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United States Department of Agriculture

Agricultural Research Service

Research Project: GMO RISK ASSESSMENT AND COMMUNICATION OF EVIDENCE

Location: Crop Improvement & Utilization Research

Project Number: 5325-21420-004-03
Project Type: Nonfunded Cooperative Agreement

Start Date: Jun 01, 2012
End Date: Mar 28, 2013

Objective:
The project GMO Risk Assessment and Communication of Evidence (GRACE) will: 1) elaborate and implement systematic, transparent and inclusive reviews of existing evidence of potential health, environmental, and socio-economic impacts (risks and benefits) of GM plants (GMPs) or food and feed derived from GMPs; 2) consider the design, execution and interpretation of results of animal feeding trials as well as in vitro studies for assessing the safety of GM food and feed. These activities will yield valuable and accessible information on the main issues associated with GMPs for risk assessors, risk managers, policy makers, scientists, technology developers, other stakeholders, and the general public. This information will be highly relevant for GMP risk assessment, risk management and broader policy making. Moreover, the project will also provide a tested framework for Good Review Practice (GRP) for studies on GMP impacts and a one-stop-shop database for relevant studies and data on GMP impacts. Both the framework and the database will be continued by JKI after the end of the project. The framework for GRP will be developed by drawing on and adapting existing methodologies for systematic reviewing and meta-analysis of studies which were initially developed for medicine and later used in environmental and social studies and recently adopted for GMO risk evaluation. The quality assessment of the reviewed papers and studies as well as the results from the in vivo and in vitro food/feed studies conducted within GRACE will be referenced by an open-access database which will be developed as a "one-stop-shop" for studies and data relevant to GMO impacts.

Approach:
Animal feeding trials and in vitro studies will be conducted to compare the scientific added value of 90-day feeding trials of whole GM foods with the use of advanced state-of-the-art analytical, in vitro and in silico tools. Standard and scientifically approved protocols will be used in these investigations and also in the analytical, in vitro and in silico approaches. These comparisons will be conducted with GM crop material containing the same GM events but also considering a number of different GM events including stacked events. Protocols for animal feeding models based on European (EFSA) and international guidance will be developed and investigated. The project will provide guidance for the use of relevant alternative in vitro cell-based approaches for specific topics within the overall food and feed safety assessment. The results of these studies will provide guidance for the use and improvement of existing and new assessment tools for GM food and feed safety evaluation.

Last Modified: 7/23/2014
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