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CODEX ALIMENTARIUS COMMISSION

TABLE OF CONTENTS JOINT FAO/WHO FOOD STANDARDS PROGRAMME

PROCEDURAL MANUAL

INTRODUCTION ..................................................................................................................................................................... 1 SECTION I: BASIC TEXTS AND DEFINITIONS .................................................................................................... 3 Statutes of the Codex Alimentarius Commission .......................................................................................................... 4 Rules of Procedure of the Codex Alimentarius Commission .................................................................................... 7 General Principles of the Codex Alimentarius ............................................................................................................... 21 Definitions for the Purposes of the Codex Alimentarius .......................................................................................... 23

Joint FAO/WHO Food Standards Programme

CODEX ALIMENTARIUS COMMISSION

The designations employed and the presentation of material in this publication do not imply the expression of any opinion whatsoever on the part of the Food and Agriculture Organization of the United Nations (FAO) or of the World Health Organization (WHO) concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or products of manufacturers, whether or not these have been patented, does not imply that these are or have been endorsed or recommended by FAO or WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.

All reasonable precautions have been taken by FAO and WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall FAO and WHO be liable for damages arising from its use.

SECTION II: ELABORATION OF CODEX STANDARDS AND RELATED TEXTS ............................. 27

The views expressed herein are those of the authors and do not necessarily represent those of FAO or WHO.

Procedures for Consideration of the Entry and Review of Food Additive Provisions In the General Standard for Food Additives ................................................................................................................. 62

ISBN 978-92-5-130341-2

Guidelines on the Elaboration and/or Revision of Codes of Hygienic Practice for Specific Commodities ...................................................................................................................................................... 71

© WHO and FAO, 2018 All rights reserved. WHO and FAO encourage 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, provided that appropriate acknowledgement of WHO and FAO as the source and copyright holder is given and that WHO and FAO’s endorsement of users’ views, products or services is not implied in any way.

PROCEDURAL MANUAL

Publications of the World Health Organization are available on the WHO web site (www.who. int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: bookorders@who. int). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press through the WHO web site: http://www.who.int/about/licensing/copyright_form/en/index.html.

Procedures for the Elaboration of Codex Standards and Related Texts ............................................................ 29 Criteria for the Establishment of Subsidiary Bodies of the Codex Alimentarius Commission ................. 42 Criteria for the Establishment of Work Priorities ....................................................................................................... 44 Guideline on the Application of the Criteria for the Establishment of Work Priorities ............................... 46 Relations Between Commodity Committees and General Subject Committees ........................................... 49 Format for Codex Commodity Standards ..................................................................................................................... 56 Guidelines for the Inclusion of Specific Provisions in Codex Standards and Related Texts ....................... 62

Procedure for the Inclusion of Additional Species in Codex Standards for Fish and Fishery Products ...... 72 Principles for the Establishment of Codex Methods of Analysis ........................................................................... 77 Principles for the Establishment or Selection of Codex Sampling Procedures ................................................ 92 The Use of Analytical Results: Sampling Plans, Relationship Between the Analytical Results, the Measurement Uncertainty,Recovery Factors and Provisions in Codex Standards ................................ 95 Provisions on the Use of Proprietary Methods in Codex standards ..................................................................... 97

SECTION III: GUIDELINES FOR SUBSIDIARY BODIES

............................................................................. 99

All requests for translation and adaptation rights, and for resale and other commercial use rights should be made via www.fao.org/contact-us/licence-request or addressed to copyright@fao.org.

Guidelines to Host Governments of Codex Committees and Ad Hoc Intergovernmental Task Forces .............................................................................................................. 100

FAO information products are available on the FAO website (www.fao.org/publications) and can be purchased through publications-sales@fao.org

Guidelines on the Conduct of Meetings of Codex Committees and Ad Hoc Intergovernmental Task Forces ................................................................................................................. 107 Guidelines to Chairpersons of Codex Committees and Ad Hoc Intergovernmental Task Forces ............. 110 Guidelines on Physical Working Groups .......................................................................................................................... 115 Guidelines on Electronic Working Groups .................................................................................................................... 119

SECTION IV: RISK ANALYSIS ......................................................................................................................................

