GENERAL COMMENTS COSTA RICA

Transcription

1 Agenda Item 4 CX/AMR 09/3/4 Add.3 October 2009 (Original language only) JOINT FAO/WHO FOOD STANDARDS PROGRAMME AD HOC CODEX INTERGOVERNMENTAL TASK FORCE ON ANTIMICROBIAL RESISTANCE Third Session Jeju, Republic of Korea, October 2009 PROPOSED DRAFT GUIDELINES FOR RISK ANALYSIS OF FOODBORNE ANTIMICROBIAL RESISTANCE (N , N , N ) Comments at Step 3 (submitted by Costa Rica, European Community, Kenya) GENERAL COMMENTS COSTA RICA Costa Rica agradece la oportunidad de expresar sus comentarios en relación con el citado anteproyecto, en su versión en español. En general apoyamos el documento, haciendo unas observaciones que a continuación se detallan: 1. Introducción y ámbito de aplicación Numeral 6: Costa Rica está de acuerdo en incluir en el documento consolidado, solo una sección de Ámbito de aplicación, eliminando los demás textos sobre esta sección en el resto del documento. 2. Organización de actividades de gestión de riesgos Numeral 9: Para organizar el documento consolidado, Costa Rica apoya la estrategia 1: ofrecer una estrategia cronológica en el cual las actividades de análisis de riesgo se debaten paso por paso, siguiendo el orden en el cual los gestores de riesgos las llevarían a cabo. 3. Figura 2: Esquema que ilustra el ámbito de aplicación Numeral 15: Costa Rica considera que la nueva versión del esquema es más claro y explicativo, por lo que debe sustituir a la figura original. 4. Figura 3: Esquemas para la caracterización de peligros en la evaluación de riesgos de la RAM Numeral 16: Consideramos que esta figura se debe dejar, ya que contribuye a enriquecer el documento. 5. Seguimiento de las opciones de gestión de riesgos (OGR) Numeral 18: Costa Rica apoya el mantener el texto específico relativo al seguimiento de las OGR, y considera que la redacción de la nueva sección para tratar el seguimiento y vigilancia del uso de los antimicrobianos y los microorganismos resistentes a los antimicrobianos y los factores que determinan la resistencia, aporta mayor claridad, tal como lo propone EE.UU. EUROPEAN COMMUNITY The European Community and its Member States (ECMS) would like to express their congratulations to the USA on the comprehensive job of integrating the three previous parts to a single document and in particular for diligent efforts to streamline the document and to reconcile all different comments received. The ECMS would also like to thank all the members of the electronic working group for the very constructive discussions.

2 CX/AMR 09/3/4 Add.3 2 GENERAL COMMENTS The ECMS noted that there are numerous changes to the text as compared to what was agreed by the Task Force on Antimicrobial Resistance (TF AMR). Generally, the ECMS accept these changes as we find the new document much easier to read without important content getting lost. The ECMS would like to propose in the comments provided below some amendments in order to further increase clarity and readability. The ECMS are pleased to provide the following SPECIFIC COMMENTS to the questions posed by the Chair and also on the Proposed Draft Guidelines for Risk Analysis of Foodborne Antimicrobial Resistance. Introduction and Scope The ECMS agree on the proposal to have a single introduction for the consolidated document as well as that the text provided for the "scope" in each section is maintained as proposed. General principles Paragraph 8 The ECMS would like to re-iterate its previous comments in relation to the inclusion of a General Principle to address animal health and welfare aspects. This question was agreed at the last session of the TF AMR. The ECMS would therefore like to suggest that the following principle is added: "Principle 8: Evaluation of pre-harvest AMR risk management options should include, whenever appropriate, aspects related to animal health and welfare." Organisation of Risk Management Activities Paragraph 9 As explained by the US chair the structure of the document differs from the one agreed at the second session of the TF AMR (ALINORM 09/32/42, para. 15). In principle, the ECMS would favour the step-by-step approach as proposed by the USA, as the current proposed draft provides substantial improvement in readability. Working on the basis of the current structure would allow sufficient time for in-depth consideration of the proposed draft and ample scope for improving its wording while ensuring successful completion of the work in the schedule set for the Task Force by the Codex Alimentarius Commission. Long Document The ECMS fully share the views that the Guidelines would be further improved by focusing on AMR-specific issues. Detailed comments in this respect are provided below. Placing of supplemental RMOs The ECMS strongly support that the supplemental RMOs are maintained in the main body of the text and are not inserted in an annex. The ECMS consider that the use of a table places this list in its right context avoiding misinterpretations of its purpose. Specific comments are provided below. Monitoring of RMOs vs. surveillance of AMR The ECMS support the separate section on monitoring and surveillance as proposed by US. KENYA The 2 nd Session of the Codex ad hoc Intergovernmental Task Force on Antimicrobial Resistance (2 nd TFAMR) made significant progress on the development of three documents, one each on risk assessment, risk profiling, and risk management, but noted that some sections in these documents and in the proposed structure were not complete and required further development. The Task Force agreed to establish an electronic working group (ewg), hosted by the U.S., open to all Members and Observers and working in English only, to prepare a consolidated document entitled, Proposed Draft Guidelines for Risk Analysis of Food borne Antimicrobial Resistance (AMR). Consequently, a new Scope section was drafted for the consolidated document and should be reviewed by the Task Force. The heading Scope was dropped from the individual sections, but the information was retained in each section for further discussion and possible deletion. INTRODUCTION AND SCOPE First of all Kenya would like to appreciate the work well done by ewg led by United States of America to come up with one document from three documents (risk assessment, risk profile and risk management). We have gone through the guidelines and find it acceptable with the changes made by the ewg.

