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Report on Consumer Focus Groups on Biotechnology

20.oct.00, U. S. Food and Drug Administration Center for Food Safety and Applied Nutrition Office of Scientific Analysis and Support, The Complete Report is available at: http://www.cfsan.fda.gov/~comm/biorpt.html

Report on Consumer Focus Groups on Biotechnology
October 20, 2000

If a food, including a bioengineered food, is significantly different from its conventional counterpart, for example in terms of its nutritional value or because it introduced a known allergen, this information is required in the labeling of the product.

U. S. Food and Drug Administration Center for Food Safety and Applied Nutrition Office of Scientific Analysis and Support

The Complete Report is available at: http://www.cfsan.fda.gov/~comm/biorpt.html


INTRODUCTION
The Food and Drug Administration (FDA) regulates the labeling of food products, including foods that are produced through recombinant DNA techniques ("bioengineered" foods). FDA published a policy in 1992 to provide guidance to industry on scientific and regulatory issues related to bioengineered foods. FDA did not establish special labeling requirements for bioengineered foods. If a food, including a bioengineered food, is significantly different from its conventional counterpart, for example in terms of its nutritional value or because it introduced a known allergen, this information is required in the labeling of the product.

Recently European and other countries have proposed labeling requirements for foods that have been created through genetic modification techniques or that contain ingredients that are genetically modified. These types of foods have become of growing interest in the United States as well.

FDA conducted three public hearings in 1999 to hear the views of consumers, producers and others. The information available on consumer awareness and understanding of bioengineered foods is very limited. Surveys in the U.S. have shown growing concern but also limited factual knowledge. There are a variety of terms that are in use to describe foods
produced through bioengineering, such as "genetically engineered," "genetically modified," "genetically modified organism (GMO)," "modern biotechnology," "foods derived through biotechnology," "bioengineered foods," and "food derived through recombinant DNA techniques."

FDA conducted a series of consumer focus groups in Spring 2000 to help better understand how U.S. consumers think about these issues. The focus groups were designed to provide insight into consumers' awareness of foods produced through biotechnology, their familiarity and understanding of possible terms for describing these foods, and their reactions to options for identifying whether foods are or are not products of bioengineering.

Study Design
Twelve groups were conducted between May 10-24, 2000 in four cities: Calverton, Maryland; Burlington, Vermont; Seattle, Washington; and Kansas City, Missouri. The cities were selected to provide a broad representation of geographical and cultural diversity. Participants were recruited from the general population. The three groups at each site were composed of a mix of males and females of varying ages and ethnicity representing the makeup of the local community. One group at each site was defined as concerned about biotechnology on the basis of screening questions. (See Screener in Appendix 1).

Moderator's Guide
The final moderator's guide is included in Appendix 2. Refinements were made to the guide over the course of groups. After the first set of groups in Maryland, a handout was added that showed examples of foods that contain genetically modified ingredients (see Appendix 3). Other handouts consisted of descriptions of possible types of food modified through biotechnology, examples of terms or phrases that could be used to identify foods/ingredients produced through biotechnology, and terms or phrases that could be used on foods that are not (or do not contain ingredients) produced through biotechnology. These are included in the moderator's guide.

The discussions generally followed the following progression:
1. Prior assumptions and attitudes about genetically modified foods, such as overall awareness, familiarity with terms, and concerns and issues related to bioengineered food, including views about labeling.
2 .Reactions to information on prevalence of bioengineered foods in the U. S. marketplace.
3. Reactions to various labeling options for bioengineered foods and foods not produced through bioengineering.

FINDINGS
A. Consumer Expectations and Beliefs
The groups discussed the general topic of bioengineering of foods and their understanding of what this encompasses. Participants demonstrated an uneven knowledge and understanding of bioengineered foods. On the one hand, they have heard a fair amount about the uses of biotechnology in the context of medical and drug research and other areas, and they are not surprised that biotechnology is being applied to foods. On the other hand, most were vague about the details. Few participants could report on any direct product experience with foods produced by biotechnology. Some had heard that other countries in Europe did not want to import these types of American foods but most of these participants were uncertain why. Very few participants had any sense of what recombinant DNA procedures involved, and some participants had fanciful views on the subject, e.g., Miracle-Gro as a form of bioengineering. For the most part, participants had heard about biotechnology as a new technology with great potential, but they knew very little about how it was being applied. Some participants, particularly in Vermont, had heard about the rBST controversy from news stories. In other words, general awareness was high, though largely abstract and based on second hand reports, while specific knowledge was low.

