Dr. James H. Maryanski, Biotechnology Coordinator
Center for Food Safety and Applied Nutrition;
Dr. Eric L. Flamm
Office of Biotechnology; and
Dr. Linda S. Kahl
Division of Food and Color Additives
Center for Food Safety and Applied Nutrition;
Food and Drug Administration
Washington, DC
The Food and Drug Administration (FDA) recently clarified its legal and regulatory framework for oversight of food (including animal feed) derived from new plant varieties.
An FDA policy statement published in the May 29, 1992, issue of the Federal Register (57 FR 22984) addresses foods--such as fruits, vegetables, grains, and their by-products--derived from any new plant variety, whether developed by traditional breeding techniques or cellular or molecular techniques.
Standard of Care Established
Of particular importance to producers is the policy's Guidance to Industry section, which describes scientific and regulatory issues that should be addressed during the development of new crop varieties. This section establishes a "standard of care" for producers of foods derived from new plant varieties. It is based on current practices and, FDA believes, does not impose new burdens on breeders.
This policy is based on FDA's understanding of current developments in agricultural research and is intended to be sufficiently flexible to accommodate rapid advances in this field. The scientific principles that underpin FDA's policy were discussed in an article in Science magazine (see Kessler, et al., 256:1747, June 26, 1992). FDA invites comments on the policy.
Postmarket Authority
The policy explains that the Federal Food, Drug, and Cosmetic Act (the Act) provides broad authority to FDA to ensure the safety and wholesomeness of foods and food ingredients. FDA regulates the safety of foods primarily under the agency's postmarket authority under the adulteration provisions of Section 402(a)(1) of the Act. This section provides FDA with authority to remove unsafe foods from the market and places a legal duty upon producers to ensure that the foods they market are safe and wholesome.
Food Additives
FDA also has pre-market approval authority for food additives, stemming from Section 409 of the Act. Under the food additive provisions, all substances intentionally introduced into food must undergo pre-market approval unless they are generally recognized as safe (GRAS). The policy statement makes clear that substances introduced by breeding are subject to these provisions just as are chemical additives introduced during processing.
Labeling Requirements
The Act also contains labeling requirements. Section 403 of the Act requires that a producer of a food product describe the product by its common name, and reveal all facts that are material in light of representations made or suggested by labeling or with respect to consequences that may result from its use.
FDA's policy does not contemplate special "genetically engineered" labeling for foods derived from plants developed via recombinant DNA methods. Historically, FDA has not considered plant breeding techniques to be material information subject to labeling. Such labeling would not provide information about the composition of the food and often would be impractical.
For example, wheat varieties developed with different techniques would have to be segregated during production, storage, distribution, and processing. The difficulties would be magnified as varieties developed with different techniques are crossed in breeding programs.
Rather, FDA believes that food labeling should identify significant changes in composition or safety or usage issues. So, for example, if wheat gluten were introduced into potatoes, labeling would be required so that consumers sensitive to gluten, such as those with celiac sprue, would be able to avoid those potatoes and products containing those potatoes.
Industry Guidance
The Guidance to Industry section addresses principal safety and regulatory issues through a series of flow charts and accompanying text. Briefly, this section points out that developers should initially consider the characteristics of the host plant that is being modified, the donor organism that is contributing genetic information, and the genetic material and substances being introduced or modified.
Based on this information, the developer can then decide what other information may be needed to evaluate the safety and regulatory status of food derived from the new plant variety.
For example, the developer should evaluate whether or not existing varieties of the host plant are known to produce toxicants at unsafe levels and, if so, ensure that the levels of these toxicants in the new variety are within acceptable limits. Similarly, if the donor organism produces undesirable toxicants, the developer should ensure that the genes for these toxicants were not introduced or that the new variety does not produce unacceptable levels of such toxicants.
The guidance section provides criteria by which developers can determine whether a substance intentionally introduced or altered by genetic modification will require pre-market approval as a food additive. Presently, these substances are primarily proteins, fats and oils, and carbohydrates since they are the focus of plant breeding programs using the newer molecular techniques.
In general, the policy states that newly introduced or modified proteins of known function would not require FDA review if they are derived from food sources or are substantially the same as food substances; are not known to be toxic or raise food safety concerns; and will not be a major constituent of the diet.
New carbohydrates with unusual structural or functional groups or oils that contain new, unusual fatty acids may also require premarket approval as food additives.
The guidance section also identifies other instances where FDA consultation is required. For example, producers may need to consult FDA about test protocols for allergens when genetic material from a commonly allergenic food has been introduced into a new variety. Generally, modifications to carbohydrates do not raise safety questions that would warrant consultation with FDA, unless the digestibility or nutritional value of a carbohydrate has been altered and the substance is likely to be a major constituent of the diet.
When producers modify fats or oils to the extent that they are likely to be a major constituent of the diet, they should contact FDA to determine if a safety issue exists (for example, if the modification results in a change in digestibility) or if labeling will be required (for example, if the composition is no longer representative of fats and oils ordinarily obtained from that crop).
Consultations Encouraged
These are some of the safety and regulatory issues discussed in the policy statement. Because of the potential consequences that may arise if FDA challenges a product on safety or legal grounds, producers routinely consult with the agency before introducing new products. FDA encourages such consultations, especially when new, scientific techniques are under development.
For more information, contact:
Dr. James H. Maryanski
Biotechnology Coordinator
Center for Food Safety & Applied Nutrition
Food and Drug Administration (FDA)
HFF 300
200 C. St., SW
Washington, DC 20204
Ph. (202) 205-4359