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Hiram A. Meléndez-Juarbe, LL.M. 2002

Olivette Rivera-Torres, LL.M. 2002

February, 2002

Food and Drug Law

(In satisfaction of the course requirement)

Prof. Peter Barton Hutt

Harvard Law School

Winter, 2002



“Traveler, your footsteps are the road,

and nothing else.

Traveler, there is no road;

you make the road as you go”

Antonio Machado[*]

Like Machado’s traveler, governmental agencies are often confronted with new reasons to travel. In doing so they must choose between familiar legal highways, or make the journey by exploring new and uncharted streets, roads and boulevards. That is the option policymakers confronted when deciding how to regulate the labeling of genetically modified foods: either to address the issue through existing legal and regulatory mechanisms, or to create a new and particular organizational scheme to deal with the issues presented by this new technology. The former alternative, the one that promotes traveling through the more familiar roads, presents great advantages to policymakers: those highways have several lanes and thus, there may be plenty of room for creativity and flexibility. Regulating new technologies through existing legal and regulatory paradigms has the additional advantage of not requiring expensive new bureaucracies. After all, if technology changes or if new information surfaces about these foods that were not perceivable at the beginning, you can always change lanes. Or can you?

In this paper we will explore the choices made by the FDA when adopting its policies regarding the labeling of genetically modified foods. We will try to point out some of the alternative roads policymakers could have taken even within the existing legal and regulatory mechanisms. We will argue that every alternative was an equally reasonable path under the circumstances, and show that none (either those followed, nor the roads not taken) were a necessary regulatory choice. But we will also argue that, in some cases, each choice was not without it cost, for each entailed the blocking of roads that would have otherwise been available. Thus, for example, the choice of utilizing existing regulations to deal with this emerging technology brought into play a set concepts with preexisting meanings (such as the word “material”), which have shaped current labeling policies and limited available alternatives.


Because the focus of this paper is the labeling of genetically modified foods, we will begin by defining and describing what is meant by genetic modification; and what makes genetically modified food different from traditional food.

In very general terms biotechnology is “the pragmatic combination of science and technology to make use of our knowledge of living systems for practical applications”.[1] In this general sense, biotechnology has been used in the production of food for hundreds of years.[2] But in modern times biotechnology has progressed to such a degree as to merit its distinction from traditional breeding technologies.

Modern biotechnology differs form traditional cross breeding in that it is not limited to traits within a single species. Genetic engineering methods begun in the 1970’s allow for the transfer of genes between species that would never interbreed in nature.[3] Thus, these new biotechnological methods permit scientists to select and implant genetic material from one organism into the genetic material of a second organism, creating a new organism reflecting traits of both.[4] This procedure is what is normally referred to as genetic engineering or genetic modification , and more specifically, recombinant DNA technology. A plant or animal that is produced thorough the described methodology is called transgenic .[5]

Traditional cross-breeding techniques, on the other hand, involve selective mating between two like organisms to produce offspring with desirable characteristics.[6] These breeding techniques require multiple and subsequent crosses between those generations of offspring that express some desirable characteristics, thus making the process quite long.[7] Another limitation is that, with traditional breeding, the resulting organism may take up the desired traits as well as undesired ones, thus rendering the process somewhat unpredictable.[8] Because recombinant DNA techniques occur immediately and are highly selective, biotechnologists claim they can achieve breeding results with greater certainty and at a faster pace.[9] In short, its results are more predictable and it is not limited by traditional plant-breeding techniques allowing plants to express traits that are present in other plants, animals and microbes.[10]

Genetic engineering of this sort has been employed in agricultural biotechnology to produce plants that exhibit selected traits. For instance, plants have been developed that are pest resistant (e.g. , the so-called B.t. Corn, “which is corn modified by the inclusion of a Bacillus thuringiensis (‘B.t.’) gene that codes for a protein toxic to some insects”[11] ); that are tolerant to chemical pesticides (e.g. , a soybean modified to resist an increased amount of a specific herbicide); and which have improved fruit ripening (e.g. , the FlavrSavr tomato).[12] When a genetically modified organism (GMO) of this kind is introduced into our food supply, be it whole or processed, we are dealing with genetically modified food. Since crop plants of this sort are the predominant group of GMOs to enter the human food chain to this date, these will be the focus of this paper. However, it must be noted that transgenic animals, fungi, and bacteria are also in development for their use as food.[13]

Throughout this paper we will use the terms “genetic modification” or “genetic engineering” to refer to those new food-producing techniques described above. And more specifically we’ll use the term “genetically modified foods” (GMF) to refer to those foods derived through these modern processes of genetic modification.

The presence of GM foods and food ingredients in our diet is widespread. According to some reports, products ranging from infant formula to granola bars; and from hot dogs, soy burgers and taco shells to dog food and McDonald’s Veggie Burgers contain ingredients produced using modern biotechnology.[14] Despite the pervasiveness of such products in the US food supply, few Americans know this fact or know which of the products they consume are genetically modified. But the increased knowledge of the presence of such products in the US market and, to a lesser degree in the rest of the world, has raised diverse concerns and reactions from consumers and consumer groups. Some of these concerns have triggered requests to ban these products, to regulate them more stringently and/or to at least adopt strong labeling policies that will empower the citizenry to make informed decisions about the kinds of food they consume.[15] In the US such requests have found limited institutional response both from the Food and Drug Administration and Congress.[16]

But why do some consumers and consumer groups in the US and around the world want labeling or in some cases even bans on GMFs? The truth is that GMFs seem to hold both promise and peril.

Perhaps the most ambitious claim forwarded by proponents of biotechnology is the belief that it will help feed the world.[17] Although admittedly this goal is far from becoming a reality and is mostly dependant on what has been termed “next” or “second generation” technology, these goals involve the introduction of improvements to plants such as the enhancement of nutritious content, the development of resistance to inhospitable conditions, higher yielding crops and even vaccine containing plants.[18] But currently, the technology has mostly been focused on agricultural productivity by developing genetic modifications like, for instance, an insect-protected potato; a self-protecting corn against common pests, which is also resistant to a certain herbicide; a virus resistant squash; and a reduced ripening tomato.[19] Although it seems difficult to oppose such a promising new technology, GMOs and GMF’s have not been without their critics.

The concerns raised to GMF can be grouped in four general categories: (1) health and safety; (2) ecological and environmental concerns; (3) ethical and religious concerns and; (4) socio-developmental preoccupations.[20]

Health concerns range from, the more recognized possibility of allergic reactions to antibiotic resistance, cancer and a general fear of the unknown consequences that long-term use of these products might produce.[21] As stated by Franken, “[o]ne need only consider the examples of DDT or cigarettes to be reminded of the fact that science does not always keep up with risks and dangers.”[22]

Ethical and religious concerns include, the belief that the technology involved is unnatural, and preoccupations regarding the consumption of religiously forbidden ingredients from certain animals. These new technologies, it is argued, violate religious freedom by placing a burden on those who follow strict religious dietary laws.[23]

Environmental concerns are, of course, more related to the production of GMFs, i.e. genetically altered crops. Genetically modified plants present various potential environmental risks; for example, the possibility that new genes from herbicide resistant crops would spread to wild relatives creating “super weeds” or that the introductions of pesticidal characteristics into crops will lead to the creation of new pesticide resistant insects.[24] Other concerns include a generalized threat to the loss of biodiversity brought upon by the intensive use of just a few species of crops and the threat to the ecosystem that the introduction of any new exotic organism is though to represent.[25]

Lastly, some people oppose this technology because of the effect it could have on small family farms “that cannot afford large-scale production [and which] often see their prices forced down by the prolific output of farms that use GM methods, [who] can afford greater economies of scale and lower labor costs.”[26] Also, there is concern for the increasing amount of control a small number of industries would acquire over farmers in general. For instance, GM seed developers are limiting the use of their seeds to one season, forcing future sales each season, which in turn prevents the self-sustainable farming practice of seed-saving.[27] Others fear this is a continuation of the so-called “green revolution”, which has also caused “increased social, political, and economic inequalities in may areas of the world”.[28]

Although, in general we believe that these concerns justify or even require some sort of labeling of GM foods in order for the average consumer to be able to both decide the risks it considers appropriate or simply to voice through their purchase the approval or disapproval of the GMF industry, it is not the purpose of this paper to convince the reader to be against or in favor of such position.[29] Our purpose is to demonstrate that the US Government had several opportunities in which it could have made some sort of GMF labeling a reality. Following the analysis of the roads not taken by the US government and the FDA on this issue, we will briefly explore some alternative routes that have been taken by other countries, in particular the European Union.


In recent times, and especially during the last ten years, the Food and Drug Administration (FDA) has been called upon to exercise its regulatory authority with regard to both the approval and the labeling of genetically modified food products.[30] The following sections will first consider the general food labeling statutory scheme under the Food, Drug and Cosmetics Act of 1938; and then we’ll consider its use by the FDA to grapple with the problems posed by modern biotechnology in food production. It is impossible, however, to analyze FDA’s approach to GMFs labeling without giving some consideration to the concomitant regulatory responses towards safety and premarket approval of genetically modified foods. Accordingly, when appropriate, we will consider food safety regulations inasmuch as they are helpful to understand the FDA’s food labeling approach.

Throughout this analysis we will consider whether, regardless of the soundness of not requiring mandatory labeling of GMF as a class , and only permitting it voluntarily (with further restrictions to those opting for voluntary negative labeling): (1) the FDA was arguably correct in interpreting that it lacks the statutory authority to require mandatory labeling of GMF only once it had assumed the position that GMFs are, from a scientific standpoint, equivalent to regular non-GM food and; (2) whether in some instances an intermediate labeling approach could have been achieved by the FDA even within the existing statutory framework (i.e. through ingredient labeling and the requirement that non-standardized food bear its common or usual name). This could have arguably accommodated both consumer’s interest in knowing the source of the food ingested, and legitimate concerns about misleading the public with fear-triggering broad terms such as “genetically modified food” .[31] (3) We will also consider whether under prevalent first amendment constitutional case-law, a state or Congress could require such mandatory labeling in light of current lower-court and Supreme Court jurisprudence

A. Food Labeling Requirements in the Food, Drug and Cosmetic Act of 1938

In very general terms, the FDA is the agency charged with ensuring that the products under its jurisdiction are safe and adequately labeled.[32] More specifically, the FDA as an agency (currently organized under the Department of Health and Human Services, or HHS) has the main responsibility of administering the Food, Drug and Cosmetic Act of 1938 (FD&C Act)[33] . The FD&C Act is broadly structured to address situations where a food, drug, cosmetic or device may be adulterated or misbranded . The law prohibits such adulteration and misbranding, and defines FDA’s authority to commence enforcement proceedings such as injunction, seizure and criminal prosecution.[34]

Several statutory sections address the labeling requirements under the FD&C Act. Principally, under section 403(a), 21 U.S.C.A. § 343(a), a food is determined to be misbranded , and therefore prohibited, if its label is “false or misleading in any particular”.[35]

The term misleading , to which the statutory concept “misbranded” refers, is further defined in section 201(n) of the Act in the following terms:

If an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the labeling or advertising is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device or any combination thereof, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling or advertising related under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual.[36]

Most of the debate regarding FDA’s authority to require mandatory labeling of GMF has dealt with the statutory construction of some of the terms in this section. But before getting into that discussion, we must first make several statutory observations pertinent to the current labeling requirements.

In general, not only does the FD&C Act prohibit certain types of representations to be made in the label; it also requires the affirmative disclosure of certain information that it deems valuable. In the first instance, and as it has been noted, the act attaches the misbranded rubric to those representations made about a particular food product, that are false or misleading in any particular way. This means that the statute “condemn[s] every statement, design and device which may mislead or deceive”[37] even by statements that are “not technically false or which may be technically true”.[38] A misleading representation is not generally considered as such under the standard of a “reasonable consumer”, but rather, a statement may be misleading when considered in light of what “the ‘ignorant, the unthinking and the credulous’ consumer” [39] might believe.

On the other hand, and more relevant to the GMF labeling issue, the FD&C Act affirmatively requires the disclosure of five central pieces of information, for which it authorizes the FDA to require mandatory labeling. These required statements are: (1) the statement of identity, or common or usual name of the food;[40] (2) the list of ingredients;[41] (3) the name and place of business of the manufacturer, packer or distributor of the food;[42] (4) an accurate statement of the quantity of contents [43] and; (5) nutrition information.[44] The law states that required label information must be conspicuously displayed, in terms that the ordinary consumer is likely to read and understand under ordinary conditions of purchase and use.[45] Of these required statements, the most important for our analysis are the first two: the name of the food and the list of ingredients.

With regard to the name of the food , section 403(g) of the act states that if the food named in the label purports to represent a food for which a definition or standard of identity exists, the food must conform to such definition and standard as it has been established by regulation.[46] Most importantly, section 403(i)(1) states that, if the FDA has not published a definition or standard of identity and where no representation is sought regarding an established standard of identity, “the common or usual name of the food” shall be used, “if any there be”.[47]

In practice, and since the beginning of the 1970’s, the FDA has decided to accommodate so-called new foods (such as frozen dinners, potato chips and seafood cocktails) under section 403(i)(1) thus relying on the “common or usual name” language for non-standardized foods, instead of issuing a new standard of identity for each new food.[48] As we shall later see, the FDA has resorted to section 403(i)(1) when determining whether a particular GMF can be labeled using the “common of usual name of the food” or if it will require for it a new and distinct name.

With regard to the list of ingredients , section 403(i)(2) of the FD&C Act states that a food shall be deemed misbranded “unless its label bears ... in case it is fabricated from two or more ingredients, the common or usual name of each such ingredient”.[49] What constitutes the common or usual name of ingredients is not subject to specific FDA regulation.[50] In practice, however, and as professors Hutt and Merrill describe, the FDA establishes the name of an ingredient when, among other things, it enacts GRAS regulations approving a determined food additive to be generally recognized as safe (GRAS).[51] This fact is relevant to our current analysis because, as it will be further discussed, if a component of a GMF is subject to food additive premarket safety review procedures and the FDA subsequently determines that it is GRAS, under certain circumstances such GRAS substance may or may not be required to be included as an ingredient under a new name. [52]

Aside from these mandatory labeling requirements, and as stated earlier, section 201(n) also establishes that in determining whether the labeling is misleading “there shall be taken into account (among other things) not only representations made or suggested, ... but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article.”[53]

This section has been considered to be an additional source of FDA authority to require mandatory labeling,[54] and since the 1970’s the “FDA has exploited this provision to prescribe, by regulation, additional requirements for affirmative disclosure of information in food labeling”[55]

As it is readily apparent from its text, section 201(n) authorizes the FDA to require affirmative disclosure of information that is material in one of two ways. First, the FDA can require material information in light of representations made in the food label by the seller. This kind of material information is conditional , for its requirement depends on a prior decision by the seller to say something on the label about the food.[56] In this sense, the term material refers to that information necessary to ensure that the statements already made in the label are truthful and not misleading.

The other way in which section 201(n) authorizes a disclosure requirement of material facts is when such information is in some way important with regard to consequences that may result from the use of the particular article of food regardless of representations made by the seller.[57] Naturally, the inherent ambiguity in the terms of this last clause of the article, has in some respect framed the discursive parameters of the issue. The debate over the meaning of this second type of materiality (i.e. , the construction of the technical word “material”) has been to some degree the legal counterpart of the social and political discussion regarding the labeling debate in the United States, for as we shall promptly see, the breadth of this term has actually defined in part FDA’s authority to require mandatory labeling in the current era of genetic food modification.

In sum, the relevant labeling provisions of the FD&C Act that come into play on this issue are (1) the requirement that the label bear the common or usual name of the food under section 403(i)(1); (2) the mandatory placement in the label of the list of ingredients under section 403(i)(2) and (3) FDA’s authority under section 201(n) to require the disclosure of material facts regarding the consequences which may result from the use of the article.

B. The Framing of the GMF Labeling Issue Within Existing Law

Following considerable debate whether the regulation of biotechnology was to be addressed with special legislation or through existing laws and agencies, in June 26, 1986, the Office of Science and Technology Policy of the Executive Office of the President of the United States, issued the Coordinated Framework for Regulation of Biotechnology preferring the latter approach.[58] This 1986 policy specifically provided for a tripartite regulatory scheme composed of the FDA, the United States Department of Agriculture (USDA) and the Environmental Protection Agency (EPA).[59]

This organizational decision was made based on the expressed pragmatic belief that the “[e]xisting statutes provide a basic network of agency jurisdiction over both research and products”[60] and that the

existing health and safety laws had the advantage that they could provide more immediate regulatory protection and certainty for the industry than possible with the implementation of new legislation. Moreover, there did not appear to be an alternative, unitary, statutory approach since the very broad spectrum of products obtained with genetic engineering cut across many product uses regulated by different agencies.[61]

According to some accounts,[62] however, the selection of this regulatory approach responded to several other factors: first, to the conflicting goals of regulating enough to reassure the public of governmental vigilance over the development of this technology while at the same time being as flexible as possible to encourage innovation[63] in an industry that has been heralded as an important player in the U.S.’s economic future[64] and; second, it was said to reflect the anti-regulatory drive of the Reagan administration. Interestingly, although in general the 1986 policy was received with enthusiasm by the entire biotech industry, big and small enterprises alike,[65] it has been told that Monsanto, one of the leading developers of this food technology, actually favored a stricter regulatory scheme in the hopes that it “might discourage the proliferation of start-up companies and small-change operators lacking a Washington presence and unequipped for the expense and red tape of new testing requirements”.[66]

Two basic substantive premises emerged from this Coordinated Framework, which have framed current FDA labeling policies. First, that these new technologies “are an extension of traditional manipulations that can produce similar or identical product[s]”;[67] and—closely related—second, that genetically modified foods will not be regulated according to the process used to make them, but rather, according to the use and final characteristics of the product.[68] This 1986 policy established the working premises for future FDA action and, from it, the agency has partially drawn the necessary command and guidance to actively regulate genetically modified food.