Despite their limited technical understanding of bioengineered food, participants had well developed and nuanced opinions of the wisdom of food biotechnology. These opinions, both pro and con, reflected similar understanding of the potential benefits and dangers of the technology, though individual participants weighed the benefits and dangers differently.

Most participants recognized that food bioengineering is a powerful and promising technology that offers both benefits and dangers to modern society. Several types of benefits were mentioned, including feeding the world's hungry, improving agricultural production to make it cheaper and easier to grow crops, and making possible new varieties of foods with desirable characteristics such as improved taste, appearance or nutritional characteristics. While fewer dangers were identified, there was strong consensus as to what the major worry was--unknown long-term health consequences that might be associated with the technology but which cannot be anticipated based on current science or knowledge.

This widely held view that there might be unknown long-term consequences of food biotechnology seems to be based on analogies that participants made between food biotechnology and other technological innovations of modern agriculture. Some of the examples that people considered similar to food biotechnology were use of pesticides, growth hormones and antibiotics to promote animal growth; tomatoes bred for transportability rather than taste; and novel products such as Olean. Cloning was mentioned in several groups, often with concerns expressed about a progression to such research on humans. In each case, participants saw a technological innovation that was introduced mainly for the sake of producers/distributors, with little apparent benefit to the consumer. Such innovations are seen as being approved by scientists and regulators, but later found to have unanticipated long-term health effects. It is this hazard model, drawn from recent experience with technological innovation, that underlies participants' views about the wisdom of food biotechnology.

This hazard model includes roles for various actors such as producers, industry, government regulators, scientists and consumers. It is marked by skepticism that the interests of consumers are sufficiently taken into account by the other actors. Some participants complained consumers are being used as "guinea pigs" and many were doubtful that government regulators and scientists have the ability to counteract the powerful profit motives of industry and producers.

For most participants, their concerns about food biotechnology did not include recognition of possible environment or societal impacts of food biotechnology. Although the monarch butterfly study was mentioned in several groups, there was little discussion of the issue when it was mentioned. Most participants appeared to be unfamiliar with this research. A few participants expressed concerns about negative impacts on small farmers or problems with sterile seeds and contamination across fields but these mentions were rare.

Most participants accepted as a matter of course that the short-term safety of bioengineered foods can be determined by science and therefore it was not in question. The concept of unknown deleterious long-term effects seemed to arise from a hazard model based on their experience with the limitations of technology.

Opinions about food biotechnology varied considerably among participants. Many participants recognized possible benefits and believed the risks should be tolerated for the sake of these benefits. Men were more likely than women to express this opinion. Participants who were more familiar and sympathetic with farmers also expressed the view that the benefits of biotechnology may outweigh the risks. Level of knowledge about food biotechnology was not obviously correlated with how people saw the risk/benefit tradeoff. There was a degree of technological fatalism, the belief that ordinary people can't have much influence over the spread of new technologies, associated with acceptance of food biotechnology.

Understanding of various terms to describe bioengineered foods.
The participants were asked if they had heard of several terms that have been used to describe foods produced by biotechnology. It was clear that participants did not have marketplace experience with the terms. As a result they tended to evaluate the terms linguistically--how accurate or appropriate these terms seemed to be as possible labels to be used in marketing or product labeling for the designated class of products. The terms "genetically engineered," "genetically modified," or "bioengineered" were viewed as reasonably descriptive but linking the concept of engineering with food was off-putting to some participants. The term "modification" was seen as a vaguer, softer way of saying engineered. The "bio" prefix had a positive connotation for some participants. Terms such as "product of biotechnology," or "biotechnology" had the least amount of negative implication. Acronyms such as GM and GE, discussed later in the groups, were unfamiliar to most participants and not viewed favorably. Most participants were unfamiliar with the term "genetically modified organism" and considered it to be a strange and inappropriate label for bioengineered foods since it seemed to imply that foods are organisms or contain organisms, which people think is inaccurate and unappealing.

