Genetically Modified Food, Risk Assessment and Scientific Uncertainty Principles: Does the New Understanding of the Networked Gene Trigger the Need for Post-Market Surveillance to Protect Public Health?

Abstract

Consumers in the United States are unaware that they have high daily and long-term exposure levels to novel and untested genetically modified substances through a heavy consumption of genetically modified plant food (“GM food”). This ignorance exists because labeling of GM ingredients on food packaging is not required by the Food & Drug Administration (“FDA”). Labeling is not required because genetically modified plant food is presumed by FDA regulations to be bioequivalent to traditional plant food. Thus, manufacturers of GM plant food are not required to test their products for safety for human consumption, are not required to obtain premarket approval from the FDA and are not required to list GM ingredients on product labels.

The FDA’s regulatory presumption of bioequivalence is based on the now dated Central Dogma of molecular biology. According to the Central Dogma, a gene is a static stretch of genetic code that acts like a blueprint, or a complete set of instructions, on how to build a protein. Based on this model, scientists have presumed that a gene from any organism can be precisely excised and neatly, predictably and safely moved into another organism.

Directly contrary to the Central Dogma, in the past year numerous scientific discoveries involving the network effects of junk DNA, hybrid mRNA, SNPs and epigenetics have created a new model of a Networked Gene. Instead of viewing DNA as just a string of biological code, scientists now know that genes operate in a highly contextual way, engaging in intricate biochemical cross-talk. Consequently, changing the context in which a gene operates can change the way the gene works. And changing how even one gene works can have a ‘butterfly effect’ on the entire organism. Critically, epigenetics and epigenetic inheritance explain that these unintended consequences can be passed on to future generations and may not manifest themselves until triggered by external environmental factors.

In the context of GM foods, a genetic modification changes the biochemical cross-talk between genes, creating genetic material that has never existed before in nature. This novel genetic material can create unintended health risks, as seen with the case of the GM peas that contained a novel and unexpected allergenic protein and primed test mice to react to other allergens. The bottom line is that the scientific acceptance of the existence of the networked gene establishes that the FDA’s presumption that GM plant food is bioequivalent to traditional plant food is no longer scientifically supportable and that a new system for GM plant food regulation is required.

This Article discusses the public health, regulatory, legal and ethical issues raised by the new understanding of the networked gene and proposes an alternative method of regulating GM plant foods that protects public health while encouraging technical innovation.

Keywords: genetically modified food, food, fda, innovative technology, tort liability, network gene