European Community comments on the. Proposed Draft Guidelines for Risk Analysis of Foodborne Antimicrobial Resistance (CX/AMR 09/3/4)
|
|
- Lesley Cannon
- 5 years ago
- Views:
Transcription
1 European Community comments on the Proposed Draft Guidelines for Risk Analysis of Foodborne Antimicrobial Resistance (CX/AMR 09/3/4) At Step 3 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. 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 1
2 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. ANNEX I 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)" 2
3 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: DALYs 6. " Definitions cited from existing FAO/OIE/WHO documents are referenced as appropriate." 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 3
4 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: 4
5 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 Principle 4: GENERAL PRINCIPLES FOR FOODBORNE AMR-RISK ANALYSIS 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. Principle 6: "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." 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. 5
6 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.. 6
7 Proposal for Figure 1: Framework for AMR-Risk Analysis 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
8 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. 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 8
9 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 9
10 21- 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: Paragraphs 30-31: " Timelines for milestones and completion of the risk assessment and review 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: 10
11 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 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. 11
12 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. 12
13 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. 59. 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. 13
14 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 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 14
15 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. Food crop production 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. 15
16 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 noncompliance at the level of: Sorting Reprocessing Rejection Further investigation. 16
17 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 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: 17
18 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. 78. To effectively execute control measures, food producers and processors generally implement complete food control systems using comprehensive approaches such as Good Manufacturing Practices (GMP), Good Hygiene Practices (GHP), and HACCP systems. These approaches provide a platform to implement specific food safety RMOs as identified and selected by risk managers. 18
19 Monitoring and review of AMR-RMOs The ECMS suggest to condense this section to avoid repetitions and to merge with some information given or repeated in the following chapter on Monitoring and Surveillance. More information is available in CAC/GL The ECMS propose the following revision: 79. National/regional authorities should define a process to monitor and evaluate whether the RMOs have been properly implemented and whether or not an outcome has been successful. or food chain partners should evaluate and effectiveness of RMOs regularly, at a predetermined moment in time, and/or following the emergence of significant new evidence that has the potential to alter the approach to address the AMR food safety issue. This should also include the monitoring and review of the provisional decisions. The effectiveness of the RMOs should be assessed against the specific food safety metrics, or ALOP, or public health goals. Appendix 3 contains suggested endpoints that may be monitored. New 80 (partly from 85). Information from standardized programs designed to monitor the presence of AMR microorganisms and the use of antimicrobials can help establish a baseline against which the effectiveness of RMOs can be measured. New 81. When considering the results of the monitoring of a specific RMO, the effectiveness and appropriateness of the action taken should be reviewed. The risk management measures should also be reviewed when new relevant information becomes available. 80. Monitoring/control points related to specifically implemented RMOs should be measured to assess the effectiveness and need for potential adjustment. Additional monitoring/control points may be measured to identify new information on the specific food safety issue (e.g., emerging hazard, virulence of a pathogen, change in AMR patterns, prevalence and microbial load in foods, sensitivity of sub-populations, or changes in dietary intake patterns). 