IFT Expert Report on Biotechnology and Foods

U.S. Food Labeling in General
Current Requirements, Policies, and Constraints
· Food and Drug Administration Requirements and Policies. Generally speaking, the Food and Drug Administration (FDA) has authority over food labeling, and the Federal Trade Commission (FTC) has authority over food advertising. A detailed analysis of FTC and its responsibilities regarding food advertising is beyond the scope of this paper; however, a brief overview follows later in this section.

Except for meat and poultry products regulated by the U.S. Department of Agriculture (USDA), the federal law governing the labeling of food generally is the Federal Food, Drug, and Cosmetic Act (FFDCA) [21 USC §§301–397]. The FFDCA is administered by FDA. Under this statute, FDA regulates food labeling through a series of requirements that are intended to assure that information of significance about a food product is provided and that food labeling is truthful and not misleading.

“Labeling” is defined in the FFDCA as “written, printed, or graphic matter (1) upon any article or any of its containers or wrappers,or (2) accompanying such article” [21 USC §321(m)]. Thus, “labeling” includes—but is not limited to—the “label” that is physically attached to the immediate container of foods in package form [21 USC §321(k)]. Physical attachment or proximity of the material to the product is not required for the material to be considered “labeling” for purposes of the statute. In 1948, the Supreme Court found that a booklet containing information about a product that was sold separately from the product was nevertheless “labeling” for purposes of the statute because the product and the booklet “were parts of an integrated distribution scheme” [Kordel v. United States, 335 US 345 (1948)]. The court in Kordel also pointed out that material that is not regulated as labeling by FDA will be regulated as advertising by FTC.

At the most basic level, the FFDCA and its implementing regulations specify that certain information is required on the labels of almost all foods. These label requirements are intended to assure provision of information that is fundamental to the description of the food or the operation of the food safety regulatory system. Examples of these label requirements are the common or usual name (or other name) of the food; net contents statement; an ingredient listing for food products made from more than one ingredient; name and place of business of the manufacturer, packer, or distributor; and nutrition labeling.

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· Constitutional Constraints. In the American legal system, the U.S. Constitution is paramount. Therefore, all statutory labeling requirements, their implementing regulations, and FDA labeling policies must satisfy constitutional requirements. The principal constitutional consideration in food labeling matters is First Amendment constraint of government labeling regulation. The First Amendment of the U.S. Constitution states: “Congress shall make no law . . . abridging the freedom of speech.” This right has recently been extended to include “commercial speech,” which is commonly defined to be speech in any form that advertises a product or service for profit or for any business purpose, or as speech that proposes a legitimate business or commercial transaction [Virginia State Bd. of Pharmacy v. Virginia Citizens Consumer Council, 425 US 748 (1976)].

Until the 1970s, advertising or labeling restrictions were viewed as purely economic regulations that did not implicate the First Amendment. Indeed, until the late 1970s, the Supreme Court had excluded commercial speech from the coverage of the First Amendment [Valentine v. Chrestensen, 316 US 52 (1942)]. Today, commercial speech is protected under the First Amendment, but can be subject to more stringent government regulation than other kinds of speech, such as political commentary.

For food labeling purposes, the most important modern commercial speech case is Central Hudson v. Public Service Com’n of N.Y. [447 US 557 (1980)]. In Central Hudson, the Supreme Court held that commercial speech is protected by the First Amendment, and set forth a four-pronged test for determining permissible regulation of commercial speech. Under Central Hudson, the government may restrict commercial speech if (1) the speech is either misleading or concerns an unlawful activity, or if (2) the asserted governmental interest in support of the restriction is substantial, (3) the restriction directly advances the government’s substantial interest, and (4) the regulation is not more extensive than is necessary to serve that interest.

The First Amendment protects both the right to speak and the right not to speak. The constitutionally protected right not to speak, the compelled speech doctrine, is clearly established in Supreme Court precedent [Harper & Row, Publishers, Inc. v. National Enter., 471 US 539 (1985); Wooley v. Maynard, 430 US 705 (1977)]. Indeed, the Supreme Court has suggested that compelling someone to speak involuntarily is an even more serious constitutional matter than preventing speech [West Virginia State Bd. of Ed. v. Barnette, 319 US 624 (1943)].

The regulation of food labeling involves both the commercial speech and the compelled speech doctrines. The courts have not articulated a “compelled commercial speech” doctrine. Therefore, in assessing the constitutionality of government restrictions on commercial speech, the courts have applied the four-pronged Central Hudson commercial speech analysis. It should also be noted that the courts have been at least as skeptical about government requirements that compel speech as about limitations on speech.

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· False or Misleading Statements. Beyond these fundamental label requirements and constitutional constraints discussed above, the food processor is generally at liberty to make use of label or labeling space in the manner it deems fit, provided that the label or labeling is not false or misleading. The FFDCA deems a food to be misbranded if “its labeling is false or misleading in any particular” [21 USC §343(a)(1)]. As noted above, the prohibition on misleading commercial speech is specifically reinforced by the Supreme Court’s decision in Central Hudson. Under that case, government restrictions on misleading commercial speech are not subject to the rigors of the second, third, and fourth prongs of the Central Hudson test. The prohibition of misleading labeling is the objective of many of the specific labeling requirements of the FFDCA, as well as the basis for most FDA regulation of voluntary labeling statements.

If a statement, picture, or other representation on the label or labeling of any food product is false or misleading, the food is misbranded regardless of the importance of the representation to the consumer. The Supreme Court has held that it is not necessary to show that anyone was actually misled or deceived, or that there was any intent to deceive, in order to find that a product is misbranded under the FFDCA [United States v. 95 Barrels-Cider Vinegar, 265 US 438 (1924)]. Other courts have stated that the test is not the effect of the label on a “reasonable consumer” but on “the ignorant, the unthinking, and the credulous” consumer [United States v. An Article of Food . . . ‘Manischewitz . . .Diet Thins’, 377 F.Supp. 746 (1974)].

The prohibition on false or misleading labeling statements reaches far beyond patently false claims. Statements that, while not false, are misleading are also prohibited. For example, a “cholesterol-free” claim for broccoli suggests that particular broccoli is cholesterol-free, while ordinary broccoli is not cholesterol-free. Thus, the claim is misleading, since ordinary broccoli does not contain cholesterol. To reinforce this interpretation, the FFDCA explicitly prohibits a claim that states the absence of a nutrient unless the nutrient is usually present in the food [21 USC §343(r)(2) (A)(ii)(I)]. To avoid being misleading, FDA permits the claim “broccoli, a cholesterol-free food,” but not “cholesterol-free broccoli” [21 CFR §101.13 (e)(2)].

Just as labeling statements may be misleading because of what they say or imply, they may be misleading by virtue of what they do not say. In determining whether a food labeling statement is misleading, FDA and the courts take into account the extent to which the labeling fails to reveal any material facts [21 USC §321(n)]. There is neither a statutory nor a regulatory definition of “material fact,” and the term has not been elaborately defined by the courts. Instead, determinations of whether or not a fact is material are made on a case-by-case basis, with an extensive body of precedents.

