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.6 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 is arranged as follows. Part I is this Introduction. Part II outlines the prevalence of GM [genetically modified] products in the U.S. food supply and explains why the U.S. consumer has come to have both very high daily and long-term exposure levels to novel and untested GM substances. Part III describes the explosion in new studies that reveal that, directly contrary to the dated Central Dogma model, genes operate in a highly contextual fashion. This Article explains how changing the context in which a gene operates can change the way the gene works and why these unintended consequences can have current and intergenerational health effects. Part IV describes the scientific and regulatory assumptions made by the FDA in formulating its current policy regarding GM ingredient safety and labeling and unravels the regulatory provisions that reflect these policy choices. This section spells out why the new Networked Gene model both challenges the health risk assumptions made by the FDA in formulating its regulatory structure and throws a deep shadow of doubt over the ability of the FDA’s current regulations to protect public health. Part V points out that the lack of transparency in the FDA’s regulatory framework bars a consumer’s ability to choose to avoid the unknown additional health risks associated with heavy exposure to GM substances, while the insensitivity of the tort system to injuries from innovative technologies means that an injury from a GM food product will be borne by the consumer and not the manufacturers who are reaping the profit from product sales. Part VI proposes an alternative method of regulating GM plant foods that protects public health while encouraging technical innovation. [excerpt]