81. Governments should define an evaluation process to assess whether the RMOs have been properly implemented and an assessment whether or not an outcome has been successful. MONITORING AND SURVEILLANCE OF ANTIMICROBIAL USE AND ANTIMICROBIAL RESISTANT MICROORGANISMS AND DETERMINANTS A clear distinction should be made between the monitoring and review of implemented risk management options and more general programmes. The ECMS suggest to condense this section to avoid repetitions and to move some lines to the section above. The ECMS would like to propose the following revision: New Paragraph 82 (adapted from parts of 82). 82. Programmes to monitoring of the use of antimicrobials and prevalence of antimicrobial resistance provide information that is useful for all parts of the risk analysis process. Data can be used to explore any relationships between antimicrobial use and the prevalence of AMR microorganisms in food and feed, as input for risk profiling and risk assessment, to measure the effect of interventions 19
20 aimed at reducing antimicrobial use, and to identify trends. The level of detail of data collection could be implemented according to the resources available, or as needed to assess the effectiveness of specific RMOs. New Paragraph 83 (partly from 83 & 84). 83. Monitoring schemes programmes should be harmonized (CAC/RCP & GL 63) between countries, to the extent possible. Standardized and validated testing methods are also essential to the ability to use information from such programs. New Paragraph 84 (adapted from 82 & 86). 84. Monitoring of use of antimicrobials should, to the extent possible, include all antimicrobials used in food animal and crop production. Ideally, such monitoring should provide data per animal species or crop. National/regional authorities may use established guidelines such as those described in the OIE Terrestrial Animal Health Code, (Chapter 6.6.), Monitoring of the quantities of antimicrobials used in animal husbandry to collect data on antimicrobial usage in animals, and to the extent relevant also in plant production. (text deleted from 82 and 86: is essential to try to establish the link between the use of an antimicrobial and the prevalence of resistant microorganisms and determinants. For making harmonization in results from assessing the efficacy and comparing the effectiveness of new antimicrobials, referring to a set of standard methods is recommended, or at least it should be stated in the paragraph that standard and valid methods have to be used. of antimicrobial usage in animals should be compatible with existing monitoring programs taking into account relevant aspects of the drug/microorganisms/animal species/food relationship, approved label indications and if appropriate include data collection at the species level and/or category of animal within species. The level of detail of data collection could be implemented in a stepwise fashion proportionate to the risk, as needed to obtain a consumer protection or food safety goal, or as needed to assess the effectiveness of specific RMOs. Authorities should preferably plan the collection and analysis of data on the dissemination of AMR and on antimicrobial usage. AMR data should be analyzed with AM usage data together with other relevant data to assess possible relationships.) 85. Monitoring of antimicrobial resistance in bacteria microorganisms originating from animals, plants and food should ideally be integrated with programs that monitor resistance in humans. National/regional authorities may use established guidelines such as those published in the OIE Terrestrial Animal Health Code, Chapter 6.5., Harmonisation of national AMR surveillance and monitoring programmes to describe key elements of programs to monitor the prevalence of AMR microorganisms in animals and to the extent relevant also and plant production and food.. Standardized and validated testing methods are also essential to the ability to use information from programs designed to monitor the presence of AMR microorganisms. Information from 20
