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Scope of Work: Advisory Boards Keystone Dialogues Joint Fact Finding Leadership Summit Published Works/Staff Keystone Reports |
Project Background Since that time, a Keystone facilitated advisory panel has been formed and has produced two panel reports. These reports provide information in three areas: background information regarding the panel and the current membership, the panel's consensus assessment regarding their participation on the panel, and individual perspectives from each of the panel members regarding their particular areas of interest and expertise as they relate to biotechnology.
The Keystone Environmental, Citizen, State and Local Leadership Initiative for Biotechnology, Issue Report Series, Biotechnology Decisionmaking: Perspectives on Commercialization This report will assist the reader in understanding the issues associated with commercialization of genetically altered organisms. Only through informed debate will the appropriate public policy decisions be made regarding biotechnology. -excerpt from report
Workshop Summary: Southeast Regional Workshop on Biotechnology, Atlanta, Georgia; Keystone Environmental, Citizen, State and Local Leadership Initiative This report documents the fourth of a series of four regional workshops on biotechnology conducted by The Keystone Center under its “Environmental, Citizen, State and Local Leadership Initiative.” The Initiative was designed not to develop consensus among leaders, but to disseminate information and encourage discussion regarding the future development of biotechnology. Initiative projects aided leaders in their efforts to foster constructive and informed public participation in biotechnology decisionmaking. In this workshop, which was focused on agricultural applications of biotechnology, four case studies were introduced and discussed in depth. What is Biotechnology? An Introduction to the Key Issues Associated with this Emerging Field, gave a scientific overview, an introduction to applications and development, and a detailing of the activities of the EPA, USDA and FDA. The panel on Scientific Issues examined research needs and priorities, and environmental considerations. Regulatory Issues gave an environmentalist’s view of biotechnology regulations, including “cracks” in federal policy, and industry’s view of the regulations, which emphasized the need for flexibility and focus on health, safety, environmental and efficacy issues, not social or political issues. Socio-economic Issues dealt with potential benefits, such as improved quality and insect resistance, and potential adverse effects, such as economic inequity, third world disruption, and decrease in biodiversity. Public Participation/Education presented the results of a public survey of urban consumers, rural consumers, farmers and opinion leaders, the role of public relations and the role of the media. The Summary Discussion was a wide-ranging and provocative review of the issues raised in this workshop.
Biotechnology Decisionmaking: Perspectives on the Objectives of Public Participation This report was issued by The Keystone Environmental, Citizen, State and Local Leadership Initiative for Biotechnology. The Initiative was designed not to develop consensus among leaders, but to disseminate information and encourage discussion regarding the future development of biotechnology. Initiative projects, including this report, aided leaders in their efforts to foster constructive and informed public participation in biotechnology decisionmaking. Public participation: a term that most people acknowledge as a desirable element and a goal of sound public policy and decisionmaking, but what does it actually mean? And, in particular, what does it mean regarding biotechnology policy? In this publication, we hope to shed some light on these questions from several perspectives, and raise a few more for thought. Representatives of several public and private sector organizations that were prominently involved in biotechnology policy were asked to write a normative opinion in response to the question, “What should be the objectives of public participation in the development of biotechnology policy at the local and national level?” Topics include informed decisionmaking, open questioning of those with technical expertise, inclusion of social and ethical aspects, avoiding mistrust, and public input into research efforts. The summary reviews the emergence of public participation in technological decisionmaking, and speculates on its future role.
