Hypothetical Case Study

The following hypothetical case study is designed to illustrate the navigation of a developer of a genetically engineered plant intended for food through research and development to regulatory steps before commercialization.

A. Hypothetical Genetically Engineered Corn With Pesticidal

Properties^[180]

This hypothetical crop intended for human food and animal feed is genetically engineered with pesticidal activity against certain insects.

1. The Product

Corn (Zea mays) is genetically engineered to express a protein with pesticidal activity. The gene encoding the protein is isolated from the bacterium Bacil­lus thuringiensis and controlled by the cauliflower mosaic virus-derived 35S promoter. The construct is integrated into a binary vector and introduced into the corn genome using Agrobacterium-mediated transformation. Also encoded on the vector and stably incorporated into the corn genome is a gene that ena­bles the selection of transformants during research and development.

2. Agencies With Oversight

EPA regulates the pesticidal trait in the plant. FDA regulates the safety of the corn because it will be used for food for humans and animals. USDA regulates the growing of the corn plant engineered with plant pest components.

3. Developer Responsibilities During Research and Development

Research and development will be in contained systems (such as the laboratory and greenhouse). Research and development activities in contained systems are outside the regulatory authority of USDA APHIS under the Plant Pro­tection Act.

4. Developer Responsibilities Before Starting Field Trials

Environmental release triggers USDA APHIS regulatory requirements. There­fore, under the Plant Protection Act, before starting small-scale, non-contained field trials, the developer must obtain an authorization for environmental release from USDA APHIS. If the corn involves genetic engineering from a new species or novel modifications that potentially raise new issues, then USDA APHIS must prepare an appropriate environmental analysis. This will be either an environmental assessment or an environmental impact statement.

Because the corn is intended for food use, at this stage, the developer must either obtain a tolerance for the residues of the pesticide in the food from EPA under the Federal Food, Drug, and Cosmetic Act or destroy any crops with residues of the pesticide. Additionally, the developer must ensure that the corn and any derived products to be used for food for humans or animals are safe and meet all other applicable FDA requirements. The developer should provide relevant scientific and technical information to FDA and begin a voluntary consultation about food safety and other FDA-related regulatory issues that may be associated with food from the corn.

5. Additional Responsibilities Before Starting Large-Scale Field Trials

If the field trial cumulative plot size is 10 acres or more, the developer must obtain an experimental use permit from EPA under the Federal Insecticide, Fungicide, and Rodenticide Act. If the developer has not already done so, it

Regulating Gene Technology in Food 55 must obtain a pesticide tolerance or tolerance exemption from EPA or ensure that all experimental crops with residues of the pesticide are destroyed.

6. Before Commercialization

The developer must ensure that all regulatory requirements have been met prior to the commercialization of the corn.

7. Public Engagement

The EPA, under its FIFRA and FD&C Act responsibilities, will offer the pub­lic opportunities to comment at several points, including public notices at the receipt of an application, prior to preliminary decisions, and prior to final decisions.

FDA posts the results of the completed consultation on its website. If a food additive review is required, a proposed food additive approval will be published in the Federal Register for public comment. Comments will be con­sidered and answered when the final food additive rule is published in the Federal Register.

The public is given an opportunity to comment to APHIS as it develops the EA or EIS and the Plant Pest Risk Assessment (PPRA). If an EIS is prepared, the public may have as many as three additional opportunities to provide input into the decision-making process.