Agencies: 

The role of the Food and Drug Administration (FDA) and other agencies is the one issue that continues to be the most misunderstood by analysts, investors and the general public. Few realize that FDA approval is based on a system of voluntary consulting and that the FDA is not legally responsible for genetically (GE) products and has not done any testing of its own. Understanding the role of the FDA and regulatory agencies is central to understanding the issue of liability for GE crops. The role of these agencies is both complex and confusing, as they are a patchwork of various laws that were developed before GE technology was in use and different regulations apply to different GE crops.

But two key facts stand out:

No GE plants are regulated once they have been commercialized.

All financial risks and liabilities are those of Monsanto and its shareholders.

Monsanto and other GE seed and food companies generally portray the FDA as having a much bigger role then it actually has. These companies regularly deflect questions about safety or liability by saying - as Monsanto does in its 2005 proxy opposition statement - that the "test results on our genetically engineered products are reviewed by regulatory authorities." Yet "reviewed" is a far cry from the agency actually testing the products, setting mandatory standards, reviewing original data, or monitoring the product after it is commercialized.

 

Scientific Reviews:

Two recent National Science Academy reports looked at the issue of regulatory agency review of genetically engineered products. 

A National Academy of Science report on "Biological Confinement of Genetically Engineered Organisms" found that preventing contamination of non-GE crops or wild relatives by GE was not possible in most cases with current technology

A National Academy of Science report on the "Safety of Genetically Engineered Foods, Assessing Unintended Health Effects" provides both good and bad news for investors. For example, it states that there are no confirmed cases of health impacts from GE foods, yet it then identifies sizable gaps in scientific methods to predict and assess unintended adverse effects.  

Similarly, a report by the Center for Science in the Public Interest "Holes in the Biotech Safety Net: FDA Policy Does Not Assure the Safety of Genetically Engineered Foods,"  says that there is no data showing that Bt corn and herbicide-tolerant soybeans are unsafe for consumers to eat. However, it found that the biotechnology companies provide inadequate data to ensure their products are safe.

 

Responsibilities of the FDA, EPA and USDA:

The Food and Drug Administration is responsible for food and feed. The FDA:

• Has no mandatory or binding regulations for GE crops.
• Relies on a system of voluntary consulting in which Monsanto tells the FDA the product is safe.
• Sees research summaries (only if provided by the company), not actual data or test results.
• Has no inspection or compliance program for GE food after it is commercialized and reaches the market.
• Is not legally or financially liable for these products.

While the FDA has jurisdiction over GE crops, other agencies do get involved with specific and narrow areas of regulation. For example, the Environmental Protection Agency (EPA) has responsibility for pesticides so it will look at Monsanto's Bt gene and protein as it is considered a pesticide. But the EPA is not responsible for looking at impacts from the Bt plant. [* = In practice, because the gene is inextricably part of the Bt plant, EPA has de facto regulation over some part of the plant.] These kinds of subtle distinctions are the basis for many of the "are regulated" vs. "are not regulated" arguments that GE proponents and critics use.

The Environmental Protection Agency regulates pesticides. The EPA:

• Asks for mandatory testing for pesticides.
• Only regulates the Bt gene and protein, not the GE plant
• Review process does not cover the full scope of impacts and risks of the GE plant.
• Is not responsible and does no testing or regulating for herbicide resistant plants (these account for the majority of GE crops used).

The United States Department of Agriculture (USDA)  is responsible for plant pests. The USDA:

• Asks for mandatory testing to see if a crop is invasive or has plant pest characteristics .
• Does not have the authority to evaluate the potential health impacts of the GE crop, or of conventional crops that become contaminated with experimental traits.
• Is not responsible for monitoring or enforcement of commercialized GE crops.
• Was criticized by a 2004 National Academy of Science report  "Biological Confinement of Genetically Engineered Organisms" that found that contamination of non-GE crops or wild weedy relatives could not be assured using currently available technology.
• Was criticized by a 2002 National Academy of Sciences review of the USDA’s performance at regulating GE crops for a lack of transparency, too little external scientific and public review of decision-making, poorly trained personnel, and for allowing companies to make excessive claims of confidential business information.

 

In the News:

When it comes to regulating GE crops and foods the FDA is the key agency. The FDA has come under intense fire in the last few weeks because of its insufficient testing requirements for pharmaceutical products and undue influence by industry. A few recent headlines include:

Scientist says FDA system 'broken',
USA TODAY, November 19, 2004
While the above articles are focused on the recent pharmaceutical scandal, it points to a systemic problem of corporate influence at the FDA that lowers safety standards, limits testing, hinders transparency, and virtually eliminates monitoring and oversight. Several news reports in the last year or so - including one just a few weeks ago - have highlighted the problems with the regulation of GE crops and foods.

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Oversight on Bioengineered Crops Is Poor, Report Says;
Rick Weiss, Washington Post, December 16, 2004
Federal oversight of crops genetically engineered to produce medications in their seeds and leaves is inadequate to prevent unwanted contamination of food crops, according to an analysis released on December 15th by a scientific advocacy group.

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Feds ignore evidence that biotech corn could cause allergies
The New Farm, SAN DIEGO , California , November 16, 2004
Evidence that food allergies may be caused by corn genetically modified to produce its own insecticides has been ignored by the U.S. Environmental Protection Agency (EPA), according to a peer-reviewed scientific paper published by two U.S. scientists on November 16th. The paper, “Safety Testing and Regulation of Genetically Engineered Foods,” documents fundamental flaws in how biotech companies test and the U.S. government regulates genetically modified crops. The authors raise serious questions about whether biotech foods, which have been on the market since 1994, are in fact safe, as claimed by the biotech industry and U.S. regulators. It is published in "Biotechnology and Genetic Engineering Reviews."

