(Excerpt from: Assessing the safety and nutritional quality of genetically engineered foods by John Fagan)

These studies will assess longer-term effects, and because a larger subject population will be used, will be capable of identifying small subpopulations (less than 0.1% of the population) that may have special problems with the transgenic food under study. Depending on the nature of the food and on the outcome of earlier stages of testing, 1000 to 3000 human volunteers will be fed the genetically engineered food at normal dietary levels daily for 1.5 to 2 years. In addition to vital signs, physiological parameters, and blood chemistry, this study may also provide information on the effects of the food on reproduction and cancer incidence.

Monitoring If human trials indicate the safety and desirability of a transgenic food, it will next be test-marketed in selected areas, with careful monitoring to detect impacts on the health of consumers. The monitoring system will include two important elements. (1) Hospitals and other medical facilities in the area will be alerted to the trial, and asked to report any health problems that might be related to consumption of the experimental, genetically engineered food. (2) The transgenic food will be labeled. The label will : (a) clearly designate the food as genetically engineered; (b) specify the source species from which genetic material was obtained to assemble the recombinant DNA molecule(s) used in constructing the transgenic organism; (c) describe the unique nutritional or other characteristics of the transgenic food; (d) tell the consumer that the product is experimental and ask the consumer to report any possible health impacts, minor or major, to the developer; (e) provide a mechanism th at will allow the consumer to report health impacts to the developer conveniently and without incurring cost (such as a toll-free telephone number, or local contact address). This phase of safety testing will continue for 2 to 3 years.

Even after test-marketing is complete, labeling is required, not only for continued monitoring of safety, but also to provide the consumer with sufficient information to make informed purchasing decisions.

Labeling should: (1) specify that the product is genetically engineered; (2) indicate any unique characteristics of the transgenic food relative to the natural counterpart; (3) provide a mechanism for consumer feed-back to the developer; (4) provide information on special handling or preparation requirements.