1、engInternat Io nal Standard for Phyto Sa n It ary Mea Su re SengFramework for pest risk analysis2ISPM 2This page is intentionally left blankINTERNATIONAL STANDARDS FOR PHYTOSANITARY MEASURES ISPM 2 Framework for pest risk analysis FAO 2007 Produced by the Secretariat of the International Plant Prote
2、ction Convention Adopted 2007; published 2019 FAO encourages the use, reproduction and dissemination of material in this information product. Except where otherwise indicated, material may be copied, downloaded and printed for private study, research and teaching purposes, or for use in non-commerci
3、al products or services, provided that appropriate acknowledgement of FAO as the source and copyright holder is given and that FAOs endorsement of users views, products or services is not implied in any way. When this ISPM is reproduced, it should be mentioned that current adopted versions of ISPMs
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5、o.org/publications) and can be purchased through publications-salesfao.org. The designations The designations employed and the presentation of material in this information product do not imply the expression of any opinion whatsoever on the part of the Food and Agriculture Organization of the United
6、 Nations (FAO) concerning the legal or development status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. The mention of specific companies or products of manufacturers, whether or not these have been patented, does not im
7、ply that these have been endorsed or recommended by FAO in preference to others of a similar nature that are not mentioned. The views expressed in this information product are those of the author(s) and do not necessarily reflect the views or policies of FAO. Publication history This is not an offic
8、ial part of the standard 1989-09 TC-RPPOs added topic Pest risk assessment process (1989-002). 1990-10 EWG developed draft text. 1991-05 TC-RPPOs revised draft text and proceeded with the discussion. 1991-11 EWG revised draft text. 1992-05 TC-RPPOs revised draft text and unable to recommend. 1993-05
9、 TC-RPPOs revised draft text and approved for MC. 1994-05 CEPM-1 revised draft text and requested to add PRA definitions to Glossary. 1995-05 CEPM-2 revised draft text for adoption. 1995-11 28th FAO Conference adopted standard. ISPM 2. 1995. Guidelines for pest risk analysis. Rome, IPPC, FAO. 1998-0
10、5 CEPM- added topic Revision of ISPM No. 2 (1989-002). 1999-10 ICPM-2 added topic. 2001-05 ISC-3 approved Specification 3 Revision of ISPM 2. 2002-04 ICPM-4 noted high priority topic. 2003-05 SC-7 revised Specification 3 (rev 1). 2003-11 SC revised Specification 3 (rev 2). 2004-01 EWG revised standa
11、rd. 2004-04 SC revised standard and Specification 3 (rev 3) and returned to EWG. 2004-06 EWG revised standard and Specification 3. 2005-04 SC revised standard and requested review by International Plant Health Risk Analysis Network. 2006-05 SC reviewed standard and approved for MC (*without any revi
12、sion). 2006-06 Sent for MC. 2006-11 SC revised standard for adoption. 2007-03 CPM-2 adopted revised standard. ISPM 2. 2007. Framework for pest risk analysis. Rome, IPPC, FAO. 2015-06 IPPC Secretariat incorporated ink amendments and reformatted standards following revoking of standards procedure from
13、 CPM-10 (2015). 2019-04 CPM-14 noted and IPPC Secretariat incorporated ink amendments to the term “contamination” and its derivatives. Publication history last updated: 2019-04 Framework for pest risk analysis ISPM 2 International Plant Protection Convention ISPM 2-3 CONTENTS Adoption . 4 INTRODUCTI
14、ON . 4 Scope . 4 References . 4 Definitions . 4 Outline of Requirements . 4 BACKGROUND . 5 REQUIREMENTS . 6 1. PRA Stage 1: Initiation . 6 1.1 Initiation points . 7 1.1.1 Identification of a pathway . 7 1.1.2 Identification of a pest . 7 1.1.3 Review of phytosanitary policies . 8 1.1.4 Identificatio
15、n of an organism not previously known to be a pest. 8 1.2 Determination of an organism as a pest . 8 1.2.1 Plants as pests . 9 1.2.2 Biological control agents and other beneficial organisms . 10 1.2.3 Organisms not yet fully described or difficult to identify . 10 1.2.4 Living modified organisms . 1
