SPSBCAR2 Module 1

UNDERSTANDING SANITARY & PHYTOSANITARY (SPS) AGREEMENT FOR A BETTER AGRIBUSINESS IN CARIBBEAN COUNTRIES. STAGE II

MODULE 1 RISK ASSESSMENT

COURSE AUTHOR Interamerican Development Bank (IDB) (www.iadb.org), through his Integration and Trade Sector (INT).

COURSE COORDINATOR Interamerican Development Bank (IDB) (www.iadb.org), through his Integration and Trade Sector (INT), the Institute for the Integration of Latin America and the Caribbean (INTAL) (www.iadb.org/es/intal), the Inter-American Institute for Economic and Social Development (INDES) (www.indes.org), the World Customs Organization (WCO) (www.wcoomd.org) and the General Secretariat of Central American Integration (SG-SICA) (http://www.sica.int/).

MODULE AUTHORS Clara Vidal, Lawyer. She is currently a senior analyst at the Office of Multilateral Affairs of the National Agribusiness International Relations, Ministry of Agriculture, Livestock and Fisheries of Argentina. Gustavo Idígoras, General Manager Business Issue Management (BIM).

PEDAGOGICAL AND EDITION COORDINATION The Inter-American Institute for Economic and Social Development (INDES) (www. indes.org), in collaboration with Fundación Centro de Educación a Distancia para el Desarrollo Económico y Tecnológico (CEDDET) (www.ceddet.org).

Copyright ©2016 Inter-American Development Bank. This work is licensed under a Creative Commons IGO 3.0 Attribution-NonCommercial-NoDerivatives (CC-IGO 3.0 BY-NC-ND) (http://creativecommons. org/licenses/by-nc-nd/3.0/igo/legalcode). This document is the intellectual property of the Inter-American Development Bank (IDB). Any partial or total reproduction of this document should be reported to: BIDINDES@iadb.org Any dispute related to the use of the works of the IDB that cannot be settled amicably shall be submitted to arbitration pursuant to the UNCITRAL rules. The use of the IDB’s name for any purpose other than for attribution, and the use of IDB’s logo shall be subject to a separate written license agreement between the IDB and the user and is not authorized as part of this CC-IGO license.

Note that the link provided above includes additional terms and conditions of the license.

The opinions expressed in this publication necessarily reflect the views of the Inter-American Development Bank, its Board of Directors, or the countries they represent.

These materials have been revised in light of the ministerial decisions taken in the framework of the 9th World Trade Organization Ministerial Conference held in Bali, Indonesia, in December 2013. The adjustments were made in order to reflect a higher alignment between the course topics and the priorities identified in Bali’s Ministerial Declaration and decisions, where all IDB members participated.

Bali Ministerial Declaration and Decisions

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Table of contents Index of Figures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Module Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 UNIT I. RECOMMENDED METHODOLOGIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Learning objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 I.1. Introduction of the Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 I.1.1. Risk analyses include three parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Summary of Unit I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 UNIT II. PLANT HEALTH RISK ASSESSMENT MODELS . . . . . . . . . . . . . . . . . . . . . . . 10 Learning objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 II.1. Introduction of the Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 II.2. Initiation points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 II.2.1. PRA initiated by the identification of a pathway . . . . . . . . . . . . . . . . . . . . . 13 II.2.2. PRA initiated by the review or revision of a policy . . . . . . . . . . . . . . . . . . . 14 II.3. Identification of PRA area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 II.4. Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 II.4.1. Previous PRA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 II.5. Conclusion of initiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 II.6. Stage 2: Pest Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 II.7. Pest categorization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 II.7.1. Elelusion of pest categorization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 II.7.2. Conclusion of pest categorization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 II.8. Assessment of the probability of introduction and spread . . . . . . . . . . . . . . . . 19

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II.8.1. Probability of entry of a pest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Summary of Unit II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 UNIT III. ANIMAL HEALTH RISK ASSESSMENT MODELS . . . . . . . . . . . . . . . . . . . . 24 Learning objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 III.1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Summary of Unit III . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 UNIT IV. FOOD SAFETY RISK ASSESSMENT MODELS . . . . . . . . . . . . . . . . . . . . . . . . 32 Learning objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 I.1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 IV.2. Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 IV.2.1. Identifying and Describing the Food Safety Problem that will be Reviewed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

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IV.2.2. Risk Assessment Decision Tree . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 IV.2.3. Performance of a Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 IV.2.4. Generalities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 IV.2.5. Types of Risk Assessments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 IV.2.6. Basic Components of a Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . 39 IV.2.7. Hazard Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Summary of unit IV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Reference Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Complementary Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

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Index of Figures Figure 1.1. Stages of risk assessment Figure 1.2. Areas of application of risk Figure 2.1. Process of Pest Risk Analysis (PRA) Figure 3.1. Import procedure for animals or products of animal origin including a risk assessment Figure 3.2. Risk Analysis Figure 4.1. Risk Assessment Figure 4.2. Methodological differences between risk analysis for chemical and biological hazards Figure 4.3. Components of risk analysis Figure 4.4. Generic Description of the Components of a Risk Assessment

Introduction According to Article 3 and Article 5 of the SPS Agreement, Members are permitted to adopt SPS measures that are more stringent than the relevant international standards or adopt SPS measures when international standards do not exist, provided the measures, in addition to the basic obligations set forth in Article 2, are: Based on scientific risk assessment.

Consistently applied.

Not more trade restrictive than necessary.

Article 5 disciplines the “assessment of risk and the determination of the appropriate level of sanitary and phytosanitary protection”.

Article 5.1 provides: Members shall ensure that their sanitary or phytosanitary measures are based on an assessment, as appropriate to the circumstances, of the risks to human, animal or plant life or health, taking into account risk assessment techniques developed by the relevant international organizations.

In order to establish if an SPS measure is based on a risk assessment, as required by Article 5.1, we should first determine what “risk assessment” actually means.

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IN BRIEF There are two types of risk assessment as defined by Annex A.4 of the SPS Agreement: Risks arising from pests or diseases (Animal and Plant Risk Assessment): the evaluation of the likelihood of entry, establishment or spread of a pest or disease within the territory of an importing Member according to the SPS measures which might be applied, and of the associated potential biological and economic consequences; or Food-borne risks (food safety risk assessment): The evaluation of the potential for adverse effects on human or animal health arising from the presence of additives, contaminants, toxins or disease-causing organisms in food, beverages or feedstuffs.

Module Objectives To understand the main provisions of the WTO/SPS Agreement, in particular: To identify recommended methodologies for risk assessment;

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To share information on LAC risk assessment and experiences.

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UNIT I

RECOMMENDED METHODOLOGIES

Learning Objectives Understand the main concepts of Risk Assessment on Animal Health, Plant Health and Food Safety.

To identify the three parts of the whole process of Risk Assessment.

I.1. Introduction of the Unit I.1.1. Risk analyses include three parts Risk assessment.

Risk management.

Risk communication.