It becomes readily apparent that different scientific conclusions could have reasonably premised U.S. policy. It doesn’t take a highly creative mind to contest the conclusion that these new biotechnological procedures are merely an extension of traditional genetic manipulation, for it is common knowledge that recombinant DNA technology permits the creation of transgenic plants that couldn’t have been bred in nature or through traditional breeding processes.[69] Also, the de-emphasis of process could be criticized as misguided for it is clear that in some instances the process used could hold a significant and determinant effect on the end product.[70] Thus, this framework must be treated as what it was: a policy decision that had the purposeful effect of closing the a certain set of roads that could have been available. Thus, the 1986 framework had the practical effect of eliminating both the creation of a separate scheme of regulations to deal specifically with the products of modern biotechnology[71] and also hindered the possibility of considering these new scientific processes as meriting consumer knowledge of them. It also set the groundwork for what has been touted by some as an extremely paternalistic view of the risk assessment citizens engage in when facing this new technology.[72]

C. FDA’s Response Within the Framework

In order to regulate the safety and regulatory status of foods produced using “new plant varieties”, including plants developed by the contemporary methods of genetic modification, in 1992 the FDA issued an important Statement of Policy.[73] Following up on the regulatory approach set by the 1986 Coordinated Framework , foods “derived from plant varieties developed by the new methods of genetic modification are regulated within the existing framework of the [FD&C Act], . . . utilizing an approach identical in principle to that applied to foods developed by traditional plant breeding”.[74]

The starting point of this policy, which is seen in FDA’s labeling approach, is that the newer forms of genetic modification are considered a continuum of traditional breeding techniques;[75] notwithstanding the fact that they produce food product variations with desirable traits by, among other things, introducing DNA segments derived from other organisms (which is otherwise naturally impossible), instead of using traditional hybridization between varieties of the same species. Accordingly, the Statement of Policy defines “genetic modification” in the broadest possible way to mean “the alteration of the genotype of a plant using any technique, new or traditional”.[76] Under those terms “most, if not all, cultivated food crops have been genetically modified”.[77]

In this sense, food produced by the newer methods of genetic modification are regulated regardless of the procedures used, and the regulatory focus is directed at the characteristics of the end product itself:

The regulatory status of a food, irrespective of the method by which it is developed, is dependent upon objective characteristics of the food and the intended use of the food (or its components). The method by which food is produced or developed may in some cases help to understand the safety or nutritional characteristics of the finished food. However, the key factors in reviewing safety concerns should be the characteristics of the food product, rather than the fact that the new methods are used .[78]

This approach has a direct effect in terms on food safety and labeling policies of genetically modified foods. As for food safety , section 402(a)(1) of the FD&C Act states that a food is deemed adulterated, in the cases of whole foods, “if it bears or contains any poisonous or deleterious substance which may render it injurious to health”.[79] It was not Congress’s intention to require premarket approval of traditional whole foods. However, these foods can be considered additives (and therefore subject to some pre-clearance, see infra ) if used as components of, or combined with, other foods.[80]

In the case of “food additives”—that is, any substance which intended use “results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any food”—,[81] section 409 of the FD&C Act provides for a premarket approval process to test its safety.[82] The statute, however, exempts from section 409’s safety pre-clearance process, those substances that are generally recognized as safe (GRAS) “among experts qualified by scientific training and experience to evaluate its safety . . . under the conditions of its intended use.”[83] In any event, under this process, the company that develops new ingredients, or food processing procedures, must decide –voluntarily - whether the resulting food is a food additive that requires pre-clearance by the FDA. That is, the company may make an independent GRAS determination, which is of course subject to FDA enforcement powers in case the agency makes a subsequent determination that it is unsafe.[84]

In its 1992 policy statement, and in accordance with the 1986 framework, the FDA announced that it would apply this traditional regulatory scheme to genetically modified foods.[85] In this sense, each genetically modified food introduced into the market would be subject to the regular post-market review that section 402(a)(1) provides for adulterated food, in case the genetic material “may render [the food] injurious to health”.[86]

The transferred genetic material is also treated as a food additive for premarket approval purposes, and thus, the FDA makes use of the food additive regulations and procedures to evaluate the safety of these new food products. Nonetheless, the agency determined that, because these transferred genetic material (namely, nucleic acids) are present in the cells of all living organism, they generally do not raise safety concerns as component of food. Thus –states the 1992 policy– such material is presumed to be generally recognized as safe (GRAS)[87] and therefore exempted from premarket approval regulations. However, the GRAS presumption can be rebutted if the resulting ingredient “differs significantly in structure, function, or composition from substances found currently in food”.[88] If that is the case, those substances may not be generally recognized as safe and, thus, may demand regulation as a food additive under section 409 of the FD&C Act.[89] But still, under the 1992 general food safety guidelines—and under the GRAS presumption and voluntary submission to premarket safety review—, a producer could slip into the market a genetically modified product without it being approved by the FDA, nor its safety consulted with the agency. In practice, however, individual producers have voluntarily consulted with the FDA about the safety of their products before their entrance to market.[90]

The 1992 policy addressed the labeling issue in a similar fashion as it addressed food safety. It did so in accordance with the general philosophy that was initially settled in the 1986 Coordinated Framework . This labeling policy is based on the latter’s two grounding premises: that the newer techniques are a continuum of traditional breeding methods and that the regulatory focus is centered upon the final food product and not the specific process used to manufacture it. Thus, the FDA’s labeling policy ignores the procedure used to develop the food and focuses solely on whether the resulting food differs significantly from analogous substances so as to warrant special labeling of that fact.

Accordingly, with regard to section 403(i)(1)’s requirement that the label bear the “common or usual name” of the food, the FDA explained that

consumers must be informed, by appropriate labeling, if a food derived from a new plant variety differs from its traditional counterpart such that the common or usual name no longer applies to the new food, or if a safety or usage issue exists to which consumers must be alerted. [91]

Similarly, this substantial equivalence rule would apply with regard to section 201(n)’s authorization to the agency to require mandatorily the disclosure in the label of material facts with respect to consequences resulting from the use of the article. That is, the scope of the term “material” depends entirely on the focus given to the end product and not on the process. Because, there is no evidence suggesting “that foods derived by these new methods differ from other foods in any meaningful or uniform way , or that, as a class , foods developed by the new techniques present any different or greater safety concern than foods developed by traditional plant breeding”,[92] the FDA concluded that “the method of development of a new plant variety . . . is [not] material information within the meaning of section 201(n) and would not usually be required to be disclosed in labeling for the food ”.[93]

However, the agency stated an important caveat: if genetic material from, for example, a potentially allergenic peanut protein is introduced into a tomato, a label would be warranted for that tomato even if its basic flavor and texture is unchanged. In that case, the presence of such component is a material fact with respect to consequences resulting from eating the tomato, which, if omitted, would amount to a mislabeling violation under section 201(n) the act.[94]

In a 1993 notice, the FDA further explained its GMF labeling policy while it requested public comment and suggestions on the issue.[95] In sum, and responding to consumer comments, it stated, first, that the term “material” under section 201(n) of the FD&C Act, does not include information for which consumer merely had an interest in knowing because, consistently, the FDA “has generally limited the scope of the materiality concept in section 201(n) of the act to information about the attributes of the food itself”.[96] Thus, there is no general right to know that a food has been produced using genetic engineering.

Second, and regarding section 403(i)(2)’s requirement that the label of multi-ingredient foods bear the common name of the ingredients , the FDA determined that it would not require the naming of a genetically modified ingredient in any particular way and distinguished genetic modification from a previous situation in which it had required the adequate naming of an ingredient which was asked to be disclosed by religiously and culturally concerned consumer groups. In that previous instance the agency had concluded that the ingredient name “hydrolysate ” was not informative enough, thus it required the addition of the phrase “(contains glutamate)” even though it concluded that it was completely safe.[97] When consumers now concerned with GMFs confronted the FDA with the hydrosolate example as an instance in which it required ingredient labeling based solely on ethical concerns, the agency responded with such artistry, that we would do a great disservice if we would try to explain—rather than just quote—this fascinating juggling act:

The agency’s conclusion that the food source of a protein hydrolysate is information that must be revealed in labeling was reached in the context of the addition to food of food ingredients directly derived from animal or microbial sources . . . . That situation is different from the biotechnology context, which involves the presence in a plant chromosome of deoxyribonucleic acid (DNA) that was originally derived from an animal or microorganism but is now an inherent constituent of a plant . When using recombinant DNA techniques, scientists do not infuse the plant with the original genes that were removed from the animal. The animal genes are used to produce copies in the laboratory. Once the copies are transferred to the plant, they become an integral part of its genetic information , just like thousands of other genes that are present in the plant chromosome. There is a scientific basis to conclude that such genetic alterations do not change the essential nature of the plant, nor do they confer “animal-like” characteristics to the plant. For example, a tomato does not become “fish-like” following the addition of a copy of a fish gene that causes the production of a freeze-tolerant protein. This difference in context may bear directly on whether special labeling should be required for such “genetically engineered” products.[98]

Thus, the inherent-gene-copy-theory of ingredients was born.[99]

Confronted with the 1986 framework, the FDA took to the task of applying its regulations to GMFs. In developing its policy, the agency opted out of alternative means of implementing its regulations in ways that could have once more lead to different roads relating to GMF labeling. While considering the existing potential labeling alternatives, the agency refused to read its statute and regulations in a way consistent with a less restrictive labeling approach. In this way, for instance, the FDA limited the potential use of section 201(n)’s materiality requirement; of section 403(i)(2)’s ingredient naming provisions; and of section 403(i)(1)’s common or usual name requirement for non-standardized foods. To what extent a restrictive reading of those sections was necessary is the focus of the forthcoming sections.

FDA’s policies have helped shape the legal and social debate regarding the labeling of GMF; and they have been the main focus of intense litigation between consumer groups, the FDA and industry. What follows is an account and analysis of just some of those instances where FDA’s policies have come into play. [100] Their analysis serve to a certain degree to expose some of the flaws of the policy choices made. Through the following discussion we will try to show when could the FDA have taken a different path or when was it constrained by its previous construction of existing statutory terms.

D. The Tomato and Milk Cases

1. The kanr gene and the APH(3')II Enzyme: The Ingredient Problem

In 1994 a new variety of tomato was declared to be safe by the FDA. It was the first time the agency gave its acquiescence to the marketing of a food produced through biotechnology. [101] The product: the Flavr Savr tomato developed by Calgene, Inc., a California corporation. The claim: that through gene manipulation, Calgene was able to produce a tomato that could stay firm after harvest longer that the regular tomato. The technology: new, complex and controversial.[102]

Before the issuance of the 1992 Statement of Policy, Calgene had voluntarily submitted to the FDA a request for an advisory opinion asking whether the kanr gene (a selectable marker) could be used to produce genetically engineered tomatoes, cotton and oilseed rape plants for human and animal consumption.[103] The petition was changed in 1993 to a food additive petition under section 409 of the FD&C Act, for the approval of APH(3')II as GRAS. Importantly, the agency stated that the safety of this antibiotic marker would be evaluated on a case-by-case basis; thus, it approved APH(3')II as GRAS only for the production of cotton, oilseed rape, and tomatoes.[104]

Recombinant DNA technology in plant genetic engineering, allows the selection of a particular gene from among all the genes in an organism with the purpose of inserting it into another organism to, among other things, generate new plant varieties with desirable characteristics.[105] Through this technology, a biotechnologist can insert DNA into an organism “that codes for antisense RNA that binds to RNA from the target gene, thereby blocking its function”.[106] Introduction of antisense RNA[107] permits the modification of gene activity, for it can be directed at particular genes in the host organism and suppress the production of specific enzymes that have undesirable effects.[108] In the case of the Flavr Savr tomato, a gene is introduced that blocks the tomato genes that produce polygalacturonidase . Polygalacturonidase is an enzyme that breaks down pectin , a component of the cell wall, resulting in the softening of the plant tissue.[109] The concrete effect of this suppression of polygalacturonidase by the antisense gene is the permanence of pectin in the fruit, thus, making the tomato stay firm much longer.[110]

However, because the introduction of external DNA into a cell is far from perfect, and not all cells integrate this genetic material and acquire the desired phenotype, scientists rely on selectable markers, such as the kanr gene, to distinguish transformed cells from the ones that aren’t.[111] The selectable marker, the kanr gene, “is linked to the gene (or genes) of interest and then this genetic material is inserted into plant cells”.[112] This marker gene produces the APH(3')II enzyme, which makes the plant immune to the antibiotic kanamycin . In essence, because plants are extremely sensitive to this antibiotic, those plants that take up the antibiotic resistant gene marker (and therefore incorporate also the gene of interest—the antisense gene) will survive when grown in the presence of kanamycyn .[113] By tracking the gene of interest this way, biotechnologists are able to tell which tomatoes will reflect the anti-softening trait. In short, the antibiotic resistant marker gene and the enzyme it produces—APH(3')II—is used for the identification of the successfully modified food.[114]

The FDA addressed several safety concerns with regard to the selectable marker and the APH(3')II enzyme. Briefly stated, with respect to the APH(3')II enzyme, the agency considered, first, the direct effects of its ingestion, including the possibility of allergenicity. It concluded that its ingestion did not raise any safety concern because (1) the APH(3')II enzyme is a protein, and proteins in general (as well as this particular type of enzyme), are not generally toxic and; (2) if ingested, it is quickly digested by gastric acids.[115] Also, the FDA discarded the risk that, by consuming the Savr Flavr tomato, the presence of APH(3')II would inactivate oral antibiotics (kanamycin or neomycin ) taken by patients and compromise its therapeutic use. The agency concluded that “the biological activity of APH(3')II is destroyed during gastric and intestinal phases of digestion”,[116] and even if it didn’t, it would only be present in extremely small amounts.[117]

As for the safety of the kanr gene, the agency evaluated the “horizontal transfer” issue.[118] That is, “if the gene conferring resistance could somehow be incorporated by bacteria exposed to the GM food, it could result in the development of antibiotic-resistant intestinal bacteria in humans or animals”.[119] Similarly, the agency concluded that the digestive processes would degrade the gene too quickly and that horizontal transfer was unlikely.[120]

With these safety conclusions in mind, the FDA applied the corresponding statutory labeling provisions and decided that no mandatory labeling was warranted to display the fact that these tomatoes were produced through recombinant DNA technology or that, specifically, it contained the selectable marker gene. Regarding the mandatory ingredient labeling requirement for multi-ingredient foods required by section 403(i)(2) of the Act, the FDA applied the inherent theory of ingredients with its usual non-process based approach: “FDA does not consider those substances that are inherent components of food to be ingredients that must be disclosed in the food’s label. A genetic substance introduced into a plant by breeding becomes an inherent part of the plant as well as of all foods derived from the plant . Consistent with FDA’s general approach on ingredient labeling, the agency has not treated as an ingredient a new constituent of a plant introduced by breeding, regardless of the method used to develop the new plant variety”. [121]

At an intuitive level, it seems odd, that the concept of what is an ingredient for labeling purposes would be constrained to whether the substance becomes an inherent constituent of the food so as to be considered—in this case—one with the tomato. In particular, it seems troubling that the FDA and Calgene would treat the marker gene and the APH(3')II as food additives , and thus, as independent substances for safety purposes under section 409, and then as non-independent for ingredient labeling purposes. In the end, it seems, the determination that the APH(3')II and the kanr gene became inherent to the tomato is a question of choice and not one of absolute necessity, for it wouldn’t have been unreasonable to decide otherwise in order to achieve some symmetry between these safety and labeling processes. After all, and as we have already mentioned, as a matter of practice the FDA has used its GRAS designations to determine the adequate and common nomenclature of those substances for ingredient labeling purposes and thus, it could have done so in this instance. [122] That the introduced genetic material could have been considered as something apart from the resulting food (and therefore an independent ingredient to be labeled) is shown by the nature of the premarket approval process that was followed. The whole point of this particular consultation and additive approval process was the introduction into the market of a different kind of tomato with new characteristics which were produced by the introduction of this exogenous genetic material. If it weren’t for that introduction, the Flavr Savr tomato would have been streamlined into the market as a whole food under section 402(a)(1) of the Act, without having been considered as a food additive and later as GRAS (nor would it have been necessary for the FDA to specify that its conclusions were limited to the petition sought, and that it would analyze future consultations for the use of this gene in other crops, however similar, on a case by case basis). In sum, if at least for safety considerations it is considered reasonable by the FDA that the introduced genetic material is something distinct and independent from the resulting food, then, the question remains: why isn’t it so for labeling purposes?

A possible impediment to this alternative interpretation requires brief comment. The FDA concluded that even if the APH(3')II enzyme were considered an ingredient , it qualified as a processing aid , which is exempted from disclosure by section 101.100(a)(3)(ii)(c) of FDA regulations. [123] But statutorily this processing aid exemption is not required. Section 403(i)(2) of the FD&C Act states that the Secretary of Health and Human Services may require by regulation some exemptions to ingredient labeling, when such disclosure is “impracticable”.[124] This is the statutory basis for the processing aid exemption.[125] In fact, the text of this regulatory provision actually exempts not merely processing aids per se , but “[s]ubstances that are added to a food for their technical or functional effect in the processing but are present in the finished food at insignificant levels and do not have any technical or functional effect in that food .”[126] We then see no reason why the FDA could not, in its discretion, determine that the presence of genetic material introduced by recombinant DNA technology may have a “technical or functional effect in that food”; especially considering the high degree of deference these kind of agency determination generally receive.[127] Alternatively, we see no legal reason why the FDA couldn’t amend its regulations to exempt from the processing aid exemption particular genetic material when, after its approval as GRAS, the agency determines its disclosure is not impracticable.[128]

Furthermore, the FDA and the relevant policymakers could have reasonably and plausibly interpreted in a different fashion the existing statute to address these situations. For example, the agency could have decided that, exclusively for the GM labeling context, the statutory term ingredient encompassed those genetic materials that are introduced into the food through recombinant DNA technology, rather than develop the inherent/non-inherent divide. It is common knowledge in administrative law, that when a statute is silent or ambiguous regarding a specific issue, the agency’s interpretation of the statute it administers is presumed valid—and will receive great deference by courts—when that interpretation is “reasonable” and “permissible”.[129] We highlight these alternatives to show how this particular aspect of the issue could have turned out differently and to argue that even within the current legal framework, FDA policymakers still had available alternative ingredient-disclosure options, without having to pass through the more cumbersome and complex (and perhaps, unpredictable) legislative processes. In short, we submit that the current GMF labeling policy, at least with regard to the disclosure of some genetic material through the list of ingredients , is not a necessary conclusion that falls from the mere organizational decision to apply the traditional statutory food-labeling paradigm: it was a policy decision, if there ever was one. Including an indication that an ingredient has been genetically modified in the list of ingredients is, as we shall later see, partially the solution with which the European Union has materialized its approach towards GMF labeling.[130]

Also, in the Flavr Savr tomato example it may be argued that, because the particular genetic material did not presented any demonstrable health concerns, its disclosure as an ingredient was unnecessary. Safety issues, however, are mostly linked to labeling concerns through the consequence materiality requirement of section 201(n) of the act. In this case, mandatory labeling was deemed inappropriate because APH(3')II was not proven to compromise the therapeutic effect of orally administered antibiotics and, consistent with FDA’s previous reading of the term “material” (not encompassing consumer concerns, nor process per se ), the agency concluded that there were no material consequences to be disclosed.[131] But the fact remains that the ingredient-naming requirement of section 403(i)(2) has more to do with economics, than safety.[132] And the fact that labeling is not warranted under section 201(n) does not exclude that it may be required under another section (like 403(i)(2), or as we shall shortly see, section 403(i)(1)). Therefore, the plausible argument against labeling under 403(i)(2) for lack of safety concerns is inapposite. In the next subsection we will tackle, among other things, the meaning of section 201(n)’s materiality concept as it has been debated in the context of another GMF product; but before that, we will very shortly consider another statutory labeling alternative that was arguably available.

