Reexamining the Labeling for Biotechnology in Foods: the Species Connection

• Publication year: 2021
• Citation: Vol. 82

82 Nebraska L. Rev. 1087. Reexamining the Labeling for Biotechnology in Foods: The Species Connection

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Margaret Gilhooley*

Reexamining the Labeling for Biotechnology in Foods: The Species Connection

TABLE OF CONTENTS

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

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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

I. INTRODUCTION

The Food and Drug Administration (FDA) recognizes that, in theory, through biotechnology "essentially any trait whose gene has been identified can be introduced into virtually any plant . . . ."(fn1) These genes may potentially be isolated from microbial, animal or plant sources.(fn2) The major uses of biotechnology to date in foods have involved agronomic uses that enhance yield or protect crops from pests or weeds. Some of these have involved gene transfers from the same source, such as the use of a recombinant version of a cow hormone to

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increase milk production. Widespread crop protection uses involve the transfer of a bacterial pesticide gene to corn and a gene to enable soybeans to survive spraying with an herbicide.(fn3)

More novel uses of biotechnology are pending in addition to those that are theoretically possible. Some involve transfers from different plants to affect the taste and nutritional characteristics of the food itself. Golden Rice, for example, produces Vitamin A derived from a gene from a daffodil gene.(fn4) Sweet potatoes may be modified to contain amino acids.(fn5) In the past, field tests were even conducted on the transfer of fish genes to a tomato to provide protection from frost damage. (fn6) Biotechnology may also be used in animals in new ways, including to enhance the growth of salmon in fish farms.(fn7) FDA has stated that as a result of increased knowledge of the genome, biotechnology is "likely" to be used "to an increasingly greater extent" by plant breeders, and in some cases the products may present "more complex safety and regulatory issues."(fn8)

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FDA has not required any special labeling on foods about the mere process of using biotechnology. Under its policy, labeling is needed, apart from safety risks, only if the resulting food differs in a "meaningful or uniform way" or "differs" in a way that the traditional name no longer applies.(fn9) The agency looks to is whether there are organoleptic differences in determining if there is a "material fact" that needs to be disclosed in the name.(fn10) The agency's position has been upheld in court challenges in cases.(fn11) Moreover, the effort by the state of Vermont to mandate disclosures about the use of cow growth hormone developed through biotechnology, based on consumer interest, was found to lack a substantial government interest and to be an unconstitutional form of compelled speech.(fn12) The agency, though, permits voluntary labeling that bioengineering has not been used when it does not misleadingly suggest a difference in safety.(fn13)

This Article examines whether the transfer of a gene from a different species should affect the need for labeling of the food. The complexities in developing a labeling framework are also explored. The best case for additional labeling is when a gene has been transferred from a different plant or animal species to a food to affect its taste or nutrition. Will it be sufficient that a new food identifies its new quality features, or should the name and labeling in some way indicate that the food has a gene from a different plant? One format explored here would be a specific reference to a plant as a source of a trait. If rice contained a sucrose gene, for example, the labeling would reflect that the food is "rice with a plant sweetener." Another format is to include the term "enhanced" in the name, by referring to "rice enhanced a with plant sweetener." With time and consumer familiarity, the enhanced term might become a shorthand way to indicate the addition of genes to a food of genes from another edible plant. When a gene from an animal or fish source is transferred to a plant, though,

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the labeling should indicate specifically that an animal or fish gene has been transferred.

The justification for the labeling explored here is the need to prevent deception about important changes that affect consumer's understanding of the identity of the food. If consumers do not expect foods to contain genes from a different species, a disclosure may be needed under an early Supreme Court case, United States v. Ninety Five Barrels of More or Less Alleged Apple Cider Vinegar.(fn14) The Court found a food to be mislabeled when a change was made in a constituent of the food, a change that did not affect the food's taste but which made the food differ from the popular and general understanding of "what [the food] really is."(fn15) The application of the deception theory to gene transfers from different species involves a generous but fair reading of this landmark precedent. The rationale is also different from the argument based simply on "consumer interest" about the mere use of biotechnology found wanting in the past litigation.(fn16)

The theory that underlies this paper, tied as it is to the need for labeling when a gene transfer makes a food "different," raises the complication of determining what makes a food "different." Gene transfers have occurred in plants for centuries through traditional plant breeding, with its modern extensions, with no labeling changes ordinarily needed.(fn17) Still, determining "difference" for purposes of labeling warrants consideration of whether a "wide cross" with a distant ancestor, made feasible in practice through biotechnology, should be considered the same as transfers using other extended techniques.

While the starting focus of this Article relates to gene transfers from a different species to affect the taste and nutrition characteristics of a food, the implications of the agronomic uses of biotechnology need to be recognized. The pesticide uses of biotechnology can involve gene transfers from different species, such as the transfer of a soil bacteria gene to corn. Plant pesticides could, in theory, be transferred to a different plant as a means to control pests. If consumers are deceived, absent disclosure, about transfers from a different species to affect a food's taste or nutrition, should the principle apply to...