Risk assessment is a set of actions that identify and qualitatively or quantitatively estimate the risk and severity of the hazards to public health present in food, and to animal and plant health. Risk assessment is mainly a scientific process.

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Source: Prepared by the author

Figure 1.1. Stages of risk assessment The purpose of risk management is to select the most appropriate measures to avoid or minimise a risk to public, animal or plant health based on the results of the risk assessment. Although management actions are selected based on scientific principles, risk management requires legislative actions and policy decisions that take into consideration the wishes and needs of society as well as particular economic, cultural or religious aspects of each country or region.

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For these reasons, this module will only address risk assessment as a scientific process that generates the information that is necessary for decision-making. Risk management is left to political and legislative levels in each region or country.

Source: Prepared by the author

Figure.1.2. Areas of application of risk

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SUMMARY OF UNIT I OBJECTIVE OF RISK ASSESSMENT Risk assessment is a set of actions that identify and qualitatively or quantitatively estimate the risk and severity of the hazards to public health present in food, and to animal and plant health. Risk assessment is mainly a scientific process.

PARTS OF RISK ASSESSMENT Risk analyses include three parts: Risk assessment; Risk management; and Risk Communication

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UNIT II

PLANT HEALTH RISK ASSESSMENT MODELS

Learning Objectives Understanding of risk assessment procedures developed by Plant Protection Convention and National Plant Protection Organisations.

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II.1. Introduction of the Unit In the case of plant protection, the risk analysis procedures implemented by the national plant protection organisations (NPPOS) are based on the international standards for phytosanitary measures (ISPM) that were developed by the secretariat of the international plant protection convention (IPPC) as part of FAO’S global programme of policy and technical assistance in plant quarantine. This programme offers standards, guidelines and recommendations to fao members and other interested parties with the goal of harmonising phytosanitary measures at international level, facilitating trade and avoiding the application of unjustified measures that are obstacles to trade. specifically ISPM 11/2004 “pest risk analysis for quarantine pests, including analysis of environmental risks and living modified organisms” provides details to conduct a pest risk analysis (PRA), determine if a pest is a quarantine pest and describes integrated processes for risk assessment and selection of risk management options.

The objectives of a PRA are, for a specified area, to identify pests and/or pathways of quarantine concern and evaluate their risk, to identify endangered areas, and, if appropriate, to identify risk management options. PRA for quarantine pests follows a process defined by three stages: Stage 1 (initiating the process) involves identifying the pest(s) and pathways that are of quarantine concern and should be considered for risk analysis in relation to the identified pra area.

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Stage 2 (risk assessment) begins with the categorization of individual pests to determine whether the criteria for a quarantine pest are satisfied. Risk assessment continues with an evaluation of the probability of pest entry, establishment, and spread, and of their potential economic consequences (including environmental consequences – s1).

Stage 3 (risk management) involves identifying management options for reducing the risks identified at stage 2. These are evaluated for efficacy, feasibility and impact in order to select those that are appropriate.

SECOND LAYER (TO BE DEVELOPED WITH IT GROUP) PEST RISK ANALYSIS FOR QUARANTINE PESTS 1. Stage 1: Initiation The aim of the initiation stage is to identify the pest(s) and pathways which are of quarantine concern and should be considered for risk analysis in relation to the identified PRA area.

S2 Some LMOs may present a phytosanitary risk and therefore warrant a PRA. However other LMOs will not present phytosanitary risks beyond those posed by related non-LMOs and therefore will not warrant a complete PRA. Thus, for LMOs, the aim of the initiation stage is to identify those LMOs that have the characteristics of a potential pest and need to be assessed further, and those which need no further assessment under ISPM 11.

S2 LMOs are organisms that have been modified using techniques of modern biotechnology to express one or more new or altered traits. In most cases, the parent organism is not normally considered to be a plant pest but an assessment may need to be performed to determine if the genetic modification (i.e. gene, new gene sequence that regulates other genes or gene product) results in a new trait or characteristic that may present a plant pest risk.

S2 A plant pest risk from LMOs may be presented by: The organism(s) with the inserted gene(s) (i.e. the LMO) The combination of genetic material (e.g. gene from plant pests such as viruses) or The consequences of the genetic material moving to another organism.

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Source: ISPM 2 – FAO, 2007a

Figure 2.1. The process of Pest Risk Analysis

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II.2. Initiation points The PRA process may be initiated as a result of: The identification of a pathway that presents a potential pest hazard The identification of a pest that may require phytosanitary measures The review or revision of phytosanitary policies and priorities.

S1 The initiation points frequently refer to “pests”. The IPPC defines a pest as “any species, strain or biotype of plant, animal, or pathogenic agent, injurious to plants or plant products.” In applying these initiation points to the specific case of plants as pests, it is important to note that the plants concerned should satisfy this definition.

Pests directly affecting plants satisfy this definition. In addition, many organisms indirectly affecting plants also satisfy this definition (such as weeds/invasive plants).

The fact that they are injurious to plants can be based on evidence obtained in an area where they occur. In the case of organisms where there is insufficient evidence that they affect plants indirectly, it may nevertheless be appropriate to assess on the basis of available pertinent information, whether they are potentially injurious in the PRA area by using a clearly documented, consistently applied and transparent system. This is particularly important for plant species or cultivars that are imported for planting.

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S2 The types of LMOs that a national plant protection organization (NPPO) may be asked to assess for phytosanitary risk include: Plants for use (a) as agricultural crops, for food and feed, ornamental plants or managed forests; (b) in bioremediation (as an organism that cleans up contamination); (c) for industrial purposes (e.g. production of enzymes or bioplastics); (d) as therapeutic agents (e.g. pharmaceutical production).

Biological control agents modified to improve their performance in that role.

Pests modified to alter their pathogenic characteristic and thereby make them useful for biological control (see ISPM 3:2005).

Pest risk analysis for quarantine pests including ISPM 11 analysis of environmental risks and living modified organisms ISPM 11-8.

Organisms genetically modified to improve their characteristics such as for biofertilizer or other influences on soil, bioremediation or industrial uses.

S2 In order to be categorized as a pest, an LMO has to be injurious or potentially injurious to plants or plant products under conditions in the PRA area. This damage may be in the form of direct effects on plants or plant products, or indirect effects.

For guidance on the process of determining whether an LMO has the potential to be a pest, refer to Annex 3, “Determining the potential for a living modified organism to be a pest”.

II.2.1. PRA initiated by the identification of a pathway The need for a new or revised PRA of a specific pathway may arise in the following situations: International trade is initiated in a commodity not previously imported into the country (usually a plant or plant product, including genetically altered plants) or a commodity from a new area or new country of origin.

New plant species are imported for selection and scientific research purposes.

A pathway other than commodity import is identified (natural spread, packing material, mail, garbage, passenger baggage etc.).

A list of pests likely to be associated with the pathway (e.g. carried by the commodity) may be generated by any combination of official sources, databases, scientific and other literature, or expert consultation. It is preferable to prioritize the listing, based on expert judgement on pest distribution and types of pests. If no potential quarantine pests are identified as likely to follow the pathway, the PRA may stop at this point.

