Country Consultation 2006 DRAFT ISPM:

PEST RISK ANALYSIS(Revision of ISPM no. 2)

Steward: Ebbe Nordbo

OUTLINE of PRESENTATION

• Reason for revision• Scope of ISPM 2• Three definitions• Background section• Section and subsections on Initiation• Section on summary of Stages 2 and 3• Section and subsections on generic aspects for

all stages• Flowchart

Reasons for revision

• Align with IPPC text of 1997• Align with ISPMs no. 11, 21 and 3• Describe analysis of organisms not

known to be pests

Section: Scope

• Describing basic concepts of pest risk analysis (PRA)

• Describing Initiation Stage, incl. analysis of organisms not known to be pests

• Referring to ISPMs no. 11, 21 and 3 for Assessment and Management stages

• Describing issues common to all stages

Definition: ’Pest risk’

‘The probability of introduction and spread of a pest and the magnitude of the associated potential economic consequences’

This is a function of the probability of an event and the effect of that event

Similar definitions in OIE and Codex

Revised definition: ’Pest risk assessment’

‘Evaluation of the probability of the introduction and spread of a pest and the magnitude of the associated potential economic consequences’

Slight amendment to align with proposed definition of ’pest risk’

Agreed interpretation: PRA

‘The process of evaluating biological or other scientific and economic evidence to determine whether an organism is a pest, whether it poses an unacceptable pest risk, and the strength of any phytosanitary measures to be taken against it’

• covers organism not known to be pest• 3 stages high-lighted in 3 subsentences• regulation criteria high-lighted• separating analysis process from regulatory process

Section: Background

• PRA is scientifically based and provides rationale for phytosanitary measures

• A commodity may be a pathway or itself be a pest

• PRA is about injury to plants• PRA consists of 3 stages

Subsection: Provisions of IPPC

• Phytosanitary measures need technical justification

• Technical justification should be based on PRA

• PRA is National Plant Protection Organization (NPPO) responsibility, regulation is contracting party responsibility

• Other particularly relevant IPPC principles

Sect. 1: Initiation stage

Initiation: identification of organisms and pathways that may be considered for risk assessment, incl. The steps:

• determination of an organism as a pest • defining the PRA area • evaluating any previous PRA• conclusion• for pathway analysis, assembling first a

list of associated organisms

Sect. 1.1: Initiation points

A PRA may be triggered when:• a pathway that may require PS

measures is identified• a pest that may justify PS measures is

identified• PS measures need reviewing• an evaluation whether an organism is

a pest is needed

Sect. 1.2: Determination of an organism as a pest

• Known as ‘pre-selection’ or ‘screening’ • Specify organism’s taxonomic identity,

or at least: consistent and transmissible symptoms

• Organism’s taxonomic level: Species. Higher or lower taxonomic level needs justification

• Predictive indicators: characteristics that suggest the organism may be a pest

Sect. 1.2 Determination of an organism… (cont.)

‘Is this organism a pest ?’ - Particular cases:

• plant species• beneficial organisms• organisms new to science • intentional import of organisms of

possible phytosanitary concern • Living Modified Organisms (LMOs)

Sect. 1.3: PRA area

• Define PRA area, covering the whole or part of a country or several countries. The analysis of establishment, spread and economic impact should relate only to the defined PRA area

• Reminder of: endangered area (Stage 2) and regulated area (Stage 3)

Sect. 1.5: Conclusion of initiation

• The PRA area has been defined• Organisms or pathways of no PS

concern need no further assessment• An organism deemed to be a pest may

need risk assessment. Each pest associated with a pathway should be assessed separately

• Organisms appearing to meet • QP criteria => ISPM No. 11 • RNQP criteria => ISPM No. 21

Sect. 2: Summary of stages 2 and 3

• Linked ISPMS tabled• Brief outlines of stages 2 and 3

Sect. 3: Aspects common to all PRA stages

• Uncertainty• Information gathering• Documentation• Risk communication• Consistency

Sect. 3.1: Uncertainty

• Sources of uncertainty• Nature and degree of uncertainty

should be documented• Documentation needed for transparency

and research prioritization• Monitoring of post-regulation situation is

appropriate

Sect. 3.2: Information gathering

• Sufficient information should be gathered throughout the process

• Information gaps may be identified necessitating further research

• Expert judgement may be used • Cooperation in information provision is

IPPC obligation. Requests should be specific and limited.

Sect. 3.3: Documentation

• Rationale for regulation should be available, incl.:

• Documentation regarding general procedure• Documentation for individual PRAs, incl.:

• PRA area and endangered area • Organism’s biological attributes• pathways, hosts, intended use of plants• evidence of economic impact• phytosanitary measures evaluated• sources of information

Sect. 3.4: Risk communication

Interactive process between NPPO and stakeholders, to

• achieve common understanding of pest risks

• develop credible pest risk management options

• develop credible and consistent regulations and policies to deal with pest risks

• promote awareness of the phytosanitary issues under consideration

Sect. 3.5: Consistency

NPPO should strive for consistency in conducting PRAs, as it

• facilitates non-discrimination and transparency • improves familiarity with the PRA process• increases efficiency in completing PRAs• improves comparability between PRAs on

similar products or pests, aiding the development of equivalent measures

Consistency may be assured through generic decision criteria and templates, training of PRA practitioners, and peer review of draft PRAs

Flow chart

• Illustrating information flow• Overview for visually oriented readers• Appendix is non-binding whatsoever

REVIEW OF PRESENTATION

• This ISPM presents the rationale, scientific basis, IPPC provisions and process structure of PRAs

• A novel term is defined and 2 terms amended

• An expanded Initiation Stage describes the evaluation of whether an organism is a pest

• Guidance to relevant other ISPMs is provided• Aspects common to the entire PRA process

are described