3 CX/AMR 09/3/4 Add.3 3 ORGANIZATION OF RISK MANAGEMENT ACTIVITIES Two approaches that have been considered for the organization of the consolidated document: 1) provide a chronological approach, in which the risk analysis activities are discussed on a step-by-step basis in the same order in which they would be carried out by risk managers; or 2) group the activities by function in which the two main activities are grouped into risk management and risk assessment. We would like to comment as follow: Comment: The first approach is preferred because it provides clear guidance on the steps required to be taken by the risk managers, starting with hazard identification to Risk characterization which is easier to follow. The first approach also states provide a chronological approach, in which the risk analysis activities are discussed on a step-by-step basis in the same order in which they would be carried out by risk managers. LONG DOCUMENT/SPECIFIC TO AMR VS. SHORT DOCUMENT/MORE GENERAL In the course of consolidating and harmonizing the guideline and considering the responses to the CL, the ewg noted that the length of the document was long compared with similar Codex guidelines. It believes the reason for the length is the considerable detail that this draft contains (e.g., Appendix 1 and 2), as well as overlap with existing Codex texts. Some overlap is unavoidable and even necessary to adapt risk analysis methodology to AMR, and to make the guideline complete and coherent. Also, a guideline with additional detail may provide risk managers with more useful information in addressing AMR food safety issues. To that end, a balance was sought between a need for brevity without compromising the utility of the document. The ewg chose to eliminate redundant text in some cases, but maintained text specific to AMR or adapted some text to be specific to AMR. However, pending discussions in the Task Force, further condensation and focus on AMR-specific issues may be beneficial. We would like to comment on the issue above as follows: Comment: Although it is beneficial to focus AMR specific issues, the guidelines could include detail to provide risk managers with useful information in addressing AMR food safety issues. Issues that crosscut three areas/documents to be annexed so that we have one point of reference. RISK COMMUNICATION Although there is little debate concerning the importance of risk communication in all risk the Task Force should consider the overall approach to the comprehensiveness of the guideline (see paragraph above) and determine whether the existing text on risk communication should be revised to make it more AMR specific. Comment: We have considered the overall approach of the existing text on risk communication and find it acceptable at this step 3. It has been noted that the current document provides an excellent summary of the principles of risk communication/risk analysis. REFERENCES Many in the ewg agreed that references should be eliminated in the document and retained in a separate section at the end of the document, but some requested that references be retained both in the appropriate locations in the document as well as in a later section. For now, references are retained both within the document and in a section at the end of the document for further consideration by the Task Force. Comment: We prefer the references at the end of the document as norm. BROAD RISK MANAGEMENT GOALS Background Goal setting should occur at steps before the risk profile; during preliminary risk management activities; and prior to the onset of the identification, selection, and evaluation of risk management options. The intent of establishing goals at this particular step is to incorporate the information gathered up to this point in time and refine existing goals to determine the most appropriate activities to address the food safety issue. In response to many conflicting comments, the ewg retained much of the language that was in the document, pending additional discussion at the next Task Force meeting. Comment: We fill that to address the food safety issues, goal setting management should start after the preliminary risk management activities, before the risk profile, have been done. Process of AMR-risk assessment The key issue is whether Figure 2 adequately illustrates the relationship between the four general steps (Codex) of risk assessment. Comment: We would like some clarifications on the figures indicated below as follows:

