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Lessons learned



Stakeholder perceptions and participation in the Food and Drug Administration (FDA) Public consultation process regarding the labelling of genetically modified foods .


Janice Albert

Background document providing these lessons learned:

Labeling of Genetically Modified Foods: Stakeholder Perceptions of the Food and Drug Administrationís Public Consultation Processes and Food Industry Reactions to the United States Voluntary and European Union Mandatory Policies, PhD dissertation in Food Policy and Applied Nutrition, Tufts University, Boston (Massachusetts), 2007


This study focuses on stakeholders’ perceptions and participation in twoFood and Drug Administration (FDA) processes: public meetings and public comments. These processes aimed to give citizens the opportunity to exercise their rights to speak, to be informed, and to participate in deliberations over regulatory policies as protected by law.

Background and methodology

In the United States of America (US), the 1992 policy of the Food and Drug Administration (FDA) regarding the regulation of GM foods did not consider the use of recombinant DNA techniques to produce food to be a legal basis for mandatory labelling of these foods. In 1999-2001, FDA reconsidered this position and, as required by law, the regulatory agency sought public views about proposed changes in the US approach to labelling.

Policy makers have obtained public and stakeholder group views with regard to the labelling of GM foods through official and unofficial sources such as public opinion polls, consumer surveys and experiments, focus groups, advisory committees, consensus forums, referenda and official comment periods.

For the analysis of the public consultation processes, the review analyzed the official transcripts from 3 public meetings held in 1999 and a random sample of the public comments sent to FDA in 2001. The criteria for assessing the participatory processes included: fairness, quality of the deliberations and influence of participation on FDA decisions. In addition, in-depth telephone interviews were conducted from May 2003-April 2004 with 18 stakeholder groups representing the conventional and organic food industries, the biotechnology industry, consumer organizations, and groups which oppose agricultural biotechnology to obtain information about stakeholder perceptions.

Stakeholder perceptions and participation in the FDA consultative process regarding labelling of genetically modified (GM) foods

The analysis of official records found that the FDA processes of public meetings and comments sent to FDA differed in terms of participants, accessibility, and representativeness of different views.

The analysis of information obtained from the transcripts of the public meetings and comments sent to FDA demonstrated that the agency followed the law by informing the public of the policies it was considering and inviting public comments. The FDA processes were accessible to citizens and a wide range of views were expressed. The participation procedures gave FDA information about the priorities of various stakeholders. While the interviews with FDA officials suggested that FDA heard and understood the various viewpoints, the information obtained through the participatory process did not lead to a change in the general approach to labelling of GM foods. Some stakeholder group representatives were disappointed or dismissive of the procedures.

There was not a consensus among stakeholders about the value of the participation processes or whether the processes could be used to guide policy decisions. The conventional food industry, biotechnology industry and scientific associations supported the FDA voluntary approach to labelling GM foods, while the organic food industry, environmental organizations and some consumer advocates favoured mandatory labelling of GM foods. The stakeholders’ perceptions of the procedures were consistent with their stances on the policy under consideration.

Stakeholders were very engaged in the public meetings and the quality of statements indicated a high level of understanding of the topics. In contrast, the comments that were sent in response to the Federal Register announcement were lower in quality since the messages did not demonstrate knowledge of the relevant technical or legal issues.

In the interviews for this study, stakeholders’ views of the FDA participation processes seemed to be determined by their stances on the policy under consideration, and their perceptions of the agency were inconsistent. The perceptions of the specific process corresponded with the outcome of the particular process. Thus, the same stakeholder group could have a positive view of one process and a negative view of another process, depending upon how well the process outcome reflected their views. The outcome of the public meetings favoured voluntary labelling, and in this case, the advocates of mandatory labelling charged that the agency officials ignored their views at the public meetings, suggesting dissatisfaction with the process. Based on the analysis of the comments obtained from FDA, the majority of messages called for mandatory labelling. In this case, the critics of mandatory labelling, who supported voluntary labelling, argued that the comments were not meaningful. This suggests that stakeholders view a process as not being worthwhile when the results of the process do not support their case. When an issue is highly controversial, a government agency must actively demonstrate that the processes are fair and accessible to all relevant groups and avoid actions that might lead to perceptions of bias. The FDA officials and panels provided background information during the meetings that was appropriate for a non-technical audience.

However, the meeting structure and venues did not allow for the audiences to have sufficient time to study the information or exchange views with experts about the information they received. The short, well-phrased statements from the audience were probably prepared before the FDA and panel information had been received. Thus, it appears that each speaker had an opportunity to give a statement, but there was not a dialogue. While hearing each other’s views is useful by itself, it is limited.

Another participatory process such as citizen panels or consensus meetings might be more effective and more appreciated than public meetings for complex issues such as GM foods. Nonetheless, through the processes used by FDA, the officials gained an awareness of the wide range of views among stakeholders and citizens and learned that the agency needed to be more transparent and to communicate more clearly about its approach to regulating GM foods.

Through the interviews, however, the study found that some stakeholder group representatives and officials believed that the agency should be cautious in communicating with the public about GM foods because this information could be interpreted as promotion of the technology and this would undermine the role of the agency as a regulator of the technology. While the officials understood the various perspectives, they stated that some stakeholders ignored or failed to understand the legal principles that underpin labelling policies in the US, and they failed to provide any new information that would justify shifting to a requirement to label GM foods. To achieve greater balance and improve the quality of participatory processes, FDA could assist inexperienced organizations and citizens to prepare for participation in policy debates . The provision of information about the technical and legal aspects of an issue in advance of the process and greater opportunities for interaction could give different stakeholders and average citizens the opportunity to participate more effectively.

To conclude, the analysis suggests that the reasons for the weak effect on decisions were not related to disrespect by FDA for the democratic process as some critics have charged. Rather, the limited influence may have been due to a failure of critics to provide new information which might have persuaded FDA that there was a material reason to require labelling. Negative perceptions of the procedures may have been the result of misunderstanding of the process and disagreement with the outcome on the part of some stakeholders.

The study concluded that FDA fulfilled its obligations to encourage public participation in the discussion of guidance on GM food labelling and to consider a wide range of views. The study found that some stakeholders are more skilled in participation than others and that those with less effective participation skills were more dissatisfied.

The study suggests that FDA assist inexperienced citizens to prepare for participation in policy debates, especially those involving complex technologies. The agency should clearly explain the purposes of the participation processes and inform the public of how the information will be used to avoid disillusionment with participation processes.


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