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Canadian coalition petitions for moratorium on GMOs as study exposes regulatory troubles
Council of Canadians press release, October 25, 2004
Today in Ottawa Canadian and Québécois environmental, farm and civil society groups demanded a moratorium on new approvals of genetically modified organisms (GMOs), to support a petition signed by approximately 20,000 Canadians. The call comes after a recent report confirms that the Government has not taken the necessary steps to ensure safe regulation of GMOs. "Our report clearly shows that the Federal Government has not implemented the 58 critical recommendations of the Royal Society of Canada's Expert Panel," said Lucy Sharratt of the Polaris Institute, "We can only conclude that the government is currently unable to regulate genetically modified organisms for safety."

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Study shows lack of research into GM health effects
Soil Association ( UK), June 24, 2004
A study by scientists in Norway and Denmark shows a serious lack of published research into the health effects of GMOs (genetically modified organisms). The study by Professor Ian Pryme and Rolf Lembcke was published in the journal Nutrition and Health earlier this year (2003). It says that there have only been ten published studies of the health effects of GM food or feed. The researchers found that the quality of some of these was inadequate. Over half were undertaken in collaboration with companies (fully or partially), and these found no negative effects on body organs. The other studies were independent and looked more closely at the effects on the gut lining. Several of these found potentially negative changes that have not been explained.

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New report: USDA hijacked by agribusiness
Organization for Competitive Markets Press release, July 23, 2004
Omaha – A new report released today finds that regulatory policy at the U.S. Department of Agriculture (USDA) has been “hijacked” by the agribusiness industry, which has seen to it that many key policymaking positions at the agency are now held by individuals who previously worked for the industry. The report, titled USDA INC., was commissioned by the Agribusiness Accountability Initiative (AAI), a network of family-farm and public interest groups concerned about the growing power of the big agri-food corporations.

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Open USDA biopharm permit process to public -study
Reuters, June 2, 2004
The U.S. Agriculture Department's process for approving permits to grow biopharmaceutical crops is "shrouded in secrecy," making it difficult to know if the crops pose a risk to humans or the environment, a study said on Wednesday. The Center for Science in the Public Interest, said the USDA's failure to disclose more details, such as the drug or chemical being produced, could lead to problems. "It is impossible to know whether these biopharmed crops present any food-safety or environmental risk, since the whole process is shrouded in secrecy," said Greg Jaffe, a director of biotech projects at CSPI who authored the study.

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Biotech regulations fall short, report says
Washington Post, April 1, 2004
Federal regulation of the increasingly exotic products of the biotechnology industry may soon be inadequate to assure the public the products are safe, according to a new report. Opinion in Washington is sharply divided on whether the 18-year-old biotech regulatory system can be fixed with administrative tweaking or whether Congress needs to pass new laws, said the report by the Pew Initiative on Food and Biotechnology, a think tank. But either way, the report cites numerous examples to make the case that action by the federal government is needed to ensure credible oversight of an industry that is tinkering with the very foundations of life.

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New health dangers of GM food (and vaccines) discovered
Institute for Responsible Technology press release, February 24, 2004
Kuala Lumpur , Malaysia -- Data from three groups of studies currently being conducted by the Norwegian Institute for Gene Ecology, in Tromsö, Norway, reveal potentially serious health dangers of genetically modified (GM) foods and vaccines. Jeffrey M. Smith, Director of the Institute for Responsible Technology, presented a summary of the findings and their implications for human health to delegates at the UN Cartagena Protocol for Biosafety meeting. Smith also presented additional evidence of health dangers from his recently published book, 'Seeds of Deception', including new information that incriminates the genetic engineering of the food supplement L-tryptophan as the cause of an epidemic in the U.S. in the 1980s, which took the lives of about 100 Americans and caused 5-10,000 to fall sick or become disabled.

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Agency studies revamping biotech rules
AP, January 23, 2004
WASHINGTON - Worried about the inadvertent spread of new bioengineered plants that produce drugs and chemicals, the Agriculture Department is studying whether to adopt a risk-based system to protect the environment and food supply. Agriculture Secretary Ann Veneman said her agency is doing environmental studies as a first step toward revamping controls over biotech products. Federal regulators must try to anticipate and keep pace with the rapidly evolving science behind biotech crops, she said.

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Monsanto leads list in biotech violations
Houston Chronicle, October 17, 2003
Monsanto Co. and its partners violated federal regulations by planting genetically modified crops 44 times between 1990 and 2001 and paid $69,550 in fines in four of those cases, according to reports made public Friday. The agrochemical and biotech-seed company, based in Creve Coeur, Mo., had more violations than any other company or institution, according to the report issued by a division of the Agriculture Department and information released by Monsanto. In all, there were 115 infractions resulting in eight fines over the 11-year period -- and 60 percent were self-reported. None resulted in damage to the environment, the food supply or the agricultural commodity system, said the Biotechnology Regulatory Services program of the USDA's Animal and Plant Health Inspection Service.

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New biotech crops need watchdogs: Ex-Monsanto executive says agencies must prepare for "unanticipated problems"
Bill Lambrecht, St Louis Post Dispatch, April 25, 2003
A report written by a former federal regulator and Monsanto Co. executive concludes that the government is unprepared to monitor the safety of the next generation of genetically engineered crops. The report found that federal agencies don't have monitoring programs once products are approved and therefore lack the ability to find or fix "unanticipated health or environmental problems" from the new generation of biotech products.    

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FDA Policies for Gene-Altered Foods Faulted in Report
Justin Gillis, Washington Post Staff Writer, Tuesday, January 7, 2003
Excessive levels of harmful compounds could show up in genetically engineered foods because the government has failed to put strong safeguards in place to catch them, a consumer group says in a report scheduled for release today.  

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