Safety assessment and labeling

Illustrative Quotes

"The predominant philosophy behind current regulation can be summarized by the 'No need - don't look - don't see' futile cycle .....this forms a self-reinforcing cycle, a motor for effectively passing with impunity any and every genetically engineered product to the public that the industry so wish. We repeat, the industry have been handed carte blanche to do as they please for maximum profitability, with the regulatory body acting to allay legitimate public fears and opposition."

Professor Mae-Wan Ho
, Biology Department, Open University, Milton Keynes, UK. (Excerpt from Fatal Flaws in Food Safety Assessment)

"Over the last fifteen years, I and other scientists have put the FDA on notice about the potential dangers of genetically engineered foods. Instead of responsible regulation we have seen bureaucratic bungling and obfuscation that have left public health and the environment at risk"

Dr. Philip Regal, professor at the University of Minnesota and an internationally recognized biosafety expert. Statement in conjunction with a Lawsuit Challenging FDA Policy on Genetically Engineered Foods at 27 May 1998. See also professor Regal's website:

GE= Genetically Engineered.
Text difficulty: [EL] = elemenatry level.   [ML] = medium level.   [AL] = advanced level.

A summary of the most important points in this section:

That genetically engineered foods are approved at all is a result of the serious negligence, distortion and sometimes even suppression of evidence that took place when the rules were made. This may surprise you but there is objective evidence behind this statement. (Our principle is not to publish any allegations which cannot be backed up.)

The rules for safety assessments of GE foods were designed with the purpose of making rapid approval possible. Weighty scientific reasons for very careful testing have been ignored. The consequence is that none of the GE foods on the market can be considered safe. The approval of these foods is nothing less than blind mass-experimentation with peoples' health (without even any of the experimental design which enables reliable conclusions to be drawn). We conclude that these foods should therefore be withdrawn from the market immediately, before people come to harm.

Similarly, GE organisms have been released into the environment without adequate safety assessment. There is far too little knowledge about the environmental effects of GE organisms for justifying any releases at all. So it cannot be excluded that, in the worst case, the releases might cause damage to soil and plants which can never be repaired. We conclude that all approvals for release should immediately be withdrawn.

The GE industry has hired leading PR firms to make people believe that the GE foods on the market are a boon to mankind. In reality they are of little, if any, benefit, and most important, they have not been proven to be safe. But the truth is coming out and becoming apparent to the public, resulting in well justified protests from farmers and consumers all over the world.

For more details, see: Considerable deficiencies in safety regulations - an overview. [EL]

The texts and the comments after the links are written so as to give you rapid general idea of the issues. If you are in a hurry, you will get an idea about the safety issues by only reading them throughout this page without clicking on the links.

Food safety assessment

The internationally established method for assessing the safety of GE foods is based on the "principle of substantial equivalence". As you will learn below, this method is unscientific and unreliable.

"The fact that this principle has become an internationally established norm is an unacceptable failure of the procedures for developing food safety regulations." (PSRAST)

This principle is an insufficient basis for safety assessment of food as it may allow harmful foods pass undetected. Foods approved in this way, cannot be considered safe. The GE foods on the market today have all "passed" this deficient approval procedure, which has been internationally accepted. This is remarkable as this principle is based on scientifically untenable assumptions. It has been developed by lawyers only in order to facilitate rapid approval procedures for GE-foods.

The inadequacy of Substantial Equivalence for safety assessment


The above collection of papers demonstrates, beyond the least shadow of any doubt, that the present method for GE food safety assessment has no valid scientific basis. It is too superficial and insensitive to detect the unexpected and potentially dangerous substances that may be generated through genetic engineering.

The fact that this pseudoscientific and inadequate approval procedure is accepted by national and international bodies, responsible for food safety, indicates that these don't work adequately, as explained below.

Inadequate functioning of governmental bodies

We expect governmental bodies to responsibly fulfil their duty to protect the public and environment. And we expect governmental experts to be reliable and impartial. Here we present some documented cases indicating that, apparently, industrial interests have flagrantly been favored on the expense of public and environmental safety by suppressing or distorting important scientific facts. New fully transparent procedures are required to ensure impartial assessment.

  • New!  How It Happened That We Don't Regulate Biotech by professor Donella Meadows. A revealing article about scientists systematicaly hiding the truth and lying about important discoveries of hazards due to genetic engineering. This paved the way for approval of genetic engineering without any demands on stringent safety evaluation.

  • Revolving Doors: Monsanto and the Regulators. From the Ecologist September -98 issue that was trashed by the printing office after threats from Monsanto. Explains how it was possible for GE foods to be approved in spite of insufficient scientific safety assessment. It reveals the close relation between Monsanto and the US government.

  • Landmark Lawsuit Challenges FDA Policy on Genetically Engineered Foods (May 1998)  [EL] As USA is the leading country in this field, the decisions of FDA have influenced the decisions world-wide in this field. In this lawsuit this important regulatory body is accused of serious negligence. - "The FDA has placed the interest of a handful of biotechnology companies ahead of their responsibility to protect public health" according one of the plaintiffs..

  • FDA records support the lawsuit challenging its policy (June 1999)   [EL]   FDA records delivered to the court reveal the agency declared genetically engineered foods to be safe in the face of disagreement from its own experts--all the while claiming a broad scientific consensus supported its stance.