Generally, if a new or modified food is significantly different from its conventional counterpart in composition, nutritional value, or safety, the difference in the food would be considered a material fact. For example, if a new processing technique resulted in a significant decrease in the nutrient content or change in flavor, color, or other valued characteristic of a food, a label statement would be required to inform consumers of that material fact. Absent a label statement disclosing a material fact about a food, the presentation of the food would be misleading. So the FFDCA prohibition on false or misleading labeling may effectively require that a label include a disclosure of the material fact.

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While some FDA disclosure requirements are imposed to provide for safe use of food ingredients [e.g., 21 CFR §172.804, “Phenylketonurics: contains phenylalanine,” and 21 USC §343(o) regarding saccharin warnings] or to provide consumer warnings, many disclosure requirements are imposed to clarify or explain an otherwise misleading label statement. For example, FDA decided that a statement of the percent reduction is necessary to clarify a claim like “reduced fat” [21 CFR §101.13(j)(2)]. The agency determined that consumers would likely be confused unless the magnitude of the reduction was specified.

· Federal Trade Commission Requirements. FTC regulates food advertising under the Federal Trade Commission Act (FTCA) [15 USC §§41-58], which is similar in structure to the FFDCA. The FTCA generally prohibits “deceptive acts or practices in commerce” [15 USC §45(a)(1)]. It prohibits false advertising that is likely to induce the purchase of foods, and declares such false advertising to be prohibited as “deceptive acts or practices” [15 USC §52]. The term “false advertising” is defined as advertising that is “misleading in a material respect” [15 USC §55(a)(1)]. These FTCA provisions are similar to the FFDCA provisions on labeling that is false or misleading. To determine if advertising is false or deceptive, FTC examines whether and to what degree the information in the advertising can be substantiated, and whether there is a reasonable basis for the claims made in the advertising.

In the past, FTC has issued enforcement policy statements stating that it will defer to FDA regarding the enforcement of certain kinds of food advertising, e.g., the use of health claims and nutrient content claims (FTC, 1994). FTC has not yet elaborated on how it plans to enforce advertising regarding rDNA biotechnology-derived foods, so it is not clear whether and to what extent FTC might follow any FDA policy that is issued with respect to rDNA biotechnology-derived foods.

Labeling Case Studies
In evaluating the labeling framework for rDNA biotechnology-derived foods, consideration should be given to at least three analogous situations: irradiated foods, milk from rBST-treated cows, and organic foods.

· Food Irradiation. Irradiation is defined by statute as a food additive, the only process that is so defined. It entails the treatment of a food with an FDA-approved energy source that kills bacteria or pests, prevents sprouting of root vegetables, or extends shelf life in some foods.

Irradiation is an example of a process that triggers a label disclosure requirement because FDA determined that irradiation can render food materially different organoleptically, e.g., taste, smell, and texture. (Although the scientific information available today might support a different agency conclusion, that view is not relevant in the context of this case study.) Therefore, FDA determined by regulation that the fact that a food is irradiated is material, justifying the labeling requirement of a logo and a phrase such as “treated with irradiation” [21 CFR §179.26(c); FDA (1986)].

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Despite some limited studies indicating good consumer acceptance of irradiated food, food processors generally took a conservative position in adoption of the technology. They concluded that irradiated products with the mandatory labeling would be avoided by consumers and could result in loss of sales, bad publicity, and loss of investment. Other factors that may have inhibited use of irradiation are opposition by some activist groups, low-volume demand, overall cost of operation, high capital investment, technical expertise needed by workers, limited availability of suitable packaging, slow equipment development, and large sums of money already invested in alternative technologies. Nonetheless, there is considerable evidence that the irradiation labeling requirement slowed the food industry’s adoption of this technology.

Today, there are several recent examples where consumers have preferred an irradiated product to the traditional nonirradiated product. One example is strawberries, where irradiation extends the shelf life of the raw fruit. Recent concerns about microbiological safety of foods have drawn the public’s attention to the potential benefits of irradiation processing. As a result, some food processors are again considering further utilization of this technology.

In summary, FDA determined that the process of irradiation caused food to differ significantly from its conventional counterpart, thus making irradiation of food a material fact that must be disclosed. The irradiation label disclosure requirements have been cited as at least one significant factor inhibiting the use of this pathogen-reducing technology.

· Milk from rBST-Treated Cows. In the early 1990s, FDA approved treatment of dairy cows with recombinant bovine somatotropin (rBST), an rDNA biotechnology-derived version of a naturally occurring hormone that increases a cow’s milk production. FDA determined that milk produced by cows treated with rBST was not significantly different from conventional milk. Nonetheless, significant controversy accompanied the introduction of rBST into the marketplace. Some manufacturers attempted to address consumer interest in avoiding milk from rBST-treated cows by labeling milk products as “rBST-free.” FDA discouraged “rBST-free” claims because they implied that there is some compositional difference, such as the presence of rBST, between milk from treated and untreated cows. Rather, FDA encouraged the use of claims that address the production procedure rather than the product. So FDA announced that an appropriate way to phrase such an acceptable claim would be, “from cows not treated with rBST,” as long as the statement also provided a context that did not imply a difference between the milks. FDA’s example was to include with the claim the statement, “No significant difference has been shown between milk derived from rBST-treated and non-rBST-treated cows” (FDA, 1994).

The controversy over introduction of rBST was most pronounced in New England states where it was seen as a threat to the economic viability of the region’s small dairies. The state of Vermont enacted a law requiring that milk from cows treated with rBST bear a mandatory label disclosure. The constitutionality of this state labeling requirement was challenged in International Dairy Foods Association v. Amestoy [92 F.3d 67 (2d Cir. 1996)]. Vermont sought to justify its law on the basis of the consumer’s right to know, not on health or safety concerns. However, the U.S. Court of Appeals for the Second Circuit stated that Vermont’s limited justification was understandable, as “the already extensive record in the case contains no scientific evidence from which an objective observer could conclude that rBST has any impact on dairy products.” The Second Circuit applied the Central Hudson test for permissible commercial speech regulation, concluding that “consumer curiosity alone is not a strong enough state interest to sustain the compulsion of even an accurate, factual statement.”

Thus, without a material fact that distinguishes the characteristics of milk from rBST-treated cows from other milk, there was not a “substantial government interest” to justify the labeling requirement. As a result, Vermont’s disclosure requirement was unconstitutional. Voluntary label statements are required to meet the FFDCA’s “truthful and nonmisleading” standard. So voluntary label statements could only be made in a manner that did not mislead consumers about the milk product on which the claim appeared or the conventionally produced milk to which it was being compared.

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· Organic Foods. The term “organic” has been used to describe foods grown without certain modern farming practices that some consumers find objectionable. The organic food movement began using statements concerning the production of foods without the use of certain types of commercial pesticides and fertilizers. The focus of the organic movement has expanded and centered on the societal goals of some citizens, including a reduction in the usage of agricultural chemicals, a healthier environment, more humane treatment of animals, greater worker safety, and enhanced food safety. The movement established production criteria that not only pertained to conditions for growing crops but also for labeling and distribution of such foods. The organic movement originally enlisted several state governments to recognize or adopt documentation and inspection programs designed to demonstrate compliance with these criteria. In some cases, it has become necessary to provide separate production and distribution systems for organic and non-organic foods.

