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BIOTECHNOLOGY RESEARCH PROGRAM
Citation:
Reiter, L W., J R. Fowle* III, M J. Bagley, A Fairbrother, E Z. Francis, R J. Frederick, J A. Glaser, MJK Selgrade, S K. Sikdar*, L S. Watrud, AND J. L. Andersen. BIOTECHNOLOGY RESEARCH PROGRAM. U.S. Environmental Protection Agency, Washington, DC, EPA 600/R-03-/068 (NTIS PB2005-110707), 2005.
Impact/Purpose:
To guide the implementation of an integrated Biotechnology Research Program and to improve the science needed to inform Agency decisions about the risk and safety of the products of biotechnology
Description:
In accordance with EPA's mission to minimize risks to human health and to safeguard ecological integrity, the EPA Office of Prevention, Pesticides, and Toxic Substances (OPPTS) is committed to assessing and mitigating any risk posed by biotechnology-derived crops. Consequently, the Biotechnology Initiative Steering Committee prepared this plan to guide the implementation of an integrated Biotechnology Research Program. This plan was formulated with the goal of improving the science needed to inform Agency decisions about the risk and safety of the products of biotechnology.
Many of the scientific concerns about the risk and safety of genetically engineered crops were raised in three reports from the National Research Council (NRC) of the National Academy of Sciences1 (NAS). These scientific concerns served as a departure point for the development of this implementation plan. There are three main areas of concern: (1) allergenicity, (2) gene transfer, and (3) mitigating resistance and gene transfer. The breadth of scientific issues related to safety of bioengineered crops, as well as limited resources, make it imperative to have a focused, integrated, cross-ORD research program that coordinates with ongoing research programs in other federal agencies. We also needed to ensure that the work funded under this research initiative complements work underway in other sectors.
The Biotechnology Initiative Steering Committee convened a workshop to meet with colleagues from OPPTS and key senior officials from other federal agencies, the National Academy of Sciences, and the European Union to discuss the EPA's proposed Biotechnology Research Program. During our discussions, we wanted to determine the following: (1) Is our proposed program scientifically sound and relevant? (2) Does it compliment related efforts elsewhere? and (3) Is the proposed work appropriate for EPA? The conclusion by non-EPA attendees was that our proposed research program and implementation plan meet these objectives. We also discussed opportunities for inter-agency collaboration.
Following the workshop, the Steering Committee finalized the initial phase of the Biotechnology Research Program: a demonstration project to assess ecological risks. This project will be used to evaluate the extent to which the tools and approaches can be integrated across the risk assessment/risk management paradigm to inform Agency decisions. The demonstration project is designed to facilitate inter-laboratory cooperation and is a reflection of EPA's commitment to integrate the Biotechnology Research Program across ORD.
A coordinating workshop is being planned for Fall 2003. This workshop will include scientists from outside EPA and will provide an opportunity for EPA scientists to describe the Biotechnology Research Program, outline progress to date, discuss the demonstration project, receive constructive feedback, and discuss future plans.
1 NRC (National Research Council), 2000. Genetically Modified Pest-Protected Plants: Science and Regulation, Washington, DC: National Academy Press.
2 NRC, 2001. Ecological Monitoring of Genetically Modified Crops: A Workshop Summary, Washington, DC. National Academy Press.
3 NRC, 2002. Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation, Washington, DC: National Academy Press.