  • 200 Health Canada Scientists Speak Out. By Richard Wolfson. The scientists have signed a letter expressing concern about the erosion of safety standards at Health Canada, which is risking the health of Canadians. This includes the approval of GE foods foods for humans without extensive safety testing.

  • Flawed safety assessment of genetically engineered hormone.[ML] Inadequate scientific basis for approval of GE (or recombinant) Bovine Growth Hormone (rBGH) for milk production by the American FDA. This authority concluded in 1993 that rBGH poses no safety problems to humans and animals.

  • Europe readies for GM disaster [EL] . A five-point Emergency Response Plan has been formulated by the European Commission, designed to cope if genetically engineered plants result in widespread illness or the death of wildlife. So the European Commission consciously exposes the population of Europe and the ecology to unpredictable and potentially serious hazards in stead of prohibiting their use.

  • The scientific committee of the European Commission admits Genetically engineered foods are not safe [EL]  . A recently discovered document of the Commission of the European Union agrees with our opinion concerning the unreliability of present safety tests for GE foods. The Commission has obviously known that by approving GE foods, it is exposing the European public to unknown health hazards.


Labeling of all GE-foods is necessary to minimize damage from unexpected substances until they are withdrawn from the market (which should be done as soon as possible). This is all the more important as the methods for safety assessment are highly inadequate.

Risk assessment of ecological effects

Current knowledge of the long term ecological effects of release of GE organisms is highly insufficient. Therefore there is no scientific basis for judging the hazards from such releases.


Why safety evaluations may be unreliable

What you have learnt above is certainly startling. How could it occur that highly deficient safety assessment methods were approved and established by regulatory bodies including FDA and the European Commission? How can enormous amounts of genetically engineered organisms be allowed to be irreversibly released into the environment without any reliable knowledge of their ecological effects?   - In spite of knowledge indicating various potentially serious hazards. This situation is due to factors that disturb impartial assessment. Such factors are discussed in the articles in this section.

"..along with many other scientists and informed citizens, I have grown over the years to be extremely critical of the ways in which the power of biotechnology has been appropriated and developed, especially agricultural and environmental biotechnology. The scientific education of genetic engineers and regulators has been inadequate even to understand the technical challenges of biosafety, let alone to take appropriate precautions and conduct science-based testing. And, it has proved impossible to develop government regulatory programs that are truly science-based and not compromised by political pressures. This dismal situation necessarily leaves individual biotech projects suspect with regard to safety, whether or not any given project proves in fact to be dangerous."


Philip Regal, Professor of Ecology, Evolution, and Behavior, College of Biological Sciences, University of Minnesota.

  • Dysfunctional science - Towards a "pseudoscientfic world order"? The successful launch of genetically engineered foods with the aid of a useless safety assessment principle endorsed by leading scientists in national and international expert committees is a very serious warning for us all. It may indicate that we are already on the way towards a "new pseudo-scientific world order" where the short term interests of powerful industrial corporations override global long term ecological and health safety considerations.
  • The Fallibility of Scientific Authorities  By Dr Jaan Suurküla [EL] There are a number of factors that may predispose scientific experts to partiality, including the fact that most of the reasearch in this field is supported, sponsored or directly controlled by the Biotechnology industry. In addition, Biotechnology has been made a national issue in some countries, including the USA, resulting in strong political pressures on scientists and regulatory bodies. There are striking similarities with another former "national issue" - Nuclear Energy. A massive majority of leading nuclear energy experts decided that nuclear energy was safe, ignoring and even ridiculizing importants doubts raised by a few corageous scientists and expert engineers who dared to think independently and act responsibly. It turned out that the leading experts were wrong.  
  •  The selfish commercial gene  By Dr Robert Mann. A general overview of the problems with GE, especially concerning deficient regulatory procedures, revealing a/o the fallacy of the (pesudo)scientific risk assessments that paved way for regulatory approval of releases. Also this article describes (though in greater detail than the one above), the striking and interesting parallells with the history of Nuclear Energy.
  •  World renowned scientist lost his job when he warned about GE foods - The Pusztai case  This demonstrates that there is a danger of suppression of important facts when industry has a strong influence on science.
  •  Are scientific experts always reliable? [EL] A scientific study in New England Journal of Medicine reports corruption of scientists. This is a problem when potentially dangerous products like GE-foods are to be assessed for safety.

Procedures to ensure adequate safety assessment

  • The Precautionary approach to the safety of new products. An introduction. [EL]
  • Wingspread Statement on the Precautionary Principle [EL] "When an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically. In this context the proponent of an activity, rather than the public, should bear the burden of proof." Today, the opposite is the case for Genetic Engineering.
  • "The uses of scientific uncertainty". [EL] This important article explains how the present practice to allow industry to release any product without demands for safety assessment has been a major reason for serious global environmental and health problems. And it presents principles for the application of the precautionary principle.

  • A suggested procedure for ensuring impartial and reliable safety assessment of commercial applications of science [EL] A fully transparent impartial evaluation of all possible complications to health and environment is required. The risks have to be carefully weighed against the advantages. The burden of proof of safety must lie entirely on the proponents. If the advantages are minor and the risks incompletely known and potentially serious, approval cannot be justified.

"Genetically Engineered Food - Safety Problems"
Published by PSRAST

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