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Introduction Findings Appendix 1: Participant Screener Appendix 2: Revised Moderator's Guide Handouts |
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.
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).
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:
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.
The groups discussed the utility and acceptability of several labeling approaches. There were three basic labeling approaches presented:
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.
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:
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.
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.
Recruiting Goals
The participants shall be consumers from the general population. There will be three groups held in [facility name] in [location] on [dates].
Hello [Mr./Ms.] ____________, my name is ___________ and I'm calling from ________.
We are presently working with ORC/Macro International, a research and consulting firm, on a project regarding health issues among general populations. Could I ask you a few short questions for this survey?
Screening Questions
"Until we know more, biotechnology should not be used to develop new food products."
Those who answer Strongly Agree or Agree would go in the GM concerned focus group.
We would like you to participate in a group discussion on health issues. The discussion will take place on [Date], at [time]. It will last about 1-1/2 hours, and you will be given [$amount] cash for your time. Would you like to participate?
I would like to send you a confirmation letter and directions to the facility. In order to do so, could you please tell me your mailing address and give me a phone number where you can be reached.
We are inviting only a few people, so it is very important that you notify us as soon as possible if for some reason you are unable to attend. Please call us if this should happen. We look forward to seeing you on [Date] at [time].
Usual introduction and background on focus groups. Ice breaker question.
Today we are going to talk about labeling issues that arise from the new DNA manipulation technologies that scientists have developed over the past 20 years. In recent years these technologies have been applied to develop new varieties of foods and agricultural products. We often refer to these applications as food biotechnology or genetic engineering.
What have you heard about food biotechnology?
When you hear the terms like "bioengineered food", "genetically modified food" or "genetically engineered food", what comes to mind?
Are there any important differences between these terms? What are they?
Is there anything about these types of food that might concern consumers?
Is there anything about these foods that worries you personally?
How are these concerns being addressed, if at all? By whom?
Who do you think is responsible for ensuring the safety of these foods?
Have you heard anything in the news lately about genetically engineered foods?
Are there any genetically engineered foods in your supermarket? What are they?
How can you tell if a certain food or food ingredient is genetically engineered or contains genetically modified ingredients?
Handout: List of foods tested for GM ingredients as reported by the Union of Concerned Scientists
Moderator reads:
The foods most likely to be genetically engineered today are some of the common grains such as corn and wheat, soybeans, and some cooking oils. Based on safety and composition studies, the U.S. government is confident these bioengineered foods are safe for human and animal consumption.
According to recent estimates, 25 to 50 percent of these crops in the U.S. and Canada use genetically engineered seeds. The August 1999 Consumer Reports estimated that 60 percent of all processed foods that are on supermarket shelves today contain some amounts of genetically engineered ingredients. One reason that processed foods are likely to have genetically engineered ingredients is that grains and oils from bioengineered plants are not usually kept separate after harvesting from those that are not bioengineered. What this means is that many processed foods that contain grains, soy or oil will contain a mixture of bioengineered and non-bioengineered ingredients.
Are you surprised by the amount of genetically engineered food that is available today?
What, if anything, concerns you about the current situation?
Do you think products like these need any special type of labeling, or not? Explain.
Given these circumstances, what kinds of information do you think that consumers need?
Now lets talk about some examples of the different kinds of products that could have some kind of biotech labeling. Here us a list of some products that may already be on the shelf in your local supermarket, some others are close to being introduced into the marketplace, and others are still in the research and development phase. We want you to have a sense of the whole range of products that are involved when we discuss labeling options.
HANDOUT LIST OF PRODUCTS CONTAINING GE INGREDIENTS (cake mix, corn oil, canola oil, Flavr-Savr tomato, vitamin A rice, and growth hormone salmon) Read the product descriptions. (Handout 1)
Now I want to describe some possible kinds of labeling to you so that we can talk about how the you think these options will work for the 6 examples of genetically engineered products.
Option 1:
Do you think, for example, that one or more of them should have a simple statement such as "Genetically modified food" or "Contains genetically modified ingredients" somewhere on the label? Which one needs this kind of labeling the most? Which one needs it the least?
Where do you think such a disclosure needs to be on the label? On the front of the package or included in the ingredient list? Should it vary by product?
Do you think a seal or logo of some kind would be better or worse than a simple statement?
How do you think consumers will respond to such disclosures? Will it make them more or less likely to buy the product?
Option 2:
Do you think a more product specific kind of disclosure statement might be better, such as "Genetically modified to increase Vitamin A content" or "Genetically modified to grow faster" or "Contains soy from plants genetically modified to be pest resistant." Or "Grown from plants that have been genetically modified to resist herbicides."
Why do you think these kinds of statements might be better or worse than Option 1?