4 CX/AMR 09/3/4 Add.3 4 FIGURE2 AND 3 SCHEMES FOR HAZARD CHARACTERIZATION IN AMR RISK ASSESSMENT Comment: Kenya would like clarification why Release assessment, interface and consequential stages were left out in these figures PLACEMENT OF SUPPLEMENTAL RMOS The Task Force should consider whether the brief descriptions adequately describe the RMOs or whether additional detail is needed. If additional detail is required, the use of an appendix may need to be re-evaluated to maintain readability of the document. Comment: Table1 in page 19 of this document is the examples of risk management options supplemental to Codex codes of practice are adequate and this table of RMOs should be moved to the appendix. MONITORING OF RMO VS. SURVEILLANCE OF AMR Comment: Regarding Section 8.5 we accept the splitting of the monitoring and review of RMOs and setting new monitoring surveillance guidelines for antimicrobial Res. Determinants as proposed by the USA team. For example the whole issue on Para is on the use of set standards and validated testing methods. In our view, Monitoring RMOs is management tool and making changes in management where necessary while Surveillance is a component required for management (scientific verification tool). SPECIFIC COMMENTS COSTA RICA 6. DEFINICIONES Con el propósito de aclarar las definiciones en español, se sugiere realizar las siguientes modificaciones: 6.1-Modificar la definición Antes de la recolección para que diga: Antes del sacrificio o la recolección: La etapa en el desarrollo de animales o plantas destinados a la producción de alimentos hasta el sacrificio o la cosecha (con inclusión de transporte y refugio) Modificar la definición Después de la recolección para que diga: Después de la recolección: La etapa en que los animales o plantas son destinados a la producción de alimentos a partir del sacrificio o la cosecha, que a menudo incluye la refrigeración, la limpieza, la clasificación, el embalaje y otros procesos En la definición Directrices para el uso responsable, eliminar el último párrafo, ya que está de más Modificar la definición de Patógeno, para que se lea: Patógeno: Un microorganismo capaz de producir una afección o enfermedad. 7. En el numeral 20, línea 5, cambiar el párrafo debería definirse el plazo, por debe (must be) definirse el plazo. Esto en beneficio de ambas partes. TABLA 1 8. En el numeral 57, página 25, línea 8, agregar al punto para que se lea:. Cambios en los sistemas de producción, promoviendo programas todo dentro todo fuera (promote all in, all out programs), a fin de reducir al mínimo. 9. En el numeral 57, página 25, línea 17, para que el punto se modifique y se lea:. Mejoras en la higiene, medidas sanitarias (desinfección en período de vacío sanitario(en ingles, growouts ), control de insectos, control de roedores, uso de desinfectantes etc. 10. En el numeral 57, página 26, se sugiere cambiar Gestión de residuos, por Manejo de residuos. 11. En página 26, agregar al título del último párrafo de la tabla, para que se lea: OPCIONES DE POSTCOSECHA O POSTSACRIFICIO. 12. En página 26, Costa Rica considera que el termino recolección es limitante porque solo se aplica para los productos que se cosechan. Por lo tanto propone que el título del último párrafo de la tabla, se lea: OPCIONES POSTERIORES A LA POSCOCECHA Y SACRIFICIO. APÉNDICE En el punto 2.2, cuarta viñeta, cambiar farmacocinesis por farmacocinética.

5 CX/AMR 09/3/4 Add En la página 35, en el punto Parámetros del uso no humano de antimicrobianos, viñeta tercera, cambiar farmacocinesis y farmacodinámica por farmacocinética y farmacodinamia. EUROPEAN COMMUNITY INTRODUCTION Paragraph 1: The ECMS would like to propose re-wording of the second sentence in order to improve its clarity. The sentence would read as follows: 1. Problems related to AMR is are inherently related to antimicrobial use in any environment, including human and non-human uses. Paragraph 2: In order to make the language clearer the ECMS would like to suggest replacing the word "concurred" by "agreed". It is also suggested to insert the word "foodborne" in the final sentence last use of AMR in last line: 2..A series of FAO/OIE/WHO expert consultations have concurred agreed that specific to foodborne AMR risk analysis" Paragraph 5: The ECMS note that the chapter numbers and titles of the OIE Terrestrial Animal Health Code may change over time. Therefore, the ECMS would like to suggest that the chapter numbers quoted in the draft Guidelines are deleted. The last part of the last sentence would read as follows: 5. ".and the chapters 6.5 to 6.8 related to the control of AMR for the Terrestrial Animal Health Code (OIE)" If accepted, this comment also applies to all the paragraphs in the text where reference is made to the Terrestrial Animal Health Code. SCOPE Paragraph 6: In view of the fact that the entire document is titled Proposed Draft Guidelines for Risk Analysis of Foodborne Antimicrobial Resistance, the ECMS believe that foodborne antimicrobial resistance should be included in the first sentence in this paragraph. Therefore the ECMS would like to suggest an amendment to this paragraph as follows: 6. "The scope of this guideline is to provide science-based guidelines on methodology and processes for risk analysis and its application to non-human use of antimicrobials and foodborne antimicrobial resistance. The intent of the guideline " In addition, the ECMS suggest re-wording the second sentence as follows: 6. " develop advice on appropriate risk management advice based on that assessment to reduce such risk. Paragraph 7: Many of the areas referred to are not areas of use. The ECMS suggest to revise the beginning of the paragraph to: 7. As there are existing Codex or internationally recognized guidelines, the following areas related to uses of antimicrobials are outside the scope of the guideline: : DEFINITIONS Paragraph 8 The ECMS would like to suggest to amend the last sentence of this paragraph as there are definitions cited from other existing texts than the FAO/OIE/WHO, e.g. WTO/SPS Agreement. Therefore, it is proposed to delete the reference to the FAO/OIE/WHO: 6. " Definitions cited from existing FAO/OIE/WHO documents are referenced as appropriate." DALYs The ECMS would like to propose to insert a definition of DALYs as this term is used in paragraphs 45 and 47. The proposed definition has been adapted from the WHO definition ( DALYs: a measurement of the gap between current health status and an ideal situation where the entire population lives to an advanced age, free of disease and disability

