CONFERENCE PROPOSAL: PROBLEM FORMULATION FOR THE ENVIRONMENTAL RISK ASSESSMENT OF RNAI PLANTS

• Sponsoring Institution: National Institute of Food and Agriculture
• Project Status: COMPLETE
• Funding Source: OTHER GRANTS
• Reporting Frequency: Annual
• Accession No.: 0223297
• Grant No.: 2010-33522-21796
• Proposal No.: 2010-02700
• Project Start Date: Sep 1, 2010
• Project End Date: Aug 31, 2011
• Grant Year: 2010
• Program Code: [HX]- Biotechnology Risk Assessment

Recipient Organization
ILSI Research Foundation
1156 Fifteenth Street N.W., Suite 200
Washington,DC 20005

Performing Department
(N/A)

Non Technical Summary
New plant varieties are being developed using an array of approaches, from traditional cross-breeding to the use of newer molecular techniques such as RNA interference (RNAi). RNAi refers to the machinery in living cells that helps to control which genes are active and how active they are. Researchers, by studying RNAi in many cell types, can now reproduce its effects to purposefully manage the activity of specific genes. Plant scientists are using RNAi to introduce or modify specific traits that are beneficial in agriculture, such as insect resistance, virus resistance or to reduce the levels of natural plant toxins that may be harmful to human health. This newer application of genetic engineering in plant breeding differs from techniques like plant transformation using the gene gun or Agrobacterium tumefaciens which were used to develop the genetically engineered plants that have been approved for cultivation in the US. This conference will examine if the existing approaches that are used to evaluate the environmental safety of genetically engineered plants are applicable to the assessment of RNAi plants and will additionally attempt to identify any areas where changes in the risk assessment paradigm are warranted. Because there are existing applications of this technology in genetically engineered plants, with more expected in the near future, this is an opportune time to organize a proactive discussion of the characteristics of the technology and the implications for environmental risk assessment. Conference participants will include risk assessment experts from regulatory agencies, academia, government research institutions and the private sector. The conference will take place over three days. It will include a series of presentations about RNAi applications that are being used to develop new plant varieties followed by the presentation of two contrasting case studies of RNAi plants which will form the basis for breakout group discussions. Finally, the conference participants will explore what differences, if any, will be required to assess the environmental safety of RNAi plants and how these may be best addressed. It is expected that the conference itself, as well as the publications that will come out of the conference, will be particularly timely and helpful to regulatory authorities as well as product developers in the public and private sectors.

Animal Health Component

100%

Research Effort Categories

Basic

(N/A)

Applied

100%

Developmental

(N/A)

Classification

Knowledge Area (KA)	Subject of Investigation (SOI)	Field of Science (FOS)	Percent
205	2410	1060	25%
205	2410	1080	25%
205	2499	1060	25%
205	2499	1080	25%

Knowledge Area
205 - Plant Management Systems;

Subject Of Investigation
2410 - Cross-commodity research--multiple crops; 2499 - Plant research, general;

Field Of Science
1060 - Biology (whole systems); 1080 - Genetics;

Keywords

conference

agricultural biotechnology

genetically engineered plants

environmental risk assessment

rnai plants

problem formulation

Goals / Objectives
The Center for Environmental Risk Assessment, ILSI Research Foundation, will host the conference "Problem Formulation for the Environmental Risk Assessment of RNAi Plants". Regulatory review of GE plants that use RNAi mechanisms are a challenge for product developers and regulators because RNAi differs from the classic paradigm for genetic engineering upon which most of the regulatory guidance and review structure has been built over the past 20 years. Regulators are forced to apply these same methodologies on an ad hoc basis with uncertain results in terms of regulatory efficiency and environmental protection. The objectives of the conference are: 1. To share information about current applications of RNA interference to produce novel, transgenic plants; 2. Use two contrasting case studies of RNAi plants to explore: (a) if problem formulation for RNAi plants leads to new or additional risk hypotheses when compared with non-RNAi plants expressing similar traits; (b) if new risk assessment methodologies are necessary to accommodate RNAi plants (or sub-categories of these); 3.To develop a conceptual framework that may be applied to the environmental risk assessment of RNAi plants. A report of the conference proceedings will be prepared and the conceptual framework that is developed as a work product of the conference will be submitted for publication.

