Regulating Food Safety Risks

A. FDA Oversight

The FDA regulates the safety of food and animal feed through the general safety requirements of the Food, Drug, and Cosmetic Act. This authority derives largely from two provisions of the act: the section 402(a)(1) adulteration standard and the section 409 food additive requirements.

1.Adulteration

Under section 402(a)(1) of the FD&C Act, a food that bears or contains any added poisonous or deleterious substance that may render it injurious to health is deemed adulterated.^[159] “Added” under this section includes additions by gene technology.

The sale of such adulterated food is a violation of the FD&C Act, and under the authority of the Act, FDA has the power to remove the food from commerce.

2. Food Additive Requirements

The FD&C Act section 409 food additives provisions require an FDA premarket approval of any food additive, which includes products of gene technology.^[160] An unapproved food additive is automatically deemed food unsafe, and any food containing an unapproved food additive is adulterated under section 402(a)(2) (C) of the FD&C Act. The proponent of a new food additive must prove with a reasonable certainty that the substance is not harmful under the conditions of intended use.^[161] When the FDA approves a new additive use, it is published in the Federal Register. The public has a comment period for submission of objec­tions and requests for a hearing.^[162]

The procedure of obtaining pre-market approval requires the submission of safety data, including animal studies, toxicological studies, and other such evidence of safety by the proponent of the additive. FDA reviews the submis­sions and makes a determination regarding the safety of the additives under the conditions of their intended use.

• The identity and composition of the additive

• The proposed use in food

• The amount to be added to food

• Data establishing the intended effect

• Quantitative detection methods in food

• Full reports of all safety studies (e.g., toxicology, allergenicity, nutrition)

• Proposed tolerances (if needed)

• Environmental review information

Additive approvals issued are generic; therefore, anyone in compliance with the conditions of use laid out in the regulation may use the additive in food. Approvals are safety based only. There is no balancing of risks versus benefits.

However, the law specifically excludes from food additive review pesticide residues and new animal drug residues because their safety is reviewed under different requirements of the FD&C Act.^[163] Also excluded from food additive approval are uses of substances that are generally recognized as safe (GRAS) among experts qualified by scientific training and experience to evaluate the

Regulating Gene Technology in Food 49 safety.^[164] The safety standard for both food additive and GRAS substance uses is a reasonable certainty that the substance is not harmful under the conditions of intended use.^[165] Although the safety standard is the same, the GRAS stand­ard requires publicly available proof that is accepted by most scientific experts qualified to evaluate the safety.

Because GRAS determination is based on the consensus of experts in the field rather than FDA approval or acceptance, no submission to FDA is required for GRAS use. Therefore, a company may self-determine GRAS status with­out notifying the FDA. This intentional loophole in the law creates a lack of certainty and oversight.

Consequently, FDA established a voluntary premarket consultation process to encourage the use of the FDA-premarket review and ensure that any safety issues associated with a food derived from gene technology are resolved.^[166] This includes the potential for allergenicity, toxicity, and anti-nutrient effects.

The FDA posts the results of completed consultations on its website. Although the FDA consultation is voluntary, it appears that all genetically engineered food crops intended for marketing have been submitted to FDA for a consultation or other relevant premarket process prior to marketing. Com­pletion of the voluntary consultation provides a company with an assurance that their product is in compliance with the law, and a satisfactory FDA con­sultation is important for marketing. Moreover, if a company were to skip the FDA consultation and be wrong about the safety or the need for food additive, color additive, or pesticide residue approval, enforcement action could ensue, including warning letters, product recalls, seizures, injunctions, and criminal prosecution.

3. Genetically Altered Animals

The definition of “drug” under FD&C Act section 201(g)(1)(C) includes “arti­cles (other than food) intended to affect the structure or any function of the

body of man or other animals.”^[167] The use of technology to alter the genetic material of an animal is a use that is intended to affect the animal’s structure or function, which, therefore, meets the Act’s definition of drug. The FD&C Act generally makes it unlawful to introduce new animal drugs into commerce without FDA’s approval.^[168]

It is the FDA Center for Veterinary Medicine that is responsible for evaluat­ing the safety and effectiveness of any genetic engineering of an animal.

B. EPA Oversight

Under the Federal Insecticide, Fungicide, and Rodenticide Act, the EPA regu­lates the labeling, sale, distribution, and use of all pesticides, including those produced through gene technology.^[170] Under FIFRA, a pesticide may not be sold or distributed unless it is registered by EPA. Thus, “register” is equivalent in meaning to the term “authorize.” There are two separate tests to meet before the EPA may register a pesticide for use. EPA may register a pesticide only if (1) it has no unreasonable adverse effect to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of a pesticide, and (2) no human dietary risk results from food residues from the use of a pesticide; specifically, the use of the pesticide cannot be inconsistent with the pesticide residue tolerances established for food under section 408 of the Food, Drug, and Cosmetic Act.^[171]

An application to EPA for a pesticide registration requires extensive scien­tific data and information on the potential effects of a pesticide. The safety of pesticide residues and other substances resulting from the use of a pesticide on a crop or food, which includes any metabolic or other degradation products of the pesticide, must be proven safe under section 408 of the FD&C Act. The act makes it unlawful to enter into interstate commerce any food that has a pesticide residue that has not been registered or for a food to have a pesticide residue for which a tolerance has not been set.^[172]

The tolerance must be set to ensure “a reasonable certainty that no harm will result from aggregate exposure to residues of the pesticide” in food for humans or animals, including all anticipated dietary exposures and all other exposures for which there is reliable information.^[173] EPA in response to a petition or on its own initiative may modify or revoke a tolerance.

C. USDAFSIS

The USDA Food Safety and Inspection Service is responsible for ensuring the safety of meat, poultry, egg products, and fish of the order Siluriformes. While FDA oversees the safety of substances added to these FSIS-regulated products, including additions via gene technology, the FSIS reviews whether the use of these additions in meat, poultry, egg, and or fish of the order Siluriformes is suitable under FMIA, PPIA, and EPIA. Therefore, FDA informs FSIS of any reviews of the safety of any genetic engineering related to meat, poultry, eggs, or fish of the order Siluriformes when intended to be used for human con­sumption, as well as the safety of any substances added as a result of the gene technology.^[174]

III.