6 CX/AMR 09/3/4 Add.3 6 Extra- and Off-label use The ECMS consider that as human antimicrobials can also be used off-label it seems appropriate to delete non-human. Extra- and Off-label use: the non-human use of an antimicrobial that is not in accordance with the approved product labelling. Intrinsic resistance and National treatment guidelines The need for these definitions seems questionable as the expressions were not found in the text. Therefore the ECMS would like to propose its deletion. Prevention and prophylactic use: In the current Proposed Draft, the term prevention/prophylaxis is used only once, in Table 1 page 19 ( avoid or limit use of antimicrobial agents or a specific agent for disease prevention/prophylaxis in healthy animal not considered to be at risk of infection ). The ECMS consider that this sentence seems to use the terms prevention/prophylaxis in a different way: it implies that prevention/prophylaxis may also cover situations where animals are not considered to be at risk. This is in contradiction with the definition adopted by Codex/OIE that can be found in the glossary of terms of the Code of Practice to Minimise and Contain AMR (CAC/RCP/ ), which makes clear that prevention/prophylaxis deals only with situations where healthy animals are considered at risk or prior to the onset of clinical infectious disease. Therefore, the ECMS would like to propose that the text in Table 1 page 19, is amended to read: Table 1, Food animal production, fourth bullet Ensure that antimicrobial agents are not used in healthy animals that are not considered at risk. As there is no longer any mention of prevention/prophylaxis in the new text, then the definition of prevention and prophylactic use can be deleted. Responsible Use Guidelines The ECMS observe that the text in the definition provides a list of synonyms of what these guidelines may be called in other documents rather than a true definition of the expression itself.. If this definition is kept in the text the ECMS would like to suggest that a reference to the relevant Codex text is inserted. Guidance on Responsible Use can be found e.g. in the Code of Practice to Minimize and Contain Antimicrobial Resistance (CAC/RCP ). Risk Manager: The ECMS note that risk manager is defined in CAC/GL and if the definition is maintained, it should be in italics and not be limited to those managing risks with AMR as there is no limitation in the term defined. Therefore, the ECMS would like to suggest a change to: Risk Manager A national or international governmental organization with responsibility for AMR risk management activities. Risk Management Option (RMO): The ECMS understand that the options are the menu of identified actions that could potentially be taken, and not limited to the one(s) selected for implementation. Consequently, the ECMS suggest a modification as follows: Risk Management Option (RMO) A specific action that could be implemented taken to mitigate risk at various control points throughout the food production to consumption continuum. GENERAL PRINCIPLES FOR AMR-RISK ANALYSIS The ECMS would like to suggest that the term "foodborne" is introduced in the title GENERAL PRINCIPLES FOR FOODBORNE AMR-RISK ANALYSIS Principle 4: The ECMS do not find this text sufficiently clear. For instance the expression resistant microorganism is repeated twice in the list. Further development of Principle 4 to increase readably would be appreciated. Principle 5: It is the understanding of the ECMS that the intention in Principle 5 is that AMR risk analyses should consider microbiological risk analyses that may have been conducted. Therefore the ECMS propose to delete the word guidelines.

7 CX/AMR 09/3/4 Add.3 7 "Principle 5: AMR-risk analysis, should build on existing microbiological risk analysis guidelines and, in addition, needs to consider factors relating to antimicrobial susceptibility of the microorganism(s) in question and related consequences to human disease." Principle 6: The ECMS note that different ways of expressing what a combination is have been used in this document. The wording of principle 6 is not consistent with the wording used in paragraphs 17 (2 nd bullet), 38 and 70. The ECMS therefore propose that a harmonised approach is used throughout the document. The ECMS would like to express their preference for the combination proposed below: Principle 6: AMR-risk analysis should focus on clearly defined combinations of the food commodity + antimicrobial resistance+ microorganism/genetic resistance determinant with consideration of co-resistance in certain situations. FRAMEWORK FOR AMR RISK ANALYSIS Figure 1: The ECMS appreciate Fig 1 and would like to provide some comments to further clarify the framework. The figure gives the impression that following risk profile, only very urgent or provisional decisions can be taken. This is not in line with CAC/GL Section 5.2 on Microbiological risk profile: National governments may also base their decisions on Codex standards, recommendations and guidance where available. In some cases, the risk profile can give enough information for identification and selection of MRM options. The ECMS find those lines fully applicable to the AMR risk analysis, especially relevant in case of general measures like information campaigns and implementation of prudent use recommendations where it would be superfluous to commit a full risk assessment. The ECMS suggest the following changes to the Figure: Deletion of the box Immediate public health concern. The text in the box Immediate and/or [provisional] decision] should be changed for clarity to immediate decision, provisional in cases when data are insufficient. The grey colour in the centre of the figure should be deleted. The box with No action should be moved further down to fit within the section risk management rather than with the section risk assessment. The text in the box "Ranking of the hazard for RA/RM priority" should be amended to read: "Ranking of the food safety issue hazard for RA/RM priority" The text in the box Commissioning a risk assessment should be amended to Conducting a risk assessment to fit with the structure.. Proposal for Figure 1: Framework for AMR-Risk Analysis