A somewhat similar analysis to that of ingredient labeling of GM foods may be applied with regard to another labeling route that policy-makers had available within the existing statutory framework: section 403(i)(1)’s common or usual name requirement. Recall that in its 1992 policy the FDA stated that it would be willing to require a distinct name for a GM food if the new variety differs from its traditional counterpart in such a way that its common or usual name is not applicable.[133] In fact, the FDA has apparently required the adequate labeling (through the use of a new name) of genetic modifications of soybeans and canola oils, which have different fatty acids composition.[134] But as Lara Winn has argued, FDA’s analysis could have looked quite different (and gone much further) in being more permissive of GMF labeling through the disclosure of different names for food.[135]

Winn points out to an existing regulatory provision dealing with the common or usual names of non-standardized food. Section 102.5(c) of FDA regulations states, in part, that:

The common or usual name of a food shall include a statement of the presence or absence of any characterizing ingredient(s) or component(s ) . . . when the presence or absence of such ingredient(s) or component(s) in the food has a material bearing on price or consumer acceptance or when the labeling or the appearance of the food may otherwise create an erroneous impression that such ingredient(s) or component(s) is present when it is not, and consumers may otherwise be misled about the presence or absence of the ingredient(s) or component(s) in the food.[136]

This provision could be interpreted to mean that, if the introduction of genetic material (or “characterizing components”) through human intervention may mislead consumers as to their presence in food, that genetically modified food’s name should be different from that of its traditional counterpart.[137] The operative regulatory word here is “characterizing component” for, if broadly read, it would arguably encompass introduced genetic material. As the argument goes, such a liberal interpretation is warranted, first, because the regulation refers to both, characterizing components and characterizing ingredients as different items. Thus, the regulatory language implicitly recognizes that a new common name may be needed when a component is introduced (as opposed to an ingredient) which need not be a substance that can be consumed directly.[138]

Secondly, Winn’s argument emphasizes on a reasonable interpretation of what a “characterizing component” may be, and concludes that such interpretation may very well consider the term “characterizing component” as describing a part of the food that gives it its distinguishing features.[139] In that vein, “new genetic material that could appear in a plant only as a result of genetic engineering is a distinguishing feature of that biotech plant,”[140] and thus may be considered a “characterizing component” for common or usual name purposes.

Finally, Winn argues that “characterizing component” must be read in light of the relevant statutory and regulatory purposes. She emphasizes on previous agency expressions regarding the purpose of the common or usual name requirement for non-standardized food, and concludes that its purpose is “to assure consumers that they are purchasing and eating exactly what they think they are”.[141] Ms. Winn wraps up the argument for a broader reading of the “characterizing component” element of the “common or usual name” requirement by citing directly from the FDA the following statements:

A common or usual name should “accurately reflect the reasonable expectations of consumers .” . . .Common or usual names are not required for all nonstandardized foods. Such names should be established for nonstandardized foods “when it is necessary fully to inform the consumer ,” . . .such as when foods are “modified in ways that are unfamiliar to consumers, and when the same formulated products are being marketed with different names by different firms, the nature of the foods may become less obvious, and there may be need for regulation to ensure that consumers are not misled or deceived .”[142]

In all “with information disclosure and consumer deception prevention at the heart of common or usual name requirements, it is reasonable to conclude that new genetic material is a characterizing component of biotech food.” [143] Thus, it must be concluded that, at least, and similar to the ingredient disclosure provisions, section 403(i)(1)’s common or usual name regulatory scheme was a viable and reasonable labeling alternative which policy makers had available as they chose not to command the labeling of genetically modified foods.

2. Recombinant Bovine Somatotropin: Material Facts and Constitutional Issues

Bovine Somatotropin (bST)—or as commonly known, the bovine growth hormone—is a natural protein hormone occurring in cattle, which is secreted by the cow’s pituitary gland and which—among other things—stimulates milk production.[144] Basically, if a cow is given additional bST, it will produce more milk. Thus, in order to commercially produce the hormone as an animal drug that could be injected to cows intravenously, Monsanto—a large biotech corporation—genetically engineered the gene that produces the hormone to market it as Posilac (its commercial name).[145] In 1993 the FDA approved Monsanto’s recombinant bovine somatotropin (rbST) as an animal drug.[146] Even though rbST stimulates the production of milk, the milk itself nor the cow are genetically modified.[147] After a heated national public debate about its safety and labeling related issues (which involved such diverse actors ranging from Ben & Jerry’s ice creams to Congress)[148] various lawsuits found their way into federal courts. We will briefly analyze those court decisions in order to assess the current labeling policies as applied to the rbST.

a. What is “Material”?: Stauber v. Shalala, 895 F. Supp. 1178 (1995) & Alliance for Bio-Integrity v. Shalala, 116 F. Supp. 2d 166 (2000)

In Stauber v. Shalala [149] a group of consumers sought declaratory and injunctive relief against the Secretary of the HHS and the Commissioner of the FDA challenging the approval of the milk-enhancing animal drug, Posilac . Among other things, and relevant to our discussion, the plaintiffs contended that the FDA failed to require mandatory labeling of milk and milk products from cows treated with the approved drug.[150] The Court rejected these allegations as statutorily unwarranted for there were no material facts that required such labeling under section 201(n) of the FD&C Act.

The Court anchored its labeling conclusion in several safety-related base points: First, with regard to the safety of the cows injected with Posilac , the FDA had found that, even though there was a risk of mastitis (an udder infection), that risk was “less than the risk of mastitis posed by seasonal change”[151] and thus, the risk was not “significant enough to warrant denial of the drug application”.[152] Second, and with regard to human safety , the Court acknowledged FDA’s conclusions as to the following: (1) The FDA found that orally ingested rbST was completely safe, even if consumed by large amounts, because that protein hormone is broken down by the digestive enzymes and—like insulin—it must be injected to have some effect in living organisms. It furthermore found that pasteurization of milk and cooking of meat would destroy at least 90% of the rbST, leaving little residue in the final product.[153] (2) Because the risk of infection or mastitis was low, the FDA concluded that there was little chance that greater amounts of antibiotics would be applied to treat mastitis in cows and, hence, no consequent increased amount of antibiotics would enter the food chain as a result of Posilac use.[154] (3) The FDA found that the protein hormone IGF-1, whose production is partially regulated by somatotropin , is present in milk treated with rbST in greater amounts than in milk from non-treated cows. However, the agency concluded that that increase represented no health concerns to consumers because (a) the levels of IGF-1 in milk from treated cows were not substantially higher than the level of IGF-1 in regular milk; (b) like bST, IGF-1 is not active when orally ingested; (c) IGF-1 is already present in the human bloodstream in higher amounts than the relatively insignificant quantities that would be ingested from milk derived from treated cows and; (d) IGF-1 is denatured in the process of making baby formula (although not destroyed by pasteurization).[155] In all, the FDA concluded that milk derived from cows treated with Posilac , was as safe as regular milk and that there was “no significant difference between milk from treated and untreated cows and, therefore, concluded that under the [FD&C Act], the agency did not have authority in this situation to require special labeling for milk from rbST-treated cows.”[156]

On February 10, 1994, the FDA had issued an Interim Guidance on the voluntary labeling of milk derived from cows not treated with rbST. [157] In it, the agency advised about the appropriate labeling that would be permissible if milk producers wanted to differentiate their products from those derived from sbST treated cows. First, because in reality no milk is completely free from bST, it would be false to claim that any milk is “bST free”, and it would misleadingly suggest that there are “compositional differences” between the two kinds of milk; thus a difference in terms of the quality of the milk itself cannot be claimed. A label regarding the way the milk was produced was, in a limited sense, preferable. Thus, in FDA’s view a statement in a label would not be false if it announces that the product is “from cows not treated with rbST”, but an important caveat was presented by the guidance, for such a statement would give undue weight to process and therefore be misleading. Consistent with the non-process based labeling approach adopted since 1986 for genetically modified food, the FDA—apparently applying the ignorant, credulous and unthinking standard—[158] concluded that it would be misleading not to contextualize such process-based statement (i.e. “from cows not treated with rbST”). Thus, a statement of that nature should avoid implying that “milk from untreated cows is safer or of higher quality than milk from treated cows. Such an implication[, the agency concluded,] would be false and misleading.” [159] The impact of that guidance is readily palpable, as the following example will show. In compliance with it, and in order to assume no risk of portraying a misleading label, our favorite Ben & Jerry’s Ice Cream (a Vermont-based corporation) currently state in their labeling the following contextualized and significantly qualified expression:

We oppose Recombinant Bovine Growth Hormone. The family farmers who supply our milk and cream pledge not to treat their cows with rBGH. The FDA has said no significant difference has been shown and no test can now distinguish between milk from rBGH treated and untreated cows. Not all the suppliers of our other ingredients can promise that the milk they use comes from untreated cows.[160]

All the FDA’s rbST safety conclusions as well as the 1994 interim guidance were factored-in by the Stauber Court as it determined that the use of Posilac was not a material fact which should be mandatorily expressed in the label. Plaintiffs, on the other hand, argued that there were organoleptic differences (i.e. , differences in physical properties, flavor characteristics or functional properties) between the two types of milk, which were in turn material facts, requiring labeling. Alternatively, they argued that there was such a pervasive public outcry for mandatory labeling that that, in itself, was a material fact.[161] The court, giving deference and credence to FDA’s conclusions, rejected plaintiffs argument of organoleptic differences stating that they were “unable to put in dispute the agency’s conclusion that ‘administration of [rbST] ha[d] no significant effect on the overall composition of milk’”.[162] But perhaps more important for present purposes, the Court defined the scope of the concept “material” limiting it to organoleptic effects on the food (which were to found in this case) but excluding consumer’s desire to know as an independent basis for mandatory labeling.

Regarding widespread consumer demand, plaintiffs are incorrect in their assertion that by itself consumer opinion could suffice to require labeling. The FDA does consider consumer opinion relevant when determining whether a label is required to disclose a material fact, but a factual predicate to the requirement of labeling is a determination that a product differs materially from the type of product it purports to be. If there is a difference, and consumers would likely want to know about the difference, then labeling is appropriate. If, however, the product does not differ in any significant way from what it purports to be, then it would be misbranding to label the product as different, even if consumers misperceived the product as different. In the absence of evidence of a material difference between rbST- derived milk and ordinary milk, the use of consumer demand as the rationale for labeling would violate the Food, Drug, and Cosmetic Act. Because plaintiffs have not presented any evidence demonstrating organoleptic differences between regular and rbST-derived milk or of any harmful effects of rbST on consumers, they have failed to carry their burden of demonstrating the arbitrary and capricious nature of the agency's determination.[163]

Several key concepts were reiterated by this judicial interpretation of what are material facts that need to be disclosed through labeling. In short, the substantial equivalence rule[164] is reiterated, for there are no facts to be disclosed when there is no significant difference amongst products. Only those differences in flavor, physical structure, or functional properties are being considered material facts, and thus the mere fact that a different process was used to produce the milk is irrelevant if that process has no bearing on those organoleptic characteristics. Similarly, there is no consumer “right to know” about those processes which would, per se , trigger a labeling requirement under section 201(n) of the act, absent those organoleptic consequences.

The United States District Court for the District of Columbia in Alliance for Bio-Integrity v. Shalala reached an equal conclusion.[165] Consumer groups challenged, among other things, FDA’s failure to require mandatory labeling for genetically modified foods in its 1992 statement of policy. They based their labeling claims in statutory as well as constitutional grounds.[166] As for the statutory claim, the Court concluded that, according to FDA’s interpretation, consumer concerns were only relevant once materiality—as construed in Stauber —has been established as a threshold matter.[167] Thus, it determined that the agency’s materiality interpretation, which does not consider consumer interest alone, must stand because it was not unreasonable or capricious.[168] Under this paradigm, the process itself is not a material fact requiring disclosure; and as the Court reiterated (citing a Supreme Court interpretation of the 1906 Act) “[w]hen considered independently of the product, the method of manufacture is not material. The act requires no disclosure concerning it.”[169]

With regard to the constitutional claim—freedom of religion—, the Court relied on a relatively recent case: Employment Division v. Smith. [170] There, the Supreme Court held (in the context of a law proscribing the use of peyote) that a neutral rule of general applicability that has incidental effects against the exercise of religion (when it is not intended to burden religion) does not violate the Free Exercise Clause. Thus, according to Smith , the government is not constitutionally obligated to make accommodations in favor of religious groups that are incidentally affected by neutral rules. Accordingly, the neutral decision of not labeling genetically modified foods met this constitutional standard and was not subjected to a more rigorous constitutional adjudication test.[171] We will not contest this constitutional conclusion. Although we do not agree with the current Supreme Court’s approach in this area of Constitutional law, the fact is that the Court’s consistent and sweeping approval of neutral rules of general applicability with incidental effects on religion or speech is sufficiently rooted so as to bring support to the conclusion that this labeling decision should not be subjected to a higher constitutional standard. [172] This strongly indicates that, at least in terms of precedent, this conclusion by the Alliance court would be upheld by the current Supreme Court.

Another hurdle that the Court encountered was the Religious Freedom Restoration Act of 1993 (RFRA). In reaction to the Smith decision Congress enacted RFRA,[173] which requires the application of a more stringent adjudication standard for neutral laws or decision with incidental effects on religion (i.e. , the constitutional standard that applied before the Smith ruling in 1990). In 1997 that law was declared unconstitutional by the Supreme Court, as applied to the states, by narrowly interpreting section 5 of the XIV Amendment.[174] But since the religious challenge in this case was brought against FDA officials and not against a state, the Alliance Court considered the validity of the claim even in light of the more stringent statutory standard posed by RFRA. Under RFRA the government may not substantially burden a person’s exercise of religion unless there is a compelling governmental interest.[175] The Court concluded that, as a threshold matter, the non-labeling decision did not substantially burdened anybody’s exercise of religious belief, and thus the claim was dismissed.[176] In our estimation that conclusion was not without support. For as difficult as it may be for a Court to engage in an adequate assessment of what is central to a religious belief and to what extent that belief may be substantially affected by a governmental action, in any event there is no substantial effect on religion if the challenged law permits other routes for religious exercise.[177] “[T]he mere fact that the government . . . adopted a law or policy . . . inconsistent with a person’s religious beliefs [does] not create the type of burden that would trigger” a higher scrutiny.[178] But of course, it remains unanswered by the Supreme Court whether this particular kind of law leaves sufficient alternatives for religious practice so as not to reach the level of a “substantial burden”. After all, if a person whose religious tenets forbid the consumption of GMF is not able to identify whether the food she ingests is or not genetically modified, the a non labeling policy may suggest such a burden.

Now, and aside from these constitutional issues, let us turn for a moment to the materiality requirement and consider whether it was adequately treated by these cases.

Commentators have debated whether section 201(n)’s materiality requirement encompasses consumer’s rights to know or whether some other form of stronger justifying principle is needed to authorize the FDA to require mandatory labeling.[179] An analysis of FDA’s previous labeling mandates show that the agency has been consistent in interpreting the term “material” in section 201(n) in a way that goes beyond the process with which the food was derived and that requires something more than simply consumer concerns. Although this is the FDA’s interpretation of an ambiguous statutory term, and thus it is not an absolute straightjacket to the scope of its labeling authority, the fact remains that a departure from that consistently-followed approach must be sufficiently justified for it not to be deemed arbitrary or capricious. Thus, (through section 201(n)’s the materiality concept) once the FDA assumed the position that GMFs are, from a scientific standpoint, equivalent to traditional food , it is difficult to see how it could justify a category-based mandatory labeling requirement for the former when it does not requires it for the latter. Nonetheless, and as it has already been stated, this conclusion does not exclude that some other form of disclosure requirement may be applicable to GM food (namely, through a reasonable interpretation of the ingredient labeling requirements when exogenous genetic material is introduced or through the requirement that each food be labeled with its common or usual name).[180]

On one side of the spectrum, some have argued that in occasions the FDA has required mandatory labeling by loosely interpreting the materiality standard in a way that encompasses popular notions about the importance of disclosing a particular food process.[181] Accordingly, they argue, the “material” concept of section 201(n) must be broadly interpreted in the current context to cover genetic modification as a category.[182] These critics point out as evidence and support to an instance in which the FDA required the labeling of irradiated food even though that process was not proved to cause safety concerns in human consumption.[183] On the opposite end of the spectrum, others have read the agency’s historical labeling practice in a more restricted manner and even (almost pejoratively) deemed totally irrelevant for materiality purposes some interests, concerns and preoccupations of those consumer that the agency is called upon to serve. Both appreciations are somewhat misplaced.

This latter strand of critique has stated, for instance, that:

[F]or over sixty years, . . . [t]he agency has exercised [section 201(n)’s] authority sparingly, largely reserving its use for the disclosure of truly important, noncollateral and nonlabel- cluttering “material” information . The food label would be an entirely different entity from what it is today if FDA had acted otherwise: for example, imagine the possible array of different types of information that could be “required” if FDA deemed “public desire” for information an indicator of materiality; and further imagine the possibly unworkable contours, and the size and space demands, of a label capable of accommodating such information.

. . .

Without question, trivial or insignificant facts about a product have not been deemed material. And something more than a desire to know has been needed to establish an empirical basis for why information is material.[184]

Granted, responsiveness to every consumer concern may turn the food label into an overcrowded and unreadable statement of unrecognizable facts. But the fact that particular information has at any given moment not been considered “material” is no justification to condemn the concerned information as unimportant or not “truly” important, merely cluttering, insignificant or trivial. Such characterization in the context of GMFs mocks serious long-term environmental and health concerns voiced, not only by radical consumer activists but also (as we shall later see) expressed by political, social and civic European and world leaders.[185] In fact, it must be recognized that the FDA has in some cases sensibly considered consumer interests as a factor (although not a determinative one) in its decision whether some information should be labeled. Consider the following statement in the irradiation case:

Whether information is material under section 201(n) of the act depends not on the abstract worth of the information but on whether consumers view such information as important and whether the omission of label information may mislead a consumer. The large number of consumer comments requesting retail labeling attest to the significance placed on such labeling by consumers.[186]

However, the fact is that in that same irradiation instance, the FDA went through great pains to base its labeling decision, and its materiality determination, on organoleptic changes (i.e. , changes in taste, color, smell, or texture of foods), that occurred in the food as a result of the irradiation process and not solely on consumer concerns. To that effect, the agency stated:

[S]everal comments argued that irradiation of food altered the organoleptic properties of food, thereby reducing its nutritional value. These changes in the food, the comments asserted, make the irradiation of the food a material fact that must be disclosed under section 403(a) and 201(n) of the act. Because of these comments, FDA had decided to require that the label and labeling of food products bear the appropriate statements to inform consumers that the food has been irradiated . The agency emphasizes, however, that the labeling requirement is not based on any concern about the safety of the uses of radiation that are allowed under this final rule .[187]

In short, traditionally the FDA—without harshly downplaying consumer concerns nor exalting them as determinative—has considered particular information to be material under section 201(n) of the act “where the absence of such information may: 1) pose special health or environmental risks . . . ; 2) mislead the consumer in light of other statements made on the label . . . ; or 3) in cases where a consumer may assume that a food, because of its similarity to another food, has nutritional, organoleptic, or functional characteristics of the food it resembles when in fact it does not . . . ”.[188]

Consistent with this approach, other instances in which some information has been considered material and where labeling has been required by the FDA include, for example, (a) safe use warnings of aerosolized containers for food and; (b) ingredient labeling of common allergens.[189] Another telling example of this attitude (in which consumer concerns were permitted to have some secondary weight in the labeling determination), is the agency’s 1990 proposal to require labeling, as material information, of nutritional information just three months before Congress specifically amended the FD&C Act to require such labeling.[190] The 1990 nutrition labeling proposal was premised on evidence that “that the nutritional content of the total diet has a substantial impact on the health of Americans”[191] Thus, the proposed mandatory nutrition labeling information under section 201(n) of the act was based, not only on material health-premised notions but also, albeit somewhat collaterally, on consumer’s interest in knowing their food’s components in order to shape their diets.

