Reexamining the Labeling for Biotechnology in Foods: The Species Connection

I. Introduction . . . . . 1089 II. Regulatory Framework for Biotechnology in Foods . . . . . 1096 A. FDA Safety Authority with Respect to New Plant Varieties . . . . . 1096 1. FDA Basis for Safety Regulation: The 1992 Policy Statement . . . . . 1096 2. Emergent Uses and FDA’s 2001 Proposal for Pre-Market Notice . . . . . 1097 B. FDA Safety Regulation for Animal Biotechnology: Growth and Yield Promotion . . . . . 1098 C. Pest and Crop Protection Uses of Biotechnology . . . . . 1098 D. FDA’s Policy Statement on Labeling of Biotechnology in Foods . . . . . 1100 1. Material Omissions and Process . . . . . 1100 2. Food Names and Ingredient Labeling . . . . . 1101 III. Statutory and Constitutional Limits on Biotechnology Labeling: Litigation and the Deception Rationale . . . . . 1101 A. Litigation on FDA’s Statutory Authority and Policy . . . . . 1102 1. Litigation on Recombinant BST in Milk . . . . . 1102 2. Litigation on General FDA Policy Statement on Labeling . . . . . 1102 B. Constitutional Challenge to State-Mandated Labeling for rBST in Milk . . . . . 1103 C. Deception Theory for Labeling . . . . . 1103 1. Deception and Food Constituents Changed by the Process . . . . . 1103 IV. Framework and Rationale for Additional Labeling . . . . . 1105 A. Labeling for Gene Transfers from Different Species in New Plant Varieties . . . . . 1105 1. Need and Labeling Format . . . . . 1105 2. Wide Crosses: Wide Crosses as Different . . . . . 1108 a. Existing Wide Crosses . . . . . 1109 3. Varieties for Which Labeling Distinction Not Needed . . . . . 1110 4. Transfers from Animal Species: The Need for Labeling . . . . . 1111 B. Plant Biotechnology for Pesticide Use and Labeling . . . . . 1112 1. Impact of Biotechnology on Need for Labeling . . . . . 1112 2. Form for General Labeling . . . . . 1113 C. Objections to Labeling and Assessment . . . . . 1114 1. Absence of Deception . . . . . 1114 2. Insufficiency of General Labeling . . . . . 1114 3. Limits on FDA’s Authority, and Labeling Exemption for Pesticide Chemicals . . . . . 1114 a. History . . . . . 1114 b. Wider Applicability of Policy? . . . . . 1115 4. Assessment of General Labeling Approach . . . . . 1116 D. Animal Biotechnology and Labeling . . . . . 1118 1. Growth Promotion and Emerging Uses . . . . . 1118 2. Species Impact and Salmon . . . . . 1119 a. Scientific Issues . . . . . 1119 b. FDA’s Statutory Authority with Respect to Environmental Impacts . . . . . 1120 c. Role for Consumer Labeling . . . . . 1121 3. Environmental Risks from Bt Pesticides in Crops . . . . . 1122 V . Conclusion . . . . . 1123