Improving oversight of genetically engineered organisms

Available online at www.sciencedirect.com

Policy and Society 28 (2009) 279–299 www.elsevier.com/locate/polsoc

Improving oversight of genetically engineered organisms Jennifer Kuzma a,*, Aliya Kuzhabekova b, Kelly Morgan Wilder c a

Center for Science, Technology, and Public Policy, Humphrey Institute of Public Affairs, University of Minnesota, 160 Humphrey Center, 301 19th Ave. So., Minneapolis, MN 55455, USA b Center for Science, Technology, and Public Policy, Education Policy, University of Minnesota, Minneapolis, MN, USA c Center for Science, Technology, and Public Policy, Humphrey Institute of Public Affairs, University of Minnesota, Minneapolis, MN, USA

Abstract Genetic engineering (GE) has been used to produce plants with desirable qualities for over two decades, and widespread, worldwide market adoption of engineered crops with pest and disease resistance characteristics has occurred. Genetically engineered organisms (GEOs), including GE crops, have been formally overseen by the U.S. government since the mid-1980s. In this article, our previous work on identifying strengths and weaknesses of the U.S. GEO oversight system is reviewed, and a new analysis of the system based on expert and stakeholder interviews is presented. Using both analyses and an examination of historical controversies surrounding GEOs, three categories of improvements to oversight are identified: democratization of oversight processes, establishing clear mechanisms for inter-agency and -organization coordination, and taking on uncertainty through upstream and fluid approaches. The paper also discusses feasibility issues and barriers associated with implementing changes in these areas, notably the overarching U.S. approach to regulation and legal authorities. # 2009 Policy and Society Associates (APSS). Elsevier Ltd. All rights reserved. Keywords: Technology; Oversight; Policy; Biotechnology

1. Introduction Since the mid-1970s, scientists have had the abilities to engineer organisms with desirable characteristics through the insertion of genetic material from virtually any organism into any other organism (e.g. animal to plant, bacteria to mammals). The sector which has been the main area of market growth for genetically engineered organisms (GEOs) has been crop production. Over the past fifteen years, genetically engineered (GE) crops have permeated markets across the world. In 2008, 25 countries grew GE crops, 15 developing countries and 10 developed countries (James, 2008). Herbicide tolerance (Ht) and insect resistance (IR) are the prominent traits in these crops. In 2007, approximately 90 percent of soybeans acres in the United States were planted with Ht GE soybean; 45 percent of maize acres with IR or Ht GE maize; and 65 percent of cotton acres with Ht GE cotton (USDA-ERS, 2008). Proponents of and objectors to current policies on the environmental release and use of GEOs still seem to be polarized in opinion (Kuzma, Najmaie, & Larson, in press), despite three decades of opportunities to understand each other and cooperate in governance. Contentious issues are diverse. Safety debates surrounding GE crops include engineered genes moving into and impacting wild populations (for example, insect resistance gene called Bt

* Corresponding author. Tel.: +1 612 625 6337; fax: +1 612 625 3513. E-mail address: [email protected] (J. Kuzma). 1449-4035/$ – see front matter # 2009 Policy and Society Associates (APSS). Elsevier Ltd. All rights reserved. doi:10.1016/j.polsoc.2009.09.003

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introgressing from cultivated corn into native maize in Mexico), adverse effects from GEOs on nontarget species in the environment (for example, concerns about Bt pollen from corn killing monarch butterfly larvae), and changes in the levels of toxicants or allergens in food due to introduced genes (for example, cry 9C Bt protein with similarities to human allergens in Starlink corn which entered the human food supply without approval) (NRC, 2000, 2002, 2004). Broader concerns include impacts of GE crops on the sustainability of ecosystems, economies, markets, research and innovation, and social and cultural systems. Ethical issues are also prominent in the development and application of GEOs, including the rights of consumers to know and choose products (autonomy), the distribution of risks and benefits (justice and equity), and the hubris of tampering with life at its fundamental level (Thompson, 2007). U.S. GEOs oversight was formally developed in the 1970s first for laboratory products. In the 1980s, the Coordinated Framework for the Regulation of Biotechnology (CFRB) was established to oversee the environmental release of GEOs and their products (OSTP, 1986). The Coordinated Framework is still in operation today and involves a multiple agency approach to oversight. It was founded on the principles that regulation should be ‘‘science based’’ and that the risks were the ‘‘same in kind’’ as those of non-GE products; therefore no new laws were required (NRC, 2000). Multiple existing laws were interpreted to cover emerging products such as genetically engineered plants and microorganisms. The multi-agency and multiple statute approach has led to some confusion over the past 20 years as to which agencies would be responsible for the most novel products of biotechnology, such as genetically engineered insects or fish (OSTP & CEQ, 2001). Furthermore, the regulatory approach in the U.S. has clashed with the approach of other nations, particularly the EU. For example, the U.S. does not require labeling of foods derived from GEOs, whereas the EU does (PIFB, 2005). In this paper, policy needs for the improvement of oversight of GEOs used in agriculture and the environment in the U.S. are suggested from an analysis of interviews with experts and stakeholders, while drawing on the historical literature and our previous work to identify strengths and weaknesses of GEOs oversight. Policy options in three areas are examined along with institutional structures for the feasibility of implementation. It is important to mention that this paper does not represent a complete policy analysis, which systematically projects outcomes and tradeoffs of policy options according to a set of criteria (Bardach, 2008). However, this paper represents the initial steps towards such an analysis by identifying the problems (i.e. from strengths and weaknesses from previous work and the interviews in this paper), proposing categories of policy options (i.e. from the interviews), and exploring the feasibility of these options (i.e. from the history of operation of U.S. GEOs oversight). First, our prior conclusions about strengths and weaknesses of U.S. GEO oversight are summarized. Second, a review of the history of GEOs oversight is presented to explore how the strengths and weaknesses are manifested in previous controversies. Then, the interview data is analyzed to suggest categories of policy options. Finally, potential barriers to implementation are discussed. 2. Prior examination of strengths and weaknesses of GEOs oversight In our previous work, we used a multi-criteria decision analysis approach to evaluate the performance of GEOs oversight over time (from the CFRB to the present) (Kuzma et al., in press). A list of 28 evaluative and descriptive criteria was derived from expert and stakeholder elicitation, group consensus, and the literature (Kuzma, Paradise, et al., 2008). The 28 criteria were grouped into four categories relating to how oversight systems develop (development criteria), operate (attribute criteria), change over time (evolution criteria), and impact society (outcome criteria). The 28 criteria were presented to experts and stakeholders (n = 17) in GEOs oversight who were asked to score how the U.S. system performed with regard to each, and then statistical analysis was performed to look for relationships. Rating of the criteria, in combination with an analysis of the literature, allowed us to identify strengths and weaknesses of the GEOs oversight system which are presented in Table 1. Although there was significant disagreement among individuals and types of experts and stakeholders, score distributions for several criteria exhibited a high to moderate degree of consensus and pointed to some interesting shortcomings and strengths of GEOs oversight. The most prominent weaknesses of GEOs oversight identified by this previous work include few financial resources and low transparency in development of GEOs oversight, little post-market monitoring after product approval and release into the market, a closed treatment of intellectual property which prevents access to data on the part of the public, few opportunities for public input, low transparency for regulatory decision making, low capacity in the form of agency resources, prominent conflicts of interest in the review system, and little informed consent with regard to consumers’ or users’ ability to know and freely choose the products of GEOs (Table 1).