21 these programs can help establish a baseline against which the effectiveness of RMOs can be measured. Appendix 3 contains suggested endpoints that may be monitored for RMOs. The effectiveness of the RMOs should be assessed against the specific food safety metrics and the ALOP or public health goals. 83. A minimum level of monitoring should be established in order to measure usage and risk management effects 86. Understanding the linkage between antimicrobial use and the prevalence of AMR microorganisms in food and feed will allow risk managers the opportunity to further refine or develop new RMOs. National/regional authorities may use established guidelines such as those described in the OIE Terrestrial Animal Health Code, Chapter 6.6., Monitoring of the quantities of antimicrobials used in animal husbandry to collect data on antimicrobial usage. Monitoring antimicrobial use is important in exploring any relationships between antimicrobial use and the prevalence of AMR microorganisms in food and feed, measuring the effect of interventions aimed at reducing antimicrobial use, and identifying trends. RISK COMMUNICATION The section needs to be condensed, removing unnecessary overlaps with other Codex texts while maintaining the general idea and those points that are specific for antimicrobial resistance. Paragraph 87: The ECMS suggest to delete the first phrase of the paragraph to simplify the text. 87. To better define the food safety issue, the risk manager may need to pursue information from sources that have specific knowledge pertaining to the issue. An open process, in which the food safety issue is clearly identified and communicated by the risk managers to risk assessors, as well as affected consumers and industry, is essential to promote both an accurate definition and a well-understood and common perception of the issue. Paragraph 88: To simplify delete the last phrase as this is a reiteration of the previous phrase. 88. Risk communication decision-makers can obtain vital information, provide information, and solicit feedback from interested parties. Communication with all interested parties promotes better understanding of risks and greater understanding on risk management approaches. The great value that communication adds to any risk analysis justifies expanded efforts to ensure that it is an effective part of the process. Paragraph 90: 90. Mechanisms may be established for engaging interested parties routinely in food safety decision-making at the national/regional level in a general way. 21
22 Paragraph 91; The ECMS consider that this paragraph could be simplified as the end is already reflected above under General considerations" and in the second phrase of the paragraph. 91. Risk communication at this stage should consider the key elements of the preliminary risk management activities by the risk managers through the effective interaction with the interested parties. The scope and the extent of the specific AMR food safety issues including the impact on public health should be clearly determined with open communication among all the parties. It is important to obtain the information from multiple sources regarding the specific AMR risk issues including the known and unknown as well as the perception. Communication is also critical among the risk mangers, risk assessors, and the interested parties for activities on development of a risk profile and/or commissioning of a risk assessment in order to provide evidence-based preliminary RMOs, which are also to be communicated timely to the interested and affected parties. Paragraph 96: The ECMS propose a minor drafting change: 96...public awareness on the nature and magnitude of the risk, risks..risks.. Paragraph 97: The text under paragraph 97 does not seem to belong to risk communication but to risk management ; therefore the ECMS suggest its deletion. Paragraph 99: The ECMS suggest adding in The. at the beginning of the first sentence. 99. "The Ffood Industry is responsible " Paragraph 100: The ECMS would like to propose re-wording this paragraph to read: 100. Industry (pharmaceutical, food producer, food processor, etc.) associations may find it beneficial should be encouraged to develop and provide guideline documents, training programs, technical bulletins and other information that assists industry to decrease AMR. Paragraph 102: The ECMS would like to suggest a minor change in the first sentence as follows: 102. Consumers can enhance both responsible for adhering to, keeping aware of and following. 22
AMR in Codex Alimentarius Commission and country responsibilities
FMM/RAS/298: Strengthening capacities, policies and national action plans on prudent and responsible use of antimicrobials in fisheries Final Workshop in cooperation with AVA Singapore and INFOFISH 12-14
and suitability aspects of food control. CAC and the OIE have Food safety is an issue of increasing concern world wide and
forum Cooperation between the Codex Alimentarius Commission and the OIE on food safety throughout the food chain Information Document prepared by the OIE Working Group on Animal Production Food Safety