123

Working Principles for Risk Analysis for Application In the Framework of the Codex Alimentarius .... 124 Definitions of Risk Analysis Terms Related to Food Safety ................................................................................... 131 Risk Analysis Principles Applied by the Codex Committee on Food Additives ............................................ 134

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STATUTES OF THE CODEX ALIMENTARIUS COMMISSION PROCEDURAL MANUAL – SECTION I

BASIC TEXTS AND DEFINITIONS

1.

The Codex Alimentarius Commission shall, subject to Article 5 below, be responsible for making proposals to, and shall be consulted by, the Directors-General of the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) on all matters pertaining to the implementation of the Joint FAO/WHO Food Standards Programme, the purpose of which is:

Statutes of the Codex Alimentarius Commission (Adopted in 1961 by the 11th Session of the FAO Conference and in 1963 by the 16th Session of the World Health Assembly. Revised in 1966 and 2006) Rules of Procedure of the Codex Alimentarius Commission (Adopted in 1963 at the first session of the Commission.

Amended in 1964, 1965, 1966, 1968, 1969, 1970, 1999, 2003, 2005, 2006 and 2007)

2.

a.

protecting the health of the consumers and ensuring fair practices in the food trade;

b.

promoting coordination of all food standards work undertaken by international governmental and non governmental organizations;determining priorities and initiating and guiding the preparation of draft standards through and with the aid of appropriate organizations;

c.

finalizing standards elaborated under (c) above and publishing them in a Codex Alimentarius either as regional or worldwide standards,togetherwithinternationalstandardsalreadyfinalized by other bodies under (b) above, wherever this ispracticable;

d.

amending published standards, as appropriate, in the light of developments.

ARTICLE 2 Membership of the Commission is open to all Member Nations and Associate Members of FAO and WHO which are interested in international food standards. Membership shall comprise such of these nations as have notified the Director-General of FAO or of WHO of their desire to be considered as Members.

3.

4.

RULE I. MEMBERSHIP

1.

Membership of the Joint FAO/WHO Codex Alimentarius Commission hereinafter referred to as “the Commission”, is open to all Member Nations and Associate Members of FAO and/or WHO.

2.

Membership shall comprise such eligible nations as have notified the Director-General of FAO or of WHO of their desire to be considered Members of the Commission.

3.

Membership shall also comprise regional economic integration organizations members of either FAO or WHO that notify the Director- General of FAO or WHO of their desire to be considered Members of the Commission.

4.

Each Member of the Commission shall communicate to the Director-General of FAO or of WHO the names of its representative and where possible other members of its delegation before the opening of each session of the Commission.

2.

RULE II. MEMBER ORGANIZATIONS

1.

A Member Organization shall exercise membership rights on an alternative basis with its Member States that are Members of the Commission in the areas of their respective competence.

2.

A Member Organization shall have the right to participate in matters within its competence in any meetings of the Commission or its subsidiary bodies in which any of its Member States is entitled to participate. This is without prejudice to the possibility for the Member States to develop or support the position of the Member Organization in areas within its competence.

3.

A Member Organization may exercise on matters within its competence, in any meetings of the Commission or any subsidiary body of the Commission in which it is entitled to participate in accordance with paragraph 2, a number of votes equal to the number of its Member States which are entitled to vote in such meetings and present at the time the vote is taken. Whenever a Member Organization exercises its right to vote, its Member States shall not exercise theirs, and conversely.

4.

A Member Organization shall not be eligible for election or designation, nor to hold office in the Commission or any subsidiary body. A Member Organization shall not participate in voting for any elective places in the Commission and its subsidiary bodies.

5.

Before any meeting of the Commission or a subsidiary body of th Commission in which a Member Organization is entitled to participate, the Member Organization or its Member States shall indicate in writing which, as between the Member Organization and its Member States, has competence in respect of any specific question to be considered in the meeting and which, as between the Member Organization and its Member States, shall exercise the right to vote in respect of each particular agenda item. Nothing in this paragraph shall prevent a Member Organization or its Member States from making a single declaration in the Commission and each subsidiary body in which a Member Organization is entitled to participate for the purposes of this paragraph, which declaration shall remain in force for questions and agenda items to be considered at all subsequent meetings, subject to such exceptions or modifications as may be indicated before any individual meeting.