Prior views of the need for labeling
Before discussing specific labeling options, participants were asked how they could tell if a food had been genetically engineered or contain a genetically engineered ingredient. Their response was to complain that they could not tell. Virtually all participants said that bioengineered foods should be labeled as such so that they could tell whether a given food was a product of the new technology. What is striking about participants' initial discussion of their reasons for wanting biotechnology labeling is the widespread perception that the information they want the label to provide is how the food product was produced, rather than the compositional effect of the process on the food product. Virtually no one mentioned wanting to know the specific effects of bioengineering on the product as a reason for labeling. Instead, participants wanted to know whether the food was a product of biotechnology because they were concerned about the potential for unknown long-term effects of the technology, in particular health effects.

In other areas where we have done similar consumer research, such as nutrition labeling and use-by-date labeling, consumers want information about product characteristics that are relevant to their health and safety concerns. Typically, product characteristics capture whatever is relevant about the processes used to produce the food product. In the case of biotechnology labeling, however, information about product characteristics does not exhaust what consumers want to know. The concept of unknown long-term effects, which seems to underlie the demand for biotechnology labeling, implies that it is unknown product characteristics that are of concern. A surrogate for knowing about unknown product characteristics is knowing about the technology by which the product was produced, which may explain why they want to know about the process.

B. Reaction to Specific Labeling Options for Claims about Biotechnology
The groups discussed the utility and acceptability of several labeling approaches. There were three basic labeling approaches presented:

1."Mere disclosure" (e.g., "contains genetically modified ingredients", "a genetically modified food");

2.Disclosure plus statement of product effect or purpose (e.g., "genetically modified to increase Vitamin A content", "contains soy from plants genetically modified to be pest resistant") and

3.Caution statement (e.g., "Caution, contains genetically modified ingredients. Long term effects have not been determined.")

Virtually all participants saw value in having "mere disclosure" labeling. They thought it would allow them to make more informed decisions about whether or not to buy a product. This desire to be informed did not imply any specific health and safety concerns about the labeled product, but rather concerns about unknown long-term consequences of food biotechnology. For those participants who said they would want to avoid products they fear might have unknown long-term consequences, and any product produced by biotechnology is considered liable to such effects, mere disclosure labeling is required to exercise choice.

Many participants recognized symbolic value in choosing not to buy products of biotechnology. They felt mere disclosure labeling gave them an opportunity to register their view about the wisdom of food biotechnology, i.e., to support or not support the dissemination of the technology, apart from their views about the health and safety characteristics of the individual product. They said they wanted to "send a message" to the company..

Participants were shown descriptions of six specific bioengineered foods (cake mix, corn oil, canola oil, flavr-savr tomato, vitamin A rice, and growth hormone salmon). The descriptions provided information on the ingredient or food that was bioengineered and the purpose of the process. As participants considered the various examples, they began to see the value of having more information than mere disclosure of whether products are produced by food biotechnology. They saw value in being able to differentiate between particular products rather than applying a blanket judgment to the technology as a whole. As a consequence, they preferred label statements that give them more information about how and why a product was bioengineered. Participants saw this kind of labeling as accomplishing the same purpose as mere disclosure labeling, allowing them to register their point of view about the wisdom of biotechnology, but also giving them helpful product information and helping to educate them about the possibilities of the new technology. Some participants were concerned about the practicality of such labeling, questioning whether it might be too wordy or complicated for the average consumer to understand. Most participants recognized that such labeling put a burden on the consumer to become more informed. The general view was that it had to be executed well to be effective. They emphasized that any descriptions must be simple to understand and "not require a college degree" to make sense.

Participants rejected the option of warning-type labeling for products of food biotechnology. A caution statement was seen as overly negative and too prescriptive. Concern about long-term negative consequences of food biotechnology was considered insufficient to justify an explicit warning statement. This suggests most participants remained open-minded and open to future experience with foods produced by biotechnology.