8 CX/AMR 09/3/4 Add.3 8 Identification of an AMR food safety issue Preliminary risk management activities Immediate decision, provisional in cases when data are insufficient Establishment of a Risk Profile Ranking of the food safety issue for RA/RM priority Establishment of risk assessment policy for the conduct of the risk assessment Risk assessment Conducting Risk Assessment Consideration of the results of the risk assessemnt No Action Risk management Identification, evaluation and selection of RM option Implementation of RM options Monitoring and review of RM options Paragraph 11: The ECMS would suggest to delete this paragraph. The language used in the first sentence of this paragraph is too prescriptive and the second sentence is not consistent with paragraph 20. A decision to take RMOs prior to the establishment of a risk assessment could be undertaken provisionally at any occasion when there is evidence that a risk to human health exists, it is not necessary that the risk is immediate. Furthermore, the ECMS believe that the expression clear evidence is more restrictive than the corresponding texts in CAC/GL (section 5.1) and the SPS agreement Art 5.7. Paragraph 12: The ECMS would suggest to delete this paragraph as its content is mainly a duplicate of information in paragraph 21 and 22 (see below). PRELIMINARY AMR-RISK MANAGEMENT ACTIVITIES Paragraph 14: The ECMS believe that the last sentence in this paragraph is not needed, given what has already been said in the introduction and scope and therefore the ECMS suggest its deletion: 14. A potential food safety issue may arise when antimicrobial resistant microorganisms or resistance determinants are present or transmitted in food and/or animal feed, including aquaculture. Foodborne exposures to resistant microorganisms or resistance determinants may adversely impact human health. The risk manager initiates the risk management process, beginning with the preliminary risk management activities, to evaluate the scope and magnitude of the food safety issue and, where necessary, to commence activities to manage the identified risk. In the course of implementing these preliminary risk management activities, the risk managers should consider the different areas of use of antimicrobials, such as in food animals (including aquatic species) and in plants.

9 CX/AMR 09/3/4 Add.3 9 Identification of an AMR food safety issue Paragraph 15: The ECMS find this paragrapgh is too detailed and note that there are lists containing information to be provided to describe the extent of AMR at different stages of the process (risk profile, risk assessment, monitoring) three times in the document (here, in paragraph 34 and in Appendix 3). This results in substantial overlaps in their content. Therefore, in order to simplify the text the ECMS would like to suggest to insert a reference to the information contained in paragraph 34 and delete the rest:..: 15. AMR food safety issues may be identified on the basis of information arising from a variety of sources as described in paragraph 34. such as AMR surveillance in animals and in foods of animal origin, food safety monitoring, antimicrobial usage surveys, animal and human surveillance data (including post-marketing surveillance data on approved antimicrobials), epidemiological or clinical studies, laboratory studies, research on resistance transfer, scientific, technological or medical advances, environmental monitoring, recommendations of experts and interested parties, etc. Information on AMR microorganisms and resistance determinants related to plant production and food processing should be included. Additional potential sources of information are provided in the Code of Practice to Minimize and Contain Antimicrobial Resistance (CAC/RCP ). Development of an AMR risk profile Paragraph 17 The ECMS support the new shorter text without the reference to an abbreviated risk profile. However, the text as proposed could be further improved especially considering that risk profiles could cover also post-harvest aspects. The ECMS would like to suggest to use the same wording as proposed for Principle 6 in the second bullet point. In addition, the ECMS would also suggest that references to specific international meetings are avoided as this document will be long lasting and new meetings will be held, and new groups may be formed. The following amendments are proposed: 17. The depth and breadth of the AMR risk profile may vary depending on the needs of the risk managers and the complexity and urgency of the food safety issue. The fundamental elements that comprise an AMR risk profile include: Description of the hazard and public health problem (the AMR food safety issue); Identification and characterization of the combination of the food commodity + antimicrobial resistance+ microorganism/genetic resistance determinant with consideration of co-resistance in certain situations antimicrobial resistant microorganisms + antimicrobial use combination; Consideration of the importance of use in animals and humans of antimicrobials of relevance for the hazard e.g. by consulting critically important antimicrobial lists developed by national and international groups organisations (e.g., WHO and OIE Expert Meeting on Critically Important Antimicrobials, Rome 2008) Description of usage (extent and nature) of antimicrobials in food production, when available (such as veterinary applications, aquaculture, plant protection or food processing); including consideration of the possible links between animal or plant use of antimicrobials and exposure to the hazard; Identification of pre- and post-harvest risk mitigation measures that could be taken; and Identification of major knowledge gaps. Paragraph 19: The ECMS would like to propose the following change (please see comment on Fig 1 above): Consideration of the information given in the risk profile may result in options leading to a range of initial decisions, such as determining that no further action is needed, commissioning an AMR risk assessment, establishing additional information gathering pathways, or implementing immediate risk mitigation measures for those food safety issues that require an immediate action by the risk manager without further scientific consideration (e.g., requiring withdrawal/recall of contaminated products). Ranking of food safety issues and setting priorities for risk assessment and management Paragraphs 21 and 22 The ECMS note that in order to prioritize at least two different items are necessary and therefore would like to suggest the following amendments in paragraphs 21 and 22. In addition, a couple of typographical errors were noted in paragraph 22