To date, scientific evidence does not demonstrate that organic foods have superior nutritional or food safety benefits over non-organic foods. Therefore, FDA has deemed some claims on organic foods misleading when the term “organic” has been used in a manner that implied that the organic food is somehow superior to a similar non-organic food.

In 1990, with the vigorous support of the organic food movement, Congress passed the Organic Food Production Act [7 USC §§6501-6522] which required USDA to develop national organic standards and establish an organic certification program based on recommendations from an expert panel. On March 13, 2000, USDA announced its National Organic Program (NOP), a comprehensive proposed rule that would set uniform national standards (USDA, 2000). USDA’s goal is to issue a final NOP rule by the end of 2000. These regulations are intended to further establish a market for a niche category of “organic” foods desired by consumers. Under the proposed rule, every farm or other organic operation would have to develop and carry out an “organic plan” that would be approved and certified by a USDA-accredited agent. The NOP would include a “National List” that sets forth which chemical substances are permitted for use in organic production.

The NOP also would create three categories of permissible label claims, each with its own criteria: “100 percent organic”; “organic”; and “made with organic (specified ingredients).” Products labeled “100 percent organic” would have to be all organic product; products bearing the “organic” label would have to contain not less than 95% organically produced product; and products labeled “made with organic (specified ingredients)” would have to contain at least 50% organic ingredients. Any of the three label claims could be used, in accordance with requirements set forth in the regulations; e.g., all would have to bear the seal or logo of the certifying agent, anywhere on the package and on any other labeling or market information about the product.

With the exception of products labeled “100 percent organic,” the listing for each organic ingredient would have to be qualified with the term “organic” in the ingredients statement. Products labeled “made with organic (specified ingredients)” would be subject to labeling limitations (e.g., maximum type size, no more than three organic ingredients may be listed), and, unlike products labeled “100 percent organic” or “organic,” would not be allowed to bear the USDA Organic Seal.

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In addition to the above categories, in order for products containing less than 50% organic ingredients to use the term “organic,” the label would have to declare the total percentage of organic ingredients on the information panel (the label panel that typically includes nutrition information, the ingredients statement, and similar information) and qualify each organic ingredient with the term “organic” in the ingredients statement. The product would not be allowed to use “organic” anywhere else on the label or to bear the USDA Organic Seal or the seal or logo of any certifying agent.

The proposed NOP rule is clear that rDNA biotechnology-derived and irradiated foods are not considered “organic.” Any product made with what the proposed rule terms “excluded methods” (which include the use of rDNA biotechnology) could not be labeled as “organic.” USDA made this decision based on “overwhelming public opposition” to the use of rDNA biotechnology in organic production systems, even though the agency admitted “there is no current scientific evidence that use of excluded methods presents unacceptable risks to the environment or human health” (USDA, 2000).

Thus, it may be possible for consumers wishing to avoid rDNA biotechnology-derived foods to purchase foods bearing one of the three “organic” label claims on the principal display panel. With organic products a rapidly growing percentage of the market—organic food sales in the U.S. have risen dramatically, from $78 million in 1980 to an estimated $6 billion in 2000, and projected annual growth is approximately 20%—organic foods appear to be a readily available option for consumers who wish to avoid rDNA biotechnology-derived foods.

The labeling of organic foods is an example of a voluntary program that focuses on production differences that are of significant consumer interest, even though they do not render foods materially different from their conventional counterparts. Under the constitutional restrictions described above, such distinctions may not be addressed through government-mandated disclosures, but may be freely described through voluntary label statements. To avoid confusion regarding the meaning of terms and to clarify rules in a manner that helps organic food processors and marketers avoid making misleading claims, Congress actively monitored USDA’s development of standards. Improved clarity of labeling terms and greater efficiency associated with higher product volumes appear to be facilitating growth in organic foods.

Summary
In summary, the FFDCA works within the constitutional framework to address the so-called “consumer’s right to know” or, more accurately, right to be informed of significant or material facts about their foods. This right is addressed through a corresponding duty for food marketers to label foods in a truthful, nonmisleading manner, including the disclosure of fundamental descriptive information about the food. The corresponding right to be informed and duty to disclose concerns all material facts regarding the food product, such as the fact that a food has been irradiated (because of FDA’s conclusion that there are organoleptic changes in food treated by irradiation). However, not all facts are material. As the Vermont rBST labeling litigation demonstrates, a fact that does not render a food significantly different from its conventional counterpart is not material and therefore is insufficient to give rise to informational rights and duties.

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Nonetheless, there may be extensive consumer interest in such information. As the organic foods experience demonstrates, when marketplace interest is sufficient, consumer information desires are served by the establishment of voluntary disclosure programs where necessary, with certain limitations and authorized label statements. These voluntary programs and labeling provisions have been used to achieve advantage in a competitive marketplace. Thus, the food labeling regulatory regime provides a graduated series of requirements to address consumer information rights and desires in a truthful, nonmisleading manner.

Labeling of rDNA Biotechnology-Derived Foods
U.S. Policies
FDA has not established special labeling requirements for foods derived using rDNA biotechnology. Yet, the general framework of food labeling regulation provides a series of food labeling requirements for rDNA biotechnology-derived foods.

· Mandatory Disclosures. As explained above, constitutional restrictions specified in Central Hudson and the FFDCA prohibition of labeling that is misleading by virtue of omission of a material fact are important factors regarding mandatory label disclosures.

Labeling requirements that apply to foods in general also apply to foods derived using rDNA biotechnology. As previously noted, to avoid a misleading presentation of the food, the label must reveal all material facts. In developing its labeling policy for rDNA biotechnology-derived foods, FDA considered public comments and scientific evidence regarding the presence of material facts about such foods. FDA concluded that rDNA biotechnology-derived foods do not differ materially as a class of food from conventional foods. On the other hand, individual rDNA biotechnology-derived foods may or may not be significantly different from their conventional counterparts.

FDA requires labeling of specific rDNA biotechnology-derived foods that differ significantly in composition, nutritional value, or safety from their conventional counterparts (FDA, 1992). Thus, if a food derived using rDNA biotechnology differs from its conventional counterpart such that the common or usual name no longer adequately describes the new food, the name must be changed or qualified to describe the difference. If a safety or usage issue exists for the new food, a statement must be made on the label to describe the issue. For example, if a food derived using rDNA biotechnology has significantly different nutritional properties, its name must reflect the difference (e.g., “high oil corn”). Likewise, if a new food includes an allergen that consumers would not expect based on the name of the food, the presence of that allergen must be stated on the label (e.g., the hypothetical use of a peanut protein in a tomato).

Some have advocated that the mandatory labeling requirements reach beyond disclosure of material facts regarding the food. They have urged a blanket requirement for disclosure when a food is derived using rDNA biotechnology. In developing its 1992 labeling policy (FDA, 1992), FDA considered public comments and all available scientific evidence in connection with a possible blanket rDNA biotechnology disclosure requirement. FDA rejected such a blanket requirement because it was “not aware of any information showing that [rDNA biotechnology-derived foods] differ from other foods in any meaningful or uniform way, or present any different or greater safety concern than foods developed by traditional plant breeding.”

