A long-awaited report by the National Research Council should reassure consumers that foods derived from biotechnology are thoroughly tested and safe. The council said there is no evidence genetically improved foods pose any more risk to public health or the environment than any other food. In fact, crops modified to control insects without chemical pesticides probably pose less risk, the council said.
Most of the regulatory changes recommended by the council have already been implemented, such as improved allergenicity testing, programs to prevent insects from developing resistance to crops and follow-up studies to see if Monarch butterflies, which were adversely affected in the laboratory, could be harmed in the field. Several field studies last year showed the risk to Monarchs is very low.
One statement in the council’s report particularly resonates. “Public acceptance of these foods ultimately depends on the credibility of the testing and regulatory process.” The council urged regulatory agencies to post detailed information on websites so the public could more readily understand the process. This is far overdue. If the public understood how thoroughly biotech products are tested and scrutinized, much of the uneasiness surrounding biotech would go away.
Three federal agencies involved: Regulatory oversight of biotechnology is constant, and there are at least nine times in which a formal decision to move forward is required. This means that a number of agencies and people within those agencies have an opportunity to raise objections, ask for more information and potentially halt a project if their concerns are not satisfied. In most of these formal steps, public comment is invited and considered.
The first opportunity comes almost immediately after a scientist discovers a potentially marketable product concept. Following guidelines developed by the National Institutes of Health, developers empanel a Biosafety Committee made up of employees and members of the general public. This group considers the potential risks of the concept and can recommend that it go forward or be canceled.
The U.S. Department of Agriculture has four formal opportunities to advance or halt a product. First, USDA must determine if existing research facilities are adequate for continued development of the product. The developer must receive USDA approval to conduct field trials. USDA must give authority for the developer to ship seeds from a greenhouse to field trial sites. And, most important, USDA spends nearly a year reviewing a full package of field trials and studies.
If the new plant performs a function traditionally performed by a chemical pesticide (insect-protected corn or cotton) the Environmental Protection Agency is involved in three formal steps. EPA must grant an experimental use permit if the developer wants to test 10 acres or more. EPA must also decide whether limits (tolerances) should be set on the amount of pest-control protein in foods derived from the crop. And, finally, EPA typically spends 18 months reviewing a host of environmental and toxicological studies.
The Food and Drug Administration is involved in the process almost from the beginning and is the primary overseer of food safety. FDA meets with the developer early in the process and provides guidelines on what studies FDA considers appropriate to ensure food and feed safety. The interactive involvement between FDA and the developer spans several years. Furthermore, FDA has authority, under the Food, Drug and Cosmetic Act, to immediately remove from the market any food the agency deems unsafe.
A thorough examination: During this process, the three federal agencies examine health and environmental safety. USDA, in years of field trials, examines many parameters of the biotech crop to see if inserting a new gene caused the plant to differ from its conventionally bred counterpart. The field trials also tell USDA if the crop is having any effect on non-target species. USDA also is responsible for ensuring that the plant will not become or create a weedy pest.
EPA reviews toxicological studies to ensure the new crop does not harm wildlife or humans. High doses of the new protein are fed to rodents, beneficial insects, birds and fish. Digestibility studies and other data determine if the inserted material is an allergen or creates an allergen when inside the plant.
FDA compares every significant parameter of the improved plant with its traditional counterpart. Agronomic and physiological characteristics are compared, as are nutritional components (protein, starch, sugar, fat, amino acids, etc.) Any unexpected changes lead to further study. When no changes are seen, FDA can conclude with great assurance that the biotech crop is substantially equivalent to and hence “as safe as” the conventional crop.
The review process for biotechnology is constant, thorough and logical. It just needs to be better understood.
C.S. Prakash is a professor and plant molecular genetics director at the Center for Plant Biotechnology Research at Tuskegee University, Tuskegee, Ala.