6.

Any Member of the Commission may request a Member Organization or its Member States to provide information as to which, as between the Member Organization and its Member States, has competence in respect of any specific question. The Member Organization or the Member States concerned shall provide this information on such request.

ARTICLE 5 The Commission shall report and make recommendations to the Conference of FAO and the appropriate body of WHO through their respective Directors-General. Copies of reports, including any conclusions and recommendations, will be circulated to interested Member Nations and international organizations for their information as soon as they become available.

6.

1.

ARTICLE 4 Nations which, while not Member Nations or Associate Members of FAO or WHO, are members of the United Nations, may be invited on their request to attend meetings of the Commission as observers in accordance with the provisions of FAO and WHO relating to the grant of observer status to nations.

5.

RULES OF PROCEDURE OF THE CODEX ALIMENTARIUS COMMISSION

ARTICLE 3 Any Member Nation or Associate Member of FAO or WHO which is not a Member of the Commission but has a special interest in the work of the Commission, may, upon request communicated to the DirectorGeneral of FAO or WHO, as appropriate, attend sessions of the Commission and of its subsidiary bodies and ad hoc meetings as observers.

General Principles of the Codex Alimentarius (Adopted in 1965.

Amended in 1966, 1969, 1993, 1995 and 2007) Definitions

ARTICLE 1

ARTICLE 6 The Commission shall establish an Executive Committee whose composition should ensure an adequate representation of the various geographical areas of the world to which the Members of the Commission belong. Between sessions, the Executive Committee shall act as the Executive organ of the Commission.

CODEX ALIMENTARIUS COMMISSION

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ANTIMICROBIAL RESISTANCE

GUIDELINES FOR RISK ANALYSIS OF FOODBORNE ANTIMICROBIAL RESISTANCE The scope of these guidelines is to provide science-based guidance on processes and methodology for risk analysis and its application to foodborne AMR related to non-human use of antimicrobial agents.

The guidelines aim to assess the risk to human health associated with the presence in food and animal feed, including aquaculture, and the transmission through food and animal feed, of AMR microorganisms and determinants, to provide advice on appropriate risk management activities to reduce such risk.

The guidelines will further address the risk associated with different sectors of antimicrobial agent use such as veterinary applications, plant protection or food processing.

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These guidelines provide guidance for feed and feed ingredients risk assessment by governments in accordance with Codex principles for risk analysis. They address the potential risks to human health associated with the presence of hazards in the feed of food-producing animals and the subsequent transfer of hazards to edible products.

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PRINCIPLES FOR THE RISK ANALYSIS OF FOODS DERIVED FROM MODERN BIOTECHNOLOGY For many foods, the level of food safety generally accepted by the society reflects the history of their safe consumption by humans.

It is recognised that in many cases the knowledge required to manage the risks associated with foods has been acquired in the course of their long history of use.

Foods are generally considered safe, provided that care is taken during development, primary production, processing, storage, handling and preparation.

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GENERAL GUIDELINES ON CLAIMS These guidelines relate to claims made for a food irrespective of whether or not the food is covered by an individual Codex Standard.

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ADOPTED 2011 REVISED IN 2013, 2015, 2016 AND 2017.

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A N T I M I C RO B I A L RE S I STA N C E

GUIDELINES FOR RISK ANALYSIS OF FOODBORNE ANTIMICROBIAL RESISTANCE

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TABLE OF CONTENTS ANTIMICROBIAL RESISTANCE

GUIDELINES FOR RISK ANALYSIS OF FOODBORNE ANTIMICROBIAL RESISTANCE The scope of these guidelines is to provide science-based guidance on processes and methodology for risk analysis and its application to foodborne AMR related to non-human use of antimicrobial agents.