S2 The phrase “genetically altered plants” is understood to mean plants obtained through the use of modern biotechnology.

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II.2.2. PRA initiated by the review or revision of a policy A requirement for a new or revised PRA originating from policy concerns will most frequently arise in the following situations: A national decision is taken to review phytosanitary regulations, requirements or operations.

A proposal made by another country or by an international organization (regional plant protection organization, FAO) is reviewed.

Pest risk analysis for quarantine pests including analysis of environmental risks and living modified organisms ISPM 11 ISPM 11-9.

A new treatment or loss of a treatment system, a new process, or new information impacts on an earlier decision.

A dispute arises on phytosanitary measures.

The phytosanitary situation in a country changes, a new country is created, or political boundaries have changed.

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II.3. Identification of PRA area The PRA area should be defined as precisely as possible in order to identify the area for which information is needed.

II.4. Information Information gathering is an essential element of all stages of PRA. It is important at the initiation stage in order to clarify the identity of the pest(s), its/their present distribution and association with host plants, commodities etc. Other information will be gathered as required to reach necessary decisions as the PRA continues.

Information for PRA may come from a variety of sources. The provision of official information regarding pest status is an obligation under the IPPC (Article VIII.1(c)) facilitated by official contact points (Article VIII.2).

S1 For environmental risks, the variety of sources of information will generally be wider than traditionally used by NPPOs. Broader inputs may be required. These sources may include environmental impact assessments, but it should be recognized that such assessments usually do not have the same purpose as PRA and cannot substitute for PRA.

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S2 For LMOs, information required for a full risk analysis may include: Name, identity and taxonomic status of the LMO (including any relevant identifying codes) and the risk management measures applied to the LMO in the country of export Taxonomic status, common name, point of collection or acquisition, and characteristics of the donor organism Description of the nucleic acid or the modification introduced (including genetic construct) and the resulting genotypic and phenotypic characteristics of the LMO Details of the transformation process Appropriate detection and identification methods and their specificity, sensitivity and reliability Intended use including intended containment Quantity or volume of the LMO to be imported.

S2 Information regarding pest status is an obligation under the IPPC (Article VIII.1(c)) facilitated by official contact points (Article VIII.2). A country may have obligations to provide information about LMOs under other international agreements such as the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (CBD, 2000). The Cartagena Protocol has a Biosafety Clearing-house that may contain relevant information. Information on LMOs is sometimes commercially sensitive and applicable obligations with regard to release and handling of information should be observed.

II.4.1. Previous PRA A check should also be made as to whether pathways, pests or policies have already been subjected to the PRA process, either nationally or internationally. If a PRA exists, its validity should be checked as circumstances and information may have changed.

The possibility of using a PRA from a similar pathway or pest, that may partly or entirely replace the need for a new PRA, should also be investigated. Pest risk analysis for quarantine pests including ISPM 11 analysis of environmental risks and living modified organisms ISPM 11-10.

II.5. Conclusion of initiation At the end of Stage 1, the initiation point, the pests and pathways of concern and the PRA area will have been identified. Relevant information has been collected and pests have been identified as possible candidates for phytosanitary measures, either individually or in association with a pathway.

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S2 For LMOs at the end of Stage 1 an NPPO may decide that the LMO: Is a potential pest and needs to be assessed further in Stage 2 or Is not a potential pest and needs no further analysis under ISPM 11 (but see also the following paragraph).

S2 PRA under the IPPC only relates to the assessment and management of phytosanitary risks. As with other organisms or pathways assessed by an NPPO, LMOs may present other risks not falling within the scope covered by the IPPC. For LMOs, PRA may constitute only a portion of the required overall risk analysis. For example, countries may require the assessment of risks to human or animal health or to the environment beyond that covered by the IPPC. When an NPPO discovers potential for risks that are not phytosanitary it may be appropriate to notify the relevant authorities.

II.6. Stage 2: Pest Risk Assessment The process for pest risk assessment can be broadly divided into three interrelated steps: Pest categorization.

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Assessment of the probability of introduction and spread.

Assessment of potential economic consequences (including environmental impacts).

In most cases, these steps will be applied sequentially in a PRA but it is not essential to follow a particular sequence. Pest risk assessment needs to be only as complex as is technically justified by the circumstances. This standard allows a specific PRA to be judged against the principles of necessity, minimal impact, transparency, equivalence, risk analysis, managed risk and non-discrimination set out in ISPM 1:1993.

S2 For LMOs, from this point forward in PRA, it is assumed that the LMO is being assessed as a pest, and therefore “LMO� refers to an LMO that is a potential quarantine pest due to new or altered characteristics or properties resulting from the genetic modification. The risk assessment should be carried out on a case-by-case basis.

LMOs that have pest characteristics unrelated to the genetic modification should be assessed using the normal procedures.

II.7. Pest categorization At the outset, it may not be clear which pest(s) identified in Stage 1 require a PRA. The categorization process examines for each pest whether the criteria in the definition for a quarantine pest are satisfied.

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In the evaluation of a pathway associated with a commodity, a number of individual PRAs may be necessary for the various pests potentially associated with the pathway.

The opportunity to eliminate an organism or organisms from consideration before in-depth examination is undertaken is a valuable characteristic of the categorization process.

An advantage of pest categorization is that it can be done with relatively little information; however information should be sufficient to adequately carry out the categorization.

II.7.1. Elements of categorization The categorization of a pest as a quarantine pest includes the following primary elements: Identity of the pest Presence or absence in the PRA area Pest risk analysis for quarantine pests including analysis of environmental risks and living modified organisms ISPM 11 ISPM 11-11 Regulatory status Potential for establishment and spread in PRA area Potential for economic consequences (including environmental consequences) in the PRA area.

II.7.1.1. Identity of pest The identity of the pest should be clearly defined to ensure that the assessment is being performed on a distinct organism, and that biological and other information used in the assessment is relevant to the organism in question. If this is not possible because the causal agent of particular symptoms has not yet been fully identified, then it should have been shown to produce consistent symptoms and to be transmissible.

The taxonomic unit for the pest is generally species. The use of a higher or lower taxonomic level should be supported by scientifically sound rationale. In the case of levels below the species, this should include evidence demonstrating that factors such as differences in virulence, host range or vector relationships are significant enough to affect phytosanitary status.

In cases where a vector is involved, the vector may also be considered a pest to the extent that it is associated with the causal organism and is required for transmission of the pest.

S2 In the case of LMOs, identification requires information regarding characteristics of the recipient or parent organism, the donor organism, the genetic construct, the

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gene or transgene vector and the nature of the genetic modification. Information requirements are set out under section 1.3.

II.7.1.2. Presence or absence in PRA area The pest should be absent from all or a defined part of the PRA area.

S2 In the case of LMOs, this should relate to the LMO of phytosanitary concern.