OIE Strategy on Antimicrobial Resistance and the need for new diagnostic tools
Dr Elisabeth Erlacher-Vindel Head Science and New Technologies Department OIE Strategy on Antimicrobial Resistance and the need for new diagnostic tools 12 th OIE SEMINAR 18 th WAVLD, Sorrento (Italy),
OIE Standards for: Animal identification and traceability Antimicrobials
OIE Standards for: Animal identification and traceability Antimicrobials OIE regional seminar on food safety Singapore, 12-14 October 2010 Yamato Atagi 1 Deputy Head, International Trade Department, OIE
The promise of aquaculture and the challenge of antimicrobial use
The promise of aquaculture and the challenge of antimicrobial use This article is published in two parts. Part 1 identifies the promise of aquaculture and the challenge of antimicrobial use (please see
Dr Elisabeth Erlacher Vindel Head of Science and New Technologies Departement OIE AMR strategy and activities related to animal health
Dr Elisabeth Erlacher Vindel Head of Science and New Technologies Departement OIE AMR strategy and activities related to animal health Regional Workshop for National Focal Points for Veterinary Products
OIE Strategy on Antimicrobial Resistance and the Prudent Use of Antimicrobials in Animals Part I
Dr Elisabeth Erlacher-Vindel Head of the Antimicrobial Resistance and Veterinary Products Department OIE Strategy on Antimicrobial Resistance and the Prudent Use of Antimicrobials in Animals Part I 2nd
OIE strategy on AMR and the Prudent Use of Antimicrobials
Dr. Jocelyn Mérot OIE Sub-Regional Representation for North Africa OIE strategy on AMR and the Prudent Use of Antimicrobials 14th JPC REMESA 19-20 July 2017 Naples (Italy) The OIE Strategy on AMR and the
OIE Standards on biosecurity and compartmentalisation
OIE Standards on biosecurity and compartmentalisation Dr. Etienne Bonbon Vice-President, OIE Terrestrial Animal Health Code Commission Scientific Counsellor, EU Delegation to the International Organisations
CODE OF PRACTICE TO MINIMIZE AND CONTAIN ANTIMICROBIAL RESISTANCE CAC/RCP Adopted 2005
CODE OF PRACTICE TO MINIMIZE AND CONTAIN ANTIMICROBIAL RESISTANCE CAC/RCP 61-2005 Adopted 2005 CAC/RCP 61-2005 2 1. INTRODUCTION 2. AIMS AND OBJECTIVES 3. RESPONSIBILITIES OF THE REGULATORY AUTHORITIES
OIE Resolution and activities related to the Global Action Plan. Regional Seminar for OIE National Focal Points for Veterinary Products 4 th Cycle
Dr Elisabeth Erlacher Vindel Deputy Head of the Scientific and Technical Departement World Organisation for Animal Health (OIE) OIE Resolution and activities related to the Global Action Plan Regional
International Food Safety Authorities Network (INFOSAN) Antimicrobial Resistance from Food Animals
International Food Safety Authorities Network (INFOSAN) 7 March 2008 INFOSAN Information Note No. 2/2008 - Antimicrobial Resistance Antimicrobial Resistance from Food Animals SUMMARY NOTES Antimicrobial
National Action Plan development support tools
National Action Plan development support tools Sample Checklist This checklist was developed to be used by multidisciplinary teams in countries to assist with the development of their national action plan
OIE Standards for Animal feed and food safety: terrestrial and aquatic animals
OIE Standards for Animal feed and food safety: terrestrial and aquatic animals OIE regional seminar on food safety Singapore, 12-14 October 2010 Yamato Atagi 1 Deputy Head, International Trade Department,
Draft ESVAC Vision and Strategy
1 2 3 7 April 2016 EMA/326299/2015 Veterinary Medicines Division 4 5 6 Draft Agreed by the ESVAC network 29 March 2016 Adopted by ESVAC 31 March 2016 Start of public consultation 7 April 2016 End of consultation
The impact of Good Veterinary Services Governance (GVSG) on the control over Veterinary Medicinal Products (VMP s)
The impact of Good Veterinary Services Governance (GVSG) on the control over Veterinary Medicinal Products (VMP s) The evaluation of Good Veterinary Governance with the OIE Performance of Veterinary Services
HMA-V Action plan on antimicrobial issues Version for publication (27 January 2011)
HMA-V Action plan on antimicrobial issues Version for publication (27 January 2011) 1. Introduction Antimicrobial resistance (AMR) is considered to be a major global public health concern and a potential
OIE Activities for the Containment of Antimicrobial Resistance. Dr Elisabeth Erlacher-Vindel, Deputy Head of the Scientific and Technical Department
OIE Activities for the Containment of Antimicrobial Resistance Dr Elisabeth Erlacher-Vindel, Deputy Head of the Scientific and Technical Department Contents Introduction OIE International Standards OIE
in food safety Jean-Luc ANGOT CVO France