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Table 1 Strengths and weaknesses of GEOs oversight: quantitative expert elicitation. Criteria

Assessment

Development D1 Impetus (reactive, proactive) D2 Clarity of subject (not clear = 0, clear = 100) D3 Legal grounding (weak = 0; strong = 100) D4 Public input (minimal = 0; significant = 100) D5 Transparency (low = 0; high = 100) D6 Financial resources (not at all = 0; sufficient = 100) D7 Empirical basis (weak = 0; strong = 100)

neutral * strength * weakness neutral * weakness * weakness neutral

Attributes A8 Legal basis (weak = 0; strong = 100) A9 Data requirements and stringency (weak = 0; strong = 100) A10 Post-market monitoring (little = 0; extensive = 100) A11 Treatment of uncertainty (limited = 0; extensive = 100) A12 Empirical basis (weak = 0; strong = 100) A13 Compliance and enforcement (weak = 0; strong = 100) A14 Incentives (few = 0; many = 100) A15 Treatment of intellectual property (closed = 0; open = 100) A16 Institutional structure** (simple = 0; complex = 100) A17 Flexibility (low = 0; high = 100) A18 Capacity (low = 0; high = 100) A19 Public input (minimal = 0; significant = 100) A20 Transparency (low = 0; high = 100) A21 Conflict of interest (prominent = 0; avoided = 100) A22 Informed consent (little = 0; extensive = 100)

neutral neutral * weakness neutral neutral neutral neutral * weakness * complex * strength * weakness * weakness * weakness * weakness * weakness

Evolution E23 Extent of change** (none = 0; extensive = 100)

medium change

Outcomes O24 Public confidence (low = 0; high = 100) O25 Research and innovation (negative = 0; positive = 100) O26 Health and safety (negative = 0; positive = 100) O27 Distributional health impacts (inequitable = 0; equitable = 100) O28 Environmental impacts (negative = 0; positive = 100)

neutral neutral neutral neutral neutral

Strengths and weaknesses indicate criteria rated high (over 60) or low (under 45) respectively with a moderate to strong degree of consensus by the expert and stakeholder group (Kuzma et al., in press). They are generally confirmed by the literature on GEOs oversight. If there was a low degree of consensus among the experts or a moderate score (45–60), the criteria is judged as neither a strength nor weakness (neutral). The criteria denoted by ** are descriptive, not evaluative criteria.

Despite the numerous weaknesses, outcomes of GEOs oversight such as impacts on health and environmental safety, research and innovation, and public confidence were rated as neutral on average (Table 1). Also, the empirical foundations of GEOs oversight were considered neutral (neither low nor high). Strengths of the system included its flexibility which can lend itself to adaptation to new technologies or circumstances and a high degree of clarity in technological subject matter that is subject to regulatory review (Table 1). These results generally confirm that the goal of U.S. GEOs oversight to be a ‘‘science-based’’ system has materialized. Another key focus of our prior work was to determine whether critical elements associated with how oversight systems operate are linked to positive outcomes or other normatively important features. In order to probe relationships among the criteria, we performed a correlation analysis on the criteria scores (Kuzma et al., in press). Criteria related to democratic and ethical principles (informed consent, public confidence, public input to system development, just distribution of health outcomes, and transparency); evidentiary foundations (data requirements, specific empirical basis, and treatment of uncertainty); and enforcement provisions (incentives, compliance and enforcement, capacity, proprietary information provisions, and financial resources) were found to be correlated at a high significance level ( p < 0.002). The general lesson that we suggested for emerging technologies oversight was that ‘‘science-based’’, institutional, and normative elements of oversight are not completely separable, and all types should be strengthened for effective oversight.

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We continue the evaluation of U.S. GEOs oversight in this paper. In the following sections, we build upon prior analyses by providing historical illustrations of some strengths and weaknesses and by qualitatively examining interviews with experts and stakeholders with experience with GEOs oversight. We suggest some policy alternatives, focusing on how to improve GEOs oversight beyond the strictly ‘‘science-based’’ approach and by enhancing normative and institutional dimensions of oversight. 3. Discussion of the historical review of GEOs oversight After reviewing the literature, we summarized the historical development of GEOs oversight in the United States according to three phases: evolution, implementation, and adaptation (Fig. 1). The development of the oversight system for GEOs has its roots in the Asilomar conference (Berg, Baltimore, & Brenner, 1975), which brought together scientists and the media to discuss whether experiments with recombinant DNA (rDNA) in the laboratory warranted precaution. This meeting eventually led to the involvement of National Institutes of Health (NIH) Recombinant DNA Advisory Committee (RAC) which was then tasked with oversight of laboratory experiments involving GEOs (NIH, 1978). Over time, researchers wanted to move GEOs out of the laboratory and into the environment and marketplace. The Coordinated Framework for the Regulation of Biotechnology (CFRB) was formulated in 1986 in response to Congressional hearings and court cases over the release of the ‘‘ice-minus’’ GE bacteria into the environment (USCongress, 1983). CFRB instructed three federal agencies, the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to use the Toxic Substances Control Act (TSCA), Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Federal Food Drug and Cosmetic Act (FFDCA), and the Federal Plant Pest Act (FPPA) to regulate the products of biotechnology and GEOs. The framework relied on the policies that the ‘‘product not process’’ should be the focus of regulation and no new laws were needed to cover GEOs and products from them. The framework was set up as a ‘‘science-based’’ decision making process, one that rested on empiricism, costs and benefits in accordance with overall U.S. federal regulatory policy (EOP, 1993). Prominent civil society groups have stated opposition to the CFRB (Gaskell & Bauer, 2001). Many opponents believed that new and focused policies and laws were needed to fully cover the risks and societal impacts associated with GEOs and their products. They argued that biotechnology is a ‘‘process’’ that presents new risks and requires special regulation. This viewpoint runs counter to the U.S. policy of focusing on products being the ‘‘same in kind’’ as those that are bred by conventional means (NAS, 1987). Twenty years later, this framework is still operational, although it has evolved over time (Fig. 1). The interpretation of the CFRB and the explosion of GE products in agriculture mark the second phase of oversight in Fig. 1, implementation. During this phase, the boundaries of various statutes were significantly stretched to promulgate agency regulations for diverse products. Genetically engineered (GE) plants were regulated as ‘‘plant pests’’ under FPPA, because they often contained engineered sequences from viruses and bacteria that cause plant disease or because the plants themselves can be considered plant pests (USDA, 1993; USDA, 1997). GE plants engineered with pesticidal-like proteins (‘‘plant incorporated protectants’’) were regulated under FIFRA and FFDCA as pesticides by the EPA (EPA, 2001; NRC, 2000). GE microorganisms were regulated as ‘‘toxic chemicals’’ under TSCA (EPA, 1997). GE or bioengineered foods were reviewed under FFDCA by the FDA through a voluntary consultation mechanism (FDA, 1992). At the time of development and during initial phases of implementation, the CFRB framework did not specifically consider regulation of GE insects, trees, plant pharmaceuticals, fish or mammals. There is still some ambiguity about oversight for these GEOs and their products. Most recently, the FDA proposed to oversee GE animals as ‘‘investigational new animal drugs’’ under FFDCA (FDA, 2008b). The first GE animal for food use has been waiting for approval for over a decade, because of a lack of a regulatory guidance documents to interpret existing laws. This delay in decision making about how to regulate GE animals seems to have caused a lack of investment in GE animal technology (Pollack, 2007). Although the laws and their interpretations for GE crops have largely remained the same they were first commercialized in the mid-1990s, over time, several guidance documents and regulatory policies have been published to adapt to emerging GE plant products (Fig. 1). Adaptations to the CFRB were in part prompted by public and stakeholder reactions to new risk information or perceived failures of the system. The controversies surrounding Starlink corn, Bt crops and Monarch butterflies, and cross-contamination of food crops with GE crops with pharmaceutical proteins mark a

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Fig. 1. Timeline of GEOs oversight and key events.