The guidelines aim to assess the risk to human health associated with the presence in food and animal feed, including aquaculture, and the transmission through food and animal feed, of AMR microorganisms and determinants, to provide advice on appropriate risk management activities to reduce such risk.

The guidelines will further address the risk associated with different sectors of antimicrobial agent use such as veterinary applications, plant protection or food processing.

GUIDELINES FOR RISK ANALYSIS OF FOODBORNE ANTIMICROBIAL RESISTANCE

1.

1.

INTRODUCTION .............................................................................................................................................................................................................................. 4

2.

SCOPE ............................................................................................................................................................................................................................................................ 5

3.

DEFINITIONS....................................................................................................................................................................................................................................... 5

4.

GENERAL PRINCIPLES FOR FOODBORNE AMR RISK ANALYSIS ............................................................................. 6

5.

FRAMEWORK FOR FOODBORNE AMR RISK ANALYSIS....................................................................................................... 7

6.

Identification of an AMR food safety issue Development of a foodborne AMR risk profile Ranking of the food safety issues and setting priorities for risk assessment and management Establishment of preliminary risk management goals Establishment of a risk assessment policy Commission a foodborne AMR risk assessment

7.

FOODBORNE AMR RISK ASSESSMENT ......................................................................................................................................................10

7.1.

7.2.

7.3.

7.4.

7.5.

7.6.

8.

More specifically, these guidelines provide a structured risk analysis framework to address the risks to human health associated with the presence in food and animal feed, including aquaculture, and the transmission through food and animal feed, of AMR microorganisms or determinants linked to non-human use of antimicrobial agents.

FOODBORNE AMR RISK MANAGEMENT................................................................................................................................................. 14

Consideration of the foodborne AMR risk assessment results Identification of foodborne AMR RMOs Evaluation of foodborne AMR RMOs Selection of foodborne AMR RMOs Implementation of foodborne AMR risk management decision(s) Monitoring and review of foodborne AMR risk management measures

9.

SURVEILLANCE OF USE OF ANTIMICROBIAL AGENTS AND AMR MICROORGANISMS AND DETERMINANTS........................................................................................................................................................................................................... 19

These guidelines present compone3nts of foodborne AMR risk analysis in a chronological order of the risk analysis process. For better readability, the “Foodborne AMR risk communication” and “Surveillance of use of antimicrobial agents and AMR microorganisms and determinants” sections are placed at the end of the document, recognizing that the activities identified within these sections are applicable throughout the process.

10. FOODBORNE AMR RISK COMMUNICATION..................................................................................................................................... 20

A.1.

A.2.

A.3.

Foodborne Risk Communication as a Risk Management Tool

1

FAO/OIE/WHO. 2003. First Joint FAO/OIE/WHO Expert Workshop on Non-human Antimicrobial Usage and Antimicrobial Resistance: Scientific assessment, Geneva, Switzerland, 1-5 December 2003. http://www.who.int/foodsafety/micro/meetings/nov2003/en/.

2

FAO/OIE/WHO. 2004. Second Joint FAO/OIE/WHO Expert Workshop on Non-Human Antimicrobial Usage and Antimicrobial Resistance: Management options, Oslo, Norway, 15–18 March 2004. http://www.who.int/foodsafety/publications/micro/mar04/en/index.html.

3

APPENDICES

Elements for Consideration in a Foodborne AMR Risk Profile ........................................................................................................... 21 Suggested Elements for Consideration in a Foodborne AMR Risk Assessment .......................................................... 24 Examples of Qualitative Foodborne AMR Risk Assessment ................................................................................................................ 27

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The initial part of the risk analysis framework consists of a group of tasks collectively referred to as “Preliminary Risk Management Activities”, which are carried out by the risk managers. This allows the risk manager to decide what action to take. This may involve the establishment of a risk assessment policy and the commissioning of a risk assessment or another appropriate action. If it is decided to commission a risk assessment, the preliminary risk management activities will provide some of the basic information required by risk assessor undertaking this task. Following parts of the risk analysis framework include the identification, evaluation, selection and implementation of appropriate risk management actions to, if necessary, minimise and contain the identified risk to human health. Risk managers are responsible for verifying that the risk management measures implemented are achieving the intended results, that unintended consequences associated with the measures are limited and that the risk management goals can be achieved. Good communication among risk assessors, managers and interested parties is essential for a transparent and informed risk analysis.