II.7.1.3. Regulatory status If the pest is present but not widely distributed in the PRA area, it should be under official control or expected to be under official control in the near future.

S1 Official control of pests presenting an environmental risk may involve agencies other than the NPPO. However, it is recognized that ISPM 5 Supplement 1 (Guidelines on the interpretation and application of the concept of official control for regulated pests), in particular section 5.7, applies.

S2 In the case of LMOs, official control should relate to the phytosanitary measures applied because of the pest nature of the LMO. It may be appropriate to consider any official control measures in place for the parent organism, donor organism, transgene vector or gene vector.

II.7.1.4. Potential for establishment and spread in PRA area

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Evidence should be available to support the conclusion that the pest could become established or spread in the PRA area. The PRA area should have ecological/climatic conditions including those in protected conditions suitable for the establishment and spread of the pest and where relevant, host species (or near relatives), alternate hosts and vectors should be present in the PRA area.

S2 For LMOs, the following should also be considered: Changes in adaptive characteristics resulting from the genetic modification that may increase the potential for establishment and spread Gene transfer or gene flow that may result in the establishment and spread of pests, or the emergence of new pests Pest risk analysis for quarantine pests including ISPM 11 analysis of environmental risks and living modified organisms ISPM 11-12.

Genotypic and phenotypic instability that could result in the establishment and spread of organisms with new pest characteristics, e.g. loss of sterility genes designed to prevent outcrossing.

S2 For more detailed guidance on the assessment of these characteristics, see Annex 3.

II.7.1.5. Potential for economic consequences in PRA area There should be clear indications that the pest is likely to have an unacceptable economic impact (including environmental impact) in the PRA area.

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S1 Unacceptable economic impact is described in ISPM 5 Supplement 2 (Guidelines on the understanding of potential economic importance and related terms including reference to environmental considerations).

S2 In the case of LMOs, the economic impact (including environmental impact) should relate to the pest nature (injurious to plants and plant products) of the LMO.

II.7.2. Conclusion of pest categorization If it has been determined that the pest has the potential to be a quarantine pest, the PRA process should continue. If a pest does not fulfil all of the criteria for a quarantine pest, the PRA process for that pest may stop. In the absence of sufficient information, the uncertainties should be identified and the PRA process should continue.

II.8. Assessment of the probability of introduction and spread Pest introduction is comprised of both entry and establishment. Assessing the probability of introduction requires an analysis of each of the pathways with which a pest may be associated from its origin to its establishment in the PRA area. In a PRA initiated by a specific pathway (usually an imported commodity), the probability of pest entry is evaluated for the pathway in question. The probabilities for pest entry associated with other pathways need to be investigated as well.

For risk analyses that have been initiated for a specific pest, with no particular commodity or pathway under consideration, the potential of all probable pathways should be considered.

The assessment of probability of spread is based primarily on biological considerations similar to those for entry and establishment.

S1 With respect to a plant being assessed as a pest with indirect effects, wherever a reference is made to a host or a host range, this should be understood to refer instead to a suitable habitat1(that is a place where the plant can grow) in the PRA area.

1 In the case of organisms that affect plants indirectly, through effects on other organisms, the terms host/habitat will extend also to those other organisms.

S1 The intended habitat is the place where the plants are intended to grow and the unintended habitat is the place where the plants are not intended to grow.

S1 In the case of plants to be imported, the concepts of entry, establishment and spread have to be considered differently.

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S1 Plants for planting that are imported will enter and then be maintained in an intended habitat, probably in substantial numbers and for an indeterminate period.

Accordingly, section 2.2.1 on entry does not apply. The risk arises because of the probability that the plant may spread from the intended habitat to unintended habitats within the PRA area, and then establish in those habitats. Accordingly, section 2.2.3 may be considered before section 2.2.2. Unintended habitats may occur in the vicinity of the intended habitat in the PRA area. Pest risk analysis for quarantine pests including analysis of environmental risks and living modified organisms ISPM 11 ISPM 11-13 S1 Imported plants not intended to be planted may be used for different purposes (e.g. used as bird seed, as fodder, or for processing). The risk arises because of the probability that the plant may escape or be diverted from the intended use to an unintended habitat and establish there.

S2 Assessing the probability of introduction of an LMO requires an analysis of both intentional and unintentional pathways of introduction, and intended use.

II.8.1. Probability of entry of a pest

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The probability of entry of a pest depends on the pathways from the exporting country to the destination, and the frequency and quantity of pests associated with them.

The higher the number of pathways, the greater the probability of the pest entering the PRA area.

Documented pathways for the pest to enter new areas should be noted. Potential pathways, which may not currently exist, should be assessed. Pest interception data may provide evidence of the ability of a pest to be associated with a pathway and to survive in transport or storage.

TIP TRAINING OPTIONS IPPC has developed a website for a better understanding and training on PRA, including E Learning for some Latin America countries in particular. For further information, please visit the following link: http://elearning.phytosanitary.info/course/category.php?id=2 IPPC created Phytosanitary.info where you can find and contribute phytosanitary technical resources from and to the world’s plant protection community.

The IPPC Secretariat encourages contributions in any language from anyone in the world working in the field of plant protection including IPPC Contracting Parties, Regional Plant Protection Organisations and other relevant organisations.

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Phytosanitary technical resources produced under the auspices of the IPPC Secretariat is identified with an IPPC symbol: USDA- APHIS Plant Health experts have been the primary source for the authoring of several distance learning modules in collaboration with Texas A&M University (TAMU). Currently there are three SPS plant health modules that have been completed specifically for the training of Plant Health workers in Pakistan.

A specialized group at Texas A&M University is responsible for the production of the modules including the technology platform, editing of material, video clips, photos, and other interactive elements.

USDA/APHIS subject matter experts are the ones developing the content only.

The modules that have been created thus far can be adapted to make them more generic – that is taking out the references to Pakistan in the banners and removing the Urdu language overlay. These are written in English.

The first three modules are: 1. The WTO and the SPS agreement, live link: http://vetmed.tamu. edu/files/etc/SPS/mod1/index.html 2. International Standard Setting for Plant Health, the IPPC., live link: http://vetmed.tamu.edu/files/etc/SPS/mod2/index.html 3. Market access process: http://vetmed.tamu.edu/files/etc/SPS/mod3/index.html The links next to each of these modules are live and you can take a look at what has been produced thus far. Three more modules are currently in production: 4. Pest Risk Assessment (PRA), 5. Risk Management, 6. Risk Communication.