C. Reaction to GM Free Labeling Claims
Similarly, the groups discussed different ways to label foods that were not products of biotechnology, using as examples three products that could plausibly show some type of non-GM labeling (organic carrots, milk, and tortilla chips). The groups discussed the utility and acceptability of three basic kinds of non-GM type labeling:

1.GM-free claims about the compositional status of the product (e.g., "GM-free", "contains no genetically engineered ingredients)

2.Non-GM claims about how the product was produced (e.g., "not a product of bioengineering", "not produced from genetically engineered seeds", "our suppliers do not plant genetically engineered corn,")

3.Organic claims (e.g., "Certified Organic")

Participants viewed claims that a given food was not a product of biotechnology as being a familiar type of product promotion claim, highlighting a product feature that some people may value and making it easier for those who want such a product to find it and buy it. Because such claims were seen as largely promotional in intent, they were not held to very high standards, in the sense that a certain amount of puffery and advocacy associated with the claim would be tolerated because it is easily discounted.

Nevertheless, participants did expect such claims to be accurate. They interpreted compositional claims (e.g., "GM-free", "contains no genetically engineered ingredients"), as meaning there should not be any bioengineered ingredient in the product. They considered it deceptive to define "GM-free" so as to allow a small amount defined by a threshold level. The prevalent view was that "free" means zero.

Participants had little problem with claims that described the process by which the food or ingredient is produced such as "not a product of bioengineering", "not produced from genetically engineered seeds", "our suppliers do not plant genetically engineered corn." Such claims communicate relevant information in light of people's prior views about the wisdom of food biotechnology. Participants had little appreciation of possible verification and enforcement issues raised by such statements, in part because they saw such statements as more promotional than scientific. For the same reason, participants saw little value in requiring disclaimers to disavow health or safety implications of such claims. For the most part, participants did not interpret process or compositional claims about foods "not produced by biotechnology" as adding anything to their prior understanding of the relative advantages of genetically modified foods compared to other kinds of foods. Whatever implications they were likely to make from such claims followed from their existing beliefs about the wisdom of food biotechnology. The idea that such claims need a disclaimer seemed forced and unnecessary to most participants, and it was often interpreted as a partisan stance that is pro-food biotechnology.

Participants also had little problem with certified organic claims standing in as surrogates for "not genetically engineered" statements. The idea that organic foods are by definition not products of food biotechnology seemed reasonable to most participants. To many participants, organic foods represent a rejection of modern agricultural practices and therefore stand at the opposite end of the spectrum from food biotechnology that represents the highest level of modern technology.

Participants had a hard time discussing how food products that are not organic, but which are also not products of food biotechnology should be described. Because such products seemed to have mixed characteristics, the participants were not certain how they should be described.

Prevalence of Bioengineered Foods in the U.S.
The moderator provided information about the prevalence of bioengineered foods in the marketplace (initially through a short factual description read to participants, later groups received a handout showing examples of everyday foods that are or contain bioengineered ingredients). The discussion explored participants' reactions to this information about the extent certain grain crops in the US are produced from bioengineered seed and the extent such foods are present in processed foods.

After being presented with a factual account of the extent to which certain grain crops in the US are being produced from bioengineered seed and the extent to which bioengineered ingredients are present in processed foods, most participants expressed great surprise that food biotechnology has become so pervasive in the U.S. food supply. Even among participants who considered themselves well-informed about biotechnology, many registered amazement. The typical reaction of participants was not one of great concern about the immediate health and safety effects of unknowingly eating bioengineered foods, but rather outrage that such a change in the food supply could happen without them knowing about it.

Some participants remarked that bioengineered foods have been "snuck in" to the food supply. They were mainly disturbed by the lack of public information and public input to a major development in the quality of their food supply. This information about prevalence served to reinforce the most negative and cynical views some participants held about food biotechnology. Some participants saw this as evidence of a conspiracy to keep consumers in the dark, that is, the rationale for not informing the public must be that there is something to hide.

Appendices available at: http://www.cfsan.fda.gov/~comm/biorpt.html