Introduction to rDNA Biotechnology-Derived Foods

The use of modern biotechnology to produce foods and food ingredients is a subject of significant public interest today, at the consumer, public policy, and scientific levels. The popular press and media have reported a wide range of views on these foods and food ingredients. The IFT Expert Panel Report on Biotechnology and Foods reviews the science behind these issues.

Overview of Biotechnology

Biotechnology has a long history of use in food production and processing. It is not a discrete technology but rather a group of scientific tools that are the result of a long history of increasingly precise and sophisticated techniques used to produce improved plant varieties for food production. Recombinant DNA (rDNA) biotechnology, also called genetic engineering or gene splicing, is the latest step in the development of these methods.

With rDNA biotechnology, scientists can insert one or more genes encoding for a particular trait into a plant or microorganism with greater precision and speed than older techniques. It should be noted that sexual reproduction also produces “recombinant” organisms, in the sense that the organisms possess DNA rearranged and combined from two separate organisms.

Genes are basically instructions for making proteins. Stated more scientifically, genes are DNA sequences that encode traits or regulate gene expression. Most genes do not have characteristics unique to the specific organism in which they are found. In fact, identical genes exist in organisms that are only remotely related. Furthermore, it is impossible to determine the organism from which a given gene arises by inspection of the DNA sequence alone; there is no way to identify “fish genes” or “tomato genes.” The uniqueness of organisms lies not only in the DNA sequences of their genes but also in the organization of the genes and at what time and to what extent they are expressed.

Federal Regulation of rDNA Biotechnology

Regulatory oversight of rDNA biotechnology spans three federal agencies and jurisdiction over the various rDNA biotechnology products is determined by their use, as is the case for products made by traditional means. In 1986, the White House’s Office of Science and Technology Policy (OSTP) published a comprehensive federal policy for ensuring the safety of rDNA biotechnology research and products. In addition, a 1992 OSTP statement described a scientific approach focused on the risk-related characteristics of the products, not the process by which the product was created.

In practice, the way the federal government has reviewed and regulated rDNA biotechnology- derived products is both processbased and product-based. As the regulatory mandate of the agency varies, so does the nature of its risk assessment and management protocols.

Food and Drug Administration. FDA is responsible for ensuring the safety and proper labeling of human foods (except meat and poultry products) and animal feed. It is also responsible for the safety and efficacy of human and animal pharmaceutical products and for human vaccines.

U.S. Department of Agriculture. USDA’s Food Safety and Inspection Service is responsible for the safety and labeling of meat and poultry products for human consumption. The agency’s Animal and Plant Health Inspection Service regulates the field testing and commercial sale of agricultural rDNA biotechnology- derived crops and is responsible for the safety and efficacy of animal vaccines.

Environmental Protection Agency. EPA is responsible for registering pesticides, setting environmental tolerances for pesticides, and establishing safe levels for pesticide residues in and on crops. Pesticides are substances intended for preventing, destroying, repelling, or mitigating pests.

Pharmaceuticals, human vaccines, and animal vaccines are all subject to premarket approval based on safety and efficacy testing. Although food additives are subject to premarket approval, foods are not. However, FDA has conducted almost fifty reviews of rDNA biotechnology-derived plant products used for human food or animal feed to date under its voluntary consultation procedure.

In an effort to contribute to a meaningful dialogue on scientific issues and consumer concerns about rDNA biotechnology, the Institute of Food Technologists, a non-profit society for food science and technology, conducted a comprehensive review of biotechnology. IFT convened three panels of experts, consisting of IFT members and other prominent biotechnology authorities, to evaluate the scientific evidence and write a report divided into four sections: Introduction, Safety, Labeling, and Benefits and Concerns.