[T]he individual food selections that a person makes in structuring his or her diet, coupled with numerous similar food choices, can have real and significant consequences for the person's health, both in terms of classical nutritional deficiencies and risk of some chronic diseases.

Because the total diet has significant effects on health, FDA believes it is important that consumers have the ability to make informed decisions about the individual food choices they make. . . . Therefore, given the history and use of nutrition labeling, the advances in nutrition science discussed above, and the public interest in healthful diets, FDA concludes that the nutritional content of a food is a material fact, and that a food label is misleading if it fails to bear the nutrition information that would be required under this proposal.[192]

FDA’s nutritional labeling proposal was in part also driven by “a great desire for nutrition labeling on more foods and for more label information about food components that have been identified as important in maintaining good health”[193] Thus, those “interests” or “great desires” have been in some cases factored-in by the FDA in its labeling determinations.

In short, an analysis of previous instances where the FDA has required mandatory labeling based on the rather ambiguous scope of section 201(n)’s “material” concept, shows that it has never considered consumer’s right to know, standing alone, as a sufficient factor to justify its labeling authority, although it has taken it into consideration to help shape its labeling determinations. Thus both, the Stauber and the Alliance courts, can be said to have interpreted the scope of that concept in a manner consistent with the agency’s repeated construction of its statute.

b. Commercial speech and compelled disclosure: The Constitutionalization of Materiality?: International Dairy Foods v. Amestoy, 92 F.3d 67 (2nd Cir 1996)

Having considered the agency’s authority to require (1) the labeling of GMF as ingredients; (2) the display of the common or usual name for non-standardized food and; (3) the disclosure of “material” information in the label, we must consider to what extent either a state or Congress—under current constitutional law—could compel private entities to disclose certain information to the public about their genetically modified foods. Such controversy was presented (and in our estimation wrongly decided by the Second Circuit) in International Dairy Foods v. Amestoy. [194]

In International Dairy Foods , a group of dairy manufacturers sought injunctive relief against the application of a Vermont law that required the identification of milk or milk products derived from cows treated with rbST. The Vermont statute was based on the premise that, even when the FDA found no significant difference between milk from treated and untreated cows, “[i]t is the law of Vermont that products made from the milk of rBST-treated cows be labeled to help consumers make informed shopping decisions .”[195] Thus, the law prescribed that “[i]f rBST has been used in the production of milk or a milk product for retail sale in this state, the retail milk or milk product shall be labeled as such.”[196] Accordingly, the state Commissioner of Agriculture issued the corresponding labeling regulations.[197] Plaintiffs argued that the challenged statute violated their First Amendment rights. The Court ruled in their favor.

The Court concluded that the statute impermissibly forced dairy manufacturers to make involuntary statements about their foods. In essence, the Court ruled that since the First amendment protects the right not to speak as strongly as the right to speak,[198] and because such right encompasses commercial speech, the Vermont statute must pass the commercial speech constitutional test. Furthermore, because the only interest supporting the state’s disclosure requirement was consumer preoccupations , and not health or safety concerns, that interest was not deemed constitutionally sufficient to pass muster.

The Court’s basic premises are correct. The First amendment does protect against compelled disclosure of commercial speech.[199] But in this case it is our belief that the second circuit misinterpreted the degree and scope of such protection.[200]

Ordinarily, a law that abridges freedom of speech because of its content is presumed to be unconstitutional and will be strictly scrutinized by the Courts. This means that the government must show that the challenged law is necessary to serve a compelling state interest and that it is narrowly tailored to achieve that end.[201] In the commercial speech context, the Supreme Court has developed a less stringent standard for constitutional adjudication. Thus, to determine whether a particular commercial speech restriction is permissible the Central Hudson adjudication test is generally applicable, under which a court must determine:

[(1)] whether the expression is protected by the First Amendment. For commercial speech to come within that provision, itat least must concern lawful activity and not be misleading ; . . . [(2)] whether the asserted governmental interest is substantial ; [(3)] whether the regulation directly advances the governmental interest asserted , and [(4)] whether it is not more extensive than is necessary to serve that interest.[202]

In International Dairy Foods the Second Circuit applied straightforwardly this test to the facts of the case. Because in this case the Court found that Vermont defended the statute solely on the basis of “strong consumer interest and the public’s ‘right to know’”[203] , it concluded that the state “failed to establish the second prong of the Central Hudson test, namely that its interest is substantial.”[204] The Court’s conclusion that (absent a showing that the use of rbST presents any safety concern) Vermont’s interest in satisfying the demands of its citizenry was not sufficiently strong, was challenged in dissent by Judge Leval. The dissent found other more substantial state interests which either independently or considered together would have satisfied the “substantial interest” requirement of the Central Hudson test. In short, “[t]he interests which Vermont sought to advance by its statute . . . [encompassed:] [(1)] ‘concerns about FDA determinations about the product as regards health and safety or about recombinant gene technology’; [(2)] concerns ‘about the effect of the product on bovine health’; . . . [(3)] ‘concerns about the effect of the product on the existing surplus of milk and in the dairy farm industry’s economic status and well-being.’”[205] [and (4)]; “[p]ublic philosophical objection to biotechnological mutation.”[206]

All of these concerns, according to the dissenting justice, afforded constitutional legitimacy to Vermont’s labeling requirements.

Nonetheless, a stronger objection could be levied against the Majority Opinion; an objection to which Leval briefly referred to in his dissent: this is that, according to clear Supreme Court jurisprudence, commercial speech protection under the Central Hudson test is further weakened specifically in situations in which the government is compelling commercial speech, rather than proscribing such expression. Under this lessened protection, compounded with the interests emphasized by the dissent, we believe the Court in International Dairy Foods should have ruled in favor of the state. Thus, under this alternative analysis—and admittedly contrary to the Second Circuit’s ruling—Congress or a state should be constitutionally able to require mandatory labeling of genetically modified foods.

The main judicial support for our contention is the 1985 Supreme Court decision, Zauderer v. Office of Disciplinary Counsel. [207] There, the Supreme Court struck down several state-imposed regulations of attorney advertising. Those were “prohibitions on soliciting legal business through advertisements containing advice and information regarding specific legal problems [and]; restrictions on the use of illustrations in advertising by lawyers.”[208] But significantly, a different standard was applied when in that case the court upheld disclosure requirements regarding the terms of contingent fees.

The basis for treating disclosure requirements differently (and definitively more deferentially) from complete prohibitions on speech is at the core of the societal interests that justify first amendment protection of commercial speech. The Supreme Court articulated this less stringent constitutional approach in the following terms:

Appellant . . . overlooks material differences between disclosure requirements and outright prohibitions on speech . In requiring attorneys . . . . to state that the client may have to bear certain expenses even if he loses, Ohio has not attempted to prevent attorneys from conveying information to the public ; it has only required them to provide somewhat more information than they might otherwise be inclined to present .

The State has attempted only to prescribe what shall be orthodox in commercial advertising, and its prescription has taken the form of a requirement that appellant include in his advertising purely factual and uncontroversial information about the terms under which his services will be available. Because the extension of First Amendment protection to commercial speech is justified principally by the value to consumers of the information such speech provides , . . . appellant's constitutionally protected interest in not providing any particular factual information in his advertising is minimal . Thus, in virtually all our commercial speech decisions to date, we have emphasized that because disclosure requirements trench much more narrowly on an advertiser's interests than do flat prohibitions on speech , “warning[s] or disclaimer[s] might be appropriately required . . . in order to dissipate the possibility of consumer confusion or deception.”[209]

Accordingly, the Supreme Court in Zauderer concluded: “because the First Amendment interests implicated by disclosure requirements are substantially weaker than those at stake when speech is actually suppressed, we do not think it appropriate to strike down such requirements merely because other possible means by which the State might achieve its purposes can be hypothesized.”[210] Thus, in such cases “an advertiser’s rights are adequately protected as long as disclosure requirements arereasonably related to the State’s interest in preventing deception of consumers.[211]

Even though the state’s interest in Zauderer was the prevention of lawyer’s deceptive practices, that fact does not prevent applying the same deferential analysis to the governmental interests identified by the dissent in International Dairy Foods . The crux of the Zauderer holding has nothing to do with deception per se , but with the recognition of a different constitutional approach when the governmental interest promotes the circulation of truthful information in the market place of ideas, rather than preventing such expression. That the Zauderer decision is primarily about this profound constitutional principle and not about the validity of some precise governmental interest is reiterated by what a leading constitutional treatise says on the matter: “Zauderer’s distinction between disclosure requirements and outright prohibitions on speech is an important principle in free speech cases. The usual remedy for the speech we do not like is more speech (disclosure) not less (prohibition).[212]

It must be noted, of course, that this lesser scrutiny does not give the government carte blanche to require any information it desires. Thus, it must not require for instance the disclosure of information regarding ideological or political preferences.[213] But more importantly, even outside the ideological realm, the government cannot compel a commercial viewpoint-based expression regardless of its justifying interests. That is—and as the 2001 Supreme Court decision, United States v. United Foods shows—the government may not compel a speaker to express aparticular commercial viewpoint that the government favors.[214] Hence, and as it was held in United Foods , when a mushroom producer wants to convey the message that its brand of mushrooms is better than other unbranded mushrooms grown by other producers, the government cannot subtract value to that message, and compel the contrary viewpoint that “mushrooms are worth consuming whether or not they are branded”[215] The broader principle involved is that it is the speaker and the audience, and not the government, which must give value to the ideas available.[216] But, conversely, when the government is not aiming at the suppression of any particular commercial viewpoint, nor is compelling the disclosure of a particular viewpoint-based commercial statement, the lessened Central Hudson-Zauderer standard must apply.

In the genetically modified food-labeling context, this constitutional doctrine must translate into a permissible approach for governmental (be it state or federal) disclosure requirements, when such disclosure does not command conveying a particular viewpoint about the quality of GM food. Thus, as long as the government does not force a GM food producer to disclose facts about the production process in a way that communicates that non-GM food is better (like in the generic mushroom example), such requirement should generally pass constitutional muster under Zauderer’s more deferential standard. By the same token, under this more relaxed standard, as long as this constitutional limitation is respected, the government does not have to justify is labeling requirements strictly on safety and health concerns, although those are paradigmatically constitutionally sufficient interests.[217] To require such a demanding justification would transform the less stringent Central Hudson test (“important interest”) into a strict scrutiny (“compelling interest”); and would be tantamount to the constitutionalization of a statutory concept: i.e. , section 201(n)’s materiality requirement.

In sum, we believe that after applying the Central Hudson standard as qualified by Zauderer , Vermont’s statute should have passed the constitutional test for it did not forced private corporations to voice a self-detrimental commercial message. Rather, to attend the state’s legitimate and important interests (economical, ethical and long-term unknown health concerns), the regulations enforcing the act merely required a blue rectangle on the shelf, or a blue dot on the food label.[218] That neutral labeling requirement left ample opportunity for civil society and industry to engage in a dialogue about the issues surrounding the product, without the government tipping the balance to either viewpoint of the conversation and without passing or suggesting judgment on the quality of the food.

A law similar to that recently considered, but not approved, by Congress may present am analogous issue. The proposed bill named the “Genetically Engineered Food Right-to-Know Act” (or GEFRKA)[219] prescribed, without any qualification, that any food containing genetically engineered material or produced with such material, must bear in its label a notice that such food was “genetically engineered” and that the product “contains a genetically engineered material, or was produced with a genetically engineered material”[220] To the extent that such sweeping notice may mislead consumers into thinking that such food is of lesser quality than traditional food, it may be argued that it would not be a valid disclosure requirement under United Foods .[221] But, to the extent that such law is neutral in the sense that it would not force the expression of any particular commercial viewpoint , only a neural fact, it may be regarded as constitutional under Central Hudson and Zauderer .[222] In any event, whether such labeling requirement would promote a particular commercial viewpoint is an unresolved question, which no court has had the opportunity to address; but in our estimation, at a minimum, Congress should be able to successfully defy the Second Circuit precedent in International Dairy Foods and enact a law similar to that of Vermont. Or at the very least, Congress should be able to require without constitutional problem the disclosure of new ingredients or require new names for GM foods.

E. Current FDA Labeling Policy: On the Road Again

Almost sixteen years have passed since the issuance of the premise-setting Coordinated Framework , and almost ten since FDA announced its fundamental 1992 statement of policy. Time has created the opportunity for the agency’s GMF positions to either harden or evolve; and as we’ll see, they have indeed stayed essentially intact.

In October 29, 1999 the FDA announced the celebration of three public meetings to evaluate its safety and labeling policies regarding foods derived from bioengineered plant varieties.[223] The main purpose of these meetings was to “afford consumers, industry and academia an opportunity to provide focused comment on these issues in a manner that will assist FDA in evaluating and refining its existing policies and procedures.”[224] One of the main reasons for these meetings had to do with the appeasement of public uneasiness with this technology as applied to food. As the then Secretary of HHS, Donna Shalala, stated at a press release announcing these public meetings: “[a]lthough people have enthusiastically accepted new drugs made from biotechnology, some consumers have concerns about the use of this technology in foods, and we need to ask why those concerns exist and how we can address them.”[225]

As a result of these meetings, and after evaluating thousands of comments, on January 18, 2001, the FDA released two documents: first, a Draft Guidance for voluntary labeling for when a producer wanted to indicate whether or not the food has been developed using biotechnology[226] and; second, a proposed rule for a supposedly more stringent premarket review process through the submission of a mandatory premarket notice.[227]

From the labeling guidance, it becomes readily apparent that the agency’s labeling policy remained unchanged (albeit, with the scale tilted against those producers who whish to state that their food is non-GMF). At the outset, the guidance restates the 1992 labeling attitude of treating genetically modified food, as a class, the same way as regular food. Thus it reiterates the non-mandatory labeling approach and limits its scope to address the voluntary labeling of either the fact of genetic modification or the lack thereof.[228]

In terms of the direction the 2001 Interim Guidance affords the industry, we find that it merely sums up previous general labeling principles and applies them predictably to the GMF context. Thus, if a manufacturer wants to make a statement regarding a particular bioengineered food or that a food contains ingredients produced with biotechnology, the guidance provides some pointers on how to make such statements without them being misleading in light of the representations made.

For instance, a plain statement that a tomato was genetically engineered is optional, and is permissible because it is not thought by the FDA to be misleading. But if such statement is made with a qualification that it was genetically engineered for something in particular, e.g. to improve texture, that qualification may or may not be misleading depending on the context in which is made. That is, if the improvement in texture is not perceivable to the final consumers (and was only pertinent during processing), the phrase “to improve texture” may mislead consumers into buying the product because of a characteristic they would not finally detect. Thus a more explicative statement (one that adequately addresses the purpose of the genetic modification) may be warranted. For instance, something like “genetically engineered to improve texture for processing” may be required. The guidance reiterates that, although reference to genetic modification is not generally required nor prohibited, if there is a substantial difference (i.e. an organoleptic difference) in the final product brought upon by its genetic modification, that fact must be disclosed pursuant to section 201(n)’s “material” requirement; or a new name may be warranted pursuant to section 403(i) if the food “differs from its traditional counterpart such that the common or usual name no longer adequately describes the new food”.[229] The Guidance also states that if a manufacturer wishes to make a statement about a GM ingredient , such statement—to avoid being misleading—must make clear that it is only the ingredient and not the whole food which is genetically altered.[230]

The FDA had a less permissive attitude towards manufacturers who whish to state in their labeling the fact that their foods are not genetically modified. While a producer can make a statement that its food is genetically modified (without it being misleading), the FDA believes that a manufacturer cannot state in its label that the food is “GMO-Free” or that a particular food or ingredient is “not genetically modified” without it being misleading. The expressed premise for this asymmetric guidance is that technically “[m]ost, if not all, cultivated food crops have been genetically modified”.[231] Thus, “while it is accurate to say that a bioengineered food was ‘genetically modified’, it likely would be inaccurate to say that a food that had not been produced using [modern] biotechnology was ‘not genetically modified’”.[232] Under that premise, therefore, a producer could not make the plain statement that its food is not genetically modified, unless it presents an accompanying clarifying statement indicating that such statement only means that the food is not bioengineered. Neither could the producer state that a food is GMO Free , because that will imply that zero bioengineered material is present in the food. The agency solution to this problem was rather drastic: to ban the GMO Free statement altogether. “Because of the potential for adventitious presence of bioengineered material, it may be necessary to conclude that the accuracy of the term ‘free’ can only be ensured when there is a definition of threshold above which the term could not be used;”[233] and because a method to determine such threshold is not available at this time, the agency opted to deem misleading a statement that a particular food is GMO Free . The producer nonetheless has the option, like in the rbST labeling situation,[234] of making a statement that a particular food was “not produced using biotechnology”, rather than a statement that it is GMO Free.[235] Now, this latter alternative is further restricted for, such statement may not suggest that the food is superior (of better quality or safer) to foods that are not so labeled. Thus, the FDA “will evaluate the entire label and labeling in determining whether a label statement is in a context that implies that the food is superior.”[236]

The unarticulated premise of this guidance is that the statement that a food is genetically modified, is seen by the FDA as stigmatizing. Thus, it tolerates the statement that a food is genetically modified (for a producer takes the risk of announcing self detrimental statements); but it is particularly vigilant when a producer wants to announce that its food is not.

