Rulemaking, public comments and participation: a case study of genetically engineered organisms.

Abstract

For the oversight of emerging technologies and their products, public comment periods on proposed federal rules is one of the most popular methods of gaining public insight into public values and opinions about emerging technologies in federal rulemaking. Many science and technology scholars suggest that this level of participation is not effective, or broad enough according to democratic and ethical principles. In this analysis, we set out to examine this issue using the case study of genetically engineered organisms (GEOs) in the food supply and recent proposed rule changes coming from the primary regulatory body for these products, the USDA’s Animal and Plant Health and Inspection Services (USDA-APHIS). This paper addresses the issue of public participation looking at the following areas of research: 1) what are the substantial differences between the old and new proposed regulations for GEOs, 2) what stakeholder groups comment on proposed rules 3) what do the comments say about the proposed rule (as expressed through formal public comments on the Federal Register notice) and 4) to what degree should these comments be taken into consideration by the agency in final rule-making process? Stakeholder groups that have participated in the comment period on this new rule have been identified and the substance of their comments have been examined in order to consider group-diversity and potential patterns of opinions based on affiliation, expertise, demographics, or culture to determine the extent and substance of participation through comment and rule making. Stakeholders were identified, and public comments from these stakeholders were analyzed based on thematic coding schemes in the software NVivo. Areas were identified from these comments that need to be addressed if APHIS should choose to publish the final rule. The method of public participation also was examined using democratic theory and the literature on public participation, including perspectives and social goals of public participation. Negotiated rulemaking was identified as a method to resolve conflict between competing interests and educate and inform the public about issues.