RECALL IPPC has developed Regional Plant Protection Organizations (RPPO) which are an inter-governmental organization functioning as a coordinating body for National Plant Protection Organizations (NPPO) on a regional level. Not all contracting parties to the IPPC are members of RPPOs, nor are all members of RPPOs contracting parties to the IPPC. Moreover, certain contracting parties to the IPPC belong to more than one RPPO. There are currently 10 RPPOs. From Latin America and Caribe four RPOs are quite active:

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Asia and Pacific Plant Protection Commission (APPPC) Comunidad Andina (CA) Comite de Sanidad Vegetal del Cono Sur (COSAVE) Caribbean Plant Protection Commission (CPPC) European and Mediterranean Plant Protection Organization (EPPO) Inter-African Phytosanitary Council (IAPSC) Near East Plant Protection Organization (NEPPO) North American Plant Protection Organization (NAPPO) (including Mexico) Organismo Internacional Regional de Sanidad Agropecuaria (OIRSA) Pacific Plant Protection Organization (PPPO) For more information, you may visit https://www.ippc.int/partners/ regional-plant-protection-organizations.

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SUMMARY OF UNIT II OBJECTIVE OF PLANT HEALTH RISK ASSESSMENT In the case of plant protection, the risk analysis proceduresimplemented by the National Plant Protection Organisations (NPPOs)are based on the International Standards for PhytosanitaryMeasures (ISPM) that were developed by the Secretariat of theInternational Plant Protection Convention (IPPC) as part of FAO’sglobal programme of policy and technical assistance in plantquarantine. This programme offers standards, guidelines andrecommendations to FAO members and other interested partieswith the goal of harmonising phytosanitary measures atinternational level, facilitating trade and avoiding the application ofunjustified measures that are obstacles to trade. Specifically ISPM11/2004 “Pest risk analysis for quarantine pests, including analysisof environmental risks and living modified organisms” providesdetails to conduct a pest risk analysis (PRA), determine if a pest is aquarantine pest and describes integrated processes for riskassessment and selection of risk management options.

The objectives of a PRA are, for a specified area, to identify pestsand/ or pathways of quarantine concern and evaluate their risk, toidentify endangered areas, and, if appropriate, to identify riskmanagement options.

Stage 1 (initiating the process) involves identifying the pest(s) and pathways that are of quarantine concern and should be considered for risk analysis in relation to the identified PRA area.

Stage 2 (risk assessment) begins with the categorization of individual pests to determine whether the criteria for a quarantine pest are satisfied. Risk assessment continues with an evaluation of the probability of pest entry, establishment, and spread, and of their potential economic consequences (including environmental consequences – S1).

Stage 3 (risk management) involves identifying management options for reducing the risks identified at Stage 2. These are evaluated for efficacy, feasibility and impact in order to select those that are appropriate.

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UNIT III

ANIMAL HEALTH RISK ASSESSMENT MODELS

Learning Objectives Understanding the main concepts on Animal Health Risk Assessment.

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III.1. Introduction The Agreement on the Application of Sanitary and Phytosanitary Measures of the World Trade Organisation establishes that the measures applied to protect animal, plant or public health within the framework of international trade shall be based on scientific principles and shall not be maintained if there is insufficient scientific evidence.

Risk analysis has become a cornerstone for establishing these measures as it offers a framework to effectively assess, manage and communicate risk, in collaboration with the different stakeholders, and increase the capacity of animal health regulatory authorities to develop science-based disease control and eradication programmes.

Animal health regulatory authorities are increasingly interested in applying risk assessment techniques for the international trade of animals and products of animal origin. In this area, risk assessments estimate the probability of occurrence of an adverse effect and its magnitude if it were to occur.

It is important to remember that whenever risk assessments associated with the importation of animals or products of animal origin between countries or regions are performed, imports cannot occur in the absence of some risk (“zero risk�).

A controversial aspect in this area is related to the costs and benefits associated with the importation of animals and genetic material. The beneficiaries of these imports

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are usually a small group of persons, businessmen, first importers and distributors of new genetic material. However, the risks are taken by a much larger group including the keepers of these animals that may be infected with an exotic agent and the general population that is exposed and who will have to assume the cost of controlling or eradicating an outbreak of the exotic agent that was introduced.

In this context, quarantine services must decide whether to allow the importation based on uncertain or incomplete data. Additionally, the application of sanitary measures that affect the international trade of animals or products of animal origin may cause significant economic losses and trade conflicts. Countries are obliged to provide a technical justification for the sanitary measures they adopt in order to avoid them being considered unjustified trade barriers.

Finally, regionalisation, understood as the identification of an area with unique characteristics, for the probable presence or spreading of an etiological agent or its vectors regardless of national borders, is another reason to apply this methodology. The process for assessing similar intra-regional characteristics requires the use of the risk assessment methodology. These three reasons justify the adoption of risk assessment as a methodology that attempts to quantify the risk based on sound scientific evidence.

The risk assessment scheme selected by a country or region should be flexible and adapt to the complexity of the real situation. There is no one method that is appropriate for all cases. Risk assessments should be capable of taking into account the differences in animals and products of animal origin, the multiplicity of hazards that may be identified in imported animals or products and the specificity of each disease, detection and surveillance system, exposure conditions and quality and quantity of available data and information. Therefore the administrative structure that performs the risk assessment must be flexible and capable of adapting to the changes in existing and emerging risks.

Both qualitative and quantitative risk assessments have merits, advantages and disadvantages.

Enforcement authorities should establish a functional separation between risk assessors and risk managers to avoid biased risk assessments.

As risk assessments are based on existing information, they may be some problems: Biased data.

Incomplete or missing data.

No uniformity in the performance of the assessment.

Variability in the results of the analyses.

Irrelevant data for the use which will be given to the imported product or animals assessed.

The analyses shall be assessed and classified; consultation with experts in different fields may be necessary to determine the information that should be included in the model. The opinion of experts may also be necessary when:

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Data is missing or requires interpretation.

The validation of the conceptual model (theoretical model describing the main elements that should be included in the assessment) developed by the risk assessors must be evaluated.

The adjustment of the mathematical model to the conceptual model must be evaluated.

The results of the risk assessment must be interpreted.

Risk assessments should be based on the best available information and duly documented and supported with references to scientific literature, expert opinions and other recognised valid sources. The results of the risk assessment should be reviewed and updated as new information becomes available. This requires optimising access to information, especially in developing countries where scientific data may be sufficient but disperse and statistical or epidemiological information is partial. For this reason, generating mechanisms to articulate the work with universities and research centres is of vital importance.

In the area of animal health, risk assessments may be used to assess the probability of introduction or establishment of an etiological agent or its vector and disease spread, and to estimate their possible economic impact and consequences for public health.

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Consistency and transparency of risk assessment methods are essential to guarantee impartiality and rationality in the assessment, consistency of decisions, and understanding by all stakeholders.

Import risk assessments for animals or products of animal origin include the following stages: a. Scope of application b. Definition of the type of risk assessment required c. Assessment of the risks Hazard identification Risk assessment Sensitivity analysis Scenario analysis Validation of the model d. Risk management (decision regarding the import) e. Risk communication

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Figure 3.1. Import procedure for animals or products of animal origin including a risk assessment In response to an application for import (usually), the first step is determining whether a risk assessment is necessary. At this stage, risk managers must clearly formulate the questions to which they need answers, determine what alternative risk assessment methods exist to answer them, whether there is data to perform a risk assessment and identify the uncertainties that exist.