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turning point in the U.S. oversight history, the end of the implementation phase and beginning of adaptation (Fig. 1). These controversies and mishaps in the regulatory system sparked revisions to the framework’s policies and guidance documents, although the premises of U.S. biotechnology regulation still hold today. Concerns over cross-contamination issues have continued to be prominent. For example, an EPA study demonstrated a potential for migration of herbicide-tolerant (Ht) genes from creeping bentgrass into natural grasslands; unapproved Ht rice varieties were discovered in the human food supply; and GE pigs for research have entered the human food supply without regulatory approval (Fig. 1) (CFS, 2006). These adverse events seem to have impacted the GE crop industry. For instance, the development of GE wheat has been put on hold from time to time because of regularly occurring resistance from farmers that do not want it near their fields (Ament, 2003). Although the percentage of corn, cotton and soybean, which are GE have increased over past 8 years, the number of GE crops approved for market use and approval per year (i.e. number of deregulated crops per year) has been declining since 1997, and the number of approved field trials has declined since the year 2002, around the time of many of the controversies and cross-contamination issues mentioned above (ISB, 2008). Most recently, in the past few years, several court challenges have been made by non-governmental organizations (NGOs). In 2007, USDA’s Animal Plant Health Inspection Service (APHIS) lost two district court cases for inadequate data to support its decision to allow deregulation of GE alfalfa and for ignoring evidence of environmental harm in field trials of GE bentgrass (McHugen & Smyth, 2008). In 2008, USDA proposed a reinterpretation of the Plant Pest Act and revisions of its regulations stating that ‘‘this is the first comprehensive review and revision of the regulations since they were established in 1987’’ (USDA, 2008). The revisions are complex and are currently being contested through the public comment and meeting process, with consumer and other citizen groups arguing that the new rules would weaken USDA’s regulatory process (CFS, 2009). The agency has extended the comment period twice after receiving several thousand comments and hosting public meetings in 2009 (USDA, 2009). As of September 2009, the revisions have not yet gone into effect. Among other things, the revisions include explicit attention to risks of noxious weeds from GEOs and propose tiered, administrative categories for field trial permits which are based on risks of the recipient plant and engineered trait (USDA, 2008). Debates about the oversight of GEOs in food and agriculture have operated in an adversarial culture (Jasanoff, 1990), and as discussed, controversy has been periodically fueled by mishaps in the system. Some believe that a lack of clear consumer benefits from the initial phase of developing GE products has led to rejection of the technology. However, U.S. consumers have been largely unaware of or fairly neutral in their thinking about GEOs (PIFB, 2001). In the European Union (EU), there has been greater public and stakeholder resistance, and the EU oversight approach differs substantially from the U.S. approach. The U.S. and EU were involved in a protracted WTO dispute over the EU’s de facto moratorium on importing GE products from the U.S. from 1998 to 2004 (PIFB, 2005). It has been estimated that U.S. farmers lost $200 million per year in trade during the moratorium on several U.S. GE crop varieties. The EU regulatory documents cite a more precautionary approach to oversight, including mandatory product labeling above a threshold of 0.9 percent GE ingredients (PIFB, 2005). The U.S. does not have a mandatory labeling policy, although products can be voluntarily labeled as containing or not containing GE ingredients. In summary, the GEOs oversight story is rich and complex, and it can be used to inform the development of future oversight of emerging technologies. As such, in this paper, we set out to more formally assess the strengths and weaknesses of U.S. GEOs oversight and the challenges and opportunities for improving it. The following sections discuss a new analysis of interviews with stakeholders and experts to identify policy needs for the improvement of GEOs oversight. In the analysis, we draw upon a blend of democratic, applied ethics, and risk perception theories for evaluating oversight and policy options for the future. 4. Interview methodology We used semi-structured or semi-standardized expert interview methodology for data collection (Berg, 2007). A list of experts was generated from extensive literature searches, the authors’ knowledge of the U.S. GEO oversight system, media reports, government contacts, and national reports. Purposive sampling, relying on the authors’ specialized knowledge of GEOs oversight, was used to identify categories of experts. Experts were categorized according to affiliations, terminal degrees obtained, perspectives, biases, and expertise. The list contained over 50 people who have dealt with the oversight system for GEOs or study agricultural biotechnology and fit the definition of expert. These include substantive contributions to the scientific or technical literature, status in the scientific

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community, membership on editorial committees of key journals, membership on advisory boards, or peer nomination (Evans et al., 1994). The experts were chosen based upon their knowledge; prominence in the literature, debates, and other studies on oversight for agricultural biotechnology; or their key roles as actors in agencies, think-thanks, nongovernmental agencies, and industry during the formation and execution of the GEOs oversight in the U.S. Experts and stakeholders were recruited to participate first over email and then with follow-up phone calls. Information about the project, IRB exemption and confidentiality, and how the results would be used was provided in the email prior to the phone calls. Interviews were scheduled either over email or phone. Eleven experts and stakeholders1 were interviewed from the resulting list of 50 experts. Such a number is sufficient for a number of reasons. First, it is within the realm of other expert elicitation studies (Morgan & Henrion, 1990). Second, as a result of the aforementioned procedure for identification of experts, we were able to include in the group of 11 people key informants that have experienced the system at a very high level (formulation of national policies and statues, approval of products, studying risk assessments used, etc.) and to make the group sufficiently diverse in biases, expertise and affiliation.2 Most importantly, in interviewing experts our goal was not to reveal some general agreement about strengths and weaknesses of the oversight system as would be allowed by a survey, but rather was to determine some general or most frequently mentioned themes in our discussions with a limited number of well-recognized experts each of whom, by definition, has a unique and invaluable perspective about the U.S. GEOs oversight system. In the discussions, the interviewees were encouraged to share stories about their interactions with the GEO oversight system. In addition, the following questions were asked, although the conversation was allowed to deviate from these questions: How did the development and the characteristics of the GEO oversight system affect outcomes such as: consumer/public confidence, health and environmental effects, or innovation and economic development?; Any other comments on GEO oversight? (If no response, then we asked about the strengths and weaknesses of the oversight system or other follow-up questions); With respect to oversight, describe the features that you think are the greatest predictors of effects or outcomes? Please explain the most important lessons from the history of the GEO oversight system for the oversight of nanotechnology products? Notes and verbatim comments were recorded as the interviews were taking place. The interviews were not audio recorded in order to encourage more candid conversation given the sensitivity of the subject and the prominence of the experts and stakeholders interviewed. Interviews typically took 30–45 min. Qualitative data from the interviews were analyzed with the help of the content analysis software QSR’s NVivo7. Notes from the interviews were read first and then coded using the software. To analyze the interviews, we used a coding framework to expound on previously identified strengths and weaknesses (Kuzma et al., in press) and to look prospectively at what should be done about them for GEOs oversight policy. After analyzing the interviews for previously identified strengths and weaknesses, we developed a coding scheme based on six categories of possible policy improvements for GEOs oversight.

5. Interview results and identification of policy options The results of expert interview analysis are presented in Tables 2 and 3. Table 2 summarizes comments relating to strengths and weaknesses of GEO oversight, and Table 3 summarizes policy recommendations from the interviews in each of six categories: (1) environmental health and safety review processes, (2) communication and transparency, (3) coordination and capacity among regulatory bodies, (4) learning and adaptation, (5) attention to social and ethical implications of decision making, and (6) economic impacts from oversight. Two different coders3 independently extracted comments falling under the themes. From each of the lists, they identified quotations describing strengths,

1 Note, we consider all experts to be stakeholders in one way or another. We use the term stakeholder to denote that we sought experts from various stakeholder groups such as academic researchers, consumer organizations, government agencies, and companies involved in producing or using GEOs. Thus, we use both terms to describe our group. 2 Members of the group represent the following affiliations, disciplines, and expertise areas: academic, ecology, GEOs risk assessment; academic, molecular genetics, GEOs risk assessment; academic, sociology, agriculture and development; academic, sociology, public participation; academic, sociology and communications, public perception; government, genetics and forestry, GEOs regulation; industry (consulting), law, GEOs regulation; industry, business, food industry and trade; industry, law, regulatory affairs; NGO, law and biology, biotechnology policy; and NGO (previous government), public policy, agricultural regulatory policy. 3 Coders are the three co-authors.