We turn now to the proposed mandatory review process. Although the mandatory premarket notice process was originally announced through the press under the seemingly reassuring heading “FDA to Strengthen Pre-Market Review of Bioengineered Food ”,[237] it is hardly accurate to state that this proposed rule represents a real strengthening of premarket approval, for in fact it is merely a codification of the existing voluntary consultation practice.[238] This proposed review process would require the developer to submit to the agency data regarding the safety of the GM food 120 days previous to its marketing. Prior to submission of the notice (properly named premarket biotechnology notice or PBN), the promoter may enter in a pre-submission consultation program set up to facilitate the cooperative consideration of safety related issues with the agency. After submission of the PBN, the FDA must evaluate in 120 days whether the submitted premarket notice provides a basis for the conclusion that the GM food is safe or lawful.[239] But as it was earlier stated, in practice the FDA has approved over 50 genetically modified food products through the current voluntary consultation process,[240] and it has stated that “all developers of bioengineered foods commercially marketed in the United States have consulted with the agency prior to marketing the food” under the existing voluntary regime.[241] In short, the proposal will only “make the current practice of voluntary consultations mandatory”[242] and not really creating a more rigorous approval process.

In fact, there are other features of the proposed rules that may shed some light on what seems to be the true motivating factors behind them. An important part of the proposed regulation has to do with regulating the public access to the information disclosed during pre-submission consultation and that contained in the PBN. The agency, while protecting confidential information such as trade secrets, proposes to make some of this information available upon request and is also willing to post some of the information on the agency’s web site.[243] This proposal reveals a genuine concern for the public transparency of the process[244] and recognizes an existing consumer desire to know more about GMFs. But once more the reality is that this proposal doesn’t add much to the existing legal framework; in this case the informational public disclosure regime under the Freedom of Information Act (FOIA) of 1965.[245] FOIA already establishes a general presumption that documents in the hands of federal agencies must be made available to the citizenry,[246] with the exception of a few situations.[247] One of the kinds of information exempted from disclosure, are trade secrets and commercial or financial information.[248] The agency must already keep confidential trade secrets if disclosing them is likely to cause substantial harm to the competitive position of the person which presented the information.[249] Thus, the new public disclosure elements of the 2001 proposal are little more than a repetition of what the FDA is already required to provide to the public under FOIA (i.e. , the information submitted to it during the existing premarket consultation process, except what determined to be a trade secret).

If a consultation process is already in place and information furnished in it must already be made available under FOIA, then what would be the purpose of enacting this regulation? When asked about public concerns regarding genetically modified foods after this proposal was made public, the Director of FDA’s Center for Food Safety and Applied Nutrition, Joseph Levitt, hinted an answer:

The issue of bioengineered foods certainly has captured the public’s attention over the last couple of years. In fact, there was so much interest that the FDA decided to hold three public meetings around the country on this issue .

. . . .

Earlier this year, we proposed stronger regulations for food derived from biotechnology that would do two basic things: First, these regulations would require that all new foods derived from biotechnology be reviewed by the FDA before they go on the market. While this has been occurring on a voluntary basis, we want to be sure that the public has confidence in knowing that this will be a legal requirement, and that the FDA will ensure that any bioengineered foods are as safe as their conventional counterparts. Second, we proposed to increase the openness or transparency of the process so that consumers would have more access to what products we are reviewing, what safety data has been submitted on these products, what decisions we are making, and the reasons behind the decisions. [250]

In short, it seems clear that the main goal of this proposal is to increase public confidence in the FDA, its processes and the food supply. An important aim of this scheme is to make the official public statement that the FDA is opening up its processes for public scrutiny, in direct response to the prevailing public sentiment and popular interest to know whether the food that enters the food chain is produced through genetic modification. It remains to be seen if those consumers the FDA was worried about when issuing this proposal will be content with the seemingly cosmetic changes proposed to GMF regulations.

On a more positive note, it is interesting to see the FDA making an effort to react to consumer concerns on GMFs even though it is convinced there are no safety concerns with this technology. Moreover, even when the FDA considers that it lacks authority to require mandatory labeling of GMFs it is recognizing, to a certain extent, a responsibility to respond to consumer fears and concerns and provide the public with more information regarding the food they consume.


The previous sections have summarized the status of U.S. GMFs labeling policies up to date. We have examined the policy choices made and those that have been rejected. Now we will briefly take a look at how other countries and regions around the world have been reacting to the same questions posed by the introduction into the food supply of GMOs. The general purpose of this brief examination is to explore how different policy decision have led to the adoption by other jurisdictions of some of the alternative regulatory approaches discarded by the U.S.

A recent survey of national labeling policies for GMFs, yielded the following information: As of August 2001, Canada, the United States, Argentina and Hong Kong have adopted voluntary labeling strategies.[251] But at the other side of the spectrum, about twenty-three countries, including the European Union have adopted or have announced plans to adopt mandatory labeling strategies.[252] Australia, New Zealand, Thailand, Brazil China, Ethiopia, Mexico, Indonesia, South Korea, Taiwan, Switzerland and Japan, are among those countries requiring mandatory labeling of some sort for genetically modified foods.[253]

For instance, Australia and New Zealand require labeling of food and food ingredients where novel DNA and/or a novel protein is present in the final food product.[254] Labeling is not required: (1) for highly refined foods; (2) for foods that use GM processing aids that are not present in the final food or; (3) for a food product that contains no ingredient which is more that one percent genetically modified.[255] As for the way in which the labeling is presented, if it is a single ingredient GM Food the phrase “genetically modified” must appear next to the name on the front of the food package.[256] For a genetically modified ingredient, the phrase “genetically modified” must appear next to that ingredient in the list of ingredients.[257] “These labeling requirements are not based on safety concerns about GM foods, but are instead based on the consumer’s right to exercise a choice of whether to consume GM foods.”[258] They also reflect a lack of preoccupation that the term “genetically modified” could in any way be misleading.

Japan is another example of a country who has required mandatory labeling for various GMFs[259] based on consumer concerns.[260] Japan’s threshold tolerance label for unlabeled presence of GMOs in food is five percent and those products that do require labeling must include the terms “genetically modified”.[261]

But for a more comprehensive example of a distinct labeling approach, we will briefly turn our attention to the European Union. Since 1997 E.U. legislation has made the labeling of GM food mandatory in two instances: first, when the product consists of a GMO or contains a GMO and; second, when a product is derived from a GMO if the product still contains DNA protein resulting from the genetic modification.[262] The three principal legislations from which these general principles are derived are Regulation (EC) 258/97 on novel foods and novel foods ingredients;[263] Regulation (EC) 1139/98 as amended by Regulation (EC) 49/2000 concerning the compulsory indication of the labeling of certain foodstuffs produced from genetically modified organisms;[264] and Regulation (EC) 50/2000 on the labeling of foodstuffs and food ingredients containing additives and flavorings.[265]

The European Parliament and the Council adopted Regulation 258/97 concerning novel foods and novel food ingredients on January 27, 1997. [266] The Regulation, proposed by the Commission in 1992, originated as a response to an increasing number of new raw materials, processes and technologies that had begun to emerge in food production.[267] Amongst these new procedures were the new genetic modification techniques. Regulation 258/97 was aimed at dealing with a number of problems including the need (1) to create consistency within the European common market and remove obstacles to the free flow of food stuff eliminating unfair competition that had arisen because of the lack of European regulation;[268] (2) to create a uniform safety assessment process in order to protect public health and;[269] (3) to boost consumer confidence in food stuffs, by increasing transparency.[270]

Article 1 of Regulation 258/97 establishes the scope of the regulation. It reads:

1. This Regulation concerns the placing on the market within the Community of novel foods or novel food ingredients.

2. This Regulation shall apply to the placing on the market within the Community of foods and food ingredients which have not hitherto been used for human consumption to a significant degree within the Community and which fall under the following categories:

(c) foods and food ingredients with a new or intentionally modified primary molecular structure;

(d) foods and food ingredients consisting of or isolated from micro-organisms, fungi or algae;

(e) foods and food ingredients consisting of or isolated from plants and food ingredients isolated from animals, except for foods and food ingredients obtained by traditional propagating or breeding practices and having a history of safe food use;

(f) foods and food ingredients to which has been applied a production process not currently used, where that process gives rise to significant changes in the composition or structure of the foods or food ingredients which affect their nutritional value, metabolism or level of undesirable substances. . . .

After complying with the procedures laid out in the Regulation and after being authorized to introduce a product into the Community, an applicant must also comply with the labeling requirements set out in Article 8 of the Regulation in addition to those that are set out in other community laws concerning the labeling of foodstuffs.[271] Importantly, Article 8 specifies the instances in which this additional labeling is required. For example, labeling of novel foods is mandatory (1) “where the characteristics of the novel food make it no longer ‘equivalent’ to an existing food or food ingredient;” (2) “where the product contains material which may have health implications for certain sections of the population;” (3) “where the product contains material which is not present in an existing equivalent food product and which gives rise to ethical concerns” and; (4) “where the product contains an organism genetically modified by means of techniques of genetic modification . . . .”[272]

It is important to point out that these labeling requirements are not a substitute for a safety assessment of these food products. Article 3 of the regulation makes it very clear that all products allowed under these provisions must also prove (1) not to present a danger for the consumer; (2) not to mislead the consumer; and (3) not to differ from the food or food ingredients they intend to replace to such an extent that their consumption will be nutritionally disadvantageous for the consumer. Notably, this Regulation did not establish the specific wording for the labeling required.[273]

The European Union in this first instance of requiring labeling of certain GMFs took one of the roads the US had previously discarded. It evidently decided to treat GMOs as a distinct and new technology whose involvement in the production of food was information of material importance for its consumers, and not as a mere continuation of traditional breeding techniques.

Since to be bound by Regulation 258/97 a product had to be novel and, thus, not have been used for human consumption to a significant degree prior to the regulations entry into force,[274] GMO’s that had been previously approved by the E.U. did not come under its guise. Thus, a loophole in the labeling of GM food existed in the case of food products containing or derived from previously approved varieties of GM soy[275] and GM maize.[276] As a result of this loophole several member states had taken independent measures requiring labeling of food containing or derived from GM soy and maize.[277] Thus, once again the E.U. felt compelled to legislate in order to eliminate differences among member states’ legislation that could “impede the free movement of those foods and food ingredients and thereby adversely affect the functioning of the internal market”.[278] Regulation 1139/98 filled this loophole. In general, the regulation simply adds food products derived from GM soya or maize to the list of those requiring labeling. But this new regulation also introduced more specific guidelines as to the actual nature of the label required. Article 2, paragraph 3, laid out the specific labeling requirements that should be followed. As summarized by Teel the Regulation specified that:

the genetic modification information must be placed in the list of ingredients in parentheses immediately after the ingredient is listed or is to appear prominently (at least in the same sized typeface as the list) in a footnote to the list relating to an asterisk after the named ingredient. The information “produced from genetically modified soya” or “produced from genetically modified maize” may also appear clearly on the product label if no list of ingredients exists. If an ingredient is represented as a category, the information may consist of “produced from genetically modified maize/starch.” [279]

This regulation used the presence in food or ingredient of DNA or protein resulting from genetic modifications, as the criteria that triggered the additional labeling requirements.[280] In this sense, and similar to the U.S. approach, this Regulation seemed to focus on the resulting product and not on the process. However, the E.U.’s determination that the mere presence of DNA or proteins resulting from genetic modification rendered a product not equivalent to its traditional counterpart was quite different from the US approach.

Regulation 1139/98 was also the first E.U. regulation to recognize that some level of advantageous contamination may occur and to suggest that a threshold should be established under which labeling would not be required.[281] Moreover, this Regulation was later modified by Regulation 49/2000 which actually established that labeling would not be required when material derived form genetically modified organisms was adventitiously present in the food in a proportion no higher than one percent of the food ingredients individually considered or food comprising a single ingredient.[282]

Regulation 50/2000 was later approved in order to fill another void in the emerging E.U. GMF labeling scheme. Neither Regulation 258/97 nor Regulation 1139/98 had addressed the labeling of GM additives and flavorings intended to be used in foodstuffs. Thus, this regulation, which entered into force April 10, 2000, provided for the labeling in a manner consistent with previous regulations of both GM food additives (that fell within the scope of Directive 89/107/EEC) and GM food flavorings (that fell within the scope of Directive 89/388/EEC).[283]

On January 12, 2000 the European Commission proposed the creation of an European food safety agency. As part of this initiative, and counting on the centralization that will be achieved through the creation of this new agency, an effort is currently under way to achieve several purposes: (1) to harmonize the E.U.’s system of tracing GMOs; (2) to introduce the labeling of GM animal feed; (3) to streamline approval procedures for GMOs in food and feed including their deliberate release into the environment and; (4) to reinforce the current labeling rules on GM foods.[284] The following two proposals, presented as part of this initiative by the Commission, are currently before the Parliament and the Council: (1) Proposal COM(2001)0182 for a Regulation of the European Parliament and of the Council concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC;[285] and (2) Proposal COM(2001)0425 for a Regulation of the European Parliament and of the Council on genetically modified food and feed.[286]

These regulations if approved will have the following effect on the current labeling scheme. Aside from the provisions requiring traceability of GMOs “from farm to table”, these proposals extend the current labeling provisions to all GMFs, regardless of whether there is present in the final product any detectable DNA or protein from the genetic modification. In short, these proposals stand for the proposition that any “[f]ood that consists of, contains or is produced from GMOs would have to be labelled as such.”[287] The new proposals continue to allow for the adventitious presence in food or feed of a one percent threshold without requiring labeling, but only for GMOs which have been approved by the E.U.

In sum, the European GMF labeling approach seems headed to consider the process of genetic modification as the sole significant element when determining whether to require labeling. This sharply contrasts with the previously described US approach, which does not consider as material labeling information the sole fact that a particular food has been genetically modified. But there seems to be two other significant, and perhaps more profound, distinctions between the U.S. and the E.U. approaches: one is the constant reference in the latter’s labeling regulations to ethical or religious concerns;[288] and a second related difference, is a less paternalistic recognition of consumer’s right to know as sufficient grounds for requiring labeling.[289]

This consumer-oriented attitude may be summed-up by the following statement by Erkki Liikanen, Commissioner for Enterprise and Information Society, as it was made in a recent interview:

The role of the government is to guarantee that a product is safe and if it is it can be made available in the market. But the citizens must have full knowledge. This is where it is very important to have proper labels with traceable information. It is not our task to say what the consumer should choose but to make sure it is safe.[290]

Thus, Europe is perhaps an ideal example of the various different policy choices that could have been made by the U.S. when determining how to confront this new technology in food production. The extreme differences in approach that these two highly developed jurisdictions have taken on the same issue reflect the complex nature of this debate; the ambiguousness of its premises and, most importantly, it is evidence of the reasonableness of either choice. Of course, complex policy choices are not solely a matter of rational deduction. There are differing explanations to why different countries take different roads.

Europe’s attitude towards GMO’s in general has been described as pursuing a precautionary approach, [291] and the reasons for this attitude may be found in several cultural and historical factors.

For example, in Europe public sentiment towards GM foods has been linked to events unrelated to genetic engineering. During the last several years “science itself has taken a beating in Europe.”[292] Bovine spongiform encephalopathy (BSE), or the so-called “mad cow disease”, is one of the main causes. Six years after authorities had claimed that mad cow disease was under control and that there were no safety risks to humans, British government Ministers admitted that eight people in the U.K. might have died from eating BSE-infected cattle.[293] Another recent scare was the Belgian Dioxin scandal in the summer of 1999. In that case, a Belgian animal fat processing company contaminated poultry feed with a highly carcinogenic dioxin.[294] The Belgian authorities reacted incompetently to the crisis delaying product withdrawal and failing to inform the European Commission of the crisis in a timely manner. As a result, European consumer confidence was rattled once more. As appraised by Grant “[e]vents of this kind did not provide a favorable backdrop for the introduction of a new technology.”[295] On the other hand, in recent times, Americans have been spared of scandals of this sort. This can in part explain why, many Americans view the regulatory process in the U.S. as more secure and effective than that of Europe.[296]

But food scares aside, there are other cultural and historical differences between Europe and the U.S. that have impacted and shaped their respective regulatory approaches.

For instance, it is believed that for the majority of Europeans, agriculture and food in general represent strong cultural values. Using products that come from the small valley of their homeland is for urban Europeans a way to reaffirm and consolidate their cultural identity and to support rural lifestyle.[297] Thus, a strong romanticized affection to these rural values has been pointed out as one of the main characterizing features of the European culture:

[M]ost Europeans are attached to rural values, admittedly by considering them in a very idealized way, as part of their own imaginary representation. Attachment to rural values is particularly strong in France, and in other countries such as Switzerland and Austria, as a way to demonstrate their cultural identity and diversity. Rural values, or what is perceived as such, are certain quality of life, including a more genuine and more diversified food, a closer contact with nature . . . , a return to the specific traditions of their culture including local languages, and more tolerant and less aggressive human relations. In other words, the rural space for most Europeans is the storehouse of their culture, their historical roots, and their natural and cultural heritage.[298]

In contrast, Americans reflect a different attitude towards the countryside that is thought to have an effect on their attitude towards environmental concerns arising from GMFs. In general, “Americans do not regard the countryside as a recreational asset in the way that Europeans do. For Americans, farmland is part of an industrial system and there are ample wilderness areas to enjoy for various forms of recreation.”[299]

It has also been stated that, in general, Europe and the United States have a differing appreciation of technology, progress, and scientific advances.[300] Europeans tend to reflect some skepticism towards technological advances, while Americans tend to embrace them.[301]

These are a few of the reasons that can help explain why labeling of GM foods in Europe as a means of allaying consumer concerns has been adopted. These historical and cultural realities also shed light on the possible basis for the European precautionary approach to issues which can conceivably lead to health or environmental threats. In the United States, on the other hand, the apparent inexistence of many of these concerns might be another reason why a less stringent labeling approach to GMFs has been adopted.


The labeling of GMFs, whether mandatory or voluntary, will continue to be a controversial issue for years to come. The United States, the main producer and exporter of this technology, will have to maintain some regulatory flexibility to be able to respond to industry pressures, consumer concerns, and a technology in constant flux. But as was discussed in the first sections of this paper, it seems that the U.S. has to a certain degree closed the door on more aggressive labeling options, like those adopted and/or proposed in Europe. Indeed, it would seem that for the U.S. to require mandatory labeling of GMFs it would require a reworking of the framework that has been chosen to deal with these biotechnologies, possibly at a legislative level.

This does not mean, however, that the FDA (the agency most directly involved with labeling requirements) does not maintain a certain degree of discretion to modify, if it deems necessary, the existing scheme. This has been recently evidenced by its current efforts to respond to consumer’s demand for transparency in the approval and marketing of genetically modified foods.

The previously discussed 2001 mandatory notice proposed rule, for example seems to embrace an open recognition of the FDA’s responsibility to address public preoccupations and remain accountable to its true clientele: the general public. If that effort is successful in allaying consumer concerns remains to be seen. It is to a certain degree too late now to turn back, start from scratch and select new roads that would provide consumers with more complete information about the presence of GMOs in the food they consume. If this is true, then perhaps the 2001 transparency efforts are the furthest the FDA is capable of, in order to require some disclosure about which foods are derived from or contain GMFs. On the other hand, perhaps it’s not too late for the FDA to exercise its highly regarded discretion to consider some of the alternative readings of its statute and regulations that have been suggested throughout this paper.

