DIR applications: data requirements DIR applications: data requirements and risk analysisand risk analysis
Brian WeirBrian WeirEvaluation BranchEvaluation BranchOGTROGTR
IBC ForumIBC ForumCanberra, ACTCanberra, ACT77--8 June 20118 June 2011
RRISK ANALYSIS METHODOLOGY ISK ANALYSIS METHODOLOGY
Licenceapplication
Nolicence
Yes
Issue alicence?
Ris
k co
mm
unic
atio
n
Mon
itor a
nd re
view
Licence Monitor forcompliance
Risk management plan
Risk context
Risk assessment
RRISK CONTEXT ISK CONTEXT ––
why should you care? why should you care?
∙∙
DIR licence requires a completed applicationDIR licence requires a completed application
∙∙
IBC is required to evaluate if the:IBC is required to evaluate if the:
-
application is complete
-
persons covered by licence qualified to conduct dealings
-
information provided is true and correct
∙∙
Information provided in the application forms the bulk of Information provided in the application forms the bulk of the risk contextthe risk context
∙∙
The risk context sets parameters within which risk is The risk context sets parameters within which risk is assessed, managed and communicatedassessed, managed and communicated
RECEIVING ENVIRONMENT
∙
Environmental conditions∙
Agronomic practices∙
Sexually compatible relatives∙
Presence of similar genes
PROPOSED DEALINGS∙
Proposed activities with the GMO∙
Proposed limits of the release∙
Proposed control measures
PREVIOUS RELEASES
GMO∙
Introduced genes (genotype)∙
Novel traits (phenotype)
PARENT ORGANISM
∙
Origin and taxonomy∙
Cultivation and use∙
Biological characterisation∙
Ecology
LEGISLATIVE REQUIREMENTS (Gene Technology Act and Regulations)
RISK ANALYSIS FRAMEWORKRISK ANALYSIS FRAMEWORK
OGTR OPERATIONAL POLICIES AND GUIDELINESOGTR OPERATIONAL POLICIES AND GUIDELINES
EESTABLISHINGSTABLISHING
RRISK ISK CCONTEXTONTEXT
RECEIVING ENVIRONMENT
∙
Environmental conditions∙
Agronomic practices∙
Sexually compatible relatives∙
Presence of similar genes
PROPOSED DEALINGS∙
Proposed activities with the GMO∙
Proposed limits of the release∙
Proposed control measures
PREVIOUS RELEASES
GMO∙
Introduced genes (genotype)∙
Novel traits (phenotype)
PARENT ORGANISM
∙
Origin and taxonomy∙
Cultivation and use∙
Biological characterisation∙
Ecology
LEGISLATIVE REQUIREMENTS LEGISLATIVE REQUIREMENTS (Gene Technology Act and Regulations)(Gene Technology Act and Regulations)
RISK ANALYSIS FRAMEWORKRISK ANALYSIS FRAMEWORK
OGTR OPERATIONAL POLICIES AND GUIDELINESOGTR OPERATIONAL POLICIES AND GUIDELINES
EESTABLISHINGSTABLISHING
RRISK ISK CCONTEXTONTEXT
LEGISLATIVE REQUIREMENTS (Gene Technology Act and Regulations)*LEGISLATIVE REQUIREMENTS (Gene Technology Act and Regulations)*
∙
define terms (GMO, dealings)
∙
sets protection goals (health and safety of people and the
environment)
∙
nature and extent of consultation
RISK ANALYSIS FRAMEWORK*RISK ANALYSIS FRAMEWORK*
∙
sets out the methodology used for risk assessment
OGTR OPERATIONAL POLICIES AND GUIDELINES*OGTR OPERATIONAL POLICIES AND GUIDELINES*
∙
transport and storage guidelines
∙
Certification of physical containment facilities
* Available on website or by contacting OGTR* Available on website or by contacting OGTR
EESTABLISHINGSTABLISHING
RRISK ISK CCONTEXTONTEXT
RECEIVING ENVIRONMENT
∙
Environmental conditions∙
Agronomic practices∙
Sexually compatible relatives∙
Presence of similar genes
PROPOSED DEALINGSPROPOSED DEALINGS∙∙
Proposed activities with the GMOProposed activities with the GMO∙∙
Proposed limits of the releaseProposed limits of the release∙∙
Proposed control measuresProposed control measures
PREVIOUS RELEASES
GMO∙
Introduced genes (genotype)∙
Novel traits (phenotype)
PARENT ORGANISM
∙
Origin and taxonomy∙
Cultivation and use∙
Biological characterisation∙
Ecology
LEGISLATIVE REQUIREMENTS (Gene Technology Act and Regulations)
RISK ANALYSIS FRAMEWORKRISK ANALYSIS FRAMEWORK
OGTR OPERATIONAL POLICIES AND GUIDELINESOGTR OPERATIONAL POLICIES AND GUIDELINES
EESTABLISHINGSTABLISHING
RRISK ISK CCONTEXTONTEXT
PROPOSED DEALINGSPROPOSED DEALINGS∙∙
Proposed activities with the GMOProposed activities with the GMO∙ experiments, agronomic performance∙ use in human food or animal feed
∙∙
Proposed limits of the releaseProposed limits of the release∙