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In the absence of a material fact to distinguish an rDNA biotechnology-derived food from its conventional counterpart, the imposition of a blanket disclosure requirement would be constitutionally suspect. As with the Vermont rBST label disclosure requirement that was ruled unconstitutional in International Dairy Foods v. Amestoy, the absence of a distinguishing characteristic of the rDNA biotechnology-derived food requires the government to demonstrate a substantial government interest to justify a label disclosure requirement. The Amestoy court specifically rejected “consumer curiosity” as basis for a substantial government interest.

· Voluntary Claims. As noted above, required declarations only constitute a portion of the label information that serves the consumer’s right to know. In a competitive marketplace, there are powerful incentives for the introduction of factors for distinguishing products that would be appreciated by significant population segments. When government action to compel labeling is involved, the distinguishing factors must be material facts regarding the food. Countless other factors may be advanced through voluntary label claims and, if appreciated by consumers, rewarded in the marketplace.

So foods that are not rDNA biotechnology-derived may be labeled as such in a truthful and non-misleading manner. Consumers who appreciate that distinction are served by such labeling. Government restrictions on misleading labeling can also influence the nature and even the availability of such voluntary claims. Naturally, the prohibition against false and misleading claims is an important service to the consumer’s right to know. However, ambiguity in what may be viewed as false or misleading label statements may have a chilling effect on the marketing of such claims.

For example, a processor asserting that a product includes no rDNA biotechnology-derived ingredients must be able to substantiate that claim to provide reasonable assurance of its accuracy. Before a processor undertakes that risk, it may reasonably seek guidance as to how FDA expects such substantiation to be accomplished and what degree of purity is required to justify a claim that a product is free of rDNA biotechnology-derived ingredients. As detailed below, the answers to these questions may have significant economic effects that can greatly influence the availability of such claims.

The degree of purity is a complex issue that must be resolved with careful consideration of what such a claim is likely to mean to the consumer. For example, fat-free claims are permitted on products that have up to one-half gram of fat per serving [21 CFR §101.62(b)(1)(i)] because it is not feasible to measure lesser amounts of fat in foods. Moreover, the general public health objective is to limit fat in the diet, not eliminate it altogether. Further, the degree of purity a claim represents would be considered by FDA in determining appropriate methods of substantiation. For example, a claim like “These ingredients were not genetically modified,” which addressed the process by which the food was produced, would not imply the same degree of purity as a “Free of GM ingredients” claim. Supplier certifications are generally regarded as less accurate and less expensive than product testing. FDA would seek accuracy, but would likely be reluctant to require an excessively expensive substantiation method, since its costs could discourage use of the label statement. A claim about the production process would likely be easier to verify than a claim about the composition of the food.

Moreover, the potential for a claim about the absence of rDNA biotechnology-derived ingredients to be interpreted as misleading because it inaccurately implies superiority of the food over its counterpart may also discourage such claims. One need only consider the rBST experience to see that a simple “GM-free” claim may be regarded as misleading because it implies superiority in safety or environmental effect. FDA recommended the use of terminology that disclosed the use or non-use of rBST on the cow, rather than the presence or absence of rBST in the milk.

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Therefore, as was sought by the organic foods movement, clear guidance as to government’s expectations regarding voluntary claims can eliminate the regulatory uncertainty that may discourage investment in a new product line of foods that are to be marketed as free of rDNA biotechnology-derived ingredients. However, establishing a clear definition of “GM-free” through legislation or a regulatory mechanism will be a difficult process that would require general agreement from most stakeholders.

In May 2000, FDA announced that it plans to develop a guidance document regarding the voluntary labeling of food about the presence or absence of rDNA biotechnology-derived ingredients (HHS, 2000). FDA stated that it would use focus groups and seek public comment on its draft guidance.

The Labeling Panel is mindful that not all voluntary claims regarding rDNA biotechnology-derived foods are claims that the food is free of rDNA biotechnology-derived ingredients. One of the first rDNA biotechnology-derived foods introduced to the market was the FlavrSavr tomato, which bore statements in labeling indicating that the tomato was developed through rDNA biotechnology. The issues regarding such claims are straightforward and therefore have not been addressed in this report. As discussed above, these claims also must be truthful and non-misleading.

· Summary. The following U.S. food labeling requirements apply to foods derived using rDNA biotechnology: Any material differences in the characteristics of these foods compared with their conventional counterparts must be disclosed; and voluntary label statements must be truthful and non-misleading, which entails substantiation of label claims and ensuring that the claims are not misleading, by implication or by omission.

To impose a blanket disclosure requirement for all rDNA biotechnology-derived foods would be constitutionally suspect and may inhibit consumer choice by discouraging development of the technology. Though difficult to accomplish, clear government guidance regarding such claims would lend regulatory stability and reduce a barrier to development of such products.

International Policies
Because of the world market for food and food ingredients, U.S. labeling requirements and policies should not be examined in isolation. Rather, the subject should be considered in the context of international requirements and policies.

In view of the growing conditions where cross-pollination might occur, the complexities of the harvesting, storage, and distribution practices, and other possibilities for inadvertent contamination of non-rDNA biotechnology-derived crops with rDNA biotechnology-derived crops, it would be necessary for any mandatory labeling program to include a level of inadvertent rDNA biotechnology-derived crop contamination above which labeling would be required. This level should be consistent with the objectives of the labeling program and be acceptable to the program’s proponents. It should also be legally defensible and practical to enforce, including scientifically appropriate, practical, and affordable analytical testing. There is currently no international consensus on what such a regulatory level should be.

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The regulation of rDNA biotechnology-derived foods differs widely in other countries. Some countries do not allow them to be imported at all, on the basis that not enough is known about the long-term effects of consuming rDNA biotechnology-derived foods (Anonymous, 1999a). Other countries permit such foods, with requirements that each food disclose on the label that it was produced using rDNA biotechnology (Codex, 1999). Such policies require foods at each stage of production, from raw agricultural product to finished consumer package, to bear a statement like “Contains GMO.” Still other countries, like the U.S., compare the new plant variety to varieties produced using conventional breeding to identify differences for safety evaluation and to determine whether the differences need to be described on the food label. These countries do not require statements that the food was derived using rDNA biotechnology.

International debates on labeling of rDNA biotechnology-derived foods take place in a variety of forums and often are part of the discussion of the safety of the foods. Countries that require declaration of the fact that the food was derived using rDNA biotechnology tend to have less confidence in the safety of the food. This lower confidence level is not always based on scientific assessments that indicate higher potential risk. The consumer’s right to know is an important factor in the rationale of those supporting mandatory labeling, particularly when consumer confidence in the regulatory system is low (Codex, 1999).

The primary international forum for discussion of labeling of rDNA biotechnology-derived foods is the Codex Alimentarius Commission. Codex implements the International Food Standards Program under the joint sponsorship of the Food and Agriculture Organization (FAO) of the United Nations and the World Health Organization (WHO). Its purpose is to harmonize international food requirements to foster public health and international trade. However, not all participating countries adopt all Codex standards.

