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| PROBLEM FORMULATION: A CRITICAL STEP IN RISK ASSESSMENT OF GM CROPS |
| 30-April-2009 SEARCA BIC News Release |
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The development of regulatory dossiers in the process of risk assessment of biotech crops aims to avoid unnecessary cost and delay, and must improve and provide guidance in decision making of the regulators. However, prior to risk characterization and risk evaluation, the most essential step in any risk assessment process is the problem formulation. This was shared by Drs. Hector Quemada and Karen Hokanson of the Risk Assessment Research and Biotechnology and Biodiversity Interface (BBI) Component of the Program for Biosafety Systems during the Seminar on Improving Environmental Risk Assessment, Problem Formulation and Tiered Testing held last April 28 at the Southeast Asian Regional Center for Graduate Study and Research in Agriculture (SEARCA) based at University of the Philippines Los Baños. Identification of adverse effects or problem formulation is an important initial step in rigorous risk assessment as it allows for discerning the need-to-know from the nice-to-know biosafety concerns thus narrowing down the risk hypotheses that need to be addressed. A well-designed and implemented process for problem formulation will improve the quality, consistency, clarity and transparency of environmental risk assessment. The use of tiered approaches for testing relevant risk hypotheses were also highlighted during the seminar. The established methodologies and science-based risk assessment allows for the wider adoption and use of GM crops. The seminar which was attended by professors, scientists, regulators and research managers was organized by SEARCA, SEARCA Biotechnology Information Center and the Program for Biosafety Systems. The pdf copy of the presentation can be downloaded at http://www.bic.searca.org/seminar_proceedings/index.html.
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