10 CX/AMR 09/3/4 Add Given the potentially high resource costs associated with conducting risk assessment and/or implementing RMOs, the AMR risk profiles provides the principal resource that should Beyond the description of the AMR food safety issues provided by the risk profiles, other criteria may be used for ranking or prioritization; these are generally determined by the risk managers in conjunction...other criteria that could be used to rank this ARM AMR food safety. Establishment of broad risk management goals Paragraphs 23-26: The ECMS are of the opinion that these paragraphs are redundant and could be deleted from the text. In essence the message is the same as that given above in the paragraph (with proposed amendments) on development of a risk profile and paragraph on risk ranking. What is new is the involvement of interested parties in the process and this is addressed in the section on risk communication and does not need to be repeated here. In addition, the text is not specific for AMR-related risks but reference could be given to other Codex documents if deemed appropriate. Commission the AMR-risk assessment Paragraph 28: The content of this paragraph duplicates paragraph 27 and other existing Codex texts (e.g. Principles and Guidelines for the Conduct of Microbiological Risk Management CAC/GL ). The ECMS therefore suggest to delete para 28 and introduce the relevant references, so that para 29 follows immediately after para 27. Paragraph 29: The ECMS suggest to amend the last bullet point to read: " Timelines for milestones and completion of the risk assessment and review Paragraphs 30-31: The ECMS find these two paragraphs out of place in this location with the step-by-step structure used. Should this structure be maintained after discussions in next TFAMR, we suggest to move para to the end of the Risk assessment section (i.e. para to form para 50 bis and 50 ters). The heading does not need to be maintained, as it does not reflect the content of these paragraphs. Paragraph 34: The ECMS consider that there is a need to clearly state that sources of information should not be restricted to national sources but should, wherever possible, be expanded to include international sources as well. Therefore, the ECMS would like to propose to amend this paragraph as follows: 34." Possible Both national and international sources of information should be sought, including:.." In addition, the ECMS would like to propose a slight amendment of the first bullet point to align the terminology with what is currently used: Monitoring and surveillance programs [...] or plants taking into consideration epidemiological and (microbiological) breakpoints cut off values. Process of AMR- risk assessment Figure 2 The ECMS would like to suggest that the figure within the Exposure Assessment box in figure 2 would be more appropriately placed under the same heading in the text, just before paragraph 39. This would mean that the figure within the box would have to be numbered separately. The ECMS believe this would make figure 2 more harmonious and in our opinion, will improve readability. In addition, given that both "Hazard Characterisation" and "Exposure Assessment" are of equal importance, the dimensions of the Hazard Characterisation box should be increased to equal that of the Exposure Assessment. Exposure Assessment Paragraph 41: To reflect the mobility of plasmids/transposons/gene cassettes the ECMS suggest the following minor change: 41. When the hazard of interest is the resistance determinant alone, including those in commensal microorganisms, then an exposure assessment should consider whether these resistance determinants can be transferred to human pathogens that subsequently become resistant... Hazard characterisation

11 CX/AMR 09/3/4 Add.3 11 Figure 3: The ECMS consider that Fig 3 does not reflect the likely importance of commensal microorganisms as hosts for mobile genetic elements and so the ECMS suggest the following amendments to the exposure assessment arrows on the left hand side of the diagram: Arrow 2: Antimicrobial use selecting resistance determinants in pathogens transferred to other pathogens or commensals. Arrow 3: Antimicrobial use selecting resistance determinants in non-pathogens commensals transferred to other pathogens or other commensals. Risk Characterization Paragraph 48: 48. Bullet 6:. number of microbial microorganisms species. data are is available RISK MANAGEMENT The ECMS would suggest to add the word "options" in the title RISK MANAGEMENT OPTIONS Paragraph 51: The ECMS consider this paragraph (the scope of the former RM document) redundant in this consolidated document and propose it to be deleted. Paragraph 52: The ECMS are of the opinion that also this paragraph could be deleted to allow the risk management section to start with paragraph 53. Paragraph 53: The ECMS would like to propose that the words "as fully as possible" are deleted. In addition to this comment, the current phrasing of this paragraph gives the impression that the RCPs are collections of risk management options. To align the text with the Codex Procedural Manual, the ECMS would like to suggest the following modification: 53. When considering RMOs to address an AMR food safety issue, risk managers should ensure that Codex Codes of Practices that cover the production to consumption continuum are being implemented as fully as possible. The Codes of Practice contain RMOs that impact control points at which foodborne microbiological hazards exist, provide advice to governments on the application of food hygiene provisions, including those measures that potentially contribute influence to the selection and dissemination of AMR microorganisms. These would include: Paragraph 55 and Table 1: The ECMS are of the opinion that the information on supplemental options given in Table 1 should be under the subheading Identification of AMR-RMOs (see below). If this suggestion is accepted then the text in this paragraph should be deleted and included later in the text. In addition, in order to further clarify the text the ECMS would like to propose replacing the wording "supplemental options" in para. 55 by "options not mentioned in paragraphs 53 and 54" Paragraph 56: The ECMS do not fully understand the meaning of the expression relevant food chain partners in this context and would appreciate it if a clarification could be provided. Identification of AMR- RMOs Paragraphs 58-59: The ECMS believe that much of the text in this section is non-specific or duplicates text given elsewhere. We also think that the Table with supplemental risk management options should be introduced and given in this section and not in the introduction of Risk management. In addition, the ECMS would like to replace the term "evaluation" by "review" in order to avoid problems in the Spanish and French versions of the document. Therefore, we suggest an amendment of the text as follows: 58. Risk managers will generally identify a range of RMOs with the capacity to resolve the food safety issue at hand. In general. To the extent practicable, it is valuable to consider initially a relatively broad range of possible options and then to select the most promising alternatives for more detailed evaluation review.