For several years, the Codex Committee on Food Labeling (CCFL) has been discussing how rDNA biotechnology-derived foods should be labeled, with the goal of having a single approach to labeling requirements. Two basic approaches to labeling are being considered by the CCFL. One, based on the principle of comparing new varieties of foods to those produced by conventional means, would require the description of any differences on the label. That is, where the rDNA biotechnology-derived food differs significantly from the conventional version of the food in nutritional value, in physical or handling properties, or by the presence of an allergen not indicated by the name of the food, this difference would have to be disclosed on the label.

The other approach to labeling involves the conclusion that the use of rDNA biotechnology, either in the food or to produce the food, is itself a difference that requires disclosure. The U.S., Canada, and several other countries support the approach that only the significant differences need to be disclosed, while the European countries and others favor what is called the “mandatory labeling” approach (Codex, 1999). A number of countries are currently developing national policies, and several of them are likely to require mandatory labeling.

Even though the discussion is ongoing in Codex and will likely continue for several more years, the effects of differing national rDNA biotechnology labeling policies are already being felt. For example, European countries are major markets for U.S. grains and food ingredients. Some European retailers have decided to exclude rDNA biotechnology-derived ingredients from foods manufactured for their own “store brands” (Anonymous, 1999b). Some U.S. producers have decided to return to growing non-rDNA biotechnology-derived crops rather than lose this market. Some European food manufacturers, particularly infant formula firms, have said they will not accept rDNA biotechnology-derived ingredients. Some U.S. manufacturers of processed corn and soybean consumer products have announced that they will not accept any rDNA-derived biotechnology crops for processing (Anonymous, 2000).

While Codex is the major forum for discussion of international food labeling requirements, another organization has also developed a position on labeling. The Cartagena Protocol on Biosafety was adopted by more than 130 countries at the Convention on Biodiversity (CBD) in January 2000. The protocol has been interpreted to provide that “living modified organisms” (LMO) intended for “food, feed, or processing” must be identified as LMO (Codex, 2000). While the U.S. signed the Cartagena Protocol, it has not been ratified by the U.S. Senate. As a result, it has no legal effect in the U.S. at this time. As interpreted by the U.S. Department of State (USDS, 2000), the Protocol requires international shipments of bulk LMO commodities to be accompanied by documentation stating “May contain LMOs”; however, the Protocol does not impose consumer product labeling requirements.

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The European Union (EU), Japan, South Korea, Australia, and New Zealand have all passed, or are considering, laws requiring that food containing rDNA biotechnology-derived ingredients be labeled. These countries are in various stages of implementing such requirements. The EU has been considering this issue for a substantial period of time and has approved a de minimis threshold level of 1% (Betts, 1999; EU, 2000). This de minimis threshold would apply separately to each ingredient used in the product, and only apply to those situations where the presence of the rDNA biotechnology-derived material was unintentional. Many businesses in Germany and Japan require that products be certified to contain less than 0.1% or even 0.01% of rDNA biotechnology-derived ingredients.

Compliance with de minimis thresholds requires the availability of quantitative analytical testing methods to detect the presence of rDNA biotechnology-derived ingredients. The two most common methods for detecting rDNA biotechnology-derived materials are the polymerase chain reaction (PCR)–based methods, which detect genetically modified DNA sequences, and immunoassays, which measure levels of proteins expressed by inserted DNA sequences. For a fuller discussion of rDNA testing methods, see Anonymous (1999c, d).

Most PCR-based assays are qualitative in nature and are routinely used to determine if rDNA is present in a sample. PCR is a laboratory-based technique requiring trained staff and specialized equipment. It is extremely sensitive and capable of detecting one or a few copies of a gene. DNA extraction methods need to be optimized for each food matrix, as various food components inhibit the reagents used in the assay. In general, DNA is not detectable in highly heat-treated foods, hydrolyzed plant proteins, purified lecithin, starch derivatives, and refined oils derived from rDNA biotechnology-derived crops. The use of Real-Time PCR, which uses fluorescence to monitor the PRC amplification process, shows significant promise in resolving this problem. However, the equipment is, at present, very expensive, ranging in price from $36,000 to $95,000. Because these methods are extremely sensitive, there is a significant risk of cross-contamination resulting in false positives. Sample analysis time requires approximately one day, although turnaround times for results are typically 3–5 days. Per-sample costs range from less than $100 to more than $300. Several laboratories are developing quantitative PCR methods that will be important if PCR is to be used for determining the level of rDNA biotechnology-derived ingredients in foods.

The common protein-based test methods use antibodies specific for proteins encoded by rDNA sequences. The Enzyme Linked Immunosorbent Assay (ELISA) uses one antibody to bind the specific protein and an antibody conjugated to an enzyme whose product generates a color that can be easily visualized and quantified. Nonquantitative immunoassays are also available in the form of plate or lateral strip formats. Immunoassays are less sensitive than PCR and therefore are less susceptible than PCR to false positives caused by minor levels of contamination. Assay validation is important because of the large diversity of food matrices. In addition, it is important to determine sequence homology with other proteins that might be present in the sample. Per-sample costs are in the range of $2 to $10, although up-front costs for assay development and generation of antibodies and protein standards are high. Results are available within minutes. Immunoassays are not capable of distinguishing between different rDNA biotechnology-derived events that express similar protein characteristics (e.g., immunoassays will not determine if a specific protein such as the Bt protein came from corn or soy). Since proteins are denatured by many food processing methods, immunoassays are best used for raw commodities or minimally processed ingredients.

There are some common problems no matter which assay method is used. Currently, there are no internationally recognized sampling methods or agreement on the number or size of samples. Sampling plans must be scientifically and statistically sound and take into account the potential heterogeneity of samples due to adventitious contamination from cross-pollination or during distribution. Positive and negative reference standards are not readily available to validate analytical methods or to assess the performance of methods and laboratories. As new rDNA biotechnology-derived crops are developed, sequence information must be shared by the technology generators so that new assays can be developed. Ultimately, hundreds of different assays may be necessary.

Several agencies in Europe and the U.S., including the European Commission’s Joint Research Centre, the U.S. National Institute of Standards and Technology, and USDA’s Grain Inspection, Packers, and Stockyards Administration, are working on reference standards and validation programs for rDNA testing methods (Erickson, 2000). Validation and standardization of sampling and testing methods are essential to resolving disputes regarding the status of food ingredients, and for regulatory authorities responsible for enforcing mandatory labeling laws.

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Impact of Market Segmentation of Crops
Labeling of rDNA biotechnology-derived foods, whether mandatory or voluntary, must be premised on discrete distribution channels for the underlying commodities, such as soybeans and corn. This section of the report examines market segmentation for key commodities. A fuller discussion of this subject appears in Nelson et al. (1999) and Bullock et al. (2000).

The majority of processed foods contain ingredients derived from corn and/or soybeans. One major trade association has estimated that 70% of processed foods contain corn or soy-derived ingredients. In fact, corn and soy serve as the source of thousands of ingredients used in processed foods. Common ingredients derived from corn include corn oil, corn starch, corn flour, corn meal, maltodextrins, corn syrup, and dextrose. Soy-derived ingredients include soy oil, bran, flour, sauce and meal, soy protein isolates and concentrates, texturized vegetable protein, lecithin, and mono- and diglycerides.