What is the added value to you as a consumer from this kind of labeling?
Which product needs this kind of labeling the most? Which product needs this kind of labeling the least?
Option 3:
Do you think that a statement such as "Caution: Contains genetically modified ingredients. Long term effects have not been determined" might be appropriate for one or more these products?
What is the added value to you as a consumer from this kind of labeling?
How do you think consumers will respond to such a statement? Will it make them more or less likely to buy the product?
Which product needs this kind of labeling the most?
HANDOUT LIST OF PRODUCTS THAT DO NOT CONTAIN GE INGREDIENTS (organic carrots, milk, and tortilla chips) (Handout 2)
Here is another set of products that might have labeling related to genetic engineering. This time the products do not contain any genetically engineered ingredients, and they may or may not choose to say so in their labeling.
Option 1:
Such products, for example, might choose to include a statement on the label like, "Does not contain genetically engineered ingredients." Or "This product is GM-Free"
Which of these products do you think would be most likely to choose to claim that they are "GM-Free" or "Do not contain any genetically engineered ingredients?" or "Does not contain rBST"?
For what purpose do you think they would choose to use such a label? Would the likely purpose differ by product? How would it differ by product?
What is the value to consumers of this kind of labeling?
Which of these products, if any, should be allowed to say that they are healthier for you or safer than comparable foods that may be genetically engineered?
Do you think products such as these should be able to make statements about the safety and healthfulness of other foods even when there is no scientific consensus that the statement is true?
Do you think this is a good way for consumers to become educated about food biotechnology?
Option 2:
Some products might choose to include a statement that claims that they do not have a specific kind of GM ingredient or use a specific kind of GM technology. A dairy product, for example, might say "Made from cows that have not been treated with rBST" (recombinant bovine somatotropin is a growth hormone made by genetic engineering that increases the production of milk in treated cows).
Do you think there is added-value information in knowing that a certain product has not been subjected to a specific kind of genetic engineering technology? What is the added-value?
Is this a good way for the public to become educated about food biotechnology?
What if the dairy product that chose to use such a statement was required to have a disclaimer, such as
"The FDA finds there is no significant difference between milk from cows treated with rBST and untreated cows. No test can distinguish between milk from treated and untreated cows"
What is the purpose of such a statement?
Do you feel that this is a good way to prevent the public from being misinformed about biotechnology?
Can you think of better ways to control the flow of misleading information to the public about biotechnology?
There are many different ways to say that a product does not contain genetically engineered ingredients. Look at the follow list of statements.
HANDOUT LIST OF STATEMENTS (Handout 3)
Contains no genetically engineered ingredients.
Certified Organic
Certified organic corn and soy oil.
No genetically engineered corn or oil is present in this product
Less than 5% of the corn used to make our chips is genetically engineered
Our suppliers guarantee they do not plant genetically engineered corn
All natural ingredients
GM-free
Which of these statements mean the same thing? Which are clear/easy to understand?
Some of these statements use words like "Certified" or "Suppliers guarantee".
What do you think is meant by these terms?
Is the use of such terms based on scientific testing?
How do you know what the standards are for these terms?
Is this a problem?
In Europe, the proposed definition for GM-free is that the product contains less than 1% genetically engineered ingredients by weight.
Would that be a satisfactory definition for you? Why? Why not?
Wrap Up.
We've looked at several different types of products and the different ways information about bioengineered foods and non-bioengineered foods can be shown on labels.
Do you think there should be an information program that explains the risks and benefits of genetically engineered foods to the general public?
Is there any other information we haven't discussed that you think needs to be on the label or in stores, that tells consumers about GE ingredients or foods?
The following processed foods tested positive for being genetically modified (September 1999). The tests were not "safety tests;" they were only to establish the presence of unlabeled genetically modified ingredients.
Additionally, the following whole foods have been genetically engineered and approved for commercial sales:
Source: Union of Concerned Scientists
Example 1: Cake Mix
Example 2: Corn Oil
Example 3: Canola Oil
Example 4: Flavr SavrTM Tomato
Example 5: Vitamin A rice
Example 6: Genetically modified salmon
Example 1: Organic Carrots
Example 2: Skim Milk
Example 3: Organic Tortilla Chips
Contains no genetically engineered ingredients.
Certified Organic
Certified organic corn and soy oil.
No genetically engineered ingredient is present in this product
Less than 5% of the ingredients (by weight) is genetically engineered
Our suppliers guarantee they do not plant genetically engineered seeds.
All natural ingredients
GM-free
*Authors: Alan S. Levy and Brenda M. Derby
Office of Scientific Analysis and Support
Division of Market Studies, Consumer Studies Team
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Hypertext updated by cjm 2001-FEB-08