Genetically modified foods: labeling issues are driving the regulators and counsel.

• Author: Bailey, Ronald E.

The FDA's present posture assumes GMF are OK unless proved otherwise, but that stance may not be good enough for a consumer-rights public

GENETICALLY modified foods are in the news. From the introduction of the FlavrSavr[TM] tomato in 1994 to insect-resistant corn in 2000, controversy has swirled around the genetic modification of food crops. A major concern has been safety--in particular, unsuspected allergic reactions in some people. In 1992, the U.S. Food and Drug Administration (FDA) adopted a policy on genetically modified foods; in September 2000, a federal district court rejected a challenge to the FDA's policy.

GENETIC MODIFICATION

Genetic modification is a method of breeding plants. Prior to the advent of genetic modification, which also is known as bioengineering or genetic engineering, plant breeders developed new foods or introduced new traits into crops by what was essentially a trial-and-error method--cross breeding. This process resulted in the tangelo, which is a cross between a tangerine and a grapefruit; high-yield rice; and disease-resistant corn.

Genetic modification, on the other hand, permits scientists to change food crops by introducing a copy of a gene for a specific trait, for example, a gene that protects potatoes against insects and viruses. A gene can be copied from any organism--another plant, an animal, or a microbe--thereby providing plant breeders with a much broader source of potentially useful genes than would otherwise be available through conventional breeding methods.(1)

By definition, genetically modified foods contain genes or parts of genes from other organisms, whether plant, animal or microbe. Genes function by producing specific proteins, and certain proteins can cause an allergic reaction in some people. Thus, there is always the possibility that a new gene inserted into an otherwise nonallergenic food could cause that food to become allergenic.

This is a particular problem if the new gene is derived from foods that commonly cause allergic reactions, such as milk, eggs, fish, crustacea, mollusks, tree nuts, wheat and legumes (especially peanuts and soybeans). These foods account for some 90 percent of food-based allergic reactions.

FDA POLICY STATEMENT

In 1992, in response to questions from industry and the public, the FDA published its Statement of Policy: Foods Derived from New Plant Varieties (policy statement), which was intended to clarify the agency's legal and regulatory framework for the oversight of foods derived from new varieties of plants developed through both the "old" and "new" breeding techniques.(2) At bottom, the policy statement indicated the FDA's intention to regulate foods developed through genetic modification within the existing framework of the Federal Food, Drug, and Cosmetic Act (FFDCA), the statute's implementing regulations and current practice. That is, according to the policy statement, the regulatory status of a food would depend on the food's objective characteristics and its intended use, "irrespective of the method by which it is developed."

In adopting the policy statement, the FDA did not engage in a formal notice-and-comment process or prepare an environmental impact statement or environmental assessment. Between 1992, when the policy statement was issued, and September 2000, at least 36 genetically modified foods went on the market.(3)

The FFDCA authorizes the FDA to regulate food safety. The provisions pertinent here are Section 402(a)(1) of the act, 21 U.S.C. [sections] 342(a)(1), which applies to "adulterated" food, and Section 409, 21 U.S.C. [sections] 348, applicable to food additives.

Under Section 402(a)(1), a food is "deemed" adulterated and thus unlawful "[i]f it bears or contains any [added] poisonous or deleterious substance which may render it injurious to health," but a food is not deemed adulterated if it contains a naturally occurring substance in amounts that do not "ordinarily render it injurious to health." According to the policy statement, the FDA considers any substance "that is not an inherent constituent of food or whose level in food has been increased by human intervention to be `added' within the meaning of section 402(a)(1) of the act."

The policy statement goes on to declare that Section 402(a)(1)

imposes a legal duty on those who introduce food into the market place, including food derived from new crop varieties, to ensure that the food satisfies the applicable safety standard. Foods that are adulterated under Section 402(a)(1) of the act are subject to the full range of enforcement measures under the act, including seizure, injunction, and criminal prosecution of those who fail to meet their statutory duty.(4) Section 409 applies to all food additives except those that are "generally recognized as safe," a category that goes by the acronym GRAS.(5) Typically, the producer of a food additive that is not GRAS submits data to the FDA through a food additive petition. If the FDA finds the additive "safe," the agency promulgates a regulation that specifies the conditions under which the additive may be used safely. "Safety" means "a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use."(6) The FDA deems unsafe as a matter of law those additives that are not the subject of such a regulation, and the foods containing them are considered adulterated under Section 402(a)(7) and therefore unlawful.(8)

Filing a petition proposing the issuance of a regulation for a food additive is voluntary.(9) It is up to the producer to decide whether a particular additive is a "food additive" requiring premarket approval under Section 409. The policy statement asserts that the FDA encourages producers of new food ingredients to consult with the agency where there is a question about the regulatory status of the ingredient. The FDA claims that "firms routinely do so, even though such consultation is not legally required." However, where a company markets an ingredient on its independent determination that the ingredient is GRAS, but the FDA subsequently determines that the ingredient is not GRAS, the FDA, according to the policy statement, "can and will take enforcement action to stop distribution of the ingredient and foods containing it on the ground that such foods are or contain an unlawful food additive."

POLICY STATEMENT AND GENETICALLY MODIFIED FOODS

In its policy statement, the FDA declared that its statutory authority under FFDCA Sections 402(a)(1) and 409 and related regulations were "fully adequate to ensure the safety of new food ingredients and foods derived from new varieties of plants, regardless of the process by which such foods and ingredients are produced," adding that Section 402(a)(1) would "continue to be FDA's primary legal tool for regulating the safety of whole foods, including foods derived from plants genetically modified by...