dir applications: data requirements and risk analysis · dir applications: data requirements and...

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


∙









PREVIOUS RELEASES

GMO∙



PARENT ORGANISM

∙




Ecology

LEGISLATIVE REQUIREMENTS LEGISLATIVE REQUIREMENTS (Gene Technology Act and Regulations)(Gene Technology Act and Regulations)





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




∙





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∙



PARENT ORGANISM

∙




Ecology






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




∙









PREVIOUS RELEASES

GMOGMO∙∙

Introduced genes (genotype)Introduced genes (genotype)∙∙

Novel traits (phenotype)Novel traits (phenotype)

PARENT ORGANISM

∙




Ecology






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




∙









PREVIOUS RELEASESPREVIOUS RELEASES

GMO∙



PARENT ORGANISM

∙




Ecology








PREVIOUS RELEASESPREVIOUS RELEASES∙

risk assessments and experience from the release of the same or similar GMOs

in Australia or overseas

What happened last time?


∙









PREVIOUS RELEASES

GMO∙



PARENT ORGANISMPARENT ORGANISM

∙∙

Origin and taxonomyOrigin and taxonomy∙∙

Cultivation and useCultivation and use∙∙

Biological characterisationBiological characterisation∙∙

EcologyEcology






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



RECEIVING ENVIRONMENTRECEIVING ENVIRONMENT

∙∙

Environmental conditionsEnvironmental conditions∙∙

Agronomic practicesAgronomic practices∙∙

Sexually compatible relativesSexually compatible relatives∙∙

Presence of similar genesPresence of similar genes





PREVIOUS RELEASES

GMO∙



PARENT ORGANISM

∙




Ecology






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



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


GM cottoncontaining

Bt gene

Harm: reduced

plant biodiversity

in protected area


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


RISKSCENARIO

IDENTIFIEDRISK

RISKESTIMATE

Consequenceassessment

Likelihoodassessment

Evaluation

No

identifiedrisk

RISKCHARACTERISATION

RISK SCENARIO –

EXAMPLE 2


GM glyphosate

herbicide

tolerant cotton

Harm: reduced

plant biodiversityin Northern

Australia


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


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

dir applications: data requirements and risk analysis · dir applications: data requirements and...

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