286

Table 2 Strengths and weaknesses based on interviews. Class Strengths Environmental health and safety review

N

Comment  For nanotechnology, we seem to be doing better than GEOs with environmental health and safety work.’’ (A)  Our regulatory system creates a situation in which, as a company, you realize that you will be reviewed so that creates an additional incentive to weed out any products that may cause regulatory concerns. The regulatory process has also helped to coerce companies into weeding out products that are risk due to concerns over liability. (I)  Many products have been in commerce for ten years and there hasn’t been a single case of health or environmental harm.’’ (I)  Other than Starlink, most of the right decisions were made. (A)  U.S. consumers are accustomed to oversight for safety and this helps make people confident with regulators. (I)  The consumer has not seen any adverse effects, so they have increased confidence in the system. (I)  No reports or studies that say that as a result of regulations there were inadequacies in the products. (I)

Communication and transparency

2

 FDA oversight, which is voluntary (for GE foods) seems very weak, but it is transparent and few complaints. (A)  USDA has some levels of transparency–like the website and finding of no significant impacts (FONSI) documents. (A)

Coordination and capacity among regulatory bodies

4

 FDA is generally viewed as competent (despite Vioxx, etc.). (A)  The framework facilitated innovation and economic development due to the lack of vigor in the framework, which helped industry. (NGO)  Flexibility of coordinated framework is a strength. FIFRA is transparent, USDA-APHIS–best. (NGO)  U.S. approach inspires consumer confidence. EU politicized approach means less consumer confidence. Mandatory system raises confidence. Regulation (should be) narrowly focused on safety and leave the market for efficacy and cost effectiveness. (I)

Learning and adaptation

2

 Flexibility of coordinated framework is a strength. (NGO)  USDA-APHIS evolved its system in light of NAS/NRC reports, by hiring more ecologists, banning canola for pharmaceutical (production in crops), and imposing greater isolation distances for pharma crops. (A)

Social and ethical implications of decision making

2

 When government first started dealing with the problem of GEO oversight there were two competing views. One side was advocating a halt to research until all the questions were answered. The other side was advocating for no regulation. The government ended up coming down in the middle and deciding that they would regulate GEOs, but they will regulate them the same as non-GEO products. This was a good choice. (I)  The U.S. framework is adequate. (I)

Economic impacts of oversight

2

 The framework facilitated innovation and economic development due to the lack of vigor in the framework, which helped industry. (NGO)  Our regulatory system creates a situation in which, as a company, you realize that you will be reviewed so that creates an additional incentive to weed out any products that may cause regulatory concerns. The regulatory process has also helped to coerce companies into weeding out products that are risk due to concerns over liability. (I)

12

 [Health] review is also not a transparent process. Environmental effects have been very much the same situation as health. Most things regulated through National Environmental Policy Act (NEPA), although this is not effective. (A)  The regulation of animals is based on the end product which does not necessarily mean that the right experts get involved. This is especially insufficient for regulation of environmental safety they must go out of government and bring in the appropriate experts. (A)  FDA is not as tuned into food (for safety review) and not sure if people connect food with FDA. (A)  Health effects were negative also due to the process being decentralized, complicated, and confusing. (NGO)  Things went wrong, such as open air pollination that cause gene contamination with wild stock. (NGO)

Weaknesses Environmental health and safety review

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Communication and transparency

16

 The process has been out of the public view; done through the Office of Science and Technology Policy during the Reagan years. People didn’t know what was going on; it (CFRB) only appeared in the Federal Register which is generally not observed by the public. They stretched existing authority. This did not build great confidence in oversight. (A)  This is not a transparent process. (A)  Public has low confidence in regulations. This is because the process is not transparent. (A)  FDA is not as tuned into food and not sure if people connect food with FDA. (A)  Lack of transparency about authorities and ultimate decision that gets made. Also voluntary components. FIFRA is transparent, but environmental use permits (EUP) under FIFRA–where is the site?–only flaw. APHIS-USDA–best. FDA notification for New Animal Drugs–not transparent. APHIS is improving. Alfalfa decision with APHIS was pro-industry. (NGO)  Over time public confidence was lost. (NGO)  Public confidence is low. (A)  Coordinated Framework was a closed door process. No people who were thoughtfully critical were at the table. (A)  Because the system was cobbled together for GEOs it alienated a significant chunk of the population. This affected public confidence. (A)  U.S. consumers are accustomed to oversight for safety and this helps make people confident with regulators. However, this is not enough by itself because consumer attitudes have shifted. They are demanding that their considerations be taken into account and demanding more empowerment. (I)  Frustrated with consensus exercise–advocacy groups had a larger agenda (single food regulatory agency). Impossible to get to specifics of GEOs oversight–hard to design a system in the middle. (I)  Confidential business information (CBI) issues don’t make sense, as our committee petitioned for USDA documents, they were slow and uncooperative. (A)  Lack of transparency did not build great confidence in oversight. (A)  Clinton administration OSTP papers: Couldn’t publish one of the papers they produced, because the EU would realize that the regulatory system was screwed up. Trade trumps all other consideration. (G)  CBI–Is a serious problem. How do you regulate when you have no access to the necessary information. (G)  GE pharmaceutical products developed in corn with concerns raised about drug corn crosses with food corn. ‘‘Don’t want drugs in corn pancakes.’’ Why in corn? We put it there because that is the agricultural crop we knew most about. When you are thinking about product. This whole field is so depressing. Didn’t tell where these experiments taking place. (G)

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 So many missteps with GEOs–pharmaceutical contamination in the food supply, Bt corn in Mexico–how come developers never thought about these upfront. (A)  The environmental assessments and environmental impact statements were totally hokey [poorly completed]. . .there was such a lack of studying the ecological effects of these plants. Major issues with respect to food safety. We did some sort of experiment on the American public. Things such as the current story of plants becoming resistant to pesticide are interesting because, well duh, we knew that would happen all along. (G)  No confidence that universities to regulate their safety very well, preventing accidental environment release. (G)  Too often products are field tested first to find if it works and how well it works, and then only as an afterthought to try and prove that it is safe. (G)  FDA oversight, which is voluntary (for GE food s) seems very weak, but it is transparent and few complaints. (A)  Now, with the creeping bentgrass, field trials, intentional slowness. Will transgenes be kept under control with notification process. 13 miles of wind pollination and contamination. Scots and Mondantos in a compliance violation he thinks. He wrote email messages for weeks/months about this. Applicant should not be allowed to let genes establish. Their argument is living hybrid seeds are not established. Now they are trying to kill the grasses that have the transgene. Public confidence is LOW. (A)  GE pharmaceutical products developed in corn with concerns raised about drug corn crosses with food corn. ‘‘Don’t want drugs in corn pancakes.’’ Why in corn? We put it there because that is the agricultural crop we knew most about. (G)

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Table 2 (Continued ) Class Coordination and capacity among regulatory bodies

