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Project TCP/RER/3107D “Capacity building in agricultural biotechnologies and biosafety” Regional Training in GM Risk

Project TCP/RER/3107D “Capacity building in agricultural biotechnologies and biosafety” Regional Training in GM Risk Analysis for Armenia, Georgia and Moldova Yerevan, Armenia , October 2010

Introduction to Risk Analysis Basic principles

of Risk Assessment, Risk

Management and Risk

Communication

OBJECTIVE

Introduction to basic principles of Risk Analysis and its components Risk Assessment, Risk Management and

Risk Communication

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Components of Risk Analysis

Risk Assessment

Risk Management

Risk Communication

Risk Assesment

Risk Assesment

Risk Assesment

Characterisation of the recombinant GM

plant, donor organism, genetic

modification and expression

Assessment of toxicity and allergeneity

Compositional analyses

Environmental Risk Assessment (ERA)

• Assessment of toxicity and allergeneity • Compositional analyses • Environmental Risk Assessment (ERA) 4
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Risk Management

Risk Management

Risk Management

Assessment of the scientific risks must be coupled with appropriate research-based risk management

The process, distinct from risk assessment, of weighing policy alternatives, in consultation with all interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for

the promotion of fair trade practices, and, if needed,

selecting appropriate prevention and control options. (definition of risk management from FAO Glossary of Biotechnology for Food and Agriculture)

Risk Management

Risk management measures should be proportional to the risk, based on the outcome of the risk assessment and,

where relevant, taking into account other

legitimate factors

It should be recognized that different risk management measures may be capable of achieving the same level of protection

Risk Management

Risk managers should take into account the uncertainties identified in the risk

assessment and implement appropriate

measures to manage these uncertainties

Risk management measures may include,

as appropriate, food labelling8 conditions

for marketing approvals and post-market monitoring.

Risk Management

Post-market monitoring may be an appropriate risk management measure in

specific circumstances. Its need and utility

should be considered, on a case-by-case basis, during risk assessment and its practicability should be considered during

risk management

Risk Management

Post-market monitoring may be undertaken for the purpose of verifying conclusions about the

absence or the possible occurrence, impact and

significance of potential effects and monitoring changes associated with the introduction

Specific tools may be needed to facilitate the implementation and enforcement of risk management measures.

Risk Communication

Risk Communication
Risk Communication 10
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