Keystone National Biotechnology Forum, Interim Summary Report, Public Participation and Education in Biotechnology: Summary Report and Recommendations The Keystone National Biotechnology Forum was established to provide a neutral, facilitated forum where people from diverse interests can come together to discuss the issues pertaining to biotechnology, with a focus on the federal regulatory environment, public participation and education, and research activities. Participants gain an understanding of diverse concerns and perspectives, and build consensus on issues of import to the evolving public policy affecting the field. This report is a product of the Forum, of interest both to those who are directly involved in the field of biotechnology and to those who desire to learn more about the field. By modeling public participation and consensus-building on a small scale, the Forum provided a route map for public education on a large scale. This interim report addresses several topics. Audiences outlines those groups who will most benefit from well-focused, concise informational efforts. Key Questions About Public Participation Efforts lists some questions that those designing public participation efforts need to ask themselves, Recommendations for Programs and Projects looks at considerations in designing projects geared toward the media, state programs, public meetings, and science education. Next Steps: Suggested Projects gives ideas for a resource directory and a source cataloging lessons learned from past releases. It also proposes projects for educating funders of public education projects and for a mobile education team. The Summary emphasizes that the final definition of acceptable risk associated with biotechnology is a scientific and political task, making public participation and education essential. An Analysis of the Federal Framework for Regulating Planned Introductions of Engineered Organisms
Workshop Summary: Third Regional Workshop on Biotechnology, Tiburon, California; Keystone Environmental, Citizen, State and Local Leadership Initiative This report documents the third of a series of four regional workshops on biotechnology conducted by The Keystone Center under its “Environmental, Citizen, State and Local Leadership Initiative.” The Initiative was designed not to develop consensus among leaders, but to disseminate information and encourage discussion regarding the future development of biotechnology. Initiative projects aided leaders in their efforts to foster constructive and informed public participation in biotechnology decisionmaking. The agricultural focus of this workshop allowed concentration on key issues in biotechnology. Three categories of issues were raised: risk to human health and environment, socio-economic issues, and moral and ethical issues. The relationship of the regulatory structure to these categories of issues presented the subject matter of much of the workshop, with the role of the public, public participation and public perception of biotechnology being one fundamental theme. Congressman George E. Brown, Jr. (D-CA), Chairman, Subcommittee on Department Operations, Research, and Foreign Agriculture, House Agricultural Committee, U.S. Congress, addressed the theme of the importance of public participation in his keynote address, which is included verbatim in this report. The workshop format consisted of six panels, with reactive panels, small work group sessions, and a summary addressing six key areas. Information and Participation in Decisionmaking looked at emerging cultures surrounding biotechnology, root causes of dissension, logistic difficulties in public involvement, and defining a target audience – “who is the public?” Agricultural Applications and Policy Issues looked at public fear of greed, benefits of biotechnology, and the framing of public discussions. Biotechnology Research Issues addressed international research competition, changes in the structure of land grant university research departments, and vertical integration of researchers to reduce unintended consequences in the field. Planned Environmental Introduction of Genetically Engineered Organisms examined potential superiority of genetically modified organisms over the wild relative, and example of a successful introduction without public controversy, regulation of product rather than process, and need to collect data through small field trials. Socio-economic Costs and Benefits considered the desirability of the biotechnology industry for states, consistency in various levels of regulation, barriers to getting biotechnology to the farm, and comparison of biotechnology and biomedical ethical dilemmas. Federal and State Regulatory Frameworks gave an overview of the mechanisms of different governmental regulatory bodies and and the interrelations of the different agencies. The Summary concluded that the institutional mechanisms do not yet exist to address the full range of concerns about biotechnology, and that such mechanisms must be created.
Issues Raised by Biotechnology: A Keystone Biotechnology Discussion Paper The purpose of this paper is to provide readers with general information on biotechnology that will assist them in public policy discussions on this important subject. It is written for the general reader, not for those with technical or scientific expertise. The subject matter is organized under five general headings: Should biotechnology be regulated? This question discusses risk assessment, risk management and the difficulties in making decisions in a descriptive, rather than prescriptive science like ecology. How does the federal government regulate biotechnology? This section names the pertinent federal regulatory agencies, acts and programs, and outlines their various purviews and functions. Are there problems with the federal approach to regulation? Three categories of concern are reviewed: jurisdictional confusion, agency capabilities, and public input into regulatory decisions. There is an extensive bibliography at the end of this report.