Figure 3.2. Risk Analysis

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LAYER NUMBER 2 (TO BE DEVELOP WITH IT TEAM) Risk Assessment Decision Tree In general, animal health risk assessments may be required in response to one of the following situations: Importation of an animal species or product of animal origin regarding which there is no prior experience.

Importation from a country or region with which there has been no prior trade.

Importation of products from a region or country whose sanitary status has changed.

Development of new information that modifies prior analyses and the perception of the disease.

When a country or region must demonstrate that a certain product intended for export does not represent a significant risk to the importing country. A country or region may carry out a risk assessment to estimate the risk posed by their products intended for export or to assess the risk posed by an etiological agent or its vector in the case of imports of animals or products of animal origin.

When a regionalisation process is initiated.

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When a country or region wishes to demonstrate its sanitary status.

Other cases may be resolved applying existing national or international standards and guidelines without performing specific risk assessments.

Types of Risk Assessments In general, there are two types of risk assessments even for animal health: qualitative and quantitative. Both are useful and provide relevant decision-making information.

The type of risk assessment is selected based on the quantity and quality of available information.

Qualitative risk assessments do not require quantifying the defined parameters and apply descriptive scales for each variable included in the model. Qualitative risk assessments are used to perform (Figure 3.2): Preliminary assessments as a result of which the need to conduct more comprehensive and in-depth analyses is determined.

Preliminary determination of potential risks posed by an animal species and then perform a more in-depth risk assessment (usually quantitative).

When the assessed hazard is known, has been well analysed and the perceived risk does not merit the investment in time and effort required to perform an indepth analysis.

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When there is insufficient information to quantify the input variables with an acceptable level of uncertainty.

Quantitative risk assessments use numeric values to express the estimated probability of occurrence of the events analysed. Input variables are quantified (expressed in terms of probability distributions) based on the available information wherefore their quality has a direct impact on the quality of the analysis performed.

In general, quantitative assessments are hazard-matrix specific, i.e., an independent risk assessment is required for each hazard present in an animal species.

This type of assessment offers a more solid base for decision-making, estimates the impact of each component included in the model and weighs the uncertainties associated with the process.

Steps of a Risk Assessment for Imports of Live Animals A risk assessment associated with the movement of animals or products of animal origin between regions or countries begins with a detailed description of the goods intended for import and an indication of the probable annual volume of the proposed trade. Although a precise estimate of the expected volume of trade is an important piece of information that should be included in the risk assessment, it may not be readily available particularly when the trade has recently begun.

The conceptual model to analyse the main elements and factors that should be included in the risk model should be developed first. Then, additional, general assumptions of the model should be defined (necessary to keep the model simple) and the missing data identified. A conceptual model usually consists of a chain that represents the process that will be modelled; it begins with the source of the hazard and ends with the potential consequences of its introduction.

In general terms, risk assessments for importation of animals or products of animal origin include different stages: a. Identification of the hazards associated with a certain importation. b. An estimate of the probability of the etiological agent of a certain disease, or a vector in the animal or products of animal origin, being present in the imported animals or products. c. Assessment of the probability of the agent or its vector surviving the travel and trading process. d. Assessment of the impact of import protocols and risk mitigation measures on the ability of the etiological agent or its vector to survive and be introduced. e. Assessment of the level of risk associated with the importation and comparison with the acceptable level based on the expected benefits of the importation.

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Hazard Identification At this stage, all agents that may be potential hazards are identified. The risk assessment shall determine if there is no hazard associated with the importation.

Hazards are identified according to the following criteria: A list of all the agents (viruses, parasites, bacteria, prions, etc.) that are exotic to the importing country and that may be associated with the animals and products or by-products of animal origin is developed, including strains, serovarieties, serotypes, species or subspecies.

Hazards that represent a risk for diseases included in control or eradication programmes in the country of importation should be included.

An agent shall only be a hazard if it is capable of infecting an animal or animal product intended for importation or surviving normal treatments until arrival in the country of destination and transport.

The list of hazards should include the vectors that may spread the disease if it is not present in the country of destination.

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After the associated hazards are identified, they should be prioritised based on their importance to animal health. Presence or absence of the agent in the country of origin should be determined. If the disease is present in the exporting country or region, the following precisions are necessary: whether it is a notifiable disease and if there is a control or eradication programme for the disease and its status. For practical purposes, all diseases that are exotic to the region or country, notifiable diseases and, in general, those included in OIE List A and B should be considered.

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SUMMARY OF UNIT III OBJECTIVE OF ANIMAL HEALTH RISK ASSESSMENT In general, animal health risk assessments may be required in response to one of the following situations: Importation of an animal species or product of animal origin regarding which there is no prior experience.

Importation from a country or region with which there has been no prior trade.

Importation of products from a region or country whose sanitary status has changed.

Development of new information that modifies prior analyses and the perception of the disease.

When a country or region must demonstrate that a certain product intended for export does not represent a significant risk to the importing country. A country or region may carry out a risk assessment to estimate the risk posed by their products intended for export or to assess the risk posed by an etiological agent or its vector in the case of imports of animals or products of animal origin.

When a regionalisation process is initiated; When a country or region wishes to demonstrate its sanitary status.

STAGES OF RISK ASSESSMENT Import risk assessments for animals or products of animal origin include the following stages: a. Scope of application b. Definition of the type of risk assessment required c. Assessment of the risks Hazard identification Risk assessment Sensitivity analysis Scenario analysis Validation of the model d. Risk management (decision regarding the import) e. Risk communication

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UNIT IV

FOOD SAFETY RISK ASSESSMENT MODELS

Learning Objectives Understanding main concepts on food safety risk assessment Providing guidance to national governments for risk assessment, risk management and risk communication with regard to food related risks to human health

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I.1. Introduction Food safety as a means to protect public health and promote economic development continues being a major challenge in both developing and developed countries. Foodborne diseases (FBDs) caused by microbial pathogens, biotoxins and chemical contaminants represent serious threats to the health of millions of people. Severe outbreaks of FBDs in the past decades have been documented on all continents which demonstrates their importance from both the social and public health viewpoints.

FBDs have significant effects on the health and wellbeing of persons and economic consequences for individuals, families, communities, companies and countries. They are also a considerable burden for health care systems and reduce economic productivity.

Integration and concentration of the food sector and globalisation of food trade are changing both production and distribution patterns. Products intended for use as food and feed now reach much more distant destinations which favours the spread of FBDs. Food safety regulatory authorities are increasingly interested in applying risk assessment techniques for the international trade of foodstuffs as recommended in WTO,

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Codex Alimentarius and OIE guidelines. Some of the advantages of performing food risk analyses include: Estimating the risks to human health derived from the consumption of foodstuffs.

Facilitating the identification and application of adequate measures to control the risks and communicate the risks and measures adopted to the stakeholders.

Supporting and improving the development of standards and addressing food safety concerns resulting from the new hazards or imbalances in food control systems.