Many processed foods contain multiple corn and soy-derived ingredients. For example, a typical cake mix contains hydrogenated soybean oil, modified corn starch, mono- and diglycerides, dextrose, and soy lecithin. Some corn and soy-derived ingredients serve as secondary ingredients (e.g, carriers for flavors, colors, or vitamins) and may not be listed on the label. For many of these ingredients, substitutes are not available that provide the same functionality, texture, and taste. Since corn and soy are managed as commodity ingredients and labeling is not required in the U.S., many of the processed foods on the market today likely contain ingredients derived from rDNA biotechnology-derived crops.

The world markets for corn and soybeans are currently undergoing a process of segmentation in response to concerns in the EU and elsewhere. It is clear that consumer concerns about rDNA biotechnology in some countries will determine the marketability of rDNA biotechnology-derived corn and soybeans. Several major food processors in different countries have announced that they will only accept non-rDNA biotechnology-derived crops. Thus, some supplies in the world market must be guaranteed rDNA biotechnology-free to meet this emerging demand.

In April 1999, two major processors announced that they would pay a premium for a particular non-rDNA biotechnology-derived soybean product that has been bred to resist one particular herbicide. In addition, they announced they would reject any rDNA biotechnology-derived corn not accepted in EU markets during the 1999 growing year (Anonymous 1999e). In 1999, this program provided an 18-cent-per-bushel premium (approximately 3.5%) for soybeans (Anonymous 1999f). A similar approach is expected for the 2000 crop year. One major supplier of rDNA biotechnology-derived seeds announced that it would help growers of its rDNA biotechnology-derived crops find domestic market outlets for varieties that are not approved by the EU. In August 1999, a major processor requested that its suppliers segregate rDNA biotechnology-derived and non-rDNA biotechnology-derived crops (Anonymous, 1999e). This segmentation goes beyond rejection of rDNA biotechnology-derived products not approved by the EU, and was said to be a response to growing consumer requests for such segmentation.

In fall 1999, some U.S. firms paid a premium for non-rDNA biotechnology-derived products, but the size of the premium and the extent of demand for non-rDNA biotechnology-derived products was very uncertain.

In addition to changes in demand, another source of uncertainty is the regulatory status of rDNA biotechnology-derived crops in other major producing countries, such as Brazil. Although Brazil does not allow rDNA biotechnology-derived crops, a significant portion of the crops produced are genetically modified because seed is smuggled into the country. Whether segmentation by country source or segmentation within market channels can take place will be an important determinant of eventual marketing costs. For example, EU buyers are able to source their corn imports in 2000 from countries other than the U.S., but they must still buy a significant share of their soybean product imports from the U.S. Thus, there is greater market incentive to develop guaranteed non-rDNA biotechnology-derived soybean channels in the U.S. In spite of the market forces discussed above, as of spring 2000 there had been relatively little market differentiation of rDNA biotechnology-derived crops in the U.S.

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The marketing costs and price premiums associated with the development of a segmented market include any premium paid to a producer to supply a particular variety, the costs of segregation in storage and handling, and the costs of verifying that the crop is truly not rDNA biotechnology-derived. The complexity of the U.S. grain-marketing channels makes it difficult and expensive to segregate crops when variety is the only clear difference, as testing for genetic modification is currently an expensive alternative.

Whether the objective is to label or to ban rDNA biotechnology-derived crops, only three alternative marketing strategies exist: test the product at selected points in the market channel; accept producer assurances at the first handler and maintain identity through the market channel; or use third-party supervision and certification from seed to final processing. Each alternative has its advantages and its limitations.

In May 2000, the Clinton Administration announced that USDA will work with the agricultural and food industries on the creation of reliable testing procedures and quality assurance programs to differentiate non-rDNA biotechnology-derived commodities to better meet the needs of the marketplace. USDA will do so through an Advanced Notice of Proposed Rulemaking, which will seek input on current market practice as well as the feasibility and desirability of quality assurance programs (White House, 2000).

· Final Product Testing. This approach provides assurance that the sample selected for testing meets the standards of the buyer. It focuses on the attributes of the product rather than on the process by which it was produced and delivered. The disadvantages are the costs and uncertainties of sampling and testing. Current sampling methods provide a low level of confidence that a large bulk shipment is adequately represented by the sample analyzed. The standard error for even the best sampling strategy (e.g., automatic diverter samplers in the inbound or outbound grain stream) is large for the current low tolerance levels. Sampling of inbound deliveries by farmers presents the same problem of obtaining representative samples, and it has the additional problem of time required for testing and segregating, given the speed with which inbound vehicles must be unloaded.

A single test that can be applied at the first-handler level for testing for the entire range of possible genetic modifications has not yet been developed. As discussed above, the most common rDNA biotechnology test method currently used is PCR. It is a very sensitive test which is most useful in detecting the presence of rDNA biotechnology-derived materials, but it takes 3–5 days to complete and costs several hundred dollars per sample. The ELISA approach takes 5–20 minutes and costs less than $10 per sample. However, neither approach has been accepted as being quantitatively reliable because of a lack of standardized sampling techniques and reliable control standards.

For labeling purposes, what to test for is also important. It is possible, at least with PCR, to test for the promoter or marker DNA, which is common to many rDNA biotechnology-derived organisms, or to test for the specific genes that confer the desirable traits. The first type of test would identify only whether a crop was rDNA biotechnology-derived; the second type would identify what type of modification had taken place.

· Producer Validation and Market Segregation. This strategy segregates the non-rDNA biotechnology-derived crops at the beginning of the market channel. If the product is shipped in containers dedicated to non-rDNA biotechnology-derived grain, guaranteeing the process will also guarantee the final product. However, there are problems with this approach in addition to the cost of segregation. Although producers may know the variety and the extent of potential cross-pollination at the time of harvest, much commercial grain is delivered by commercial haulers who do not have this information. Without prior contracts or arrangements with the producer, producer validation and certifications have questionable reliability. This strategy also requires grain handling establishments to maintain separate facilities, as it is not feasible to clean facilities of all rDNA biotechnology-derived grain between loads.

Some establishments designate one of their facilities for handling non-rDNA biotechnology-derived grain, thus simplifying the problem of identification at the time of delivery. Yet a major obstacle to maintaining purity through the rest of the market channel still exists, because trucks, rail cars, barges, and port equipment must also use dedicated equipment to guarantee that all rDNA biotechnology-derived grain has been excluded.

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· Third-Party Certification. This strategy reduces the danger of misinformation, questionable methods of isolation in the field, and incomplete knowledge on the part of the producer or distributor. The strategy is well known and frequently used for delivering food-quality corn and soybeans to foreign destinations.

Organic, pesticide-free, and variety-specific qualifications are common in international trade, but third-party certification adds significant costs per bushel. Illinois grain handlers currently use third-party certification from seed to river elevator and shipping in containers or small-volume segregated barge loads that are transferred directly from barge to vessel to avoid contamination. This strategy is based on the premise that it is more effective to guarantee the process than to guarantee the product. No shipper can guarantee that a very small amount of rDNA biotechnology-derived product will not be introduced into a shipment from any of many sources, including the storage facility in the destination country. Instead of guaranteeing 100% purity, this approach provides assurances that the grain has been handled in such a way as to minimize the possibility of contamination.

