Regulation on Genetically Engineered Foods

Regulatory responsibility for biotechnology in FDA is shared between the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine. In 1992 FDA ruled that foods produced through biotechnology would be subject to the same review and approval processes as are other new food products. Federal regulations evaluate the end product, not the process by which a product is made. Therefore, FDA evaluates new food biotechnology products for their individual safety, allergenicity, and toxicity, under the guidelines of the Federal Food, Drug and Cosmetic Act, just as are other new foods. Questions that must be answered during the review period are:

• Has there been an increase in any naturally occurring toxins in the plant?
• Has an allergen not commonly found in the plant been introduced?
• Has there been a change in the levels of any important nutrients?
• Have new substances that raise safety questions been introduced into the food?
• Are there any negative environmental effects?
• Have accepted, established scientific procedures been followed?

Calgene’s FlavrSavr tomato, one of the very first food biotechnology products to come under FDA regulation, is a good example. An antibiotic marker used in the genetic engineering of the tomato produced very small amounts of a protein not normally found in tomatoes. FDA viewed this new protein as a food additive since it was a substance new to tomatoes, and regulated it as such. In part because of strong public input from public outreach meetings in 1999, FDA plans to strengthen its pre-market review of genetically engineered foods.

Current U.S. labeling laws require foods produced through biotechnology to have labels stating such if a known food allergen has been introduced, the nutritional content of the food has been changed, or the product’s composition has been substantially altered. To protect consumers who have food allergies, products must belabeled if they contain any of the eight most common food allergens-milk, eggs, wheat, fish, shellfish, tree nuts, peanuts, and soy. FDA evaluates all new food products, biotech products, and traditional products for the presence of these allergens. The primary agency responsible for biotechnology in the U.S. Department of Agriculture is the Animal and Plant Health Inspection Service (APHIS). APHIS governs the field testing of agricultural biotechnology crops. APHIS determines whether genetically engineered plants are safe to grow. The Environmental Protection Agency (EPA), as the federal agency that regulates pesticides, has jurisdiction over biotechnology plants that produce pesticides to protect themselves from insects and other pests. EPA determines whether genetically engineered plants are safe for the environment. In 1996 EPA approved the use of Bacillus thuringiensis (Bt), which is regulated as a pesticide since it controls pests.