The Food and Drug Administration published in the May 29, 1992, Federal Register (57 FR 22984) a policy statement clarifying its legal and regulatory framework for oversight of food and animal feed derived from new plant varieties developed with both old and new breeding techniques. The document also discusses FDA's safety assessment approach in a guidance to industry section.
This section is establishes a "standard of care" for foods derived from new plant varieties that is based on current development practices. Much of the interest generated by publication of this statement has focused on issues surrounding use of the newer gene splicing or genetic engineering techniques to develop new plant varieties. The following are answers to some of the most commonly asked questions.
A. In fact, the FDA's policy utilizes the same effective system established for the review of traditional food additives, as well as the system for regulating whole foods. Generally, a new substance introduced via breeding for which there is not an established basis of safety (a substance that is not "generally recognized as safe", or GRAS) must be approved as a food additive prior to marketing. (Note that new pesticidal substances are under the jurisdiction of the EPA rather than the FDA).
Under the Federal Food, Drug and Cosmetic Act, however, substances that are generally recognized as safe are not considered food additives and so are excluded from the requirement for premarket approval. Many of the food crops currently being developed with gene splicing techniques do not contain substances that are significantly different from substances already in the diet, and thus would not require approval as a food additive. But those foods that do contain a substance that is significantly different from substances already in the diet have to be approved by the FDA.
The law provides the FDA with the authority to ensure the safety of whole foods. It places a legal duty on those who develop and sell food to assure the safety of the products they offer consumers, and provides FDA with a range of legal tools to enforce this duty.
A. FDA considers potential allergenicity to be a very important issue. The policy states that proteins taken commonly allergenic foods are presumed to be allergens unless demonstrated otherwise; foods to which these potential allergens have been added must be so labeled. Thus, tomatoes bred to contain a peanut protein would need to be labeled to disclose the presence of the peanut protein, unless it were conclusively demonstrated that the new tomato was not allergenic to those allergic to peanuts.
A. No, these foods are being tested by the developer prior to marketing. New plant varieties, whether developed with new or traditional breeding techniques, routinely undergo many years of testing and evaluation prior to commercialization to determine that the plants behave as expected under different environmental conditions. Plants that behave in unexpected or undesirable ways are eliminated from the breeding programs. Additionally, food from new plant varieties is routinely tasted and tested to ensure that it does not differ from food expected from that plant. The various foods developed using the new techniques that are nearing commercialization are being subjected to extensive chemical analyses and animal feeding studies.
The policy statement contains a lengthy scientific discussion to guide plant developers in understanding the issues FDA considers important for ensuring the safety of foods from new plant varieties.
A. All plant breeding involves the genetic manipulation of plants. There are hundreds of new plant varieties introduced every year in the U.S., and all have been genetically modified. FDA does not require labeling to describe what technique was used in the development of a new variety, and does not believe that the use of the newer techniques justifies a change in that policy.
One difference between the new gene splicing techniques and other techniques is that the new techniques permit the introduction into a plant of genes from essentially any organism. At the same time, the gene splicing techniques enable such modifications to be performed in a directed and predictable fashion, without the simultaneous introduction of extraneous undesirable genes. When the technique is used to significantly change the composition of a food, then labeling will be required. Thus, a tomato without any vitamin C would be required to be labeled to disclose such change; likewise, food with a potential allergen from a commonly allergenic food would need to be labeled to alert consumers of the presence to the potential allergen.
However, when the techniques is used to modify a plant in a way that does not significantly change its composition, special labeling would be inappropriate. Thus, corn that is genetically engineered to resist drought, for example, would not more warrant labeling to identify its method of development than any other new corn variety, unless it contained a suspect allergen from a commonly allergenic food or its composition was significantly different from other corn varieties.
A. While replicas of some animal genes (e.g., a fish gene encoding a protein to diminish frost damage) have been introduced into experimental crops, there are not plants nearing commercialization that have such genes in them. Food whose composition is significantly different from what is expected will have to be specially labeled. FDA invites comments from the public as to the types to compositional changes that may be considered significant.