The role of OIE and Veterinary Services in food safety Jean-Luc ANGOT CVO France «Evolving Veterinary Education for a safer World» 13th october 2009 OIE s Objectives Transparency : ensure transparency
The OIE Relevant Standards and Guidelines for Veterinary Medicinal Products
The OIE Relevant Standards and Guidelines for Veterinary Medicinal Products REGIONAL SEMINAR OIE NATIONAL FOCAL POINTS FOR VETERINARY PRODUCTS EZULWINI, SWAZILAND, 6-8 DECEMBER 2017 Dr Mária Szabó OIE
Combat Antimicrobial Resistance
Dr Hirofumi Kugita OIE Regional Representation for Asia and the Pacific Overview of OIE Activities to Combat Antimicrobial Resistance Workshop on Development of Surveillance Framework for Antimicrobial
CODE OF PRACTICE TO MINIMIZE AND CONTAIN ANTIMICROBIAL RESISTANCE
CODE OF PRACTICE TO MINIMIZE AND CONTAIN ANTIMICROBIAL RESISTANCE CAC/RCP 61-2005 INTRODUCTION 206 AIMS AND OBJECTIVES 206 RESPONSIBILITIES OF THE REGULATORY AUTHORITIES 208 Quality control of antimicrobial
Antimicrobial Resistance Direction Statement for Animals and Plants, and Work Programme
Antimicrobial Resistance Direction Statement for Animals and Plants, and Work Programme MPI Discussion Paper No: 2016/10 ISBN No: 978-1-77665-185-0 (online) ISSN No: 2253-3907 (online) February 2016 Disclaimer
The EFSA s BIOHAZ Panel perspective on food microbiology and hygiene
The EFSA s BIOHAZ Panel perspective on food microbiology and hygiene Dr Eirini Tsigarida Unit of Biological Hazards BIOHAZ Unit: Marta Hugas, Bart Goossens, Tobin Robinson, Fulvio Barizzone, Luis Vivas-
JOINT FAO/WHO FOOD STANDARDS PROGRAMME CODEX ALIMENTARIUS COMMISSION. Thirty third Session Geneva, Switzerland, 5-9 July 2010
E ALINORM 10/33/42 October 2009 JOINT FAO/WHO FOOD STANDARDS PROGRAMME CODEX ALIMENTARIUS COMMISSION Thirty third Session Geneva, Switzerland, 5-9 July 2010 REPORT OF THE THIRD SESSION OF THE CODEX AD
Council of the European Union Brussels, 13 June 2016 (OR. en)
Council of the European Union Brussels, 13 June 2016 (OR. en) 9952/16 SAN 241 AGRI 312 VETER 58 NOTE From: To: General Secretariat of the Council Council No. prev. doc.: 9485/16 SAN 220 AGRI 296 VETER
WHO perspective on antimicrobial resistance
WHO perspective on antimicrobial resistance Bernadette Abela-Ridder, DVM, MSc, PhD Global Foodborne Infections Network (GFN) Coordinator Department of Food Safety and Zoonoses (FOS) 1 Overview of presentation
Role and responsibilities of the veterinarian in the aquatic sector The OIE perspective
Role and responsibilities of the veterinarian in the aquatic sector The OIE perspective Caring for health and welfare of fish: A critical success factor for aquaculture FVE Conference Brussels (Belgium),
EU strategy to fight against Antimicrobial Resistance
EU strategy to fight against Antimicrobial Resistance OECD workshop on the Economics of Antimicrobial Use in the Livestock Sector and Development of Antimicrobial Resistance Paris, 12 October 2015 Martial
international news RECOMMENDATIONS
The Third OIE Global Conference on Veterinary Education and the Role of the Veterinary Statutory Body was held in Foz do Iguaçu (Brazil) from 4 to 6 December 2013. The Conference addressed the need for
RESPONSIBLE ANTIMICROBIAL USE
RESPONSIBLE ANTIMICROBIAL USE IN THE CANADIAN CHICKEN AND TURKEY SECTORS VERSION 2.0 brought to you by: ANIMAL NUTRITION ASSOCIATION OF CANADA CANADIAN HATCHERY FEDERATION CANADIAN HATCHING EGG PRODUCERS
Prudent use of antimicrobial agents Dairy Sector Initiatives. Robin Condron Dairy Australia
Prudent use of antimicrobial agents Dairy Sector Initiatives Robin Condron Dairy Australia INTERNATIONAL DAIRY FEDERATION Our mission To represent the dairy sector as a whole at international level, by
Dr Stuart A. Slorach
Dr Stuart A. Slorach Chairperson, Codex Alimentarius Commission 2003-2005 Chairman, OIE Animal Production Food Safety Working Group Workshop for OIE Focal Points on Animal Production Food Safety, Tunisia,4-6
Promoting One Health : the international perspective OIE
Promoting One Health : the international perspective OIE Integrating Animal Health & Public Health: Antimicrobial Resistance SADC SPS Training Workshop (Animal Health) 29-31 January 2014 Gaborone, Botwana
CHAPTER 3.3. VETERINARY LEGISLATION
1 Annex 30 s CHAPTER 3.3. VETERINARY LEGISLATION The EU thanks the OIE Terrestrial Animal Health Standard Commission for its work, and welcomes this initiative to improve the structure and consistency
( ) Page: 1/8 COMMUNICATION FROM THE WORLD ORGANISATION FOR ANIMAL HEALTH (OIE)
14 March 2017 (17-1466) Page: 1/8 Committee on Sanitary and Phytosanitary Measures Original: English/French/Spanish 68 TH MEETING OF THE SPS COMMITTEE COMMUNICATION FROM THE WORLD ORGANISATION FOR ANIMAL