[*] Antonio Machado (Spanish Poet, 1875-1939), Cantares, in CAMPOS DE CASTILLA: PROVERBIOS Y CANTARES [CC - CXXXVI-XXIX] (1912). Caminante, son tus huellas el camino, y nada más. Caminante, no hay camino; se hace camino al andar.” (translation supplied).

[1] WILLIAM BAINS, BIOTECHNOLOGY FROM A TO Z 66 ( Oxford University Press, 1998).

[2] Sean D. Murphy, Biotechnology and International Law , 42 HARV. INT’L L. J. 47, 50 (2001); Jeffrey K. Francer, Frankenstein Foods or Flavor Savers?: Regulating Agricultural Biotechnology in the United States and European Union , 7 VA. J. SOC. POL'Y & L. 257, 262 (2000) .

[3] Id.

[4] Francer, supra note 2, at 262 .

[5] Kirsten S. Beaudoin, On Tonight's Menu: Toasted Cornbread With Firefly Genes?: Adapting Food Labeling Law to Consumer Protection Needs in the Biotech Century , 83 MARQ. L. REV. 237, 241 (1999).

[6] Kelly A. Leggio, Limitations on the Consumer’s Right to Know: Settling the Debate over Labeling of Genetically Modified Foods in the United States , 38 SAN DIEGO L. REV . 893, 903 (2001) .

[7] Beaudoin, supra note 5, at 241; Leggio, supra note 6, at 903 .

[8] Judith E. Beach, Ph.D, No “Killer Tomatoes”: Easing Federal Regulation of Genetically Engineered Plants ,53 FOOD & DRUG L.J. 181 (1998).

[9] Diane Thue-Vasquez, Genetic Engineering and Food Labeling: A Continuing Controversy , 10 SAN JOAQUIN. AG. L. REV. 77, 81 (2000); Lara Beth Winn, Special Labeling Requirements for Genetically Engineered Food: How sound are the Analytical Frameworks used by FDA and Food Producers? , 54 FOOD & DRUG L.J. 667, 668 (1999).

[10] Winn, supra note 9, at 668.

[11] Denise M. Lietz, A Precautionary Tale: The International Trade Implications of Regulating Genetically Modified Foods in Australia and New Zealand , 10 PAC. RIM L. & POL'Y J . 411, 414 (2001).

[12] See Beach, supra note 8; Lietz, supra note 11, at 414. For a discussion of the FlavrSavr Tomato, see infra. Section II.D.1 (text accompanying notes 101, et. seq. ).

[13] STEPHEN NOTTINGHAM, EAT YOUR GENES: HOW GENETICALLY MODIFIED FOOD IS ENTERING OUR DIET 7 (1998). In fact, according to news reports, the FDA is currently reviewing the market introduction of a gene altered salmon that grows faster than normal. Union of Concerned Scientists, Biotechnology at UCS: Update on Genetically Engineered Fish , http://www.ucsusa.org/food/upd-gefish.html, last visited Jan. 13, 2002.

[14] Lisa Y. Lefferts, Safety and Choice: Key Consumer Issues for Genetically Modified Foods , US Department of State, International Information Program available at http://usinfo.state.gov/journals/ites/ 1099/ijee/bio-lefferts.htm (last visited, Jan 18, 2002); BILL LAMBRETCH, DINNER AT THE NEW GENE CAFé: HOW GENETIC ENGINEERING IS CHANGING WHAT WE EAT, HOW WE LIVE, AND THE GLOBAL POLITICS OF FOOD 5 (2001).

[15] Several organizations have strongly advocated for these issues. See , Unionof Concerned Scientists , at http://www.ucsusa.org/food/0biotechnology.html; Mothers for Natural Law , at http://www.safe-food.org; Greenpeace International , http://www.greenpeace.org/~geneng/ (all pages visited on February 5, 2002). See also , LUKE ANDERSON, GENETIC ENGINEERING, FOOD, AND OUR ENVIRONMENT (2000); LAURA TICCIATI & ROBIN TICCIATI, PH.D., GENETICALLY ENGINEERED FOODS: ARE THEY SAFE? YOU DECIDE (1998).

[16] FDA’s response to these concerns will be discussed throughout this paper. With regard to Congress, although several Bills have been presented regarding these issues, none of them has gained sufficient strength to get enacted. See S. 2080, 106th Cong. (2000) (Genetically Engineered Food Right-to-Know Act, or GEFRKA); H.R. 3377, 106th Cong. (2000) (GEFRKA); S. 3184, 106th Cong. (2000) (a Bill to require premarket consultation and approval of GMF); S. 2315, 106th Cong. (2000) (to require premarket consultation and approval of GMF); H.R. 3883, 106th Cong. (2000) (to require premarket consultation and approval of GMF).

Currently, a Bill has been presented in the House to provide for a public education program regarding the use of biotechnology in the production of food for human consumption and to support additional scientific research regarding potential environmental risks and benefits of such foods. See H.R. 115, 107th Cong. (2001). To date, no action has been taken on that bill.

See also , Hearing on the Future of Food: Biotechnology and Consumer Confidence Before Senate Committee on Health, education, Labor and Pensions , 106th Cong. (September 26, 2000), available at http://labor.senate.gov/Hearings/sept00hrg/092600wit/092600wit.htm (last visited, Jan. 6, 2002).

[17] Neil D. Hamilton, Legal Issues Shaping Society’s Acceptance of Biotechnology and Genetically Modified Organisms , 6DRAKE J. AGRIC. L. 8, at text accompanying fn. 4 (2001); Lietz, supra note 11, at 413.

[18] Hamilton, id. ; Lietz , id. at 414; Fiona Macmillan & Michael Blakeney, Genetically Modified Organisms and the World Trade Organization , 3 TUL. J. TECH. & INTELL. PROP . 93, 93-94 (2001). In fact, and as it has been stated by John Fagan (a leading microbiologist), the claim that GMFs can feed the world hungry is exaggerated and exploited by the industry. “The limitation is not productivity, the limitation is distribution” “If you are interested in simply feeding the hungry, you can take three times the area of Iowa, and the food cultivated there will be enough to feed the world’s hungry.” Interview with John Fagan: Food for Tort , TIMES OF INDIA ( Feb. 2002), available at http://www.thecampaign.org/News/feb02b.htm (last visited Feb. 11, 2002). Golden Rice, for instance, “is being touted as a panacea for those suffering from Vitamin A deficiency. But nearly two kg (dry) of this rice would have to be consumed daily by an individual to meet her Vitamin A requirement. It’s ridiculous. It takes our attention away from better solutions.” Id.

[19] Francer, supra note 2, at 263 .

[20] Franz Xaver Perrez, Taking Consumers Seriously: The Swiss Regulatory Approach to Genetically Modified Food , 8 N.Y.U. Envtl. L.J. 585, 587 (2000); Hamilton, supra note 17, at text accompanying fn. 6-8; Thue-Vasquez, supra note 9, at 77.

[21] For a more detailed analysis of potential human health concerns related to GMF’s see Julie A. Nordlee, et al., Identification of a Brazil-Nut Allergen in Transgenic Soybeans , THE NEW ENGLAND JOURNAL OF MEDICINE 688 (March 14, 1996); Center for Food Safety, The Hidden Health Hazards of Genetically Engineered Foods , FOOD SAFETY REVIEW ( Spring 2000, Vol. One, 1). See also , Beaudoin, supra note 5, at 246-49 (1999); Michael Whittaker, Reevaluating the Food and Drug Administration’s Stand on Labeling Genetically Engineered Foods , 35 SAN DIEGO L. REV. 1215, 1221 (1998); Mathew Franken, Fear of Frankenfoods: A Better Labeling Standard for Genetically Modified Foods , 1 MINN. INTELL. PROP. REV. 153, 158-59 (2000).

[22] Franken, id. , at 160.

[23] Lietz, supra note 11, at 416; Julie Teel, Regulating Genetically Modified Products and Processes: An Overview of Approaches , 8 N.Y.U. ENVTL. L.J. 649, 660-61 (2000).

[24] Harry A. Kuiper, et al., Risks of the Release of Transgenic Herbicide-Resistant Plants with Respect to Humans, Animals, and the Environment, 19 CROP PROTECTION 773 (2000); Henrique Freire de Oliveira Souza, Genetically Modified Plants: A Need For International Regulation, 6 ANN. SURV. INT'L & COMP. L. 129, 138-39 (2000); Lietz, supra note 11, at 415.

[25] Freire, id. at 139.

[26] Beaudoin, supra note 5, at 243

[27] Id. at 243-44.

[28] Thue-Vasquez, supra note 9, at 78-79.

[29] For an interesting economic analysis of biotech food labeling, see Elise Golan, Fred Kuchler, Lorraine Mitchell, Cathy Greene & Amber Jessup,Economics of Food Labeling , Economic Research Service, U.S. Department of Agriculture; Agricultural Economic Report No. 793 (2000), available at http://www.ers. usda.gov/publications/aer793/ (last visited, Jan. 27, 2002).

This report concludes that mandatory labeling of genetically modified foods “is . . . not the best tool suited for reducing any of the potential externalities associated with this technology”. Id . at 36. “Externalities” occur when actions “of one economic agent affects the utility or production possibilities of another in a way that is not reflected in the marketplace”. Id. at 13. That is, when the market price of the food does not reflect welfare effects that consumer decisions produce, the market outcome becomes less socially optimal.Id. It is believed that “[w]here private consumption decisions result in externalities, social welfare may be maximized by a labeling choice that differs from the one generated by private firms” Id. This analysis concludes that the social outcome preferred by risk-averse consumers will not be attained with mandatory labeling, for risk-neutral consumers would still choose biotech foods and “as long as any consumers choose to consume biotech foods, the potential risks to the environment and to public health remain, and the social outcome preferred by biotech-averse consumers is not attained.” Id. at 36. But the report focuses on how efficient a general mandatory labeling policy would be in an economic sense, without emphasizing enough the personal benefit that the individual biotech-averse consumer may gain (in terms of liberty and autonomy of personal food-ingesting decisions) from being able to fully decide what kinds of foods to consume or what industries to support.

The same critique may be levied against its conclusion that labeling is not adequate to correct potential informational asymmetries (when “the market supplies too little information to enable consumers to make consumption choices reflecting their preferences”, Id. at 12). See also id. at 36. The report concludes that mandatory labeling of GMF as a category will create confusion and reduce, rather than augment, economic efficiency. But, this analysis ignores the less “confusing” possibility of identifying GMFs through the ingredient list and not through a general reference to genetic modification. This would enable individuals to choose for themselves what they will eat or what kind of industries will they support without resorting to a possibly stigmatizing general reference to GMFs.

[30] For some of the most recent analysis on this subject, see generally, HUTT & MERRILL, FOOD AND DRUG LAW: CASES AND MATERIALS (1991); 1 FUNDAMENTALS OF LAW AND REGULATION: AN IN-DEPTH LOOK AT FOODS, VETERINARY MEDICINES, AND COSMETICS ( Robert P. Brady, et al., eds.) (1997); Fred H. Degnan, Biotechnology and the Food Label: a Legal Perspective, 55 FOOD & DRUG L.J. 301 (2000); Franken, supra note 21; Karen A. Goldman, Labeling of Genetically Modified Foods: Legal and Scientific Issues , 12 GEO. INT’L. ENV. L. REV. 717 (2000); Leggio, supra note 6; Alicia T. Simpson, Buying and Eating in the Dark: Can the Food and Drug Administration Require Mandatory Labeling of Genetically Engineered Foods?: Alliance for Biointegrity v. Shalala, et al., 116 F. Supp. 2d 166 (2000) , 19 TEMP. ENVNTL. L. & TECH. J. 225 (2001); Thue-Vasquez, supra note 9; Winn, supra note 9; Whittaker, supra note 21.

Aside from the sources cited throughout this paper, FDA’s perspective on some of the issues here presented can be found at the following sources: Center for Food Safety and Applied Nutrition, FDA’s Policy for Foods Developed by Biotechnology: Emerging Technologies—Biotechnology , available at http://www.cfsan.fda.gov/ ~1rd/bioeme.htm (last visited Jan. 9, 2002); Larry Thompson, Are Bioengineered Foods Safe? , 34(1) FDA CONSUMER MAGAZINE (2000), available at http://www.fda.gov/fdac/features/ 2000/100_bio.html (last visited, January 16, 2002); Center for Food Safety and Applied Nutrition, CFSAN HANDOUT : 1995, FDA’s Policy for Foods Developed by Biotechnology , available at http://www.cfsan.fda.gov/~1rd/biopolicy.htm (last visited Jan. 9, 2002); Center for Food Safety and Applied Nutrition, PRESENTATION: JULY 1996 , Safety Assurance of Foods Derived by Modern Biotechnology in the United States , available at http:// www.cfsan.fda.gov/~1rd/biojap96.html (last visited Jan. 8, 2002); Center for Food Safety and Applied Nutrition, Bioengineered Foods: Will they Cause Allergic Reactions? , available at http:// www.cfsan.fda.gov/~dms/pubalrgy.html (last visited Jan. 8, 2002).

[31] FDA’s focus group studies have found that a general reference to “genetic modification” may mislead consumers into thinking that GMFs are unsafe. Office of Scientific Analysis and Support, Report on Consumer Focus Groups on Biotechnology, October 20, 2000, available at http://www.cfsan.fda.gov/~comm/biorpt.html (last visited Jan. 30, 2002).

[32] HUTT & MERRILL , supra note 30 at 5.

[33] Codified in 21 U.S.C.A. §§ 301-395.

[34] HUTT & MERRILL , supra note 30 at 12.

[35] FD&C Act § 403(a); 21 U.S.C.A. § 343(a).

[36] 21 U.S.C.A. § 321(n) (emphasis added).

[37] United States v. Ninety-Five Barrels of ... Apple Cider Vinegar, 265 U.S. 438, 442-43 (1924).

[38] Id. at 443.

[39] United States v. An Article of Food ... “Manischewitz ... Diet Thins”, 377 F. Supp. 746, 749 (D.N.Y. 1974).

[40] Section 403(g), (i)(1); 21 U.S.C.A. § 343(g), (i)(1).

[41] Section 403(i)(2); 21 U.S.C.A. § 343(i)(2).

[42] Section 403(e)(1); 21 U.S.C.A. § 343(e)(1).

[43] Section 403(e)(2); 21 U.S.C.A. § 343(e)(2).

[44] Section 403(q); 21 U.S.C.A. § 343(q). The Nutrition Labeling and Education act of 1990 (NELA) amended the FD&C Act to statutorily require nutrition information. See HUTT & MERRILL , supra note 30, at 200.

[45] Section 403(f); 21 U.S.C.A. § 343(f).

[46] Section 403(g ); 21 U.S.C.A. § 343(g). See also 21 C.F.R. § 101.3.

[47] Section 403(i)(1); 21 U.S.C.A. § 343(i)(1).

[48] See HUTT & MERRILL , supra note 30, at 117-28. See also , Samia N. Rodríguez, Food Labeling Requirements, in 1 FUNDAMENTALS OF LAW AND REGULATION: AN IN-DEPTH LOOK AT FOODS, VETERINARY MEDICINES, AND COSMETICS 232-40 (1997).

[49] Section 403(i)(2); 21 U.S.C.A. § 343(i)(2)

[50] See HUTT & MERRILL , supra note 30, at 77.

[51] Id.

[52] See infra. text accompanying notes 121-122.

[53] 21 U.S.C.A. § 321(n) (emphasis added).

[54] Degnan, supra note 30 at 304 (“the section is an adjunct to FDA’s authority to require that essential pieces of information appear on the food label).

[55] HUTT & MERRILL , supra note 30, at 61.

[56] Degnan, supra , note 30, at 304 (Degnan refers to this type of materiality as “conditional in nature”).

[57] That is, “facts material ... with respect to consequences which may result from the use of the article”. Section 201(n); 21 U.S.C.A. § 321(n).

[58] Executive Office of the President, Office of Science and Technology Policy, Coordinated Framework for Regulation of Biotechnology , 51 Fed. Reg. 23302 (June 26, 1986). See also, Neil Belson, US regulation of Agricultural Biotechnology: An Overview , 3(4) AGBIOFORUM 268 (2000).

[59] Today that is still the organizational approach. See, Larry Thompson, Are Bioengineered Foods Safe? , 34(1) FDA CONSUMER MAGAZINE (2000), available at http://www.fda.gov/fdac/features/ 2000/100_bio.html (last visited, January 16, 2002).

Bioengineered foods actually are regulated by three federal agencies: FDA, the Environmental Protection Agency, and the U.S. Department of Agriculture. FDA is responsible for the safety and labeling of all foods and animal feeds derived from crops, including biotech plants. EPA regulates pesticides, so the BT used to keep caterpillars from eating the corn would fall under its jurisdiction. USDA's Animal and Plant Health Inspection Service oversees the agricultural environmental safety of planting and field testing genetically engineered plants. Id.

[60] Coordinated Framework for Regulation of Biotechnology , 51 Fed. Reg. 23302 (June 26, 1986).

[61] Coordinated Framework for Regulation of Biotechnology , 51 Fed. Reg. 23302 at 23303 (June 26, 1986).


[63] This is expressly stated in the Coordinated Framework, 51 Fed. Reg. 23302-03. (“The working group sought to achieve a balance between regulation adequate to ensure health and environmental safety while maintaining sufficient regulatory flexibility to avoid impeding the growth of an infant industry”).

[64] See Karen Anne Goldman, Compensation for Use of Biological Resources Under the Convention on Biological Diversity: Compatibility of Conservation Measures and Competitiveness of the Biotechnology Industry , 25 LAW & POL’Y INT’L BUS . 695, 698 (1994) citing PRESIDENT’S COUNCIL ON COMPETITIVENESS, REPORT ON NATIONAL BIOTECHNOLOGY POLICY 5 (1991) (“in the long run, . . . biotechnology has the potential to surpass the computer industry in size and importance.”)

[65] According to an experienced journalist’s account, LAMBRETCH, supra note 62, “[t]he fledging industry responded appreciatively. ‘I was struck by what I thought was due regard for commercial interests’, Roger Kleese, vice president of Molecular Genetics, Inc., a Minnesota start-up, told me back then. A Monsanto spokesman, David Crosson, said his company was ‘very pleased that the emphasis is on the product and its use, and not just the fact that biotechnology is the production method’”. LAMBRETCH, id. at 49-50.

[66] BILL LAMBRETCH, id. at 49.

[67] See Coordinated Framework for Regulation of Biotechnology , 51 Fed. Reg. 23302 at 23303 (June 26, 1986). (“While the recently developed methods are an extension of traditional manipulations that can produce similar or identical products, they enable more precise genetic modifications, and therefore hold the promise for exciting innovation and new areas of commercial opportunity”).