Sources of information Process of foodborne AMR risk assessment Hazard identification Exposure assessment Hazard characterization Risk characterization

8.1.

8.2.

8.3 8.4.

8.5.

8.6.

10.1.

In accordance with Codex principles, risk analysis is an essential tool in assessing the risk to human health from foodborne AMR microorganisms and determining appropriate risk management strategies to control those risks. Over the past decade, there have been significant developments with respect to the use of risk analysis approaches in addressing AMR. A series of FAO/OIE/WHO expert consultations on AMR have led to agreement that foodborne AMR microorganisms are potential microbiological food safety hazards.

Consequently, the need for the development of a structured and coordinated approach for AMR risk analysis has been emphasized1, 2, 3, 4. WHO/FAO and OIE guidelines on risk analysis provide broad, structured approaches to address the potential public health impact of AMR microorganisms of animal/crop origin via food5, 6. However, a consolidated framework specific to foodborne AMR risk analysis was considered necessary, due to the biological complexity of AMR, the multidisciplinary aspects of AMR within the entire food production to consumption continuum and the need to identify appropriate risk management strategies.

PRELIMINARY FOODBORNE AMR RISK MANAGEMENT ACTIVITIES ............................................................. 6

6.1.

6.2.

6.3.

6.4.

6.5.

6.6.

INTRODUCTION Antimicrobial resistance (AMR; also used for “antimicrobial resistant” in this document) is a major global public health concern and a food safety issue. When pathogens become resistant to antimicrobial agents they can pose a greater human health risk as a result of potential treatment failure, loss of treatment options and increased likelihood and severity of disease. Problems related to AMR are inherently related to antimicrobial use in any environment, including human and non-human uses. The use of antimicrobial agents in food producing animals/crops provides a potentially important risk factor for selection and dissemination of AMR microorganisms and determinants from animals/food crops to humans via the consumption of food.

FAO/OIE/WHO. 2006. Joint FAO/OIE/WHO Expert Meeting on Antimicrobial Use in Aquaculture and Antimicrobial Resistance, Seoul, Republic of Korea, 13-16 June 2006. ftp://ftp.fao.org/ag/agn/food/aquaculture_rep_13_16june2006.pdf.

4

FAO/OIE/WHO. 2008. Joint FAO/WHO/OIE Expert Meeting on Critically Important Antimicrobials Report of the FAO/WHO/OIE Expert meeting, FAO, Rome, Italy, 26–30 November 2007. ftp://ftp.fao.org/docrep/fao/010/i0204e/i0204e00.pdf.

5

FAO/WHO. 2006. Food safety risk analysis: A guide for national safety authorities. (FAO Food and Nutrition Paper 87). ftp://ftp.fao.org/docrep/fao/009/a0822e/a0822e00.pdf.

6

OIE. Terrestrial Animal Health Code (Section Veterinary Public Health). http://www.oie.int/eng/normes/mcode/en_sommaire.htm

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AN TIM IC R O B IAL R E S ISTAN C E

ANTI MI CROBI AL RESI STANCE

the purpose or the type of questions to be answered and data availability for a specific AMR risk assessment. In accordance with the Working Principles for Risk Analysis for Food Safety for Application

by Governments (CAC/GL 62-2007), quantitative data should be used to the greatest extent possible without discounting the utility of available qualitative information.

7.3. HAZARD IDENTIFICATION The purpose of hazard identification is to describe the foodborne AMR hazard of concern (Appendix 2). Risk assessors should review literature and information from surveillance programmes to identify specific strains or genotypes of foodborne microorganisms that may pose risks by a particular combination of food commodity, AMR microorganism and / or determinants and antimicrobial agents to which resistance is expressed. Additionally, the biology of AMR microorganisms and / or determinants within different environments/niches (e.g. interactions in animal feeds or aquaculture environment as well as in food matrices) and information on the susceptible strains of the same organisms or related AMR microorganisms and / or determinants will be useful. When necessary, science-based opinions on hazard identification can be sought from relevant experts.