OIE Regional Commission for Europe Regional Work Plan Framework Version adopted during the 85 th OIE General Session (Paris, May 2017)
OIE Regional Commission for Europe Regional Work Plan Framework 2017-2020 Version adopted during the 85 th OIE General Session (Paris, May 2017) Chapter 1 - Regional Directions 1.1. Introduction The slogan
Antimicrobial resistance: the challenges for animal health
Elisabeth Erlacher Vindel Deputy Head of the Scientific and Technical Departement World Organisation for Animal Health (OIE) Antimicrobial resistance: the challenges for animal health Rabat, 17 Feb. 2015
GLOBAL PERSPECTIVES ON ANTIMICROBIAL RESISTANCE IN THE FOOD CHAIN. Sarah M Cahill, Patricia Desmarchelier, Vittorio Fattori, Andrew Cannavan
GLOBAL PERSPECTIVES ON ANTIMICROBIAL RESISTANCE IN THE FOOD CHAIN Sarah M Cahill, Patricia Desmarchelier, Vittorio Fattori, Andrew Cannavan One Health and AMR at FAO FAO calls for a One Health and food
American Veterinary Medical Association
A V M A American Veterinary Medical Association 1931 N. Meacham Rd. Suite 100 Schaumburg, IL 60173-4360 phone 847.925.8070 800.248.2862 fax 847.925.1329 www.avma.org March 31, 2010 Centers for Disease
Global capacity for sustainable surveillance of emerging zoonoses
IOM, June 2008 Washington, DC Alejandro B Thiermann President, Terrestrial Animal Health Code Commission World Organization for Animal Health Global capacity for sustainable surveillance of emerging zoonoses
21st Conference of the OIE Regional Commission for Europe. Avila (Spain), 28 September 1 October 2004
21st Conference of the OIE Regional Commission for Europe Avila (Spain), 28 September 1 October 2004 Recommendation No. 1: Recommendation No. 2: Recommendation No. 3: Contingency planning and simulation
REPORT ON THE ANTIMICROBIAL RESISTANCE (AMR) SUMMIT
1 REPORT ON THE ANTIMICROBIAL RESISTANCE (AMR) SUMMIT The Department of Health organised a summit on Antimicrobial Resistance (AMR) the purpose of which was to bring together all stakeholders involved
Antimicrobial Stewardship in Food Animals in Canada AMU/AMR WG Update Forum 2016
Antimicrobial Stewardship in Food Animals in Canada AMU/AMR WG Update Forum 2016 What is Antimicrobial Stewardship? Conserving the effectiveness of existing treatments through infection prevention and
Stuart Slorach Chair, OIE Working Group on Animal Production Food Safety. Cooperation between the OIE and Codex: OIE perspective
Stuart Slorach Chair, OIE Working Group on Animal Production Food Safety Cooperation between the OIE and Codex: OIE perspective Regional Seminar for OIE National Focal Points for Animal Production Food
OIE standards on the use of antimicrobials and antimicrobial resistance monitoring
Caroline Planté Sub-Regional Representation in Brussels OIE standards on the use of antimicrobials and antimicrobial resistance monitoring OIE Regional Seminar on Food Safety Sofia, Bulgaria, 22-24 April
OIE STANDARDS ON VETERINARY SERVICES ( ), COMMUNICATION (3.3), & LEGISLATION (3.4)
OIE STANDARDS ON VETERINARY SERVICES (3.1-3.2), COMMUNICATION (3.3), & LEGISLATION (3.4) Ronello Abila Sub-Regional Representative for South-East Asia 1 2 CHAPTER 3.1 VETERINARY SERVICES The Veterinary
Recognition of Export Controls and Certification Systems for Animals and Animal Products. Guidance for Competent Authorities of Exporting Countries
Recognition of Export Controls and Certification Systems for Animals and Animal Products Guidance for Competent Authorities of Exporting Countries Disclaimer This guidance does not constitute, and should
Resolution adopted by the General Assembly on 5 October [without reference to a Main Committee (A/71/L.2)]
United Nations A/RES/71/3 General Assembly Distr.: General 19 October 2016 Seventy-first session Agenda item 127 Resolution adopted by the General Assembly on 5 October 2016 [without reference to a Main
14th Conference of the OIE Regional Commission for Africa. Arusha (Tanzania), January 2001
14th Conference of the OIE Regional Commission for Africa Arusha (Tanzania), 23-26 January 2001 Recommendation No. 1: The role of para-veterinarians and community based animal health workers in the delivery
Responsible Use of Veterinary Products. Bettye K. Walters, DVM
Responsible Use of Veterinary Products Bettye K. Walters, DVM Bettye.walters@fda.hhs.gov Pertinent International Resources Organization for Economic Co-Operation and Development (OECD) Understanding the
Initiatives for Addressing Antimicrobial Resistance in the Environment. Executive Summary
Initiatives for Addressing Antimicrobial Resistance in the Environment Executive Summary This executive summary highlights key themes from a scientific white paper and discussion at the International Environmental