12 CX/AMR 09/3/4 Add The approach to the identification of options specific to AMR should keep in mind two aspects: 1) the range of points along the food chain where options may be implemented, and 2) the food chain partners who have responsibility and act in various areas of food production. The first aspect seeks to identify areas of the production to consumption continuum that may be amenable to certain measures to reduce risk, such as animal/crop production or the processing of harvested food. Targeted interventions at various stages of these production areas should be considered by risk managers. The second aspect seeks to identify measures that can be developed and/or implemented by various food chain partners. Paragraphs 60-63: The ECMS believe that paragraphs 60 and 61 should be deleted as their added value is unclear and it seems to be a repetition of other paragraphs. In addition, the first sentence of para 62 should be deleted. In addition, as previously mentioned, paragraph 55 should be added directly after paragraph 63 (63 bis) 62. In addition, risk assessors, scientists, food policy analysts, economists, and other stakeholders also play important roles in identifying options based on their expertise and knowledge. Specific RMOs may be identified or developed during the process of constructing a risk profile and/or risk assessment. The potential to combine one or more RMOs or integrate them into a comprehensive food safety approach, based on a generic system such as HACCP, should be considered. 63 bis RMOs described in Table 1 are intended to be examples of RMOs not mentioned in paragraphs 53 and 54 specific for AMR that may be implemented, at the discretion of national/regional authorities and in a manner that is proportional to the level of risk. Table 1 move to this location. Please see comments on the text in the table below: Animal feed production Food animal production PRE-HARVEST OPTIONS Monitor feed and feed ingredients for resistant microorganisms and resistance determinants: Consider antimicrobial resistance when assessing the microbiological safety of feed ingredients. Set specific maximum limits on resistant microorganisms for feed and feed ingredients. Implement programs to minimize the presence and transmission of in feed and feed ingredients of antimicrobial resistant microorganisms and resistance determinants of microorganisms in feed and feed ingredients and the transmission of these through feed. Monitor feed and feed ingredients for resistant microorganisms and resistance determinants: Consider antimicrobial resistance when assessing the microbiological safety of feed ingredients. Set maximum limits on resistant microorganisms for feed and feed ingredients. Prohibit or restrict the addition of ingredients with impact on AMR in animal feed. Regulatory controls on conditions of use: marketing status limitation, extra-/off-label prohibition, extent of use limitation, avoid or limit use of antimicrobial agents or a specific agent for disease prevention/prophylaxis in healthy animal not considered to be at risk of infection, Ensure that antimicrobial agents are not used in healthy animals that are not considered at risk major label restriction, withdrawal of authorization. Development Develop and implementation implement treatment guidelines targeting a specific AMR problem supported nationally or regionally on a voluntary basis prior to regulatory control. Development Develop and regular update of species-specific

13 CX/AMR 09/3/4 Add.3 13 Food production crop responsible use guidelines by professional bodies. Improve accuracy of microbiological diagnosis by national authorities inthe development, dissemination, and use of international standards for culture and susceptibility testing breakpoints and interpretive criteria. Implement biosecurity and animal health and infection control programs to minimize the presence and transmission of foodborne microorganisms and resistance determinants between animals, to/from animals to humans and between flocks/herds: Active control programs to reduce zoonotic infections without using antimicrobials. Changes in production systems to minimize commingling mixing of naïve animals with other animals and ensuring of appropriate stocking density of animals. Improved animal husbandry including eg hygiene and sanitary, measures, housing/ventilation systems and waste management systems, to prevent respiratory infections. Improved waste management systems to minimize exposure of animals to manure. Implement quality assurance programs as part of good production practice. Improved hygiene, sanitary measures (disinfection between growouts, rodent controls, use of disinfectants, etc. Vaccination when appropriate to prevent disease. Training of personnel in the improvement of specific husbandry practices. Regulatory controls on conditions of use: marketing status limitation, extra-/off-label prohibition, extent of use limitation, discourage or limit prophylactic preventive use on healthy crops, limit use to conditions when crops are known to be at risk of developing disease, withdrawal of authorization. Implement use of alternative strategies for specific diseases: Substitution of antimicrobial use with non-antimicrobial treatments (chemical and non-chemical) and if not feasible, use antimicrobials in combination with alternative treatments. Treating only specific developmental stages where the treatment is likely to be most effective, rather than treating at all developmental stages. Development Develop and implementation implement crop-specific responsible use guidelines targeting a specific AMR problem supported nationally and regionally on a voluntary basis prior to regulatory control. Improve accuracy of microbiological diagnosis by national authorities in the development, dissemination, and use of international standards for culture and susceptibility testing breakpoints and interpretive criteria. Implement biosecurity and infection control programs to prevent minimize the presence and transmission of foodborne resistant AMR microorganisms and resistance determinants between crops and from crops to humans.