Social and ethical implications of decision making

Comment

113

 There is not enough cooperation between the federal and state experts. FDA is OK at some level for cloned meat, but USDA should be brought in (this is an example of a situation in which the appropriate experts have not been consulted). (A)  Jurisdiction unclear. (A)  Experimental Use Permits (EUP)–where is the site?–only flaw. APHIS-USDA–best. FDA notification for New Animal Drugs (NAD)–not transparent. (NGO)  Health effects were negative also due to the process being decentralized, complicated, and confusing. (NGO)  The framework facilitated innovation and economic development due to the lack of vigor in the framework, which helped industry. (NGO)  USDA has some levels of transparency. . . However, confidential business information (CBI) issues don’t make sense, as our committee petitioned for USDA documents, they were slow and uncooperative. (A)  APHIS culture is a history of arrogance, until very recently. (A)  Sometimes there is an advantage to having multiple agencies, however, in this case it was cobbled together to make the system. (A)  Because the system was cobbled together for GEOs it alienated a significant chunk of the population. This affected public confidence. However, sometimes there is an advantage to having multiple agencies, however, in this case it was cobbled together to make the system. (This) stretched existing authority. (A)  The process was no help to public confidence because it is complicated, decentralized, and confusing (who is responsible for what?). (D)  If a person really felt that GEOs weren’t needed and bad, they wouldn’t fit well into the agency. (G)  APHIS had different CBI policy than EPA, and because of that they often don’t share information well. Agency territory is a problem. You would want to have one agency to organize such an effort, otherwise it is too difficult. (G)  Regulation of agricultural biotechnology has been frustrating. EU and U.S. have different safety approaches leading to serious market problems. Different timings of approval. Recalcitrant market controlled pace as a result. Couldn’t say enough how stupid the oversight system was. Totally untrustworthy, with any other industry this would not have been allowed. (G)

5

 Often agencies take information from industry as gold cloth and use industry information in their assessment. (G)  The environmental assessments and environmental impact statements were totally hokey [poorly completed]. . .there was such a lack of studying the ecological effects of these plants. Major issues with respect to food safety. We did some sort of experiment on the American public. Things such as the current story of plants becoming resistant to pesticides are interesting because, well duh, we knew that would happen all along. (G)  CBI–Is a serious problem. How do you regulate when you have no access to the necessary information. (A)  Too often products are field tested first to find if it works and how well it works, and then only as an afterthought to try and prove that it is safe. (G)  So many missteps with GEOs—pharmaceutical crops and genes in food supply, Bt corn cross-pollinating wild relatives in Mexico–how come developers never thought about these upfront?(A)

14

 Because the system was cobbled together for GEOs it alienated a significant chunk of the population. (A)  Consumers seem to be uncomfortable with how labeling has played out with GEOs. (I)  U.S. consumers are accustomed to oversight for safety and this helps make people confident with regulators. However, this is not enough by itself because consumer attitudes have shifted. They are demanding that their considerations be taken into account and demanding more empowerment. (I)  The manifestations of biotechnology have been profitable for industry. With nanotechnology they promise much public good, but actually industry benefits most. Only the most lucrative uses come to the top like biotechnology. (NGO)  The government has been more of a cheerleader than a regulator. (NGO)  APHIS regulator has stated on the record that ‘a good regulatory never denies an application’. (A)  Often agencies take information from industry as gold cloth and uses industry information in their assessment. (G)

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Learning and adaptation

N

 They stretched existing authority. This did not build great confidence in oversight. (G)  Lack of transparency did not build great confidence in oversight. (A)  GE alfalfa decision with USDA-APHIS was pro-industry. (NGO)  For rBST (recombinant Bovine Somatatropin), the original concern was about the family farmer and putting smaller dairy farms out of business. (A)  Regulations were not meant to address social and economic issues, only safety issues. (I)  There are fungi that can break down lignin, yet these new, expensive, risky GE technologies are pursued because they bring in the research funding. It is the economic influences that make money go places. (G)  Totally untrustworthy, with any other industry this would not have been allowed. (G) Economic impacts of oversight

10

Letters after the quotes and comments indicate the affiliation of the expert-stakeholder to whom the comment is attributed. A = academe, NGO = non-governmental organization, I = industry, G = government.

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 It costs a lot of money to get a decision through. This favors larger companies [and] disadvantages smaller companies, which stifles innovation. This is especially true in the animal sector because of the high degree of regulatory uncertainty. (A)  Regulation of agricultural biotechnology has been frustrating. EU and U.S. have different safety approaches leading to serious market problems. Different timings of approval. Recalcitrant market controlled pace as a result. (I)  U.S. depends more on voluntary compliance. Small start-ups and universities lack resources for compliance. (I)  There could be some economic harm from GE plants if the genes contaminate wild genes and the farmer is unable to sell his product to discriminating consumers. (I)  When you have this type of regulatory review process small companies will have a tough time putting out products. The regulatory review process has developed so that all the plants on the market are major commodity crops because these are the only crops that are grown on such a large scale as to justify the regulatory costs. Minor crops have become cost prohibitive. Academics area also concerned with this. (I)  The regulatory process also impacts companies economically because litigation is an added expense. (I)  EU discouraged developing countries from adopting GE crops. Narrowed the market and had some affect on innovation probably. (I)  Pure out of pocket cost of approval not as much as an issue as length of time. (I)  Sometimes halting innovation and development is a good idea. Stupid, useless, environmentally dangerous research should be stifled. (G)  Recent administrations are anti-regulation, however, historically, regulation promotes industry. (A)

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Interviewee comments

Environmental health and safety review

Most things regulated through NEPA, although this is not effective. . .If the act did have regulatory authority, then it might be effective. (A) The regulation of animals is based on the end product which does not necessarily mean that the right experts get involved. They must go out of government and bring in the appropriate experts. (A) Take a Monarch Butterfly approach–look for future EHS issues. Invest more. Get smart people to identify appropriate funding level for EHS. (NGO) Mandatory system raises confidence. (I) Regulation narrowly focused on safety and leave the market for efficacy and cost effectiveness. Safety 1st. (I) Need post-market monitoring. (I) Post-market monitoring is important, should be widely distributed. (I) When desiring release to the environment, need to minimize negative environmental exposure and do it right. Study the basic environmental risks beforehand so that the field trials can be used to study them on a large scale. The lab stuff is kind of understood. Environment is different. Many uncertainties. (G) Before GEO plant concerns such as taste and health effects could be dealt with, the biotech people had to think about the agronomic aspects of growing it. So the biggest predictors are the results of greenhouse tests and then field tests. (I) Risk assessment should also be based on sound science. (I) There must be clear standards, and one must guard against risk with a clear responsible development process. (I) Mandatory regulation is positively related to public confidence. Mandatory with outdated regulations might stifle innovation however. (T) Need serious NEPA documents. An agency gets better at writing NEPA document then. People weren’t as interested when it (oversight) first was getting started. (G) Companies should be proactive, do their own risk work, have their own regulatory liaisons offices, and should consider safety their first concern. (A) So many missteps with GEOs–pharmaceutical crops and genes in food supply, Bt corn cross-pollinating wild relatives in Mexico–how come developers never thought about these upfront? (A) No confidence that universities regulate their safety very well for preventing accidental environment release. When desiring release to the environment, need to minimize negative environmental exposure and do it right. Study the basic environmental risks beforehand so that the field trials can be used to study them on a large scale. The lab stuff is kind of understood. Environment is different. Many uncertainties. (G) Ask universities: how careful are these experiments being completed? Planning for field test? (many incorrect assumptions in planning) Field tests for GE trees were designed to see if trees work, not to see what the risks are. Too often products are field tested first to find if it works and how well it works, and then only as an afterthought to try and prove that it is safe. (G)

Communication and transparency

As R&D development is going on, do more consumer education, people have time to get comfortable with products. Cultural context–two way education is important–industry and scientists should be informed about biosafety. (I) Be as transparent as possible related to safety. (NGO) One of the most important lessons learned is to promote public confidence. In order to do this the rationale must be explained. (A) Development of system should be more inclusive. Coordinated framework was a closed door process. Need to involve public, not just industry. No people who were thoughtfully critical were at the table. (A) There should be early and broad stakeholder engagement. Stakeholders should be defined very broadly meaning: public, NGOs, federal regulators, industry, academia, etc. This will allow regulators to identify areas of major concerns presented. (I) As R&D development is going on, more consumer education, people have time to get comfortable with products. (I) Technology companies for GEOs did not have effective communication with market chain rammed down our throats perception. (I) Transparency is important. (T) Trust and public perception are big factors. (A) Need open scientific discourse. (G) Need for meaningful upstream engagement. (A) Need to pick right people to participate to get the right scientific answer. (G)

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Table 3 Summary of analysis of policy recommendations based on interviews.