7.

Use of antimicrobial agents occurs in different agricultural sectors and at different stages of production, including animal feed, food producing animals, crop production and / or during food processing.

Following antimicrobial use, selection of AMR microorganisms and determinants may occur, which then could be disseminated between these sectors, such as between animal feed and food producing animals, or food producing animals’ waste being spread on crops, etc. Other risk/preventive factors may affect either selection or dissemination of resistance.

The fundamental activities in exposure assessment should include: (a) clear depiction or drawing of the exposure pathway; (b) detailing the necessary data requirements based on the pathway; and (c) summarising the data. Considerations related to exposure assessment are illustrated in Figure 2a12.

Animal/crop and microbial factors affecting dissemination of AMRM/AMRD

Other possible sources of AMRM/AMRD for target animal/crop

Food processing factors affectiong frequency and concentration of microorganism

Frequency and concentration of AMRM/AMRD at slaughter/harvest

Cunsumer factors affecting frequency/ concentration of microorganism, and food consumption rate

Microbial factors accectiong transfer and maintenance of resistance

GUIDELINES FOR RISK ANALYSIS OF FOODBORNE ANTIMICROBIAL RESISTANCE

FOODBORNE AMR RISK ASSESSMENT

7.1. SOURCES OF INFORMATION Given the fact that multiple data sources are likely to be required for a foodborne AMR risk assessment and that these data can be limited, their strengths, limitations, discrepancies and gaps should be clearly described.

AMRM = antiicrobial resistann microorganism; AMRD = antimicrobial resistance determinant

The exposure assessment covers the release and exposure assessments of the OIE risk assessment scheme (OIE. Terrestrial Animal Health Code (Risk assessment for AMR arising from the use of antimicrobials in animals)).

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Surveillance programmes (see paragraphs 68-71);

y

Epidemiological investigations of outbreaks and sporadic cases associated with AMR microorganisms;

y

Clinical studies including case reports on the relevant foodborne infectious disease incidence, primary and secondary transmission, antimicrobial therapy and impacts of resistance on disease frequency and severity;

y

National/regional treatment guidelines for foodborne microorganisms, including information on the medical importance of, and potential impacts of, increased resistance in target or other microorganisms to alternative treatments;

y

Studies on interaction between microorganisms and their environment through the food production to consumption continuum (e.g. litter, water, faeces and sewage);

y

Investigations of the characteristics of AMR microorganisms and determinants (in vitro and in vivo);

y

Research on properties of antimicrobial agents, including their resistance to selection potential (in vitro and in vivo), and transfer of genetic elements and the dissemination of AMR microorganisms in the environment;

y

Studies on the link between resistance, virulence and / or fitness (e.g. survivability or adaptability) of the microorganism;

y

Studies on the pharmacokinetics / pharmacodynamics associated with selection of AMR in any given setting;

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GUIDELINES FOR RISK ANALYSIS OF FOODBORNE ANTIMICROBIAL RESISTANCE

The AMR-related adverse human health effects (i.e. risk endpoints) may be ranked qualitatively as below23. In this example, it is considered that adverse health effects associated with the microorganisms that are resistant to critically important antimicrobials in human medicine3 are likely to have a more severe consequence than those with microorganisms resistant to other antimicrobial agents:

The foodborne AMR risk assessment guidelines described in this section provide a transparent sciencebased approach to identify and assess a chain of events that affect the frequency and amount of AMR microorganisms to which humans are exposed through the consumption of food and to describe the magnitude and severity of the adverse health effects from that exposure. An AMR risk assessment addressing the specific risk to the defined population will examine the load and likelihood of contamination of all foods (domestic and imported) by AMR microorganisms and / or determinants and, to the extent possible, the factors that are relevant and could influence their prevalence in food.

y

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y

Negligible – No adverse human health consequences or within normal limits;

y

Mild – Symptoms are minimally bothersome and no therapy is necessary;

y

Moderate – Symptoms are more pronounced or of a more systemic nature than mild symptoms but not life threatening; some form of treatment is usually indicated;

y

Severe – Symptoms are potentially life threatening and require systematic treatment and / or hospitalization; increase severity may occur due to the foodborne AMR microorganism;

y

Fatal – Directly or indirectly contributes to the death of the subject; treatment failure is likely expected due to the foodborne AMR microorganism.