14 CX/AMR 09/3/4 Add.3 14 Waste management Control the spread of AMR microorganisms through other possible sources of contamination: Avoid direct use in agriculture of human and animal waste (biosolids, manure) Use proper treatment procedures that are designed to reduce or eliminate pathogens in biosolids, manure, and other natural fertilizers. Implement control measures to limit the spread of antimicrobial resistant microorganisms and resistance determinants of microorganisms through other possible sources of contamination, such as direct use in agriculture of human and animal waste (biosolids, manure): Handling and storage systems where biosolids, manure or other natural fertilizers are used on crops or pastures, Proper treatment procedures designed to reduce or eliminate pathogens in biosolids, manure, or other natural fertilizers, Appropriate time between applying biosolids, manure, or other natural fertilizers and grazing or forage harvesting (silage and hay making) to allow the applied material to decompose and to minimize contamination, Proper use and application of biosolids, manure, compost, or other natural fertilizers and plant nutrients, Monitor biosolids, manure, or other natural fertilizers used in feed production for resistant microorganisms and resistance determinants and Prohibit the use of biosolids, manure, or other natural fertilizers in food and feed production that exceeds limits on resistant microorganism. POST-HARVEST OPTIONS Prevent food containing AMR microorganisms and AMR determinants that constitute a risk for human health, from reaching the consumer. If already placed in the market, withdraw such food from the market for reprocessing or destruction. Develop and check compliance with microbiological criteria, which define the acceptability of a product or a food lot in accordance with Principles for the Establishment and Application of Microbiological Criteria for Foods (CAC/GL ) and regulate action to be taken in cases of non-compliance at the level of: Sorting Reprocessing Rejection Further investigation. Evaluation of AMR-risk management options Paragraph 65: The ECMS would like to suggest a new bullet point to be included after the current bullet point 3 (Technical information ) as it considers that this question is relevant and it is not mentioned in the document Tools and resources to verify the correct implementation of the RMOs Paragraph 67: The first sentence of this paragraph is expressed in the Principle 8 (as proposed by the ECMS) Therefore, the ECMS suggest to delete the first sentence here. 67. Because antimicrobials play a major role in animal health, animal health should be considered when evaluating RMOs, but this must be considered secondary to human health protection. Consideration of animal

15 CX/AMR 09/3/4 Add.3 15 health and welfare could be factors in evaluating RMOs in circumstances where the options are equally effective in protecting the health of the consumer. Paragraph 70: If the ECMS proposal to follow a harmonised approach throughout the document as proposed for principle 6 is accepted then the wording of this para should be amended accordingly. Selection of AMR-risk management options Paragraph 72: The ECMS in general support the wording of paragraph 72 which indicates that risk managers should weigh the effectiveness of RMOs in relation to the goal against other factors. However, the factors exemplified in the document are mostly negative. Therefore the ECMS would like to suggest rephrasing the last part of this paragraph in order to reflect that also positive effects other than risk mitigation itself may be a factor in decision making: 72. In addition to establishing the ALOP or public health goal and evaluating the effectiveness of RMOs, risk managers must weigh those impacts against other factors that influence decision-making, including the feasibility and practicality of potential measures, cost-benefit considerations, stakeholder concerns, ethical considerations, availability of alternatives (therapeutic agents or husbandry practices), and positive or negative effects on public health or animal health and welfare. creation of countervailing risks such as decreases in the availability or nutritional quality of foods. In addition, the ECMS noted that the text on ALOP in paragraphs 71 and 72 deals with matters that could be relevant to the prioritization of human health safety issues. This are discussed earlier in the document and in particular, in paragraphs 21 and 22. Therefore, further consideration should be given in relation to the place for these paragraphs. Paragraph 73: The ECMS would like to propose the following amendment to paragraph 73: 73. An important means of reducing human exposure to antimicrobial resistant microorganisms through the food chain is to ensure decrease overall exposure as far as possible by implementing that good hygienic practice and HACCP are being followed. Paragraph 74: The ECMS suggest a minor drafting change on the final line to read: 74..cross-resistance, and co-resistance... Paragraph 75: To avoid a too high level of detail and to be consistent with risk analysis principles the ECMS would like to propose that the text on what to do in case of high level risk is made more general. In addition, the ECMS would like to add post harvest options as well. The ECMS therefore propose to replace current paragraph 75 with the following paragraph: 75. Where a high specific risk has been identified, measures such as withdrawal of contaminated food or other rapidly applied post-harvest measures might be found most appropriate. Where no urgency has been identified, but where there is clear evidence of a link to usage of a certain antimicrobial in animals and where the risk is high, restrictions of use of this antimicrobial (do not use at all, restrict their use in some species or routes of administration or specific production processes) might be considered. In cases where the level of risk is lower, measures such as information campaigns and prudent use recommendations, including improved farm management, might be found more proportionate to the level of risk. Implementation of RMO Paragraphs 76-78: This text seems redundant as it is not specific to AMR-related risks. It is proposed either to delete the paragraphs (including the title) or if kept for completeness of the document the following deletion is proposed: 76. Risk managers should develop an implementation plan that describes how the options will be implemented, by whom, and when. Risk management decisions are implemented by a variety of parties, including government officials, the food chain partners, and consumers. How to implement AMR-RMOs varies according to the food safety issue and its risk characterization, the specific circumstances, and the parties involved. 77. National/regional authorities should ensure an appropriate regulatory framework and infrastructure. Monitoring and surveillance should be supported by regulation and the enforcement of control measures.