Public education is important. (A) Sooner or later you are going to have stakeholders involved, so it might as well be sooner. Can’t make good regulatory system without broad input from stakeholders and other ‘‘independent’’ people. For example, the mining industry doesn’t decide its own oversight system. Need to get outside of influence. When your friends are doing stuff you trust them, and that is a problem with oversight. You need people that are regular people and environmental risk experts. (G) Public engagement: Danish structured version, like consensus conferences. Outside of external influences. (G) ‘‘They won’t understand it’’ excuse is bogus as environmental risk is understandable. People can understand the likely impacts of release new technology x, y, and z into environment. Those types of public discussions have to take place. They need to be consistent. (G)

Learning and adaptation

Need post-market monitoring. (I) Post-market monitoring is important, should be widely distributed. (I) Study the basic environmental risks beforehand so that the field trials can be used to study them on a large scale. The lab stuff is kind of understood. Environment is different. Many uncertainties. (G) Before GEO plant concerns such as taste and health effects could be dealt with, the biotech people had to think about the agronomic aspects of growing it. So the biggest predictors are the results of greenhouse tests and then field tests. (I) Risk assessment should also be based on sound science. (I) Regulators must also expect the unexpected, in other words avoid mistakes before they happen. (A) A good system would be flexible. (I) Be aggressive about knowing about lab R&D. (T) Assumption of downstream participation by U.S. and EU lead to incredible conflict that might not have been. Need to anticipate, and promote upstream participation. With U.S., trying to change existing systems of governance to fit GEOs caused a real strain, when some careful thought up front may have prevented that. (A) So many missteps with GEOs–pharmaceutical crops and genes in food supply, Bt corn cross-pollinating wild relatives in Mexico–how come developers never thought about these upfront? (G) Overall regulators should learn from their experiences with biotechnology. (A)

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Most things regulated through NEPA, although this is not effective. . .If the act did have regulatory authority, then it might be effective. (A) The regulation of animals is based on the end product which does not necessarily mean that the right experts get involved. They must go out of government and bring in the appropriate experts. (A) Invest more. Get smart people to identify appropriate funding level for EHS. (NGO) The regulations must be based on new regulations or relevant existing ones. (A) Regulators must also expect the unexpected, in other words avoid mistakes before they happen. (A) Companies should be proactive, do their own risk work, have their own regulatory liaisons offices, and should consider safety their first concern. (A) Need for meaningful upstream engagement. (A) Make it clear who is going to regulate what–see that the system is functional and sound. (A) We must look at whether regulations are: (1) Risk and science based. (2) Proportional to the risk presented. (3) Receiving the adequate resources to enforce them. (4) And there must be a political will to make the decision. (I) Need one agency. If you have subfactors between agency. You need coherent system run by one group. (G) APHIS had different CBI policy than EPA, and because of that they often don’t share information well. Agency territory is a problem. You would want to have one agency to organize such an effort, otherwise it is too difficult. (G) Totally mistrust science community: science community should not decide how much regulation it should be subject to. (G) Can’t make good regulatory system without broad input from stakeholders and other independent people. For example, the Mining industry doesn’t decide its own oversight system. Need to get outside of influence. When your friends are doing stuff you trust them, and that is a problem with oversight. You need people that are regular people and environmental risk experts. (G) Make it clear who is going to regulate what–see that the system is functional and sound. (A) Need to pick right people to participate to get the right scientific answer. (G) You need coherent system run by one group, open scientific discourse. (G) Increase resources to FDA, USDA, and EPA. (T)

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Coordination and capacity among regulatory bodies

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Table 3 (Continued ) Interviewee comments

Social and ethical implications of decision making

When dealing with emerging technology it is more important to follow precautionary principles. We have hubris. Nature will find a way. There are many unforeseen consequences. (NGO) Cultural context–two way education is important–industry and scientists should be informed about biosafety. (A) U.S. consumers are accustomed to oversight for safety and this helps make people confident with regulators. However, this is not enough by itself because consumer attitudes have shifted. They are demanding that their considerations be taken into account and demanding more empowerment. (I) Consumer benefits should be thought of upfront in first products that enter the marketplace. Do not ‘‘shove things down people’s throat that they don’t want’’. (A) For people to be more likely to accept the products of an emerging technology, the first products pursued should be those that specifically need the novel technology, and that are socially good products. (G) Totally mistrust science community: the science community should not decide how much regulation it should be subjected to. (G) Regulation narrowly focused on safety and leave the market for efficacy and cost effectiveness (I). Need for labor and economic stability–for GEOs this disappeared behind other issues like transparency and cultural reactions. (A)

Economic impacts of oversight

Resources–people and $ important. Compliance and enforcement require resources. Mandatory related to public confidence. Mandatory with outdated regs might stifle innovation however. (NGO) Consumer benefits should be thought of upfront in first products that enter the marketplace. Do not shove things down people’s throat that they don’t want. (A) Standards are key to industry SUCCESS, not detrimental. We have a naive view of regulation. Recent administrations are anti-regulation, however, historically, regulation promotes industry. One example is the standards for cellular phones. Motorola almost went out of business because they did not meet EU standards–there was resistant in the U.S. to standards, so EU developed them first. Now U.S. industry has to comply by EU standards in global economy. In Japan, there are bar codes that tell you where your food comes from. U.S. industry has resisted this and now is lagging behind for food tracking in the global market. (A) When the situation is disproportionate on one side or the other, then it hurts economic development. Furthermore, if regulations are too lenient then consumers will not be accepting of the product and that will hurt economic development. In other words, we need balanced regulation. (I) International oversight is problematic in light of world trade, and there is a need for uniformity. (A)

Letters after the quotes and comments indicate the affiliation of the expert-stakeholder to whom the comment is attributed. A = academe, NGO = non-governmental organization, I = industry, G = government.

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Class of weaknesses addressed

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Fig. 2. Coding results and frequency. The y-axis denotes the number of appearances of the coding theme among all interviews. Six coding themes are Environmental Health and Safety Review, Communication and Transparency, Coordination and Capacity among Regulatory Bodies, Learning and Adaptation, Social and Ethical Implications, and Economic Impacts.

weaknesses, and recommendations for improvement of the oversight system for GEOs. These results were reviewed, revised, and organized in tabular format by a third coder. From the analysis of interviews, we derived three areas of overarching policy needs for GEOs oversight that intersect multiple categories of strengths and weaknesses. These were chosen based on their prominence in the interviews (Table 2, Fig. 2) and in light of ethical, democratic, and risk perception theories. These needs also deal with the more normative elements of oversight, which have not traditionally been a priority of U.S. ‘‘science-based’’ regulation. 5.1. Democratization of oversight processes The dominant weaknesses mentioned by our expert-stakeholder group fell into the ‘‘Communication and Transparency’’ category, which intersects with other categories including ‘‘Social and Ethical Implications of Decision Making’’ (Table 2, Fig. 2). In our previous quantitative work, experts-stakeholders identified lack of public input, little transparency, little informed consent, and closed treatment of intellectual property as weaknesses of U.S. GEOs oversight (Table 1). Our interview results are consistent with these weaknesses. Only twice in the interviews experts noted that the FDA and USDA processes are ‘‘transparent’’ (Table 2). Many more comments (n = 16) indicated that there is a serious problem with a lack of transparency and opportunities for public input (Table 2). From our review of the literature and the interviews, this sentiment is supported by extensive claims of confidential business information (CBI) in regulatory documents for GEOs or by decision making processes that mainly occur between the industry and agencies (such as the FDA’s voluntary consultation process). Examples of comments supporting more transparency and public engagement came from diverse types of experts. For example, one industry expert-stakeholder stated that ‘‘U.S. consumers are accustomed to oversight for safety and this helps make people confident with regulators. However, this is not enough by itself because consumer attitudes have shifted. They are demanding that their considerations be taken into account and demanding more empowerment.’’ Another expert-stakeholder from government expressed frustration stating that ‘‘CBI is a serious problem. How do you regulate when you have no access to the necessary information?’’ One expert-stakeholder affiliated with academe suggested that the ‘‘public has low confidence in regulations. This is because the process is not transparent.’’ An NGO expert noted the ‘‘lack of transparency about authorities and [the] ultimate decision that gets made.’’ How can this be remedied? At a broad policy level, one industry expert suggested that ‘‘there should be early and broad stakeholder engagement. Stakeholder should be defined very broadly meaning: public, NGOs, federal

