A Public Consultation on Plant Molecular Farming

Abstract

Plant molecular farming (PMF) is another phase in the ongoing research and development of transgenic plants, offering possibilities of producing therapeutic and industrial proteins. Molecular farming involves the use of genetically enhanced plants to produce pharmaceuticals and industrial products. The first pharmaceutical protein made in plants—in this case, the tobacco plant— was human growth hormone (Barta et al., 1986). Since 1986, when this experiment was publicized, other proteins have been produced, from experimental vaccines to antibodies to industrial proteins (Breithaupt, 2004; Fischer, Stoger, Schillberg, Christou, & Twyman, 2004; Ma, Drake, & Christou, 2003). At the same time, plant molecular farming raises social, environmental, and regulatory challenges that need to be addressed when considering how these products might be successfully and responsibly commercialized. Recent changes to regulatory processes have taken place in response to concerns about the efficacy of seed production and commodity handling systems (Office of Science and Technology Policy, 2002), environmental safety issues, and contamination of the food supply (United States Department of Agriculture, 2004). In the face of these concerns, calls have been made for ongoing risk assessment (Peterson & Arntzen, 2004), regulatory assessment and reform, greater transparency, and enhanced public and stakeholder participation, with some arguing that “it is social support for the technology and trust in regulatory institutions that matter most” (Stewart & Knight, 2005, p. 521). We began a major initiative to investigate various commercialization aspects of PMF in late 2003. The purpose of this larger PMF project is to investigate the policy and regulatory developments in this area and to explore stakeholder views and perceptions.1 Although calls have been made to assess public views on this issue, there is very little published research in this area. One report in the United States (Nevitt et al., 2003) focused only on the use of tobacco as the PMF model crop, with data obtained via interviews by phone, faceto-face, email, and small-group discussion with a range of stakeholders (tobacco producers, policymakers, nongovernmental organizations [NGOs], and agricultural biotechnology company representatives). Although most were supportive of this technology (with the exception of those from the NGO sector), concerns were expressed about environmental impacts and regulatory capacity. The Canadian Biotechnology Secretariat (an arm of the Canadian federal government) addressed PMF in its semiannual survey work on biotechnology with two questions investigating yes/no support for two PMF applications: the production of interleukin, an enzyme for health treatments (80% supported this application), and the production of biodegradable plastics (78% supported this application). No other study has