[68] That the process, per se , is irrelevant is evident from the stated fact that the “Food and Drug Administration (FDA) would regulate genetic engineering products no differently that those achieved through traditional techniques”. Coordinated Framework for Regulation of Biotechnology , 51 Fed. Reg. 23302 at 23303 (June 26, 1986). See also, ROBERT L. PAARLBERG, THE POLITICS OF PRECAUTION: GENETICALLY MODIFIED CROPS IN DEVELOPING COUNTRIES 21 ( John Hopkins University Press, 2001).

[69] “Some argue that biotechnology is just an extension of brewing and baking. Usually, this is a prelude to an argument about how safe biotechnology is. . . . However, saying that it is an extension of traditional brewing is wrong. The difference is that biotechnology seeks to use rational approaches to developing its technologies and products, rather than traditional craft or trial and error.” BAINS , supra note 1, at 67.

[70] Consider, for example, the following assessment of the Japanese approach:

Japan ranks second to the United States in the worldwide biotechnology industry. As a result, its economic interests in biotechnology are strong. Japan’s regulatory structure for biotechnology is similar to the United States’ in that Japan's regulations are spread out across several different ministries. However, unlike US regulations, Japan’s regulations are process oriented rather than product oriented. This focus on the process of producing genetically engineered organisms rather than the end product allows regulation of biotechnology to be implemented easily .

Karen M. Graciano, Biosafety Protocol: Recommendations to Ensure the Safety of the Environment , 7 COLO. J. INT’L ENVTL. L. & POL'Y 179, 182 (1996) (emphasis added).

[71] As opposed to what has been the response with which other countries have reacted to this new technology, particularly the European Union. See infra. Section III.

[72] As one acute commentator has stated: “We need more discussion about risks, not less: children should be taught at school how to evaluate them. . . . I deserve my right to panic. The alternative, short of becoming a gluten-free, vegan nun living in Mull, is to entrust oneself to politicians and scientists. And we all know the risks of that.” Anne Karpf, Their Risks—And Ours , THE GUARDIAN, January 8, 2002 at p. 16, 2002 WL 2894293. See also , Lefferts, supra note 14 (“Survey after survey around the world shows that while consumers are generally not opposed to genetically modified foods, they are against allowing such foods to be sold without adequate labeling. Let the success of biotechnology depend on whether informed consumers vote for in the marketplace.”)

[73] Statement of Policy: Foods Derived From New Plant Varieties, 57 Fed. Reg. 22984 (May 29, 1992).

[74] Id. at 22984. Actually, the same day the Coordinated Framework was issued, the FDA issued a policy statement regarding this general approach: “...No particular statutory provision or regulation deals expressly with food produced by new biotechnology. Accordingly, when confronted by an issue concerning the regulation of food produced by new biotechnology, the Agency will apply the relevant statutory or regulatory provisions.” Statement of Policy for Regulating Biotechnology Products , 51 Fed. Reg. 23309 (June 26, 1986) cited in HUTT & MERRILL, supra note 30, at 978.

[75] “The genetic modification techniques used to develop new plant varieties constitute a continuum.” Id. at 22985.

[76] Id. at 22984, fn. 3. By the same token, “modification” is broadly defined to mean:

the alteration in the composition of food that results from adding, deleting, or changing hereditary traits, irrespective of the method. Modifications may be minor, such as a single mutation that affects one gene, or major alterations of genetic material that affect many genes. Id (emphasis added).

[77] Id.

[78] Id. at 22984-95 (emphasis added).

[79] 21 U.S.C. § 342(a)(1).

[80] Frederick Degnan, The Regulation of Food Safety, in 1 FUNDAMENTALS OF LAW AND REGULATION: AN IN-DEPTH LOOK AT FOODS, VETERINARY MEDICINES, AND COSMETICS 164, 181 (1997).

[81] Section 201(s); 21 U.S.C. 321(s).

[82] Section 409, 21 U.S.C. 348. Under 21 CFR 170.3(i), a food additive is “safe” if “there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use. It is impossible in the present state of scientific knowledge to establish with complete certainty the absolute harmlessness of the use of any substance.”

[83] Section 201(s); 21 U.S.C. 321(s).

[84] See 57 Fed. Reg. 22989. “FDA has traditionally encouraged producers of new food ingredients to consult with FDA when there is a question about an ingredient's regulatory status, and firms routinely do so, even though such consultation is not legally required.” Id. The Statement of Policy, at id. , also explains that:

In many cases, the answer is obvious, such as when the ingredient is a man made chemical having no widely recognized history of safe use in food. Such an ingredient must be approved prior to its use by the issuance of a food additive regulation, based on information submitted to FDA in a food additive petition.

In other cases, the answer is less obvious, such as when an established ingredient derived from nature is modified in some minor way or produced by a new process. In such cases, the manufacturer must determine whether the resulting ingredient still falls within the scope of any existing food additive regulation applicable to the original ingredient or whether the ingredient is exempt from regulation as a food additive because it is GRAS.

See also, Degnan, supra note 80 at 182-86.

[85] See also Statement of Policy for Regulating Biotechnology Products , 51 Fed. Reg. 23309 (June 26, 1986) cited in HUTT & MERRILL, supra note 30, at 978.

[86] Section 402(1); 21 U.S.C. § 342. See Degnan, supra note 80 at 199.

[87] 57 Fed. Reg. 22990. The Statement of Policy further explains that:

When the substance present in the food is one that is already present at generally comparable or greater levels in currently consumed foods, there is unlikely to be a safety question sufficient to call into question the presumed GRAS status of such naturally occurring substances and thus warrant formal premarket review and approval by FDA. Likewise, minor variations in molecular structure that do not affect safety would not ordinarily affect the GRAS status of the substances and, thus, would not ordinarily require regulation of the substance as a food additive. Id.

[88] See Id at 22990 (emphasis added).

[89] “For example, if a food derived from a new plant variety contains a novel protein sweetener as a result of the genetic modification of the plant, that sweetener would likely require submission of a food additive petition and approval by FDA prior to marketing.” Id.

[90] See infra text accompanying notes 240-242.

[91] 57 Fed. Reg. at 22991.

[92] 57 Fed. Reg. at 22991 (emphasis added).

[93] 57 Fed. Reg. at 22991 (emphasis added).

[94] 57 Fed. Reg. at 22991.

[95] Food Labeling; Foods Derived From New Plant Varieties , 58 Fed. Reg. 25837 (April 28, 1993).

[96] Id. at 58 Fed. Reg. 25838.

[97] Id. at 58 Fed. Reg. 25838.

[98] Id. at 58 Fed. Reg. 25839 (emphasis added).

[99] In fairness, the “inherent” language seems to stem from FDA’s food safety regulations. An “added poisonous or deleterious substance” is, according to FDA rules, a substance which is not an “inherent natural constituent of a food”, 21 C.F.R. § 109.3(c), (d) (emphasis added). But see United States v. Anderson Seafoods, 622 F.2d 157 (5th Cir. 1980). Nonetheless, those regulations have no necessary relation to ingredient labeling requirements.

[100] As of July 2, 2001, the FDA has given its approval to 52 genetically modified food products through the current voluntary consultation process (one in 1994; fourteen in 1995; eleven in 1996; six in 1997; thirteen in 1998; three in 1999; three in 2000 and; one in 2001). See Center for Food and Safety and Applied Nutrition, List of Completed Consultations on Bioengineered Foods: July 2001 , available at http://www.cfsan.fda.gov/~lrd/biocon.html (last visited, Jan. 17, 2001).

[101] Goldman, supra note 30 at 735.

[102] See FDA CONSUMER , First Biotech Tomato Marketed , Sept. 1994, available at http://www. cfsan.fda.gov/~1rd/biotech.htm (last visited Jan. 9, 2002); Center for Food Safety and Applied Nutrition, FDA Backgrounder , May 18, 1994, available at http://www. cfsan.fda.gov/~1rd/biotechn.htm (last visited Jan. 9, 2002). Aside from the sources cited throughout this section, for very general information regarding this particular issue see internet sources cited at supra note 30.

[103] Secondary Direct Food Additives Permitted in Food for Human Consumption; Food Additives Permitted in Feed and Drinking Water of Animals; Aminoglycoside 3'-Phosphotransferase II , 59 Fed. Reg. 26700 (May 23, 1994).

[104] 59 Fed. Reg. at 26705. (“. . .Calgene's petition seeks to amend the food additive regulations to permit the use of APH(3')II only in tomato, cotton, and oilseed rape; approval of Calgene's petition would not mean that developers could use the kan superr gene in crops other than those identified in the petition.”). The final incorporation of APH(3')II as a secondary direct food additive permitted in food for human consumption is in 21 C.F.R. 173.170 (59 Fed. Reg. 26711, May 23, 1994).

[105] WILLIAM BAINS, BIOTECHNOLOGY FROM A TO Z 331-32 ( Oxford University Press, 1998). See also, 59 Fed. Reg. at 26702 (May 23, 1994).

[106] Goldman, supra note 30 at 735.

[107] In more technical terms, antisense RNA or DNA is:

a single-stranded nuclei acid that is complementary to the coding, or ‘sense’, strands of a gene, and hence is also complementary to the mRNA produced from that gene. If the antisense RNA is present in the cell at the same time as the mRNA, it hybridizes to it, forming a double helix. This double helical RNA cannot then be translated by ribosomes to make protein. Thus, antisense RNA can be used to block the expression of genes that makes proteins.

BAINS, supra note 1, at 19.

[108] BAINS, supra note 1 at 17-19; see also , Goldman, id.

[109] BAINS, supra note 1 at 17-19; see also , Goldman, id. ; NOTTINGHAM, supra note 13, at 64-68.

[110] BAINS, supra note 1 at id.

[111] 59 Fed. Reg. at 26702; Goldman, supra note 30 at 736-37.

[112] 59 Fed. Reg. at 26702.

[113] 59 Fed. Reg. at 26702; Goldman, supra note 30 at 736-37; Center for Food Safety and Applied Nutrition, FDA Backgrounder , May 18, 1994, available at http://www. cfsan.fda.gov/~1rd/biotechn.htm (last visited Jan. 9, 2002).

[114] 59 Fed. Reg. at 26702.

[115] In sum, the agency concluded:

FDA agrees with Calgene that the characteristics of APH(3')II do not raise a safety concern. First, each whole food, on average, contains several thousands of different proteins. As a class, proteins are rarely toxic and APH(3')II is not known to be toxic. Second, APH(3')II is a phosphorylating enzyme, and all plants and animals that are part of the food supply contain such phosphorylating enzymes without adverse consequences. Third, APH(3')II has been shown to be rapidly degraded under simulated gastric conditions. Finally, the estimated dietary exposure to APH(3')II is very low (480 MUg APH(3')II per person per day, or 0.16 part per million in the diet, based on a 100-percent market share for tomatoes containing APH(3')II). 59 Fed. Reg. at 26702.

[116] 59 Fed. Reg. at 26703.

[117] 59 Fed. Reg. at 26703.

[118] 59 Fed. Reg. at 26704.

[119] Goldman, supra note 30 at 737-38.

[120] 59 Fed. Reg. at 26704-05.

[121] 59 Fed. Reg. at 26709 (emphasis added).

[122] See supra , text accompanying note 52.

[123] See 21 C.F.R. § 101.100(a)(3)(ii)(c). This section states that:

(a) The following foods are exempt from compliance with the requirements of section 403(i)(2) of the act (requiring a declaration on the label of the common or usual name of each ingredient when the food is fabricated from two or more ingredients).



(c) Substances that are added to a food for their technical or functional effect in the processing but are present in the finished food at insignificant levels and do not have any technical or functional effect in that food.

[124] Sec. 403(i)(2); 21 U.S.C. 343(i)(2).

[125] See Sea Snack Foods v. United States, Civ. No. 87-3229 (D.D.C. 1987) reprinted in KLEINFELD & KAPLAN, FEDERAL FOOD, DRUG, AND COSMETIC ACT: JUDICIAL RECORD 1987-1988 at 212 (1989); see also Food Drug Cosm. L. Rep.¶ 50,163.

[126] 21 C.F.R. § 101.100(a)(3)(ii)(c) (emphasis added) (see also supra note 123).

[127] See Sea Snack Foods , supra note 125.

[128] The authority to establish such regulation could be drawn either from section 403(i)(2) itself (direct grant of authority to establish exemptions) or from section 701(a) of the FD&C Act, 21 U.S.C. 371 (vesting the Secretary of HHS with the general authority to promulgate regulations for the efficient enforcement of the Act). FDA properly established final regulations are upheld by the Courts unless they are “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law”. See HUTT & MERRILL , supra note 30, at 1252.

[129] Young v. Community Nutrition Institute, 106 S.Ct. 2360, 2364-65 (1986).

[130] See infra Section III, and text accompanying n. 279.

[131] 59 Fed. Reg. at 26709.

[132] See HUTT & MERRIL , supra note 30, at 75; see also , David F. Cavers, The Food, Drug, and Cosmetic Act of 1938: Its Legislative History and its Substantive Provisions, 6 LAW & CONTEMP. PROBS. 2 (1939) cited in HUTT & MERRIL , id.

[133] See supra text accompanying note 91 (citing 57 Fed. Reg. at 22991).

[134] This particular information was found in: Larry Thompson, Are Bioengineered Foods Safe? , 34(1) FDA CONSUMER MAGAZINE (2000), available at http://www.fda.gov/fdac/features/ 2000/100_bio.html (last visited, January 16, 2002). However, we were not able to find FDA’s official statement regarding this decision.

[135] Lara Beth Winn, supra note 9, at 672-75.

[136] 21 C.F.R. § 102.5(c) (emphasis added).

[137] Winn, supra note 9, at 673.

[138] Id.

[139] Id .

[140] Id.

[141] Id. at 673.

[142] Id . at 673-74. The text in italics is directly cited by Winn from the following official documents, respectively: Proposed Common or Usual Names , 37 Fed. Reg. 12,327 (June 22, 1972); Common or Usual Names for Nonstandardized Foods , 38 Fed. Reg. 6964, 6965 (Mar. 14, 1973); Food Standards of Identity, Quality and Fill of Container; Common or Usual Name Regulations; Request for Comments on Existing Regulations , 60 Fed. Reg. 67,492, 67,498 (Dec. 29, 1995).

[143] Winn, supra note 9, at 674.

[144] BAINS , supra note 1, at 73-74; NOTTINGHAM, supra note 13, at 27; Goldman, supra note 30, at 728.

[145] Id. General information about the drug can be found at Monsanto’s Posilac web page: http://www.monsanto.com/dairy/Default.htm (last visited Jan. 20, 2002).

[146] See 58 Fed. Reg. 59,946 (Nov. 12, 1993) (codified at 21 C.F.R. § 510, 522); see also Stauber v. Shalala, 895 F. Supp. 1178, 1183 (W.D. 1995).

[147] Simpson, supra note 30 at 225 (2001).

[148] See Ben & Jerry’s Homemade, Inc., v. Lumpkin, No. 96 C 2748, 1996 U.S. Dist. LEXIS 12469 (E.D. Ill. Aug. 27, 1996) (unpublished decision). Congress declared a 90 day moratorium on the sale of the drug to review FDA’s approval. See Goldman, supra note 30, at 731.

[149] 895 F. Supp. 1178 (W.D. Wisconsin, 1995).

[150] Sauberg , id. at 1182.

[151] Sauberg , id. at 1183.

[152] Sauberg , id. at 1184.

[153] Sauberg , id. at 1184.

[154] Sauberg , id. at 1184-85. Also, the FDA found that there was no increase in the amount of somatic cells (white blood cells) on milk from cows treated with rbST any more than there is as a result of other factors such as lactation stage or “cow parity”. Sauberg , id. at 1185.

[155] Sauberg , id. at 1185.

[156] Interim Guidance on the Voluntary Labeling of Milk and Milk Products From Cows that have not been Treated with Recombinant Bovine Somatotropin , 59 Fed. Reg. 6279 at 6280 (Feb. 10, 1994) (emphasis added).

[157] Interim Guidance on the Voluntary Labeling of Milk and Milk Products From Cows that have not been Treated with Recombinant Bovine Somatotropin , 59 Fed. Reg. 6279 (Feb. 10, 1994).

[158] See text accompanying supra note 39.

[159] Interim Guidance , 59 Fed. Reg. 6279 at 6280.

[160] Ben & Jerry’s Ice Cream, Chocolate Fudge Brownie & Vanilla Heath Bar Crunch/N.Y Super Fudge Chunk/Peanut Butter Cup: 2 Twisted Ice Creams Series (2002). (Notice that the statement is qualified with (1) an uncertain reliance in farmer’s promise of not treating their cows with rbST and; (2) the fact that the FDA has found no difference among milk from treated and untreated cows).

[161] Stauber, 895 F. Supp. 1178 at 1193.

[162] Stauber, id.

[163] Stauber, id. (emphasis added).

[164] Which stems from FDA’s 1992 statement of policy.

[165] Alliance for Bio-Integrity v. Shalala, 116 F. Supp.2d 166 (D.D.C. 2000).

[166] As for the latter, they argued that FDA’s decision not to require labeling for foods developed using recombinant DNA violated the constitutional clause, as well as the Religious Freedom Restoration Act. Alliance for Bio-Integrity , 116 F. Supp.2d at 170.

[167] Id at 179.

[168] Alliance for Bio-Integrity , 116 F. Supp.2d at 178.

[169] United States v. Ninety-Five Barrels of ... Apple Cider Vinegar, 265 U.S. 438, 445 (1924).

[170] 494 U.S. 872 (1990).

[171] Alliance for Bio-Integrity , 116 F. Supp.2d at 179-80.

[172] See United States v. O’Brien, 391 U.S. 367 (1968); Heffron v. ISKCON (Int’l Soc. for Krishna Consciousness), 452 U.S.640 (1981); Clark v. Community for Creative Non-Violence, 468 U.S. 288 (1984); Cohen v. Cowles Media, 501 U.S. 663 (1991); Mitchell v. Helms, 120 S. Ct. 2530 (2000).

[173] 42 U.S.C. § 2000bb-2000bb-4.

[174] See City of Boerne v. Flores, 521 U.S. 507 (1997). Section 5 of the XIV empowers Congress to apply the First amendment and other clauses of the bill of right directly against states. However, by narrowly interpreting that section, the Court in Boerne deemed RFRA to be an ultra vires congressional enactment.

[175] 42 U.S.C. § 2000bb-1(a-b).

[176] Alliance for Bio-Integrity , 116 F. Supp.2d at 180.


[178] NOWAK & ROTUNDA, CONSTITUTIONAL LAW §17.6 at 1377 (2000).

[179] See Degnan, supra note 30; Goldman, supra note 30; Simpson, supra note 30; Thue-Vasquez, supra note 9; Winn, supra note 9.

[180] See text accompanying supra notes 121-143 (in Section II.D.1).

[181] Winn, supra note 9, at 669; Simpson, supra note 30, at 239 (2001) .

[182] Id.

[183] See 51 Fed. Reg. 13376, 13378-79 (April 18, 1986).

[184] Degnan, supra note 30, at 306, 309 (emphasis added).