Project Methods
The conference organizing committee, convened by the Center for Environmental Risk Assessment, ILSI Research Foundation, will include representatives from relevant government regulatory agencies (USDA APHIS Biotechnology Regulatory Services, Office of Pesticide Programs, Biopesticides and Pollution Prevention Division, EPA), USDA's Agricultural Research Service and/or National Institute for Food and Agriculture, academia and the private sector. The organizing committee will elaborate the draft agenda for the three day conference and propose conference speakers. Two case studies of RNAi plants will be developed and will be used as common points of departure for small group work. Participants will be asked to apply problem formulation to determine what aspects of the environment are appropriate to consider for the case-specific risk assessments and then determine what potential hazards need to be addressed by the risk assessment in the context of the RNAi plants under consideration. The groups will also discuss the methods of analysis that are appropriate to produce the information that will inform the risk assessment. This information will be synthesized into a conceptual framework for the environmental risk assessment of RNAi plants. The report of the conference proceedings and the conceptual framework that is developed as a work product of the conference will be submitted for publication. Additionally, these will be shared with regulatory authorities through a series of targeted presentations.

Progress 09/01/10 to 08/31/11

Outputs
OUTPUTS: The output from this grant was the conference Problem Formulation for the Environmental Risk Assessment of RNAi Plants. Conference presentations, cases studies, and the results of plenary discussions have been captured in a proceedings document. This document has been sent to the conference participants and has been posted on the website of the Center for Environmental Risk Assessment, ILSI Research Foundation. It has also been shared with regulators, academics, and public and private sector product developers in the United States and internationally. PARTICIPANTS: The conference lead was Dr. Morven McLean, Center for Environmental Risk Assessment, ILSI Research Foundation (Grant Recipient). The conference Organizing Committee was comprised of: Dr. Karen Hokanson, Department of Horticultural Sciences, University of Minnesota (Committee Chair); Dr. Pamela Bachman, Monsanto Company; Dr. Bob Frederick, National Center for Environmental Assessment, USEPA ; Dr. Rebecca Grumet, Department of Horticulture, Michigan State University; Dr. Margaret Jones, USDA APHIS BRS; Dr. Ben Matthews, Soybean Genomics & Improvement Laboratory, USDA ARS ; Dr. Hector Quemada, Donald Danforth Plant Science Center; Dr. Alan Raybould, Syngenta; and Dr. Chris Wozniak, USEPA Office of Pesticide Programs. Plenary presentations and written contributions to the proceedings document were prepared by: Dr. Vicki Vance, Department of Biological Sciences, University of South Carolina; Dr. Greg Heck, Monsanto Company; Dr. Alan Raybould, Syngenta; Dr. Chris Wozniak, USEPA Office of Pesticide Programs; and Mr. John Cordts, USDA APHIS BRS. Case studies were prepared and presented by Dr. James Masucci, Monsanto Company; Dr. Ben Mathews, Soybean Genomics & Improvement Laboratory, USDA ARS; Dr. Jennifer Anderson, Pioneer HiBred; and Dr. Eliot Herman, Donald Danforth Plant Science Center. TARGET AUDIENCES: The target audience is biotechnology regulatory authorities; risk assessors; public and private sector developers of genetically engineered plants; and, academics who contribute to the knowledge base about RNA interference and its application in the plant sciences. PROJECT MODIFICATIONS: Not relevant to this project.

Impacts
The conference contributed to a change in applied knowledge; consensus that the environmental risk assessment of RNAi plants does not require new approaches and that the risk assessment paradigm currently applied for the risk assessment of genetically engineered plants is also adequate for the risk assessment of RNAi plants. The conference may also contribute to a change in action if the consensus points agreed at the conference are used to inform policy considerations for the regulation of RNAi plants.

Publications

• CERA. 2011. Problem Formulation for the Environmental Risk Assessment of RNAi Plants: Conference Proceedings. Center for Environmental Risk Assessment (CERA), ILSI Research Foundation, Washington, D.C. pp.54.