Biotechnology Project
Center for Science in the Public Interest

May 16, 2001

By Fax and Regular Mail
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Re: Comments on Docket Number 00D-1598, Guidance for Industry on "Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering."

     On March 19, 2001, the Center for Science in the Public Interest ("CSPI")(1) submitted comments on the Food and Drug Administration’s ("FDA") Draft Guidance for Industry on "Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering" ("Draft Guidance"). From March 30 to April 1, 2001, CSPI conducted a national telephone opinion poll on issues surrounding the labeling of genetically engineered foods. With this letter, CSPI amends its previous comments to include the results of that national opinion poll (Attachment 1) and CSPI’s analysis of those results (Attachment 2). The results highlight the difficulty of designing a labeling system for genetically engineered foods, whether mandatory or voluntary, that provides honest, objective, value-free, non-disparaging, and non-exalting information to the consumer.

     CSPI’s poll asked 1,017 American adults questions about what information concerning genetically engineered ("GE") food should be provided on food labels and how they might react to various label statements. Consistent with other similar surveys, this poll found that 62% to 70% of respondents desire labeling of genetically engineered ("GE") food, and 17% of those surveyed picked GE food labeling (out of four choices) as their top priority. Based on these results, CSPI reiterates its previous comment that FDA consider a mandatory labeling requirement that would provide consumers with the information that many say they value in making informed purchasing decisions.

     Although a strong majority of Americans want GE-foods labeled, most Americans also desire labeling for many other currently unlabeled food processes, such as whether crops were sprayed with pesticides (76%) or imported (56%). In fact, 40% of respondents said that they would like products containing cross-bred corn to be labeled. Those results indicate that many consumers would like more information about how their food is being produced — be it through biotechnology, pesticides, importation, or even traditional breeding. Thus, whether or not labeling for genetic engineering is instituted, the results show that the public needs to be better educated about where food comes from.

     CSPI’s survey found that consumers value labeling information on GE foods but are unwilling to pay significant costs for that labeling. For example, only 28% of respondents would want GE labeling if it added $50 or more per year (about 1%) to their family’s food bill. Thus, while opinion polls should hardly be the foundation of regulatory decisions, these results show that any labeling system implemented by FDA, whether mandatory or voluntary, should not add significant costs to consumers. FDA should ensure that any labeling system adds little or nothing to a family’s food bill.

     CSPI’s survey found that if labeling is required, which foods should be labeled depends considerably on how much of the engineered ingredients are in a given food. When asked which foods should be labeled as "genetically engineered," 61% agreed that a whole food, such as a tomato, should be labeled, and 53% said that a processed food with a major ingredient (such as Wheaties made with GE wheat) should be labeled. But only 42% agreed that a multi-ingredient food (such as a frozen dinner) with a minor ingredient from a GE crop (such as corn starch) and 38% agreed that a highly processed foods, such as soybean oil lacking any transgenic DNA or protein, should be labeled. Thus, the desire for labeling is strongest for whole GE foods and decreases significantly if the food contains either none or only small amounts of a genetically engineered ingredient. That’s especially the case if one considers the baseline to be about 40% —the percentage of persons wanting cross-bred corn to be labeled.

     The survey also found that consumers’ attitudes and purchasing behavior would be significantly affected by GE food labels. Approximately 30% of consumers stated that GE-labeled foods were "not as safe" as or were "worse" than identical foods without such label information. Only about 7% thought that GE-labeled foods were "safer" than identical foods without such label information. In addition, 52% of consumers would choose a product labeled "does not contain genetically engineered ingredients" over a product labeled that it does "contain" such ingredients. In other words, the poll indicates that consumers would strongly favor non-GE foods because straightforward label statements imply that non-GE foods are better and safer than comparable GE foods, even though most scientists and FDA agree that that is not the case.

