The regulatory process for the use of any technology should take into account both the risks and benefits of implementing that technology as well as the consequences of nonimplementation and the viability of alternative technologies. Biotechnology poses unique challenges to the regulatory process because it is a new tool with the potential to affect a wide spectrum of changes in an equally wide range of products. Therefore, each use of the technology must be reviewed on a case-by-case basis. Blanket acceptance or rejection of this technology will take years of practical experience.
Four federal entities play different roles in the current process, the National Institutes of Health (NIH), the Animal Plant Health Inspection Service (APHIS) of the USDA, the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA). The combination of the regulatory protocols provides coverage over all aspects of plant biotechnology from the laboratory to the farm to the marketplace.
The first step in making a product is at the laboratory research level. The NIH has published a set of guidelines to specify practices for working with recombinant DNA and organisms and viruses containing recombinant DNA to promote a high level of biosafety. The NIH Guidelines for Research Involving Recombinant DNA Molecules cover all aspects of recombinant DNA research and require compliance from any institution that receives funds from the NIH. These guidelines are widely accepted and followed, even by institutions that do not receive NIH funding. Under the guidelines, institutions that conduct this type of research must set up an Institution Biosafety Committee (IBC) that is composed of experts in various fields relating to the subject matter and are encouraged to open their meetings to the public. The IBC is responsible for all the guidelines set forth by the NIH and must approve a project either before or during initiation, depending of the nature of the project and is keenly aware of pathogenicity and containment issues (57 ).
According to the Federal Plant Protection Act (FPPA), any transgenic crop containing DNA of a known plant pest is viewed as a potential plant pest and is therefore under the regulatory control of the APHIS Plant Protection and Quarantine within the USDA (58 ). Crop developers must file a notification for permission to import, grow, or move through state lines any genetically engineered plants. Developers must meet several criteria for APHIS to accept the notification. The species of the crop must already be considered safe for growth. The introduced genetic material must be stable. The function of the new genetic material must be known, and its expression in the regulated article cannot result in plant disease, produce products intended for pharmaceutical use, produce an infectious entity, or be toxic to a nontarget organism. In addition, the added sequence cannot pose a risk of creating any new viruses or be derived from any animal or human pathogen (59 ). If approved, the organism can only be grown with proper containment for data collection purposes and must be destroyed afterwards. After the developer has collected sufficient data, APHIS accepts petitions to deregulate the crop. Public input is invited at this stage. If found genetically stable and there is no finding of environmental concerns, the USDA grants a permit and no longer regulates the crop (58 ).
Mandated by the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the EPA is the regulatory agency ensuring the health and environmental safety of all pesticides. Therefore, the EPA becomes involved in the review of biotechnology-derived crops when they are altered to produce a pesticide (plant-incorporated protectant or PIP). To register PIPs for commercial use with the EPA, the developer must submit an extensive amount of data concerning the toxicity, biodegradability, environmental effect, and effects on nontarget organisms. The EPA Office of Pesticide Programs grants an Experimental Use Permit allowing for planting in order to conduct field trials for the purpose of collecting the Agency’s required data. Public comment is invited throughout each stage of this process via publication in the Federal Register. Under FIFRA, the EPA must review all data concerning the ecological, human, and animal health effects from the use of the PIP to certify that there will be no unreasonable adverse human or ecological effects. In addition, under the Food Quality Protection Act (FQPA), EPA must set safe tolerances for PIPs in foods for human consumption. It is then the role of the FDA to enforce the tolerance level in foods postproduction. The EPA may grant an exemption from a tolerance if there are extensive data on the safety of the introduced trait (60 ).
The FDA’s mission, among other things, is to protect public health by ensuring the safety of foods. The FDA currently does not have a mandatory premarket approval system in place for food products derived from biotechnology because it does not consider the method of production to raise significant safety issues. Rather, the FDA treats a food developed via biotechnology like other new foods and bases the safety assessment on the premise that a new food should be "as safe as" the food from which it was developed. The principles of safety assessment were published in the FDA’s 1992 policy statement, Foods Derived From New Plant Varieties (61 ).
The FDA concluded that it is sensible for developers of new varieties of foods to consult with the FDA so that "relevant scientific, safety, and regulatory issues are resolved prior to the introduction of such products into the marketplace". To facilitate this consultation process, the Biotechnology Evaluation Team (BET) was created by the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), Office of Surveillance and Compliance (OSC), and Center for Veterinary Medicine (CVM). The BET is composed of a consumer safety officer, molecular biologist, chemist, environmental scientist, toxicologist, nutritionist, and may include supplemental expertise depending on the product in question. The BET requests information, such as intended uses of the food, source of genetic material, intended technical affect of the modification, the expected effect of the composition of the food, the identity, function, and concentration of all newly expressed products, any known or suspected allergens or toxins, a comparison of the composition of the new food to that of the parental variety, and any other relevant information concerning the safety and nutritional assessment of the bioengineered food (62 ). Developing this information can require several years.
Although the FDA’s premarket review process has been voluntary, every company that has commercialized a new product developed via biotechnology has submitted its data to FDA for review, a process that can take several years. The FDA recently proposed making this premarket notification process mandatory and is currently receiving comments on the matter (63 ).
Throughout the food regulatory system the goal is minimizing risks by ensuring that a new technology or product is "as safe as" a similar product before it. Consequently the assessments are always comparative (61 ). A hazard is a hypothetical event that might do harm, and a risk is a hazard that actually occurs at some known frequency or probability. Food safety is achieved by risk identification, comprehensive hazard analysis, assessment, concluding that benefits outweigh costs, development of a risk management plan, and effective training and risk communication. Using all of these elements in a food safety evaluation maintains a precautionary approach.
Foods derived from biotechnology are more heavily regulated than any other new foods. Only new food additives and food ingredients are subjected to premarket approval— new nongenetically modified whole foods are not—and there is no required premarket screening of whole foods for toxicity or allergenicity.
Aspects of our food supply that may pose health risks include food borne illness, untested natural foods, dietary supplements, and dietary inadequacies such as over-nutrition, under-nutrition, and nutrition inadequacy. There are natural toxicants, allergies to various foods, chance additives, pesticide and herbicide residues, food ingredients and additives. Biotechnology carries a relatively low risk to human health and, in fact may become part of the solution to some of the problems mentioned above.
Consumers need to realize that there is extensive safety assessment and regulatory evaluation done on these products before commercialization. However, a fundamental difference in opinion that is driving controversy needs to be resolved: Are transgenics inherently more or less safe? For this we need additional scientific evidence and critical thinking that would lead to science-driven policy decisions. We should learn to view safety as a comparative finding, where the safety of a product from biotechnology is determined in relation to the safety of the parent product.
Scientists and regulators need to build trust and credibility with consumers without using the "trust me" approach and should strive to be better educators because of the many challenges ahead in terms of acceptance for this technology.