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regulators, industry, academia, etc. This will allow regulators to identify areas of major concerns presented.’’ Several other interviewees supported this idea (Tables 2 and 3). The concept that public engagement is important for normative reasons and positive utilitarian outcomes is also expressed in the literature. Upstream public engagement has been promoted as a way to engage interested and affected parties in dialogue early in the technological development process (NRC, 1996; Wilsdon & Willis, 2004). Prior studies also indicate that public participation has yet to be integrated into decision making for emerging technologies in the U.S. Different techniques for engagement, such as focus groups, consensus conferences, and citizen juries have been evaluated and tested, primarily in the UK and other EU countries (Rowe & Frewer, 2004). There is no consensus, however, on exactly how to do it for GEOs oversight or for individual decisions about products. Formats will ultimately depend on resource constraints and goals of engagement (Rowe & Frewer, 2004) It is expected that greater transparency and engagement would improve public confidence and oversight decisions through the consideration of localized and specialized knowledge (NRC, 1996). However, utilitarian considerations are not the only reasons for implementation. Democratic and ethical theories support the need for public engagement. Currently, regulatory decision making about GEOs seems to privilege a minority (government and industry experts), as indicated by the weaknesses and policy suggestions in Tables 2 and 3. Emerging technology regulation in the U.S. is arguably not democratic. A lack of transparency also violates ethical principles, preventing people from making independent, autonomous, informed choices about the products they consume. Along these lines, there have been increasing calls for the ‘‘democratization of science’’. Guston writes ‘‘democratizing science does not mean settling questions about Nature by plebiscite, any more than democratizing politics means setting the prime rate by referendum. What democratization does mean, in science as elsewhere, is creating institutions and practices that fully incorporate principles of accessibility, transparency, and accountability. It means considering the societal outcomes of research at least as attentively as the scientific and technological outputs. It means insisting that in addition to being rigorous, science be popular, relevant, and participatory.’’ (Guston, 2004) Implementing a more democratic approach to oversight for GEOs would likely be met with resistance among many members of the scientific community, particular those charged with developing products from GEOs. In the words of one of our expert-stakeholders from industry, ‘‘Regulation (should be) narrowly focused on safety and leave the market for efficacy and cost effectiveness. Safety 1st.’’ The U.S. agencies involved in GE products oversight have taken this approach. Criteria used by the federal government are primarily limited to human and animal safety, environmental risks, and costs and benefits, as mandated by Presidential Executive Orders and various statutes (EOP, 1993; EPA, 1983). For example, in its consideration of approval for cloned meat in the food supply, FDA stated that ‘‘the safety of the food from clones, and the health of animals involved in the cloning process. These are sciencebased processes. The agency is not charged with addressing non-science based concerns such as the moral, religious, or ethical issues associated with animal cloning for agricultural purposes, the economic impact of products being released in commerce, or other social issues unrelated to FDA’s public health mission’’ (FDA, 2008a). However, FDA’s and the ‘‘science-based’’ argument for oversight seem inadequate, in the sense that science can inform risk assessment processes, but questions of safety and the acceptance of certain levels of risk fall outside of the domain of ‘‘pure objectivity.’’ (de Melo-Martı´n & Meghani, 2008; Fischoff, Watson, & Hope, 1984; Kuzma & Besley, 2008; Thompson, 2007). Fischoff et al. (1984) discuss two types of risk, one as ‘‘subjective’’ and the other as ‘‘objective’’. Scientific research, analyses, statistics, studies, surveys fall under the domain of objective risk; whereas subjective risk includes people’s perceptions of those, plus other non-empirical considerations. However, the distinction between objective and subjective risk is not sharp and can be misleading (Fischoff et al., 1984). Objective risk includes subjectivity in determining what harms will be considered, interpreting risk-related data and uncertainty, and making conclusions about the magnitude and importance of the risk. Likewise, subjective risk is based on people’s knowledge of the available empirical research and reasoning about the relative magnitude to other risks they experience in their daily lives. Given that safety is not wholly an objective concept and in light of democratic and ethical theories, government agencies seem remiss in not engaging a broader set of values and perspectives for GEOs oversight.

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Another barrier to implementing more democratic approaches to oversight involves the closed treatment of intellectual property (Kuzma et al., in press). As discussed, CBI was highlighted in the interviews as a problem in that it prevents transparency within regulatory-industry communities and for independent review of safety studies (Table 2). There is a need to reconcile industry’s right to recoup its financial investment through patents and trade secrets with the public’s right to know and choose based on safety information. Sometimes the very nature of the product is claimed as CBI on regulatory submissions for GEO approval (NRC, 2000; PIFB, 2006). Democratization would require better access to CBI on the part of those involved in participatory processes. However, this problem does not have an immediate, politically feasible solution, although we discuss one possibility in the section below. 5.2. Clear mechanisms for coordination The second prominent set of weaknesses and recommendations of the expert-stakeholder group relates to institutional factors of oversight, namely coordination and capacity among regulatory bodies (Fig. 2, Table 2). Emerging technological products such as novel GEOs, nanomaterials, and synthetic biology applications are likely to stretch agency boundaries even more so than witnessed in the past with the first generations of GEOs (Kuzma, Romanchek, & Kokotovich, 2008). Enhanced coordination will be needed if existing multi-agency approaches to oversight continue. For GEOs oversight, this is likely to require additional resources (e.g. staff time, space for collaboration), as financial resources and capacity were identified as a weakness in the system (Table 1). Food safety regulation in the U.S., which is intricately tied to GEOs oversight, involves a patchwork of agencies and laws. One government expert-stakeholder said that for GEOs oversight we ‘‘need one agency if you have subfactors between agencies. You need a coherent system run by one group’’ (Table 3). Although there have been calls for a single U.S. food safety authority for over a decade (NRC-IOM, 1998), this has not materialized. The idea seems to be getting support from top officials in the new administration (Reuters, 2009), but in present times of resource constraints, reorganization and consolidation seems unlikely. Absent large efforts to consolidate authorities and efforts, incremental steps could be taken. Policy options to improve coordination include integrated review processes and a clear delineation on a product by product basis of agency or institutional4 roles. At a minimum, creating and regularizing mechanisms for enhanced coordination in oversight systems seem warranted. For new regulations or guidance policies, plans for facilitating inter-agency, -stakeholder and -organization interactions and information sharing should be incorporated. Enhancing coordination is not separable from public and stakeholder engagement or from better incorporating social and ethical dimensions into decision making, and it overlaps with the idea of democratizing GEOs oversight. Engagement, in theory, can support and enhance coordination throughout the life-cycle of a GE product or organism including field trials, development, deployment and post-deployment. For example, post-market monitoring was identified as a weakness in the quantitative work (Table 1) and the interviews (Table 2). USDA’s current process does not include provisions for post-market monitoring in large part because GE crops approved for commercial use and transport are considered ‘‘deregulated’’ (NRC, 2002); although the new proposed rule might change this limitation by increased record requirements for interstate movement (USDA, 2008). Government regulators cannot be everywhere at all times as a GE product enters and dissipates through society. Getting outside experts and stakeholders more engaged in oversight processes could help ensure effective execution of oversight throughout the product chain. An expanded concept of ‘‘trading zones’’ could be used to guide mechanisms for better communication and coordination among interested and affected parties (Wardak & Gorman, 2006). Trading zones provide an area for interested parties to share information and exchange ideas. Preferably, these would be equitable trading zones (no group dominates) and goal dependent (related to oversight of GEOs) and would be based on a shared language that develops over the course of the interactions (Gorman, 2003). Partially closed trading zones which would allow for the sharing of CBI between stakeholders and regulatory agencies could be established. Advanced agreements for respecting confidentiality and keeping certain CBI within the trading zones might work to overcome the dilemma between protection of intellectual property and transparency. Although partially closed trading zones would not be 4

In the case of voluntary components of oversight, non-government institutions may take the lead such as with product stewardship, compliance efforts, education, etc.