16、0 1.2.5 Import of organisms for specific uses . 11 1.3 Defining the PRA area . 11 1.4 Previous pest risk analyses . 11 1.5 Conclusion of initiation . 11 2. Summary of PRA Stages 2 and 3 . 12 2.1 Linked standards . 12 2.2 Summary of PRA Stage 2: Pest risk assessment . 12 2.3 Summary of PRA Stage 3: P
17、est risk management . 13 3. Aspects Common to All PRA Stages . 13 3.1 Uncertainty . 13 3.2 Information gathering . 13 3.3 Documentation . 14 3.3.1 Documenting the general PRA process . 14 3.3.2 Documenting each specific PRA . 14 3.4 Risk communication . 14 3.5 Consistency in PRA . 15 3.6 Avoidance o
18、f undue delay . 15 APPENDIX 1: Pest risk analysis flow chart . 16 ISPM 2 Framework for pest risk analysis ISPM 2-4 International Plant Protection Convention Adoption This standard was first adopted by the Twenty-eighth Session of the FAO Conference in November 1995 as Guidelines for pest risk analys
19、is. This first revision was adopted by the Second Session of the Commission on Phytosanitary Measures in March 2007 as the present standard. INTRODUCTION Scope This standard provides a framework that describes the pest risk analysis (PRA) process within the scope of the IPPC. It introduces the three
20、 stages of pest risk analysis initiation, pest risk assessment and pest risk management. The standard focuses on the initiation stage. Generic issues of information gathering, documentation, risk communication, uncertainty and consistency are addressed. References The present standard refers to Inte
21、rnational Standards for Phytosanitary Measures (ISPMs). ISPMs are available on the International Phytosanitary Portal (IPP) at https:/www.ippc.int/core-activities/standards-setting/ispms. IPPC. 1997. International Plant Protection Convention. Rome, IPPC, FAO. WTO. 1994. Agreement on the Application
22、of Sanitary and Phytosanitary Measures. Geneva, World Trade Organization. Definitions Definitions of phytosanitary terms used in the present standard can be found in ISPM 5 (Glossary of phytosanitary terms). Outline of Requirements The PRA process is a technical tool used for identifying appropriate
23、 phytosanitary measures. The PRA process may be used for organisms not previously recognized as pests (such as plants, biological control agents or other beneficial organisms, living modified organisms), recognized pests, pathways and review of phytosanitary policy. The process consists of three sta
24、ges: 1: Initiation; 2: Pest risk assessment; and 3: Pest risk management. This standard provides detailed guidance on PRA Stage 1, summarizes PRA Stages 2 and 3, and addresses issues generic to the entire PRA process. For Stages 2 and 3 it refers to ISPM 3 (Guidelines for the export, shipment, impor
25、t and release of biological control agents and other beneficial organisms), ISPM 11 (Pest risk analysis for quarantine pests) and ISPM 21 (Pest risk analysis for regulated non-quarantine pests) dealing with the PRA process. The PRA process is initiated in Stage 1 with the identification of an organi
26、sm or pathway that may be considered for pest risk assessment, or as part of the review of existing phytosanitary measures, in relation to a defined PRA area. The first step is to determine or confirm whether or not the organism considered is a pest. If no pests are identified, the analysis need not
27、 continue. The analysis of pests identified in Stage 1 continues to Stages 2 and 3 using guidance provided in other standards. Information gathering, documentation and risk communication, as well as uncertainty and consistency, are issues common to all PRA stages. Framework for pest risk analysis IS
28、PM 2 International Plant Protection Convention ISPM 2-5 BACKGROUND Pest risk analysis provides the rationale for phytosanitary measures for a specified PRA area. It evaluates scientific evidence to determine whether an organism is a pest. If so, the analysis evaluates the probability of introduction
29、 and spread of the pest and the magnitude of potential economic consequences in a defined area, using biological or other scientific and economic evidence. If the risk is deemed unacceptable, the analysis may continue by suggesting management options that can reduce the risk to an acceptable level.