[185] See infra Section III.

[186] 51 Fed. Reg. at 13388 (emphasis added).

[187] 51 Fed. Reg. at 13388 (emphasis added). To that extent, the agency also stated the following:

Several comments in favor of a retail label requirement argued that irradiation of food altered the organoleptic properties of food and reduced its nutritional value and that these changes are material facts requiring disclosure under sections 403(a) and 201(n) of the act. The comments stated that consumers have a right to know whether such processing has taken place . . . . Therefore, the agency must decide whether the changes in the organoleptic properties of irradiated foods constitute a material fact or whether the information that a food has been irradiated constitutes information that is material to a consumer even if the organoleptic changes were not significant.

. . . Even those opposed to a retail labeling requirement agree that under certain conditions irradiation causes substantial changes in the organoleptic properties of some foods. Moreover . . . irradiation may not change the food in any way that is visible to the consumer, so a label statement provides the only means of letting consumers know that a food has been irradiated. . . . Thus, the absence of a label statement on retail foods may incorrectly suggest that an irradiated food is essentially unprocessed. Therefore, this regulation provides that the retail label contain a statement that the food has been irradiated.

51 Fed. Reg. at 13390 (emphasis added).

[188] Draft Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have not been Developed Using Bioengineering , (Announcement) 66 Fed. Reg. 4839 (Jan. 18, 2001). The guidance is available at: http://www.cfsan.fda.gov/~lrd/../~dms/biolabgu.html (last visited Jan. 17, 2002). See also Simpson, supra note 30, at 239.

[189] HUTT & MERRILL , supra note 30, at 82-84.

[190] See Degnan, supra note 30, at 305.

[191] Proposed Rules Department of Health and Human Services 21 CFR Parts 101 and 105 Food Labeling; Mandatory Status of Nutrition Labeling and Nutrient Content Revision 55 Fed. Reg. 29487, 29491 (July 19, 1990).

[192] Proposed Rules , 55 Fed. Reg. at 29491-92 (emphasis added).

[193] Proposed Rules , 55 Fed. Reg. at 29490.

[194] 92 F.3d 67 (2nd Cir 1996).

[195] Statute cited in Adopted Rules (rBST Notification and Labeling Regulations Relating to Milk and Milk Products) of Vermont Dep’t of Agriculture, Food and Markets, § 3.1b, in International Dairy Foods , 92 F.3d 67 at 70.

[196] Vt. Stat. Ann. Tit. 6, § 2754(c). Cited in International Dairy Foods , 92 F.3d 67 at 69.

[197] Adopted Rules (rBST Notification and Labeling Regulations Relating to Milk and Milk Products) of Vermont Dep't of Agriculture, Food and Markets, § 3.1b Cited in International Dairy Foods , 92 F.3d 67 at 70.

[198] Which is undoubtedly true. See West Virginia State Bd. of Ed. v. Barnette, 319 U.S. 624, 633, 63 S.Ct. 1178, 1183, 87 L.Ed. 1628 (1943) (declaring unconstitutional a compulsory school flag salute); Wooley v. Maynard, 430 U.S. 705, 714, 97 S.Ct. 1428, 1435, 51 L.Ed.2d 752 (1977) (unconstitutional compulsory carrying of “Live Free or Die” license-plate).

[199] For a recent Supreme Court case which recognizes such protection see United States v. United Foods, 121 S. Ct. 2334 (2001). See also Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626, 105 S.Ct. 2265 (1985).

[200] Although we will offer our own constitutional assessment of this case (for very recent First Amendment case-law informs our opinion), for a general critique of some of its constitutional aspects, see Nicole B. Casarez, Don’t Tell Me What to Say: Compelled Commercial Speech and the First Amendment , 63 MO. L. REV. 929 (1998); Caren Schmulen Sweetland, The Demise of a Workable Commercial Speech Doctrine: Dangers of Extending First Amendment Protection to Commercial Disclosure Requirements, 76 TEX. L. REV. 471 (1997) .

[201] Widmar v. Vincent, 454 U.S. 263 (1981).

[202] Central Hudson Gas & Elec. Corp. v. Public Service Commission of New York, 100 S.Ct. 2343, 2351 (1980) (emphasis added).

[203] International Dairy Foods , 92 F.3d 67 at 73.

[204] Id.

[205] Id. at 75 (Leval, dissenting).

[206] Id. at 78 (Leval, dissenting).(“Any one of these concerns may well suffice to make Vermont's interest substantial; all four, taken together, undoubtedly constitute a substantial governmental justification for Vermont's labeling law” Id. )

[207] 471 U.S. 626, 105 S.Ct. 2265 (1985).

[208] Id. at 638.

[209] Id. at 650-51.

[210] Id. at 651 n.14 (emphasis added).

[211] Id . at 651 (emphasis added).

[212] 4 RONALD D. ROTUNDA & JOHN E NOWAK, TREATISE ON CONSTITUTIONAL LAW: SUBSTANCE AND PROCEDURE § 20.31 at 26 (3rd Ed. 1999, 2001 Supp.) (emphasis added).

[213] Id. at 26-27 (referring to Lamont v. Postmaster General , 496 U.S. 91 (1965)).

[214] United States v. United Foods, 121 S. Ct. 2334 (2001) (the mode of compelled speech in that case was through compelling the subsidizing of a public information program which entailed conveying a particular speech with which one mushroom producer disagreed, and where there was no broader comprehensive program restricting marketing autonomy). C.f. Glickman v. Wileman Brothers & Elliott, Inc., 521 U.S. 457 (1997).

[215] United Foods , id. at 2338.

[216] Id. (Citing Edenfeld v. Fane , 507 U.S. 761 (1993)).

[217] Note, for instance, that the Second Circuit in National Electrical Manufacturers v. Sorrel , 272 F.3d 104 (2001), upheld a labeling requirement for light bulbs that contained mercury. Of course, the safety concerns that justified such requirement, was sufficient enough for the court as opposed to the interests considered in International Dairy Foods

[218] International Dairy Foods v. Amestoy, 92 F.3d 67 at 70 (1996).

[219] S 2080 (106th Congress, 2d Session, Feb. 22, 2000).

[220] S 2080 (Feb. 22, 2000), sec. 3(a).

[221] On the difficulties that assessing the message that a specific labeling requirement may impose see, for example, Office of Scientific Analysis and Support, Report on Consumer Focus Groups on Biotechnology, October 20, 2000, available at http://www.cfsan.fda.gov/~comm/biorpt.html (last visited Jan. 30, 2002).

[222] On the general constitutional validity of neutral rules of general applicability see text accompanying supra note 172.

[223] Biotechnology in the Year 2000 and Beyond; Public Meetings , 64 Fed. Reg. 57470 (Oct. 25, 1999).

[224] Id.

[225] FDA Announces Public Meetings on Bioengineered Foods , October 18, 1999, available at http://www. cfsan. fda.gov/~1rd/hhbioeng.html (last visited Jan 8, 2002).

[226] Draft Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have not been Developed Using Bioengineering , (Announcement) 66 Fed. Reg. 4839 (Jan. 18, 2001). The guidance is available at: http://www.cfsan.fda.gov/~lrd/../~dms/biolabgu.html (last visited Jan. 17, 2002).

[227] Premarket Notice Concerning Bioengineered Foods , 66 Fed. Reg. 4706 (Jan. 18, 2002).

[228] In fact, the guidance sums up the practical conclusions of non-mandatory labeling policy in the following terms: (1) “If a bioengineered food is significantly different from its traditional counterpart such that the common or usual name no longer adequately describes the new food, the name must be changed to describe the difference.”; (2) “If an issue exists for the food or a constituent of the food regarding how the food is used or consequences of its use, a statement must be made on the label to describe the issue.”; (3) “If a bioengineered food has a significantly different nutritional property, its label must reflect the difference.”; and (4) “If a new food includes an allergen that consumers would not expect to be present based on the name of the food, the presence of that allergen must be disclosed on the label.” Draft Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have not been Developed Using Bioengineering (Jan. 18, 2001).

[229] Draft Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have not been Developed Using Bioengineering , available at , http://www.cfsan.fda.gov/~lrd/../~dms/biolabgu.html (last visited Jan. 17, 2002).

[230] Such statement must not be made on the list of ingredients, for optional descriptions of ingredients are deemed to be forbidden “intervening material” if placed in such listing. Draft Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have not been Developed Using Bioengineering , available at , http://www.cfsan.fda.gov/~lrd/../~dms/biolabgu.html (last visited Jan. 17, 2002).

[231] Draft Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have not been Developed Using Bioengineering , available at , http://www.cfsan.fda.gov/~lrd/../~dms/biolabgu.html (last visited Jan. 17, 2002).

[232] Id.

[233] Id.

[234] See text accompanying supra notes 157-159.

[235] Draft Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have not been Developed Using Bioengineering , available at , http://www.cfsan.fda.gov/~lrd/../~dms/biolabgu.html (last visited Jan. 17, 2002).

[236] Id.

[237] FDA to Strengthen Pre-Market Review of Bioengineered Foods, FDA Press Release May 3rd , 2000, available at http://www.cfsan.fda.gov/~lrd/hhbioen2.html (last visited Jan. 8, 2002).

[238] See Guidance on Consultation Procedures: Foods Derived From New Plant Varieties (October, 1997) (superseding the June 1996 version) available at http://www.cfsan.fda.gov/~lrd/consulpr.html (last visited Jan. 13, 2002).

[239] 66 Fed. Reg. at 4722.

[240] See supra note 100. See also , Proposed Rules Issued for Bioengineered Foods , FDA CONSUMER ( March-April 2001).

[241] 66 Fed. Reg. at 4708.

[242] Proposed Rules Issued for Bioengineered Foods , FDA CONSUMER ( March-April 2001).

[243] See proposed rules 21 C.F.R. 192.10, 192.20 in 66 Fed. Reg. at 4730-31.

[244] Several pages of the proposal are devoted to explaining the procedures and details of the disclosure of the relevant information. See 66 Fed. Reg. at 4714-16 (regarding public disclosure of the consultation process) and 66 Fed. Reg. 4723-24 (regarding public disclosure of the PBN).

[245] 5 U.S.C. §552.

[246] 5 U.S.C. §552(a)(3) "...each agency, upon any request for records..., shall make the records promptly available to any person."

[247] 5 U.S.C. §552(b)(1)-(9).

[248] 5 U.S.C. §552( b)(4).

[249] National Parks & Conservation Assn v. Morton, 498 F.2 d765, 770 ( DC Cir. 1974). See 1 O’REILLY, FEDERAL INFORMATION DISCLOSURE 14-11 (1990).

[250] Food for Thought: An interview with Joseph A. Levitt, FDA CONSUMER MAGAZINE ( September-October 2001) available at http://www.fda.gov/fdac/features/2001/501_food.html (last visited Jan. 22, 2002). See also HHS Press Release Jan 17, 2001 (“a series of FDA-sponsored public meetings and subsequent written public comments indicated considerable public support for a mandatory and more transparent process”), available at http://www.cfsan.fda.gov/~lrd/hhbioen3.html (last visited Jan 8, 2002).

[251] P.W.B. Philips & H. McNeill, Labeling for GM foods: Theory and Practice3(4) AgBioForum 219 (2000), available and updated at http://www.agbioforum.org/vol3no4/vol3no4ar7phillipsmcneill.htm (last visited Jan. 13, 2002).

[252] Id.

[253] Id.

[254] Matthew Rousu & Wallace Huffman, GM Food Labeling Policis of the US and its Trading Partners , Staff Paper No. 344 Consortuim to Address Social, Economic, and Ethical Aspects of Biotechnology available at http://www.biotech.iastate.edu/publications/IFAFS/gmtrade.pdf (last visited, Jan. 17, 2002); Lietz, supra note 11, at 423-24. See also Standard 1.5.2 of the Australia/New Zealand Food Standards Code, available at http://www.anzfa.gov.au/foodstandardscodecontents/standard15/standard152.cfm (last visited, Jan. 21, 2002).

[255] Id.

[256] Id.

[257] Id.

[258] Lietz, supra note 11, at 423.

[259] Teel, supra note 23, at 682.

[260] Goldman, supra note 30, at 721.

[261] Matthew Rousu & Wallace Huffman, GM Food Labeling Policis of the US and its Trading Partners , Staff Paper No. 344 Consortuim to Address Social, Economic, and Ethical Aspects of Biotechnology available at http://www.biotech.iastate.edu/publications/IFAFS/gmtrade.pdf (last visited, Jan. 17, 2002).

[262] Genetically Modified Organisms(GMOs)-Community Legislation in Force-Labelling, available at http://europa.eu.int/comm/food/fs/gmo/gmo_legi_label_en.html (last visited Jan. 8,2002).

[263] EP & Council Regulation 258/97, 1997 O.J. (L43/1).

[264] Council Regulation 1139/98, 1998 O.J. (L159/4); Council Regulation 49/2000, 2000 O.J. (L6/13).

[265] Council Regulation 50/2000, 2000 O.J. (L6/15).


[267] Christopher Wyeth Kirkham, Novel Foods and Food Development , 3 COLUM. J. EUR. L. 317, 317-18 (1997)

[268] OJ L 43,14/02/1997 p.0001-0007; Kirkham, id. at 318.

[269] OJ L 43,14/02/1997 p.0001-0007; Kirkham, id. at 318; O’ROURKE, supra note 266, at 159.

[270] OJ L 43,14/02/1997 p.0001-0007; Kirkham, id. at 318.

[271] “Novel foods and novel food ingredients must be labelled in accordance with the framework Directive on food labelling (2000/13/EC)” O’ROURKE, supra note 266, at 162.

[272] O’ROURKE, supra note 266, at 162 (emphasis added).

[273] Ruth MacKenzie & Silvia Francescon, The Regulation of Genetically Modified Foods in the European Union: An Overview , 8 N.Y.U. ENVTL. L. J. 530, 548 (2000).

[274] See EP & Council Regulation 258/97, Art. 1(2), 1997 O.J. (L43/1).

[275] See Commission Decision 96/281, 1996 O.J. (L 107) 10 (Glycine max L.).

[276] See Commission Decision 97/98, 1997 O.J. (L 31) 69 (Zea mays L.).

[277] Council Regulation 1139/98, 1998 O.J. (L159/4) Preamble ¶ 4.

[278] Id .

[279] Teel, supra note 23, at 676.

[280] Council Regulation 1139/98, 1998 O.J. (L159/4), Art. 2, ¶ 2.

[281] See Council Regulation 1139/98, 1998 O.J. (L159/4), Preamble ¶¶ 14-15.

[282] Council Regulation 49/2000, 2000 O.J. (L6/13), Art. 1(2)(a).

[283] O’ROURKE, supra note 266, at 164.

[284] Health and Consumer Protection Directorate-General, Questions and Answers on the Regulation of GMOs in the EU, Memo/01/277 Revised, Brussels, Oct. 29, 2001, available at http://europa.eu.int/ comm/dgs/health_consumer/library/press/press208_en.pdf (last visited, Jan. 26, 2002).

[285] Available at http://europa.eu.int/comm/food/fs/biotech/biotech09_en.pdf (last visited, Jan. 26, 2002).

[286] Available at http://europa.eu.int/comm/food/fs/biotech/biotech08_en.pdf (last visited, Jan. 26, 2002).

[287] Proposal COM(2001)0425 for a Regulation of the European Parliament and of the Council on genetically modified food and feed, available at http://europa.eu.int/comm/food/fs/biotech/ biotech08_en.pdf (last visited, Jan. 26, 2002), at 8.

[288] See Proposal COM(2001)0425 for a Regulation of the European Parliament and of the Council on genetically modified food and feed, available at http://europa.eu.int/comm/food/fs/biotech/ biotech08_en.pdf (last visited, Jan. 26, 2002), ¶ 21; EP & Council Regulation 258/97, 1997 O.J. (L43/1), Art. 8.

[289] The recognition of a consumer’s right to know is embodied in Article 153 of the E.C. Treaty, which has the objective of promoting “the consumer’s right to information and education and their right to organize themselves in order to safeguard their interests.” The Amsterdam Treaty: A Comprehensive Guide , available at http://europa.eu.int/scadplus/leg/en/lvb/a17000.htm (last visited, Jan. 9, 2002).

[290] EU Needs Venture Capital Market for Biotechs , Reuters, Feb. 4, 2002, available att http://www.thecampaign.org/News/feb02b.htm (last visited Feb. 11, 2002).

[291] Wyn Grant, Different EU and US Perspectives on Biotechnology and their Implications for Trade Relations , in OTTO T. SOLBRIG, ET AL., GLOBALIZATION AND THE RURAL ENVIRONMENT 393 (DRCLAS/Harvard University Press, 2001).

[292] Julia A. Moore, More than a Food Fight , Issues in Science and Technology Online (Summer 2001) available at http://www.nap.edu/issues/17.4_moore.htm (last visited Jan. 8, 2002).

[293] It is estimated that, over the next 30 years as many as 500,000 people in Britain could die from the human form of the disease. Julia A. Moore, More than a Food Fight , Issues in Science and Technology Online (Summer 2001) available at http://www.nap.edu/issues/17.4_moore.htm (last visited Jan. 8, 2002).

[294] Grant, supra note 291, at 395 .

[295] Id. at 396.

[296] Id. at 398.

[297] Francesco di Castri, Urban-Rural Interactions: Introduction , in OTTO T. SOLBRIG, ET AL., GLOBALIZATION AND THE RURAL ENVIRONMENT 415, 417 (Harvard University Press, 2001).

[298] Francesco di Castri, Rural Values and the European View of Agriculture, in OTTO T. SOLBRIG, ET AL., GLOBALIZATION AND THE RURAL ENVIRONMENT 483, 502 (Harvard University Press, 2001)

[299] Grant, supra note 291,at 399. “More recently, defense of rural values is also taken in Europe as a barrier against the cultural uniformity supposedly produced by globalization. Globalization is perceived by Europeans as an American-driven process promoted by a new economic ideology of domination, the so-called neoliberalism. ” Francesco di Castri, Rural Values and the European View of Agriculture, in OTTO T. SOLBRIG, ET AL., GLOBALIZATION AND THE RURAL ENVIRONMENT 483, 502 (Harvard University Press, 2001).

[300] “It has . . . been argued that attitudes to technology are different on either side of the Atlantic with Americans being more welcoming of the benefits of technology which is seen as a contributor to progress, which itself is viewed in a more positive light.” Grant, supra note 291, at 399.

[301] Marsha A. Echols, Food Safety Regulation in the European Union and the United States: Different Cultures, Different Laws , 4 COLUM. J. EUR. L . 525 (1998).

The culture and attitudes of European citizens have tended to favor traditional foods and minimal processing, while being skeptical of new technologies. This skepticism has slowed the Community's broader regulatory process as well as particular governmental approvals in the EU. In contrast, Americans have been more willing to accept new technologies, an attitude that supports business innovation and a flexible regulatory system supportive of changing technology but skeptical of some traditional production processes.

Id. at 526.