ILLUSTRATIVE RISK CHARACTERIZATION SCORING In a qualitative risk assessment, the risk estimate may be integrated into the qualitative (descriptive) considerations of “Negligible,” “Low,” “Medium,” “High,” and “Very High” from the outputs of the Exposure Assessment and Hazard Characterization steps. An example of integration is presented in Table 2.

Table 2. Integration of the Outputs of Hazard Characterization and Exposure Assessment into the Qualitative Risk Characterization.

Exposure Assessment

Hazard Characterization

Qualitative Risk Characterization

Probability of Exposure

Severity of Adverse Health Effect

Negligible

Negligible

Negligible

Low (Unlikely)

Negligible

Negligible

Medium (Possible)

Negligible

Low

High (Almost Certain)

Negligible

Low

Negligible

Low (Mild)

Low

Low (Unlikely)

Low (Mild)

Low

Medium (Possible)

Low (Mild)

Medium

High (Almost Certain)

Low (Mild)

Medium

y

Laboratory and / or field animal/crop trials addressing the link between antimicrobial agent usage and resistance (particularly regional data);

Negligible

Medium (Moderate)

Low

y

Science-based expert opinion;

Low (Unlikely)

Medium (Moderate)

Low

y

Existing microbiological and AMR risk assessments.

Medium (Possible)

Medium (Moderate)

High/Medium

High (Almost Certain)

Medium (Moderate)

High

Negligible

High (Severe)

Low

At the beginning of the work, the risk assessor should consider the risk profile, information documented during commissioning the risk assessment and the risk assessment policy. In addition, risk assessors may require a preliminary investigation phase to define and map the work to be undertaken within the framework of the AMR risk assessment.

Low (Unlikely)

High (Severe)

Medium

Medium (Possible)

High (Severe)

High

Foodborne AMR risk assessment is composed of hazard identification, exposure assessment, hazard characterization and risk characterization. Details of suggested elements for consideration of each component can be found in Appendix 2. Exposure assessment and hazard characterization can be conducted in parallel (Figure 1).

(...)

7.2. PROCESS OF FOODBORNE AMR RISK ASSESSMENT

The objective is to arrive at an estimate of the magnitude of exposure to AMRM/AMRD. Consider all relevant pathways and risk factors required to address the risk management question.

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EXPOSURE TO AMRM/AMRD VIA CONSUPTION OF FOOD

Antimicroal use selecting for AMRM/AMRD

SELECTION AND DISSEMINATION OF AMRM/AMRD

Figure 2a: Connsiderations for Exposure Assessment in a Foodborne ARM Risk Assessment – the Exposure Pathway.

The general principles of a foodborne AMR risk analysis apply equally to both qualitative and quantitative risk assessment. While the design differences may yield different forms of output, both approaches are complementary. The selection of a qualitative or quantitative approach should be made based on

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TABLE OF CONTENT

Possible sources of information:

7.4. EXPOSURE ASSESSMENT

GUIDELINES CAC/GL 80-2013

GUIDELINES CAC/GL 80-2013

EDITION ADOPTED 2011

CONTACTS CODEX SECRETARIAT FAO HQ Viale delle Terme di Caracalla 00153 Rome, Italy

(+39) 06 57051 codex@fao.org codexalimentarius.org twitter.com/FAOWHOCodex youtube.com/userCodexAlim

(...)

23

Modified after National Cancer Institute, 2006. Common Terminology Criteria for Adverse Events v3.0. http://ctep.cancer.gov/ protocolDevelopment/electronic_applications/docs/ctcaev3.pdf.

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BOITSHEPO GIYOSE SENIOR NUTRION OFFICER FAO Nutrition Food System Division