scope, scale, duration, number of locations and people permitted to conduct dealings
∙∙
Proposed control measuresProposed control measures∙∙
methods to restrict spread and persistence (isolation zone, methods to restrict spread and persistence (isolation zone, pollen traps, fencing to restrict access by large animals)pollen traps, fencing to restrict access by large animals)∙∙ methods of disposalmethods of disposal∙∙ the geographic area of the proposed releasethe geographic area of the proposed release
EESTABLISHINGSTABLISHING
RRISK ISK CCONTEXTONTEXT
RECEIVING ENVIRONMENT
∙
Environmental conditions∙
Agronomic practices∙
Sexually compatible relatives∙
Presence of similar genes
PROPOSED DEALINGS∙
Proposed activities with the GMO∙
Proposed limits of the release∙
Proposed control measures
PREVIOUS RELEASES
GMOGMO∙∙
Introduced genes (genotype)Introduced genes (genotype)∙∙
Novel traits (phenotype)Novel traits (phenotype)
PARENT ORGANISM
∙
Origin and taxonomy∙
Cultivation and use∙
Biological characterisation∙
Ecology
LEGISLATIVE REQUIREMENTS (Gene Technology Act and Regulations)
RISK ANALYSIS FRAMEWORKRISK ANALYSIS FRAMEWORK
OGTR OPERATIONAL POLICIES AND GUIDELINESOGTR OPERATIONAL POLICIES AND GUIDELINES
EESTABLISHINGSTABLISHING
RRISK ISK CCONTEXTONTEXT
GMOGMO∙∙
Introduced genes (genotype)Introduced genes (genotype)∙ the genetic elements and their source organisms∙
toxicity or allergenicity
of the introduced proteins and the source organisms∙ mode of genetic modification
∙∙
Novel traits (phenotype)Novel traits (phenotype)∙∙ the intended effect of the modificationthe intended effect of the modification∙∙
observed phenotype including any unintended observed phenotype including any unintended effectseffects
EESTABLISHINGSTABLISHING
RRISK ISK CCONTEXTONTEXT
RECEIVING ENVIRONMENT
∙
Environmental conditions∙
Agronomic practices∙
Sexually compatible relatives∙
Presence of similar genes
PROPOSED DEALINGS∙
Proposed activities with the GMO∙
Proposed limits of the release∙
Proposed control measures
PREVIOUS RELEASESPREVIOUS RELEASES
GMO∙
Introduced genes (genotype)∙
Novel traits (phenotype)
PARENT ORGANISM
∙
Origin and taxonomy∙
Cultivation and use∙
Biological characterisation∙
Ecology
LEGISLATIVE REQUIREMENTS (Gene Technology Act and Regulations)
RISK ANALYSIS FRAMEWORKRISK ANALYSIS FRAMEWORK
OGTR OPERATIONAL POLICIES AND GUIDELINESOGTR OPERATIONAL POLICIES AND GUIDELINES
EESTABLISHINGSTABLISHING
RRISK ISK CCONTEXTONTEXT
EESTABLISHINGSTABLISHING
RRISK ISK CCONTEXTONTEXT
PREVIOUS RELEASESPREVIOUS RELEASES∙
risk assessments and experience from the release of the same or similar GMOs
in Australia or overseas
What happened last time?
RECEIVING ENVIRONMENT
∙
Environmental conditions∙
Agronomic practices∙
Sexually compatible relatives∙
Presence of similar genes
PROPOSED DEALINGS∙
Proposed activities with the GMO∙
Proposed limits of the release∙
Proposed control measures
PREVIOUS RELEASES
GMO∙
Introduced genes (genotype)∙
Novel traits (phenotype)
PARENT ORGANISMPARENT ORGANISM
∙∙
Origin and taxonomyOrigin and taxonomy∙∙
Cultivation and useCultivation and use∙∙
Biological characterisationBiological characterisation∙∙
EcologyEcology
LEGISLATIVE REQUIREMENTS (Gene Technology Act and Regulations)
RISK ANALYSIS FRAMEWORKRISK ANALYSIS FRAMEWORK
OGTR OPERATIONAL POLICIES AND GUIDELINESOGTR OPERATIONAL POLICIES AND GUIDELINES
EESTABLISHINGSTABLISHING
RRISK ISK CCONTEXTONTEXT
PARENT ORGANISM
∙∙
Origin and taxonomyOrigin and taxonomy∙ identify parent and related species
∙∙
Cultivation and useCultivation and use∙ scale and regions of cultivation in Australia∙ use of end product
∙∙
Biological characterisationBiological characterisation∙ reproductive biology (seed or vegetative propagule) ∙ growth habit & characteristics which aid dispersal of propagules
∙∙
EcologyEcology∙∙ interactions in the environmentinteractions in the environment
* Biology documents available on website or by contacting OGTR* Biology documents available on website or by contacting OGTR
EESTABLISHINGSTABLISHING
RRISK ISK CCONTEXTONTEXT
RECEIVING ENVIRONMENTRECEIVING ENVIRONMENT
∙∙
Environmental conditionsEnvironmental conditions∙∙
