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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

Components of Risk Analysis


Risk Assessment

Risk Management
Risk Communication

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)

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

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