· Cost of Market Segregation. There will be a cost for any of the strategies described above. A survey by Bender et al. (1999) examined the marketing costs associated with specialty grains in Illinois. Such specialty grains have particular characteristics, such as oil or protein content, that bring high value in particular end-use markets. The survey reported an average additional handling cost of $0.17 per bushel for corn and $0.48 per bushel for soybeans in 1998, over and above the premium for specialty characteristics. These are similar to the 6–10% additional marketing costs estimated by Buckwell et al. (1999) in their review of several segmented or identity-preserved markets.

Interviews in May 1999 with nine firms that advertised on Internet-based e-markets to contract with farmers for non-rDNA biotechnology-derived corn or soybeans showed that the market is still sorting out methods of verification and premiums for non-rDNA biotechnology-derived crops. The current means of verification for non-rDNA biotechnology-derived products included all of the possibilities discussed above. The firms interviewed used spot testing, segregated on-farm storage, segregated on-site storage at the elevator, and segregated transportation measures. Some elevators do not do any testing and relied on the word of the farmer regarding the non-rDNA biotechnology-derived product. These firms also reported widely varying premiums for non-rDNA biotechnology-derived product that was contracted for in the previous spring (1998).

It is useful to think about rDNA biotechnology-derived and non-rDNA biotechnology-derived corn and soybeans as separate products. There is substitution in supply, but in some countries there is little substitution in demand. rDNA biotechnology-derived varieties reduce costs of production and/or increase yields for some U.S. producers. If rDNA biotechnology-derived crops have lower costs, producers presumably will look to be compensated for producing non-rDNA biotechnology-derived crops at higher cost for the EU.

The following scenario seems possible: Some portion of EU and other demand will be for guaranteed non-rDNA biotechnology-derived crops. At the same time, there will be wide-spread adoption of rDNA biotechnology-derived varieties in major producing countries. The demand for non-rDNA biotechnology-derived varieties will be met from segmented market channels that will develop in all exporting countries, and this supply will carry a marketing premium. In addition to this marketing premium, producers will receive a price premium to cover the higher costs of production of non-rDNA biotechnology-derived crops. However, this premium will be in relation to the somewhat lower world prices for corn and soybeans due to increased total supplies brought about by adoption of rDNA biotechnology. The costs of the producer premium and marketing premium are likely to be passed on to buyers in the EU and elsewhere. The long-run costs of this segmentation are more difficult to predict. These long-run costs arise from the disincentives to invest in rDNA biotechnology that result from lack of consumer acceptance.

Depending on the degree of purity demanded by any market segmentation, the current grain handling and distribution system may need to be modified, or a new, dedicated system for non-rDNA biotechnology-derived products developed. For example, while the practicality of currently available test methods for detecting rDNA biotechnology-derived organisms could be improved, the sensitivity of these methods greatly exceeds the capabilities of existing U.S. grain handling and distribution systems to deliver non-rDNA biotechnology-derived crops.

For example, USDA’s grade standards for soybeans permit 1.0% “foreign material” in U.S. No. 1 Grade (the highest grade) soybeans, to 5.0% “foreign material” in U.S. Grade No. 4 soybeans [7 CFR §810.1604]. Similarly, the USDA grade standards for corn permit 2.0% “foreign material” in U.S. No. 1 Grade corn, to 7.0% “foreign material” in U.S. No. 5 Grade corn [7 CFR §810.404]. As the U.S. commercial grain handling and distribution system works within the regulatory confines of the USDA grain grade standards, it is not realistic to expect that the same handling and distribution system could achieve a threshold level of 0.01%, 0.1%, or even 1% rDNA biotechnology-derived material in non-rDNA biotechnology-derived grain. In other words, it may be unrealistic to expect a grain handling and distribution system that tolerates, for example, 1% corn as “foreign material” in soybeans to exclude a comparable, if not lower, level of rDNA biotechnology-derived soybeans—which would not even be considered “foreign material”—in a lot of non-rDNA biotechnology-derived soybeans. Yet, as discussed above, such low threshold levels are being considered in other countries.

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Consumer Reactions in the U.S. and Canada
Most U.S. consumers are not concerned about the safety of foods derived using rDNA biotechnology. Eighty percent of consumers are confident that food in the supermarket is safe (Gallup, 1999; FMI, 1999). Most consumers support application of rDNA biotechnology in agriculture and food production. A majority (53%) believe that rDNA biotechnology does not pose a health hazard. A much smaller number (27%) believe that rDNA biotechnology does pose a serious health hazard, while 20% have no opinion. The majority of consumers believe that rDNA biotechnology will provide benefits for them or their families within five years (Wirthlin, 2000).

Labels are a valuable source of information for consumers. People indicate that they consult labels to obtain accurate information as to product ingredients and nutritional content (Bender and Derby, 1992; Rodolfo et al., 1998). Information on labels and in government publications generate greater trust than any other information source (Buzby and Ready, 1996).

It is well recognized that the method of asking a question can influence consumer response. Some surveys indicate that the majority of consumers want foods derived by rDNA biotechnology to be labeled; however, consumers frequently respond affirmatively when asked if they want additional information (Hoban and Kendall, 1993; Gallup, 1999). When asked if labels should contain a variety of information, 85% of consumers desired disclosure that rDNA biotechnology was used. Fewer consumers expressed interest in labeling if rDNA biotechnology was used to produce ingredients or processing aids, such as chymosin for cheese making (Hoban and Kendall, 1993). Other information, such as use of pesticides or country of production, was desired by 94% and 80%, respectively. In these surveys, consumers were not told that labeling would entail additional cost. Focus group research indicated that most consumers believed that cost would be minimal (Hoban and Kendall, 1993).

In one survey (Wirthlin, 2000), FDA labeling policy was explained as follows: “The U.S. Food and Drug Administration requires special labeling when a food is produced under certain conditions: when rDNA biotechnology’s use introduces an allergen or when it substantially changes the food’s nutritional content, like vitamins or fat, or its composition. Otherwise special labeling is not required.” The majority of consumers supported the policy, with 42% indicating strong support; and 28% opposed the policy, with 18% strongly opposed. When presented with an alternative view, that all rDNA biotechnology-derived products should be labeled,52% continued to support FDA’s policy, 43% supported labeling all products, and 5% did not know.

General consumer research has shown that label statements should be clear and not misleading and should provide salient facts to the consumer. Consumers indicated that labeling should be in laymen’s terms, use consistent terminology, and follow a standard format (Hoban and Kendall, 1993).

Focus group research in Canada indicated that consumers want simple information presented in lay terminology, which links changes to nature and how products are grown, identifies product improvements, and acknowledges government approval (NIN, 1999). Consumers reacted negatively when unknown scientific terminology was used. They indicated that numerous messages on foods containing multiple ingredients derived from biotechnology would be viewed as too complex and unreadable. Most terms used today to describe rDNA biotechnology were misunderstood by consumers. Following is a summary of the consumer response to specific terms:

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“Genetic,” as in “genetically modified.” Use of the term “genetic” was not viewed as neutral. It was often misinterpreted and frequently evoked concern. Some believed that plant products would no longer be grown in soil. Others viewed “genetically modified” as an improvement of some kind. Many were of the view that something was being added to the products, with “chemicals” frequently mentioned. Consumers wanted to be given more information, such as the method and purpose of the modification.