OIE Standards on Veterinary Legislation: Chapter 3.4 of the OIE Terrestrial Animal Health Code
Dr David Sherman, Coordinator Veterinary Legislation Support Programme (VLSP) OIE Standards on Veterinary Legislation: Chapter 3.4 of the OIE Terrestrial Animal Health Code REGIONAL SEMINAR FOR MEMBER
Highlights on Hong Kong Strategy and Action Plan on Antimicrobial Resistance ( ) (Action Plan)
香港藥學會 The Pharmaceutical Society of Hong Kong Kowloon G.P.O. Box 73552, Yau Ma Tei, Kowloon, Hong Kong Society s Fax: (852) 2376-3091 E-mail: pharmacist@pshk.hk Websites: http://pshk.hk Highlights on Hong
OIE Strategy for Veterinary Products and Terms of Reference for the OIE National Focal Points
OIE Strategy for Veterinary Products and Terms of Reference for the OIE National Focal Points Dr Elisabeth Erlacher-Vindel, Deputy Head of the Scientific and Technical Department OIE Strategy for Veterinary
Science Based Standards In A Changing World Canberra, Australia November 12 14, 2014
Science Based Standards In A Changing World Canberra, Australia November 12 14, 2014 Dr. Brian Evans Deputy Director General Animal Health, Veterinary Public Health and International Standards SEMINAR
Public consultation on Proposed Revision of the Australian Code of Practice for the Care and Use of Animals for Scientific Purposes 2004
RESEARCH INTEGRITY Animal Ethics Committee Web: http://sydney.edu.au/research_support/ethics Project Officer Australian code of practice for the care and use of animals for scientific purposes Health and
V E T E R I N A R Y C O U N C I L O F I R E L A N D ETHICAL VETERINARY PRACTICE
V E T E R I N A R Y C O U N C I L O F I R E L A N D ETHICAL VETERINARY PRACTICE ETHICAL VETERINARY PRACTICE The term Ethical Veterinary Practice is a wide ranging one, implying as it does, compliance with
Committee for Medicinal Products for Veterinary Use (CVMP) Work Plan 2018
7 December 2017 Committee for Medicinal Products for Veterinary Use (CVMP) Committee for Medicinal Products for Veterinary Use (CVMP) Work Plan 2018 Chairpersons Chair: D. Murphy Status Adopted in December
OIE Tool for the Evaluation of Performance of Veterinary Services (OIE PVS Tool)
OIE Tool for the Evaluation of Performance of Veterinary Services (OIE PVS Tool) Fourth edition, 2009 OIE Tool for the Evaluation of Performance of Veterinary Services Fourth Edition, 2009 Printed at the
OIE AMR Strategy, One Health concept and Tripartite activities
Dr Mária Szabó Chargée de mission OIE AMR Strategy, One Health concept and Tripartite activities Training Seminar for Middle East Focal Points for Veterinary Products Beirut, Lebanon 2017 Summary OIE strategy
GOOD GOVERNANCE OF VETERINARY SERVICES AND THE OIE PVS PATHWAY
GOOD GOVERNANCE OF VETERINARY SERVICES AND THE OIE PVS PATHWAY Regional Information Seminar for Recently Appointed OIE Delegates 18 20 February 2014, Brussels, Belgium Dr Mara Gonzalez 1 OIE Regional Activities
Managing AMR at the Human-Animal Interface. OIE Contributions to the AMR Global Action Plan
Managing AMR at the Human-Animal Interface OIE Contributions to the AMR Global Action Plan 6th Asia-Pacific Workshop on Multi-Sectoral Collaboration for the Prevention and Control of Zoonoses Dr Susan
Activities of the Tripartite on Antimicrobial Resistance (FAO-OIE-WHO)
Awa AIDARA-KANE Coordinator Foodborne Diseases and Zoonosis Unit, WHO Activities of the Tripartite on Antimicrobial Resistance (FAO-OIE-WHO) On behalf of the Tripartite Technical Focal Points One Health
Responsible use of antimicrobials in veterinary practice
Responsible use of antimicrobials in veterinary practice Correct antimicrobial: as little as possible, as much as necessary This document provides more information to accompany our responsible use of antimicrobials
The OIE s Codes, Manuals and associated standards
The OIE s Codes, Manuals and associated standards Standard setting implementation and mechanisms used Participation of Member countries Training Seminar for OIE Delegates from Europe Lyon, 5-6 November
GENERAL COMMENTS COSTA RICA
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,
Approved by the Food Safety Commission on September 30, 2004
Approved by the Food Safety Commission on September 30, 2004 Assessment guideline for the Effect of Food on Human Health Regarding Antimicrobial- Resistant Bacteria Selected by Antimicrobial Use in Food
ASEAN GOOD ANIMAL HUSBANDRY PRACTICES FOR PIGS
1 Adopted at the 40 th AMAF Meeting 11 October 2018 Ha Noi, Viet Nam ASEAN GOOD ANIMAL HUSBANDRY PRACTICES FOR PIGS ASEAN SECTORAL WORKING GROUP ON LIVESTOCK 2018 2 ASEAN GOOD ANIMAL HUSBANDRY PRACTICES
Development and improvement of diagnostics to improve use of antibiotics and alternatives to antibiotics