Collecting information and evidence on the level of risk posed by a certain contaminant in the food chain to help governments decide what response measures should be applied.

Providing a framework to estimate the impact of possible risk management measures and optimising public resources by concentrating efforts on the hazards that pose higher risk.

Assisting governments with meeting their obligations within the framework of the SPS Agreement and strengthening the scientific base for the international trade of their products or accessing new markets.

Identifying uncertainties in scientific knowledge regarding the risks which helps to establish research priorities and achieve a better understanding of the impact of the product on public health.

Improving the process to identify emerging risks and assess different management measures to prevent the introduction and spread of the hazards.

CODEX has developed several standards on risk assessment on food safety. They produce a document on Working Principles for Risk Analysis for Food Safety for Application by Governments This document intents to provide guidance to national governments for risk assessment, risk management and risk communication with regard to food related risks to human health. This first edition includes the text as adopted by the Codex Alimentarius Commission in 2007.

IV.2. Risk Assessment IV.2.1. Identifying and Describing the Food Safety Problem that will be Reviewed Risk managers should first identify the nature and characteristics of the food safety issues.

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Authorities may learn about food safety issues that require actions in different ways: National and international (point of entry) inspections, food traceability systems, environmental follow-up and laboratory, epidemiological, clinical and toxicological testing.

Surveillance of diseases in humans, investigation of FBD outbreaks, technological assessment of new foodstuffs and difficulties in complying with regulatory norms.

Academic and scientific experts, the food industry, consumers, special interest groups and the media.

Some food safety issues that are not related to concerns about FBDs are expressed as legal actions or problems in international trade.

The decision to carry out a risk assessment is based on the priority of the public health problem, regulatory needs and availability of data. In general, risk assessments are not carried out when: The risk is well described and their is conclusive data.

The public health concern is relative simple.

The public health concern does not require regulatory activities.

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An urgent regulatory response is required.

Figure 4.1. Risk Assessment

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LAYER NUMBER TWO (TO BE DEVELOP WITH IT TEAM)

IV.2.2. Risk Assessment Decision Tree However, a risk assessment should be carried out when: The agri-food chain in which the hazard is exposed is complex.

There is no data on the hazard and its impacts on public health or the data is incomplete.

The concern for regulatory systems and public health is significant.

Science-based information is needed to support an urgent risk management regulatory measure (precautionary measure) that was adopted.

The decision about whether a risk assessment is necessary is an iterative decision of risk managers and those responsible for carrying out the risk assessment.

Before beginning a risk assessment, the following questions should be answered: how can the risk assessment be addressed? What questions should be tried to be answered? What methods could provide useful results? In what cases would gaps or uncertainties not lead to clear answers?

Two examples of questions that would influence the selected risk assessment methodology to find the answers and that risk managers may ask the risk assessors are: a) Risk assessment for verotoxigenic E. coli (VTEC) (consumption of hamburgers): Quantification of the probability of a hamburger being contaminated with VTEC. Quantification of the probability of a person (differentiating between child and adult) becoming infected with VTEC as a result of consuming part of a hamburger.

Quantification of the probability of a person (child and adult) acquiring Haemolytic-uremic Syndrome (HUS) after becoming infected with VTEC. Quantification of the probability of a person (child or adult) dying as a consequence of HUS after becoming infected with VTEC as a result of consuming a hamburger.

Identification of the stage(s) that have a greater impact on the probability of acquiring HUS as a result of consuming hamburgers.

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Identification of the uncertainties and areas in which more research is necessary. b) Risk assessment for Aflatoxin M1 (AFM1) (consumption of fluid milk): Quantification of the probability of fluid milk being contaminated with AFM1.

Quantification of the probability of fluid milk containing AFM1 in quantities exceeding the maximum permitted levels.

Identification of the stage(s) that have a greater impact on the probability of consuming milk containing levels of AFM1 above the maximum permitted limits.

Identification of uncertainties and areas in which more research is necessary.

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If risk managers decide to proceed and request a risk assessment to support their management objective they should address these issues. Identifying the main “gaps� in the data from the start facilitates finding the essential information, inasmuch as possible, before and during the risk assessment. These activities usually require cooperation from scientific and research bodies and the affected sector wherefore competent authorities should make an effort to find mechanisms that enable articulation between these sectors.

IV.2.3. Performance of a Risk Assessment After deciding that a risk assessment is necessary, risk managers should adopt all necessary measures to carry it out. The content and method used to conduct the assessment may differ depending on the nature of the risk, the institutional context and the available resources, among other factors.

The risk assessment should be performed by a team of experts that shall be functionally separate from the risk managers. Functionally separate means independent whilst working within the context of risk assessment or management and while the activities are being carried out (even if they are performed by the same individuals).

Risk managers should not be tempted to guide a risk assessment in order to support a management decision. Those responsible for carrying out the assessment should collect and objectively assess all available scientific information without being influenced by risk management issues (for example, economic benefits for a sector, cost of reducing the exposure or the opinion of consumers about the risks).

If there is time and plentiful resources, an independent multidisciplinary scientific team should be established (food technology specialists, epidemiologists, physicians,

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veterinarians, microbiologists, biostatisticians, etc.) to carry out the risk assessment.

In other cases, experts of competent authorities or external suppliers of scientific services, such as academic institutions, may be summoned. Obtaining information on possible conflicts of financial or personal interest which could condition the scientific opinion of the persons involved is of critical importance.

IV.2.4. Generalities The risk assessment scheme selected by a country or region should be flexible to adapt to the complexity of the real situations. There is no one method that is appropriate for all cases. Risk assessments should be capable of taking into account the differences in animals and products of animal origin, the multiplicity of hazards that may be identified in imported animals or products and the specificity of each disease, detection and surveillance system, exposure conditions and quality and quantity of available data and information.

Consistency and transparency of the risk assessment method are essential to guarantee the impartiality and rationality of the assessment, the consistency of the decisions and the ease of understanding by all stakeholders.

IV.2.5. Types of Risk Assessments Risk assessments shall be different depending on the mathematical model used (qualitative or quantitative) and the type of hazard that will be assessed (chemical or biological).

Regardless of the mathematical model used, both qualitative and quantitative risk assessments are useful and provide relevant information for decision-making. Selection of one over the other is based on the quantity and quality of available information.

Qualitative risk assessments do not require quantifying the parameters included in the model and use descriptive scales for each variable (for example, high, medium or low). Qualitative risk assessments are used in the following cases: To perform a preliminary assessment and then determine the need for a more comprehensive and detailed analyses.

To carry out a preliminary prioritisation of the hazards that are potentially present in a food product before a more in-depth risk assessment (usually quantitative) is performed.

When the assessed hazard is known, has been well analysed and the perceived risk does not justify the investment in time and effort required by an in-depth analysis.

When there is insufficient information to quantify the input variables with an acceptable level of uncertainty.