“Genetically enhanced.” This phrase also raised concern because people were unclear about the meaning of “genetically.” Some viewed products as improved. In comparison, “genetically engineered” generated the most negative feeling. The term “enhanced” was viewed with skepticism by some, being reminiscent of advertising.

“Genetically improved.” This term, suggested by participants, was preferred because it was simpler and represents the appropriate reasons for change, i.e., improvement.

“rDNA biotechnology.” This term was not understood, and reactions were usually negative. Individuals surveyed stated that a simpler term would be better understood.

“Does Not Contain.” Messages of this type were viewed as an advertising claim to disparage competitors. Participants believed that the majority of consumers would be attracted to this type of message because the public was easily alarmed. This terminology was interpreted as guaranteeing that no genetically modified ingredients were used. Use of this phrase was criticized by participants because of the negative feelings it evoked.

“May contain.” “May contain” messages were interpreted by consumers as the failure of manufacturers to know what their products contained, because there was a mixup, the source of the product was uncertain, or the producer did not care enough to determine what was available on the market.

Consumers suggested terms that use simple language and blend science and traditional agriculture. These included “advanced growing method,” “product of the new science of farming,” and “enhanced farming” (NIN, 1999).

A recent survey of food industry leaders (Hoban, 2000) found that 67% believe that “organic” labeling is a reasonable alternative for consumers concerned about rDNA biotechnology.

A majority of consumers (86%) believe that simple labeling does not provide enough information for consumers (Wirthlin, 2000). Additional information should be available through the media, toll-free numbers, brochures, and Web sites (NIN, 1999).

Consumer Reactions in Other Countries
In addition to the U.S. and Canadian data discussed above, available foreign research is relevant. Most Australians believe that genetic engineering, in general, is a “good idea,” with as many as 90% supporting medical and environmental applications and about two-thirds supporting food and nutritional applications (Kelley, 1995). Almost all (93%) of Japanese consumers surveyed believed that rDNA biotechnology would provide benefits to them or their families in the next five years (Hoban, 1996). Interest in purchasing was greatest in applications that reduce pesticide use.

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A 1995 survey indicated that 44% of Europeans considered genetic engineering of food a serious risk (Tordjman, 1995). This was midway among potential food risks, with bacterial contamination at the top with 85% of consumers expressing concern, and sugar at the bottom with 12% expressing concern. With the exception of Austria, half or more of European consumers indicated they would purchase a product modified by genetic engineering (Hoban, 1997). Recently, response in the United Kingdom has become more conservative, with a very high percentage of consumers indicating that they would not purchase products derived using rDNA biotechnology (Blanchfield, 1999). In a survey conducted by Eurobarometer (2000), 53% of European consumers said they would pay more for non-rDNA biotechnology- derived foods.

The difference between European and U.S. consumer attitudes may be attributed to perceptions of risk, level of knowledge, or trust in regulatory authorities. Gaskell et al. (1999) indicated that those who support rDNA biotechnology believe that rDNA biotechnology is useful and morally acceptable with little risk. In regard to applications to food, this group constitutes 22% in Europe and 37% in the U.S. Risk-tolerant supporters make up 21% in Europe and 24% in the U.S. Opponents, estimated at 30% in Europe and 13% in the U.S., believe that rDNA biotechnology is risky, offers no benefit, and is morally unacceptable. Those who believe that rDNA biotechnology is useful, not very risky, but morally unacceptable constitute 2% in Europe and 1% in the U.S.

European consumers indicated that regulation of food rDNA biotechnology should rest with international organizations, such as the UN or WHO. When asked what group would be most likely to tell the truth about rDNA biotechnology-derived crops, European consumers identified environmental, consumer, and farming organizations. National public bodies received support from only 4% of respondents. In contrast, U.S. consumers indicated that they would trust statements made by U.S. regulatory agencies, with USDA generating 90% support and FDA 84% support.

European and North American consumers differed significantly in knowledge of basic concepts related to food rDNA biotechnology (Hoban, 1998). Most consumers from the Netherlands, Sweden, U.S., and Canada recognize as false the statement “Ordinary tomatoes do not contain genes, while genetically modified ones do.” Only 34% of Austrian and 35% of German consumers recognized that the statement was false. Significantly more persons from the Netherlands, Sweden, U.S., and Canada recognized as false the statement “A person’s genes could be changed by eating a genetically modified food.” Correct responses were provided by 62% of consumers in the U.S., Canada, and Sweden, 74% in the Netherlands, but only 29% in Austria.

Conclusions
The Labeling Panel concluded that the following facts are fundamental to resolving issues regarding the labeling of rDNA biotechnology-derived foods in the U.S. The information presented on food labels is highly regarded by consumers and is considered one of the most reliable sources of information about foods. Based on these facts, the panel drew the following conclusions:

· Within the constitutional framework, the FFDCA provides for a food labeling regulatory regime that is intended to ensure that information about food products is presented to consumers in a truthful, non-misleading manner. This regulatory system requires disclosure of any significant difference in the characteristics of an rDNA biotechnology-derived food when compared with its conventional counterpart. In addition, voluntary label statements must be substantiated and not misleading, either overtly, by implication, or by omission.

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· Mandatory label disclosure requirements may not reach beyond addressing material facts about a food. If rDNA biotechnology were used in the development of a plant variety but the rDNA biotechnology-derived food was not significantly different from the conventional counterpart, there would be no material fact regarding the food to disclose. Thus, absent significant differences, the fact that a food is rDNA biotechnology-derived is not by itself a material fact.

· Voluntary labeling has been used to establish markets for niche categories of foods desired by consumers.

· Any labeling requirements or policies to distinguish rDNA biotechnology-derived foods from other foods would require definitions and monitoring tools sufficiently precise to meet the objectives of the requirement or policy.

· Labeling initiatives for rDNA biotechnology-derived foods are likely to have substantial effects on the production, distribution, and cost of food to consumers.

· If a voluntary labeling initiative to distinguish rDNA biotechnology-derived foods is pursued, broad stakeholder agreement should be achieved regarding appropriate substantiation of claims.

· Terminology used in labeling should convey information to the public in an understandable, accurate, and non-misleading manner.

Labeling Panel
John E. Vanderveen, Scientist Emeritus, Food and Drug Administration, San Antonio, Tex.

John W. Bode, Esq., Principal, Olsson, Frank & Weeda, P.C., Washington, D.C.

Christine M. Bruhn, Director, Center for Consumer Research, University of California, Davis

Elizabeth (Betty) Campbell, Senior Consultant, AAC Consulting Group, Bethesda, Md.

Susan K. Harlander, President, Biorational Consultants, Inc., New Brighton, Minn.

Gerald Nelson, Associate Professor, Dept. of Agricultural and Consumer Economics, University of Illinois, Urbana

Steve Taylor, Professor and Head, Dept. of Food Science and Technology, University of Nebraska, Lincoln

References