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ideal, in so far as the general public would not have access to all of the information, they would constitute a step in the right direction. 5.3. Upstream and fluid approaches to oversight Several suggestions were made from the interviews that the current oversight system was lacking in post-market monitoring (Tables 1 and 2) and preparation for the mishaps and environmental risks that ensued (Table 2). In the words of one academic expert interviewed, ‘‘[there were] so many missteps with GEOs–pharmaceutical crops and genes in food supply, Bt corn cross-pollinating wild relatives in Mexico–how come developers never thought about these upfront?’’ Through more collaborative and engaged approaches, anticipation and adaptation could be achieved. Concerns like Starlink corn in the food supply, potential risks to Monarch butterflies, inadvertent contamination of food crops by pharmaceutical GE crops, and adventitious presence of GE herbicide-tolerant genes in grasses near national parks (Fig. 1) could have been predicted prior to market or field trial release given available scientific information. Why then were they not anticipated or at least detected sooner? Currently, few laws require monitoring and data collection after initial product approval. No oversight system, no matter how perfectly designed and executed, can anticipate all downstream consequences from product release, use, and diffusion. Only through multiple settings and over time can products truly be shown to be safe to human health and the environment and to promote overall societal well-being. Thus, post-market monitoring is a first step to learning from experience. Several of the experts-stakeholders interviewed called for post-market monitoring. One industry expert stated that ‘‘post-market monitoring is important, [it] should be widely distributed.’’ Broadening monitoring to include not only environmental health and safety, but also socioeconomic consequences and evolving stakeholder attitudes seems important for taking public considerations into account and empowering consumers and users (Table 3). Unfortunately, most statutes do not emphasize or require data collection and analysis after market approval of new technological products. Exceptions are re-registration and adverse event reporting requirements under FIFRA for GE plants with pesticidal proteins (NRC, 2000). The need for upstream and fluid approaches to oversight intersects with the need for democratization of oversight. Through multiple voices and perspectives, such as the deployment of analytical-deliberative approaches (NRC, 1996), agencies are more likely to think about possible future limitations of oversight, scenarios of harm, and relevant scientific risk issues, scenarios of harm, and socioeconomic impacts. In the words of one expert-stakeholder from academe, there is a ‘‘need to anticipate, and promote upstream participation. With U.S., trying to change existing systems of governance to fit GEOs caused a real strain, when some careful thought up front may have prevented that.’’ Anticipatory governance, real-time technology assessment, upstream public engagement, and upstream oversight assessment are complementary frameworks for preparation that have been suggested by scholars of science and technology policy in the context of nanotechnology (Guston & Sarewitz, 2002; Kuzma, Romanchek, et al., 2008; Wilsdon & Willis, 2004). They should now be considered in revising approaches to the oversight of GEOs. Strengthening the GEOs oversight system will also help prepare for novel and even more complex technologies like synthetic biology which is also likely to be governed by the CFRB (Rodemeyer, 2009). 6. Conclusions U.S. GEOs oversight was founded on science, and empiricism has taken a lead and virtually exclusive role in it. However, this focus of has neither inspired public legitimacy nor confidence in regulators and industry. Multiple studies from various disciplinary standpoints, like social psychology, mass communications, and ethics, point to the important roles of transparency, trust, autonomy, and rigor in oversight for positive public attitudes towards technological products (Fischoff & Fischoff, 2001; Hallman & Lang, 2005; Macoubrie, 2006; Siegrist, 2000; Slovic, 1987; Thompson, 2007). Yet, the challenges associated with implementing the policy suggestions from this analysis are great. They include stanch support for privileging ‘‘objectivity’’ and science and legal limitations in agency authorities in the U.S. Until these change, broad transformation in GEOs oversight approaches may not be possible. It is likely that the pace of legal change will be very slow. However, with a new political administration in the U.S., regulatory philosophy may be shifting, and incremental steps towards democratizing processes, enhancing cooperation, and implementing foresight and fluidity could be

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achieved in the near term. For example, at the time of writing this paper (March 2009), the Obama Administration posted a notice in the Federal Register for comments on formulating a new Executive Order on Federal Regulatory Review, calling for recommendations on: disclosure and transparency; encouraging public participation in agency regulatory processes; the role of cost-benefit analysis; the role of distributional considerations, fairness, and concern for the interests of future generations; methods of ensuring that regulatory review does not produce undue delay; the role of the behavioral sciences in formulating regulatory policy; and the best tools for achieving public goals through the regulatory process (OMB, 2009). This new executive order, once formulated, could require that each new rule, policy, or guidance about oversight for emerging technologies have a plan for more democratic, upstream, and collaborative engagement strategies for each phase of oversight. There now seems to be some willingness in the U.S. among multiple stakeholders to consider factors outside of science-based risk assessment and cost-benefit analysis, and the arguments in this paper would support such revisions to federal regulatory review. Along these lines, President Obama published a broader memorandum on ‘‘Transparency in Open Government’’ which states that ’’Government should be participatory. Public engagement enhances the government’s effectiveness and improves the quality of its decisions. Knowledge is widely dispersed in society and public officials benefit from having access to that dispersed knowledge. Executive Departments and Agencies should offer Americans increased opportunities to participate in policy making and to provide their government with the benefits of their collective expertise and information.’’ (Obama, 2009) The time is ripe for incorporating principles of anticipation, democracy, ethics, and collaboration into oversight for emerging technologies, and now the policy community needs to rise to the challenge by helping to design effective strategies for making it work. In the meantime, incremental steps to improve oversight for GEOs in the U.S., such as those presented in this paper, could be taken while broader transformations are considered. Acknowledgements This work was supported in part by National Science Foundation NIRT Grant SES-0608791 (Wolf, PI; Kokkoli, Kuzma, Paradise, Ramachandran, Co-PIs). Any opinions, findings, and conclusions or recommendations expressed in this article are those of the authors and do not necessarily reflect the views of the National Science Foundation. The University of Minnesota’s IRB determined that this study is exempt from review, under 45 C.F.R. Part 46.101(b) category #2. The authors would like to thank the working group participants (note this group is not the same as the expert-stakeholder group surveyed in this study, whose identities remain anonymous): Dan Burk; Steve Ekker; Susan Foote; Ralph Hall; Robert Hoerr, Susanna Priest; Terrance Hurley; Robbin Johnson; Bradley Karkkainen; George Kimbrell; Andrew Maynard; Kristen Nelson; David Norris; David Y.H. Pui; T. Andrew Taton; and Elizabeth J. Wilson; and collaborators Efrosini Kokkoli, Jordan Paradise, Susan M. Wolf, Gurumurthy Ramachandran; Alison W. Tisdale; Rishi Gupta; Gail Maddey Diliberto; Jae Young Choi; and Ralph Hall for their valuable input on the project. 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