Workshop Summary: First Regional Workshop on Biotechnology for Public Interest Leaders, Austin, Texas ; Keystone Environmental, Citizen, State and Local Leadership Initiative This report documents the second of a series of four regional workshops on biotechnology conducted by The Keystone Center under its “Environmental, Citizen, State and Local Leadership Initiative.” The Initiative was designed not to develop consensus among leaders, but to disseminate information and encourage discussion regarding the future development of biotechnology. Initiative projects aided leaders in their efforts to foster constructive and informed public participation in biotechnology decisionmaking. The focus of this workshop was on the agricultural application of biotechnology and the related public policy issues. Agricultural research and development in biotechnology have initiated questions and concerns regarding regulation, the environment, and ethics. The narrow scope of this workshop allowed a manageable framework for providing information and encouraging discussion. Presenters and participants in this Initiative Workshop consisted of leaders of environmental, citizen and public interest organizations, including labor, farm, animal rights, and conservation groups. Based on ideas generated by discussions within the Keystone National Biotechnology Forum and National Advisory Committee for Biotechnology, the Workshop used a focused panel/presentation and full session discussion format to address six key areas. Biotechnology, Agriculture and Public Policy: Agricultural Applications and Policy Issues Associated with Biotechnology consisted of four presentations centered on socio-economic issues such as risk assessment, monopolization, patenting, dispute resolution and disparate impacts. Current and Future Research: Industry’s Requirements and Public Needs looked at resources devoted to agricultural biotechnology, field-testing, intellectual property rights, introduction of problem organisms, economic impacts of increased yields, actual lawsuits and lawsuit prevention. Issues Impacting Product Development: Intellectual Property Protection and the National Regulatory Climate addressed the effects of a moratorium, the ethics of patenting life forms, the complexity of existing regulations, economic dislocations and the need for a social agenda. Benefits and Costs to Users and Non-users of Agricultural Biotechnology Products reviewed consumer and farmer acceptance/rejection of biotechnological food products, increased industry vertical integration and effects on family farms. Determining Environmental Considerations of Field Testing and Commercial Applications: Risk Assessment and Risk Management addressed uncertainty, competitiveness, categorization of risk, quantification of risk and policy implications. Regulatory Structures: An Overview of National and State Structures reviewed the relationships among the public, industry and government.
Workshop Summary: First Regional Workshop on Biotechnology, Madison, Wisconsin: Keystone Environmental, Citizen, State and Local Leadership Initiative This report documents the first of a series of four regional workshops on biotechnology conducted by The Keystone Center under its “Environmental, Citizen, State and Local Leadership Initiative.” The Initiative was designed not to develop consensus among leaders, but to disseminate information and encourage discussion regarding the future development of biotechnology. Initiative projects, including this workshop for state and local officials, aided leaders in their efforts to foster constructive and informed public participation in biotechnology decisionmaking. Using ideas generated by discussions within the Keystone National Biotechnology Forum and National Advisory Committee for Biotechnology, the Workshop used a presentation, panel, and small workgroup format to address five key areas. Educating the Public framed the need for public education on biotechnology, outlined existing programs familiar to the presenters and looked at the role of the media. What is Biotechnology? examined rDNA techniques, what practical applications have been conducted up to that point, and in which direction the technology is headed. Risks and Benefits of Environmental Applications of Modified Organisms looked at the uncertainty surrounding potential risks posed by field-testing and large-scale commercial applications of genetically engineered organisms, as well as the components of an adequate review. The Federal Regulatory Framework: Current Structure and Future Directions provided an overview of the Coordinated Framework from several different perspectives, discussed modifications, and explored its applicability to regulatory efforts at the state level. The States’ Role in Biotechnology: Economic Development and Regulation and Current Needs of States with Respect to Biotechnology asked what role, if any exists for the states in either regulating or promoting the development of biotechnology and outlined the tools available to states when addressing biotechnology policy questions. |
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