Role of theRole of the

ADVISORY COMMITTEE ADVISORY COMMITTEE

in the in the

GENETICALLY MODIFIED GENETICALLY MODIFIED ORGANISMS ACTORGANISMS ACT

(Act No. 15 of 1997)(Act No. 15 of 1997)

April 2003April 2003

Advisory Committee Advisory Committee

Biosafety StructureBiosafety Structure Section 10 of the GMO ActSection 10 of the GMO Act Appointment by Minister of AgricultureAppointment by Minister of Agriculture Period not exceeding 5 years Period not exceeding 5 years Members - recommendation from the Executive Members - recommendation from the Executive

CouncilCouncil RemuneratedRemunerated

Advisory CommitteeAdvisory Committee

Max. 10 personsMax. 10 persons 8- knowledgeable from applicable fields of 8- knowledgeable from applicable fields of

sciencescience 2- from public sector with knowledge of 2- from public sector with knowledge of

ecological matters and GMO’secological matters and GMO’s Representation from all fields of the expertise Representation from all fields of the expertise

involved with GMO’s - appointment of sub-involved with GMO’s - appointment of sub-committees (Section 11(2))committees (Section 11(2))

Review committee - 4 experts (1 chairperson)Review committee - 4 experts (1 chairperson)

Position of the Advisory CommitteePosition of the Advisory Committee

Receives documentation from RegistrarReceives documentation from Registrar Send recommendation to RegistrarSend recommendation to Registrar Questions/concerns raised - Registrar to applicantQuestions/concerns raised - Registrar to applicant Response from applicant back to RegistrarResponse from applicant back to Registrar Registrar sends response to Advisory CommitteeRegistrar sends response to Advisory Committee Committee assesses new/additional information Committee assesses new/additional information

and sends final recommendation to Registrar and sends final recommendation to Registrar

Functions of the ACFunctions of the AC

Act as national advisory body on GMO activitiesAct as national advisory body on GMO activities Advise the Minister, EC, other Ministries and Advise the Minister, EC, other Ministries and

appropriate bodies on matters concerning GMO’sappropriate bodies on matters concerning GMO’s– On the introduction, proposals for activities, On the introduction, proposals for activities,

contained use, importation and exportation of contained use, importation and exportation of GMO’sGMO’s

– On proposed regulations and written guidelinesOn proposed regulations and written guidelines Liaise internationally w.r.t. biosafetyLiaise internationally w.r.t. biosafety Invite written comments from expertsInvite written comments from experts

Functions of the ACFunctions of the AC(continue)(continue)

Safety assessments:Safety assessments:

- Health: - Health: - Environment:- Environment:Toxicity Living organisms

Pathogenicity Air, soil, water

Allergenicity Sustainability

Digestibility Biodiversity

Nutrition Stability

Unexpected products

Stability

Functions of the ACFunctions of the AC(continue)(continue)

Recommendation reportRecommendation report

– No decision - only recommendation to Council for their No decision - only recommendation to Council for their assessment assessment

– Content:Content:» Details of review committeeDetails of review committee

» Summary of applicationSummary of application

» Procedures followed during assessmentProcedures followed during assessment

» Safety issues assessedSafety issues assessed

» Non-safety issues assessedNon-safety issues assessed

» Risk managementRisk management

» RecommendationRecommendation

Conclusion Conclusion

National advisory body on GMO’sNational advisory body on GMO’s No decisionsNo decisions Only recommendations Only recommendations Primarily safety assessmentsPrimarily safety assessments