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IMPORT RISK ANALYSIS The Process David Letham Biosecurity Australia Plant Biosecurity Australia AFFA Agriculture IMPORT RISK ANALYSIS The Process David Letham Biosecurity Australia Plant Biosecurity Australia AFFA Agriculture Fisheries and Forestry - Australia

Outline • • Biosecurity Australia • Fundamental principles of the process Initiation Determination of Outline • • Biosecurity Australia • Fundamental principles of the process Initiation Determination of approach Steps in IRA process Appeals

Review of quarantine: fundamental principles • • • Biosecurity Australia • Consultation Transparency Scientific Review of quarantine: fundamental principles • • • Biosecurity Australia • Consultation Transparency Scientific basis Consistency Harmonisation Subject to appeal

IRA Process Initiation • Risk analysis • Determination • Policy application • Biosecurity Australia IRA Process Initiation • Risk analysis • Determination • Policy application • Biosecurity Australia

Initiation • • Biosecurity Australia • Import proposal lodgement Proposal acknowledgment Priority consideration Consultation Initiation • • Biosecurity Australia • Import proposal lodgement Proposal acknowledgment Priority consideration Consultation on approach of risk analysis Endorsement of proposed IRA approach by Deputy Secretary

Determination of approach • Determination of approach Ü technical complexity Ü significantly different Ü Determination of approach • Determination of approach Ü technical complexity Ü significantly different Ü potential quarantine risk Ü consider stakeholder comments Biosecurity Australia • Routine IRA or Non-routine IRA Ü stakeholders notified

Routine IRA process BA forms an in-house team • BA team conducts risk analysis Routine IRA process BA forms an in-house team • BA team conducts risk analysis • Draft IRA paper circulated for comment • Biosecurity Australia

Non-routine IRA process (1) In consultation with stakeholders, BA determines scope, timetable, and risk Non-routine IRA process (1) In consultation with stakeholders, BA determines scope, timetable, and risk analysis panel (RAP) membership • Stakeholders may appeal • RAP meets and agrees on work program and Technical Working Groups • Biosecurity Australia

Non-routine IRA process (2) RAP prepares and circulates issues paper for comment • RAP Non-routine IRA process (2) RAP prepares and circulates issues paper for comment • RAP conducts risk analysis • Draft IRA paper circulated for comment • Biosecurity Australia

The IRA Process Comments reviewed and risk analysis recommendations finalised • Risk analysis recommendations The IRA Process Comments reviewed and risk analysis recommendations finalised • Risk analysis recommendations submitted to Deputy Secretary for determination • Import proposal determined by Deputy Secretary • Determination and final IRA paper published • Biosecurity Australia

Appeals Process not followed • Failure to consider significant body of scientific or technical Appeals Process not followed • Failure to consider significant body of scientific or technical information • Considered by Import Risk Analysis Appeal Panel within 45 days • Biosecurity Australia

Summary • • • Biosecurity Australia Key elements of the process Initiation Determination of Summary • • • Biosecurity Australia Key elements of the process Initiation Determination of approach Steps in the IRA process Appeals

Review of IRA process Review based on experience, stakeholder comment, Senate enquiries and ANAO Review of IRA process Review based on experience, stakeholder comment, Senate enquiries and ANAO review · Unchanged · high level of stakeholder consultation · right of stakeholder appeal · final responsibility for determining biosecurity policy lying with AFFA · Biosecurity Australia

Proposed changes · regular advice on IRA work program Web page · Bio Aust Proposed changes · regular advice on IRA work program Web page · Bio Aust newsletter · · more involvement of States / Territories in determining work program · in providing relevant scientific expertise · Biosecurity Australia · more explicit involvement of EA

Proposed changes 2 · each IRA conducted by an IRA team · · chaired Proposed changes 2 · each IRA conducted by an IRA team · · chaired by Bio Aust membership of team determined by location of required expertise whether available in Bio Aust / AFFA · to what extent external expertise required · other govt agencies, industry, private consultants, in Aust or overseas · Biosecurity Australia · provision for IRAs conducted by third parties

Proposed changes 3 · For all IRAs, a ‘technical issues' paper Ü hazard identification Proposed changes 3 · For all IRAs, a ‘technical issues' paper Ü hazard identification / pest categorisation Ü to identify pests/diseases requiring risk assessment Ü opportunity for earlier stakeholder input into the science · Biosecurity Australia For all IRAs, independent scientific peer review to ensure that IRA meets approp standards of risk analysis · latest information utilised · conclusions are reasonable re evidence ·

Proposed changes 4 · for significant IRAs Dof. Q may call on a Scientific Proposed changes 4 · for significant IRAs Dof. Q may call on a Scientific Advisory Panel of eminent independent scientists · to evaluate provisional final IRA report re scientific method ie as a scientific argument · · Biosecurity Australia final consultation with States / Territories prior to policy determination

Biosecurity Australia Biosecurity Australia