30、Subsequently, pest risk management options may be used to establish phytosanitary regulations. For some organisms, it is known beforehand that they are pests, but for others, the question of whether or not they are pests should initially be resolved1. The pest risks posed by the introduction of orga
31、nisms associated with a particular pathway, such as a commodity, should also be considered in a PRA. The commodity itself may not pose a pest risk but may harbour organisms that are pests. Lists of such organisms are compiled during the initiation stage. Specific organisms may then be analysed indiv
32、idually, or in groups where individual species share common biological characteristics. Less commonly, the commodity itself may pose a pest risk. When deliberately introduced and established in intended habitats in new areas, organisms imported as commodities (such as plants for planting, biological
33、 control agents and other beneficial organisms, and living modified organisms (LMOs) may pose a risk of accidentally spreading to unintended habitats causing injury to plants or plant products. Such risks may also be analysed using the PRA process. The PRA process is applied to pests of cultivated p
34、lants and wild flora, in accordance with the scope of the IPPC. It does not cover the analysis of risks beyond the scope of the IPPC. Provisions of other international agreements may address risk assessment (e.g. the Convention on Biological Diversity and the Cartagena Protocol on Biosafety to that
35、convention). The PRA structure The PRA process consists of three stages: - Stage 1: Initiation - Stage 2: Pest risk assessment - Stage 3: Pest risk management. Information gathering, documentation and risk communication are carried out throughout the PRA process. PRA is not necessarily a linear proc
36、ess because, in conducting the entire analysis, it may be necessary to go back and forth between various stages. Revision of this standard This revision of ISPM 2 particularly addresses the issues of: - aligning the text with the 1997 revision of the IPPC - aligning the text with further conceptual
37、developments of the PRA scope and procedures as appearing in ISPM 3, ISPM 11 and ISPM 21 - including regulated non-quarantine pests (RNQPs) in the description of the PRA process - including organisms not known beforehand to be pests in the description of the PRA process 1 The IPPC defines a pest as
38、“any species, strain or biotype of plant, animal or pathogenic agent injurious to plants or plant products”. The understanding of the term “pests” includes organisms that are pests because they directly affect cultivated/managed or uncultivated/unmanaged plants, indirectly affect plants, or indirect
39、ly affect plants through effects on other organisms (c.f. Annex 1 of ISPM 11). ISPM 2 Framework for pest risk analysis ISPM 2-6 International Plant Protection Convention - including aspects common to all PRA stages in the description of the PRA. Thus, this standard provides detailed guidance on PRA
40、Stage 1 and issues generic to all PRA stages, and refers to other ISPMs (identified in Table 1) as appropriate for further analysis through PRA Stages 2 and 3. This standard is conceptual and is not a detailed operational or methodological guide for assessors. An overview of the full PRA process is
41、illustrated in Appendix 1. Provisions of the IPPC regarding pest risk analysis The International Plant Protection Convention (IPPC, Article VII.2(a) requires that: “Contracting parties shall not . take any of the measures specified in paragraph 1 of this Article i.e. phytosanitary measures unless su
42、ch measures are made necessary by phytosanitary considerations and are technically justified.” Article VI.1(b) requires that phytosanitary measures are: “limited to what is necessary to protect plant health and/or safeguard the intended use and can be technically justified by the contracting party c
43、oncerned.” “Technically justified” is defined in Article II.1 as: “justified on the basis of conclusions reached by using an appropriate pest risk analysis or, where applicable, another comparable examination and evaluation of available scientific information.” Article IV.2(f) states that the respon
44、sibilities of the national plant protection organization (NPPO) include “the conduct of pest risk analyses”. The issuing of regulations is a responsibility of the contracting party to the IPPC (Article IV.3(c), although contracting parties may delegate this responsibility to the NPPO. In conducting
45、a PRA, the obligations established in the IPPC should be taken into account. Those of particular relevance to the PRA process include: - cooperation in the provision of information - minimal impact - non-discrimination - harmonization - transparency - avoidance of undue delay. REQUIREMENTS 1. PRA St
46、age 1: Initiation Initiation is the identification of organisms and pathways that may be considered for pest risk assessment in relation to the identified PRA area. A PRA process may be triggered in the following situations (initiation points, section 1.1): - a request is made to consider a pathway
47、that may require phytosanitary measures - a pest is identified that may justify phytosanitary measures - a decision is made to review or revise phytosanitary measures or policies - a request is made to determine whether an organism is a pest. The initiation stage involves four steps: - determination
48、 whether an organism is a pest (section 1.2) - defining the PRA area (section 1.3) - evaluating any previous PRA (section 1.4) Framework for pest risk analysis ISPM 2 International Plant Protection Convention ISPM 2-7 - conclusion (section 1.5). When the PRA process has been triggered by a request t
49、o consider a pathway, the above steps are preceded by assembling a list of organisms of possible regulatory concern because they are likely to be associated with a pathway. At this stage, information is necessary to identify the organism and its potential economic impact, which includes environmenta
50、l impact2. Other useful information on the organism may include its geographical distribution, host plants, habitats and association with commodities (or, for RNQP candidates, association with plants for planting). For pathways, information about the commodity, including modes of transport, and its
