The development of novel foods through agricultural biotechnology involves a complex process that can be viewed as occurring in three stages: gene discovery, line selection, and product advancement to commercialization. The safety assessment for each new crop is and should be an integral part of each of the phases of this complex process.
In the first stage, gene discovery, the safety evaluation considers the source of the gene, previous consumer exposure to the source material, the history of safe use of the source material, the gene itself, the product(s) derived from the gene, and any ethical issues that might arise. In the U.S., the National Institutes of Health (NIH) have established guidelines for the product developers to follow after a potentially marketable product is conceived. If unacceptable risks are identified during this stage, the concept is abandoned.
If the new seed product concept is accepted, experiments are conducted to achieve and evaluate the desired product. Yet to proceed, companies in the U.S. must obtain approval from the USDA. USDA approves the design of greenhouses and other facilities where the plants will first be grown in isolation. Next, USDA approval must be obtained to allow field trials to occur. The data collected from these experiments must also be submitted to the USDA for consideration in removing the genetically modified crop from regulated status. It is at this point in the regulatory process that the USDA invites public comment. During the experiments, a number of plant traits are evaluated such as leaf color, root strength, yield, and others. If such traits are undesirable the implementation of the new crop product concept is terminated. These field trials also give some insight as to other safety concerns, because if uncharacteristic properties are observed one may conclude that safety concerns may exist.
Additional regulations exist by the Environmental Protection Agency (EPA) if the genetically modified crop contains pesticidal properties. The EPA also allows public comments during various stages of their review process, which includes the review of data on human, animal, and environmental safety as it relates to the pesticidal component.
As the prospective genetically modified crop(s) moves toward commercialization in the U.S., the Food & Drug Administration (FDA) offers guidance to what studies they consider appropriate for assessing the safety of the food produced from the genetically modified crops. Currently this is on a voluntary basis, but at present, all current genetically modified foods in the U.S. marketplace have been subjected to this FDA scrutiny. Soon this will be mandatory. In addition, many worldwide organizations including the Food & Agricultural Organization of the United Nations, the World Health Organization, and the Organization of Economic Cooperation & Development have established the background for the safety assessment of foods produced through agricultural biotechnology.
References:Safety Assessment of Genetically Modified Foods, Steve L. Taylor, Ph.D., 2001, Journal of Nematology, In Press.
Plant Biotechnology Regulation: Science-Based and Consumer Accessible From Plow to Plate, American Crop Protection Association, http://www.acpa.org/food&ag/transgenicprod.html