Agronomic practicesAgronomic practices∙∙
Sexually compatible relativesSexually compatible relatives∙∙
Presence of similar genesPresence of similar genes
PROPOSED DEALINGS∙
Proposed activities with the GMO∙
Proposed limits of the release∙
Proposed control measures
PREVIOUS RELEASES
GMO∙
Introduced genes (genotype)∙
Novel traits (phenotype)
PARENT ORGANISM
∙
Origin and taxonomy∙
Cultivation and use∙
Biological characterisation∙
Ecology
LEGISLATIVE REQUIREMENTS (Gene Technology Act and Regulations)
RISK ANALYSIS FRAMEWORKRISK ANALYSIS FRAMEWORK
OGTR OPERATIONAL POLICIES AND GUIDELINESOGTR OPERATIONAL POLICIES AND GUIDELINES
EESTABLISHINGSTABLISHING
RRISK ISK CCONTEXTONTEXT
RECEIVING ENVIRONMENTRECEIVING ENVIRONMENT
∙∙
Environmental conditionsEnvironmental conditions∙ relevant abiotic/biotic properties of the geographic region∙ vulnerable or susceptible entities
∙∙
Agronomic practicesAgronomic practices∙ intended agricultural practices and proposed deviations∙ standard methods to control the parent organism
∙∙
Sexually compatible relativesSexually compatible relatives∙∙
Presence of similar genesPresence of similar genes∙∙ source organism source organism ∙∙ other relevant other relevant GMOsGMOs
already releasedalready released
EESTABLISHINGSTABLISHING
RRISK ISK CCONTEXTONTEXT
What is the level of risk ?Risk estimation
How likely is harm to occur ?Likelihood assessment
How serious could the harm be ?Consequence assessment
EVIDENCE
UNCERTAINTY
What could go wrong ?
How could harm occur ?Risk identification
(Risk scenarios)
RRISK ISK AANALYSISNALYSIS––
simple questionssimple questions
RISK ASSESSMENT-
process
RISK ASSESSMENT CONTEXT
Dealings with GMO
Harm to people or environment
Risk Scenario = plausible pathway to harm
RISK SCENARIO –
EXAMPLE 1
RISK ASSESSMENT CONTEXT
GM cottoncontaining
Bt gene
Harm: reduced
plant biodiversity
in protected area
Risk Scenario = plausible pathway to harm
Loss of GM Loss of GM seed during seed during transporttransport
Establishment Establishment of GM cotton of GM cotton near native near native cottoncotton
Gene flow Gene flow from GM to from GM to native cottonnative cotton
Increased Increased weediness weediness of native cottonof native cotton
RISK ASSESSMENT-
process
RISK ASSESSMENT CONTEXT
RISKSCENARIO
IDENTIFIEDRISK
RISKESTIMATE
Consequenceassessment
Likelihoodassessment
Evaluation
No
identifiedrisk
RISKCHARACTERISATION
RISK SCENARIO –
EXAMPLE 2
RISK ASSESSMENT CONTEXT
GM glyphosate
herbicide
tolerant cotton
Harm: reduced
plant biodiversityin Northern
Australia
Risk Scenario = plausible pathway to harm
Competitive Competitive advantage over advantage over other plant other plant species species
Spread and Spread and persistence persistence in favourablein favourableenvironment environment
Increased Increased populations populations of GM cottonof GM cotton
DisplacementDisplacementof other plant of other plant speciesspecies
RISK ASSESSMENT-
process
RISK ASSESSMENT CONTEXT
RISKSCENARIO
IDENTIFIEDRISK
RISKESTIMATE
Consequenceassessment
Likelihoodassessment
Evaluation
No
identifiedrisk
RISKCHARACTERISATION
RRISK ISK AASSESSMENTSSESSMENT--
risk characterisationrisk characterisation
••What are the What are the consequencesconsequences
(severity of harm)?(severity of harm)?
••What is the What is the likelihood likelihood of harm?of harm?••What is the What is the risk estimaterisk estimate??
PPROVIDING ROVIDING AADEQUATE DEQUATE IINFORMATIONNFORMATION
∙∙
contact the OGTR contact the OGTR
∙∙
send a draft applicationsend a draft application
∙∙
examine current examine current RARMPsRARMPs**
∙∙
reference OGTRreference OGTR**or other biology documents or other biology documents
∙∙
reference Regulatorreference Regulator’’s guideliness guidelines**
as appropriate as appropriate
∙∙
support claims with referencessupport claims with references
∙∙
IBC evaluation (quality control)IBC evaluation (quality control)* Available from OGTR website or contact office* Available from OGTR website or contact office
Thank youThank you
Questions?Questions?
Plant Evaluation Section Contact Details:Plant Evaluation Section Contact Details:
1800 181 030 or email to 1800 181 030 or email to [email protected]@health.gov.au