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Quantitative risk assessments are based on mathematical models that estimate risk as a function of numerous input variables. The probability distributions represent the different points along the agri-food chain and estimate the risk of the end consumer being affected. Input variables (expressed in terms of probability distributions) are quantified based on the available information wherefore their quality has a direct impact on the quality of the analysis that is performed.

In general, quantitative assessments are hazard-matrix specific, i.e., an independent risk assessment is required for each hazard present in a food product.

This type of assessment offers a more solid base for decision-making, estimates the impact of each component included in the model and weighs the uncertainties associated with the process. There are two other types of quantitative risk assessments: a) specific or deterministic and b) stochastic or probabilistic.

Specific or deterministic risk assessments ignore both variability and uncertainty because they use only one point to represent a stage in the model (for example, mean value, 95% percentile or worst scenario). Deterministic assessments result in a substantial loss of information because each parameter is assigned a specific value. On the other hand, in stochastic assessments, the specific values are replaced by a probability distribution that specifies a range of possible values and indicates differential frequencies of occurrence for each distribution value.

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Deterministic assessments are usually carried out for chemical hazards, when there is risk of presence of chemical residues in food when consumed or if the residue value exceeds the limits established in national, regional or international legislation.

The probability distributions assigned to the variables in a stochastic risk assessment model are based on empirical data, prior knowledge about the biological phenomenon and, if there is no evidence, the opinion of experts.

There are some methodological differences between risk assessments for chemical hazards and those for biological hazards.

In the case of chemical hazards, the goal is to determine the amount of chemical substance (e.g., food additive, residue of drugs used in veterinary medicine, pesticides, etc.) that will enter the agri-food chain. The use of these substances may be regulated or prohibited if their residues at the end consumption point pose a risk to public health. Contrarily, biological hazards appear at different points in the agri-food chain and may grow, die or survive along the chain up to the point of consumption at levels that do not pose a risk to the health of consumers. The assessment therefore seeks to determine the presence and transmission of the hazard in the different phases of a continuum, from production to consumption, by analysing the different links in the agri-food chain to estimate the risk. Microbiological hazards mainly occur in a single exposure and usually cause acute problems whereas chemical hazards have cumulative effects and therefore cause chronic problems.

Additionally, the variability in the response of the population to microbial pathogens is greater than to toxic hazards.

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Biological Hazards

Chemical Hazards

May enter at any point in the agri-food chain.

Usually enter with the raw material or ingredients and in certain stages of the chain.

Prevalence and concentration of the biological hazard changes significantly along the agri-food chain.

The level of the hazard in the food does not usually change downstream from the point of introduction.

Risks to public health are usually acute.

Risks to public health are usually chronic.

Affected individuals respond differently depending on the quantity of hazard consumed.

All affected individuals show very similar toxic effects although individual sensitivity may be different.

Secondary transmission (person-to-person) may be significant.

Not relevant for person-to-person transmission.

Figure 4.2. Methodological differences between risk analysis for chemical and biological hazards

IV.2.6. Basic Components of a Risk Assessment A risk assessment is a science-based investigation that has four stages: a) hazard identification; b) exposure assessment; c) hazard characterisation; and d) risk characterisation.

This conceptual framework was adopted by the Codex Alimentarius Commission.

After the hazards are identified, these activities are performed though not necessarily in the same order; it is an iterative process because the scenarios are repeated as the data and assumptions are perfected. A risk assessment estimates the risk (and its magnitude) of an adverse effect on public health as a result of exposure to a hazard during a specific period of time, based on available scientific information in addition to, if necessary, assumptions that shall be consistent with existing scientific bases.

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Figure 4.3. Components of risk analysis

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IV.2.7. Hazard Identification Hazard identification is the first stage of a formal risk assessment. It is mostly a qualitative activity that includes a preliminary review of the information on a hazard that will be analysed in greater detail in the following stages of the assessment. The most important outcome of this stage is the determination of whether there is sufficient evidence to consider that the substance (for example, a chemical product) or a microorganism is a hazard and may cause an adverse effect on the health of the population.

Epidemiological investigations (mainly outbreak analyses) are usually the first indicator of the presence of a hazard in a food product and may provide the general context for a risk assessment. On the other hand, epidemiological surveillance systems may identify high risk products or processes. Later, experimental or observational clinical studies provide evidence on the association between the hazard and the effect on health.

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41 Figure 4.4. Generic Description of the Components of a Risk Assessment

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SUMMARY OF UNIT IV Food-borne risks (Food Safety Risk Assessment) is the evaluation of the potential for adverse effects on human or animal health arising from the presence of additives, contaminants, toxins or disease-causing organisms in food, beverages or feedstuffs.

Food safety regulatory authorities are increasingly interested in applying risk assessment techniques for the international trade of foodstuffs as recommended in WTO, Codex Alimentarius and OIE guidelines.

Some of the advantages of performing food risk analyses include: Estimating the risks to human health derived from the consumption of foodstuffs.

Facilitating the identification and application of adequate measures to control the risks and communicate the risks and measures adopted to the stakeholders.

Supporting and improving the development of standards and addressing food safety concerns resulting from the new hazards or imbalances in food control systems.

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Collecting information and evidence on the level of risk posed by a certain contaminant in the food chain to help governments decide what response measures should be applied.

Providing a framework to estimate the impact of possible risk management measures and optimising public resources by concentrating efforts on the hazards that pose higher risk.

Assisting governments with meeting their obligations within the framework of the SPS Agreement and strengthening the scientific base for the international trade of their products or accessing new markets.

Identifying uncertainties in scientific knowledge regarding the risks which helps to establish research priorities and achieve a better understanding of the impact of the product on public health.

Improving the process to identify emerging risks and assess different management measures to prevent the introduction and spread of the hazards.

CODEX has developed several standards on risk assessment on food safety. They produce a document on Working Principles for Risk Analysis for Food Safety for Application by Governments.

This document intents to provide guidance to national governments for risk assessment, risk management and risk communication with regard to food related risks to human health. This first edition includes the text as adopted by the Codex Alimentarius Commission in 2007.

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FAO. (2004). Garantía de la inocuidad y calidad de los alimentos. Directrices para el fortalecimiento de los sistemas nacionales de control de los alimentos. Estudio FAO Alimentación y Nutrición. Ed. FAO, Roma (Italia) pp. 93.

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Keene W.E. (2006). Lessons from investigation of foodborne disease outbreaks.

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Signorini M. & Tarabla H. (2009). Quantitative risk assessment for Verocytotoxigenic Escherichia coli in ground beef hamburgers in Argentina. International Journal. Food Microbiology., 132:153-161.

Signorini M., Marín V.; Quinteros C. & Tarabla H. (2009). “Hábitos de consumo de hamburguesas y riesgo de exposición a Escherichia coli VTEC”. Revista Argentina de Microbiología, 41(3): 168-176.

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Signorini M.L. & Frizzo L.S. (2009). Modelo de contaminación cruzada por Escherichia coli verotoxigénica en hamburguesas caseras utilizando la evaluación cuantitativa de riesgos. Revista Argentina de Microbiología, aceptado para publicación.

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