     These survey results indicate that it will be difficult to guarantee that label disclosures will not mislead the public. FDA states that its guidance is intended to help manufacturers ensure that their labeling is "truthful and not misleading" and to make sure that any labeling does not imply that a food is "superior" because it was not bioengineered. The survey shows, however, that a significant portion of consumers would consider simple straightforward label statements, similar to label claims that would be allowed under FDA’s Draft Guidance, as a claim of food superiority. Therefore, in order to implement a labeling system that would provide honest, objective, value-free, non-disparaging, and non-exalting information, FDA needs to more carefully analyze how consumers perceive the various label notices it has proposed in the Draft Guidance. Where genetically engineered foods have no nutritional, safety, or other human health difference from conventional foods, labeling should not deceive consumers into thinking that foods free of genetically engineered ingredients are quantitatively or qualitatively different from foods with genetically engineered ingredients.(2)

     Although CSPI’s survey only gathered information about consumers’ attitudes toward label language, to establish a non-deceptive labeling system, FDA also should explore other characteristics of a label claim, such as placement on the label, size of the lettering, and whether there needs to be an accompanying explanatory statement on the label. Where a label statement is located and how it is displayed will affect the message conveyed to the consumer. FDA should reconsider its position that only the name of an ingredient, and not how the ingredient was produced, is permitted in the ingredient statement when it addresses the possible ways to label genetically engineered ingredients. Simply putting "genetically engineered corn" or "corn (genetically engineered)" in place of "corn" in the ingredient list might be a convenient way to convey information to consumers while limiting the likelihood that someone misinterprets the disclosure to suggest that the product is quantitatively or qualitatively different from other similar products. Additional surveys or focus groups on this issue would be useful.

     CSPI would also note that its survey reached a different conclusion from FDA’s focus groups about whether consumers prefer the term "biotechnology" over such terms as "genetic modification" and "genetic engineering." FDA’s focus groups expressed some preference for the term "biotechnology" over such terms as "genetic modification" and "genetic engineering." Our survey found no significant difference between the perceived safety of products labeled as containing "genetically engineered wheat" and labeled "wheat developed with biotechnology." In both those cases, 6% to 7% of respondents said the food was safer than and about 30% said the GE-labeled food was not as safe as, an unlabeled version of the same food, while only about 33% said the foods were the same.

     Our survey was consistent with FDA’s focus groups conclusion that found that consumers preferred label statements that give them more information about how and why a product was bioengineered. When asked about labels stating that the purpose of the genetic engineering is to reduce pesticide use, 21% of consumers answered that the food was "safer," a three-fold increase compared to a label that only stated "contains genetically engineered wheat." In both cases, though, roughly the same substantially higher percentages of respondents said that engineered foods were not as safe as other foods. Thus, those results suggest that FDA needs to more carefully consider what terminology and explanations to allow or require on labels.

     FDA should establish a labeling system that is properly structured to provide useful, value-free, non-disparaging, and non-exalting information and that does not add significant costs to consumers. CSPI’s national opinion poll shows that the current Draft Guidance will not accomplish that. FDA needs to identify a labeling system, including language, prominence, and disclaimers, that would be informative to consumers but not lead them to think that non-GE foods are safer than other foods, and that GE-containing foods are less safe than non-GE foods, when that is has not been shown to be the case. FDA should consider further polling and focus groups to increase its understanding of consumers’ knowledge, attitudes, and behavior regarding the labeling of foods for the presence or absence of genetically engineered ingredients. FDA needs to work harder on this controversial matter. At the same time, though, FDA should recognize that industry, if it wishes people to accept GE-foods, must make a greater and more effective effort to convince the public that such foods are safe and beneficial because no labeling system can eliminate all possible misperceptions.

     CSPI appreciates this opportunity to supplement its comments on the Draft Guidance. If FDA would like additional information from CSPI about its national opinion poll, we would be happy to meet with FDA staff at their convenience.


Gregory Jaffe
Co-Director, Biotechnology Project
Center for Science in the Public Interest
202-332-9110, Ext. 369


1. CSPI is a nonprofit education and advocacy organization that focuses on improving the safety and nutritional quality of our food supply, reducing the damage caused by alcoholic beverages, and other issues. CSPI seeks to promote health through educating the public; representing citizens’ interests before legislative, regulatory, and judicial bodies; and working to ensure that advances in science are used for the public good. CSPI is supported by the 900,000 member-subscribers to its Nutrition Action Healthletter, through foundation grants, and through sales of educational materials. CSPI receives no funding from industry or the federal government.

2. We note that bioengineered foods may sometimes be associated with environmental benefits when compared to conventionally grown food. For instance, HT crops may need less cultivation and therefore less soil erosion. Bt crops may reduce the need for broad-spectrum insecticides that reduce biodiversity. The survey results suggest that at least some respondents would be influenced by this type of information.

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