Abstract
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
Recommended Citation
Margaret Gilhooley,
Reexamining the Labeling for Biotechnology in Foods: The Species Connection,
82 Neb. L. Rev.
(2003)
Available at: https://digitalcommons.unl.edu/nlr/vol82/iss4/5