Priority Topic B Diagnostics Development and improvement of diagnostics to improve use of antibiotics and alternatives to antibiotics The overarching goal of this priority topic is to stimulate the design,
of Conferences of OIE Regional Commissions organised since 1 June 2013 endorsed by the Assembly of the OIE on 29 May 2014
of Conferences of OIE Regional Commissions organised since 1 June 2013 endorsed by the Assembly of the OIE on 29 May 2014 2 12 th Conference of the OIE Regional Commission for the Middle East Amman (Jordan),
COMMISSION NOTICE Guidelines for the prudent use of antimicrobials in veterinary medicine (2015/C 299/04) Table of Contents
11.9.2015 EN Official Journal of the European Union C 299/7 COMMISSION NOTICE Guidelines for the prudent use of antimicrobials in veterinary medicine (2015/C 299/04) Table of Contents Introduction... 7
Veterinary antimicrobials: state of play and future developments 2013 European Medicines Agency/IFAH- Europe Info Day 7-8 March 2013
Veterinary antimicrobials: state of play and future developments 2013 European Medicines Agency/IFAH- Europe Info Day 7-8 March 2013 Mario Nagtzaam, SANCO D6 Political commitments as to addressing AMR
Overview of the OIE PVS Pathway
Overview of the OIE PVS Pathway Regional Seminar for OIE National Focal Points for Animal Production Food Safety Hanoi, Vietnam, 24-26 June 2014 Dr Agnes Poirier OIE Sub-Regional Representation for South-East
Surveillance. Mariano Ramos Chargé de Mission OIE Programmes Department
Mariano Ramos Chargé de Mission OIE Programmes Department Surveillance Regional Table Top Exercise for Countries of Middle East and North Africa Tunisia; 11 13 July 2017 Agenda Key definitions and criteria
World Organisation for Animal Health
World Organisation for Animal Health 2017 Progressive Actions for Achievement of global health security Dr Susan Corning BA MSc BVSc MRCVS FRSPH Global Health Security Agenda Steering Group Meeting Geneva,
OIE Aquatic Animal Health Code and Manual of Diagnostic Tests for Aquatic Animals
Workshop for OIE National Focal Points for Aquatic Animals Lisbon, Portugal 9 11 April 2013 Gillian Mylrea OIE Aquatic Animal Health Code and Manual of Diagnostic Tests for Aquatic Animals - trade facilitating
Human Food Safety of Veterinary Drugs. Bettye K. Walters, DVM
Human Food Safety of Veterinary Drugs Bettye K. Walters, DVM Bettye.walters@fda.hhs.gov Pertinent International Resources Organization for Economic Co-Operation and Development (OECD) Understanding the
Recommendation for the basic surveillance of Eudravigilance Veterinary data
1 2 3 25 May 2010 EMA/CVMP/PhVWP/471721/2006 Veterinary Medicines and Product Data Management 4 5 6 Recommendation for the basic surveillance of Eudravigilance Veterinary data Draft 7 Draft agreed by Pharmacovigilance
Consultation on a draft Global action plan to address antimicrobial resistance
Consultation on a draft Global action plan to address antimicrobial resistance The questionnaire is divided into four sections. The questions are broadly framed and intended to give you the opportunity
Guide to Preparation of a Site Master File for Breeder/Supplier/Users under Scientific Animal Protection Legislation
Guide to Preparation of a Site Master File for Breeder/Supplier/Users under Scientific Animal Protection AUT-G0099-5 21 DECEMBER 2016 This guide does not purport to be an interpretation of law and/or regulations
NAP on AMR: Singapore
FMM/RAS/298: Strengthening capacities, policies and national action plans on prudent and responsible use of antimicrobials in fisheries Final Workshop in cooperation with AVA Singapore and INFOFISH 12-14
Stray Dog Population Control
Stray Dog Population Control Terrestrial Animal Health Code Chapter 7.7. Tikiri Wijayathilaka, Regional Project Coordinator OIE RRAP, Tokyo, Japan AWFP Training, August 27, 2013, Seoul, RO Korea Presentation
The PVS Tool. Part 4. Introduction to the concept of Fundamental Components and Critical Competencies
Part 4 The PVS Tool Introduction to the concept of Fundamental Components and Critical Competencies Training Seminar on the OIE PVS Tool for East Asia Seoul, Republic of Korea, 26 28 April 2016 The PVS
The OIE Terrestrial and Aquatic Animal Health Codes
OIE Focal Point Seminar on Veterinary Products Vienna, Austria, November 20-22 2012 The OIE Terrestrial and Aquatic Animal Health Codes N. Leboucq OIE sub-regional Representative in Brussels 1 OIE s International
Antimicrobial Resistance at human-animal interface in the Asia-Pacific Region
Antimicrobial Resistance at human-animal interface in the Asia-Pacific Region Gyanendra Gongal Scientist International Health and Regulations Health Security and Emergency Response WHO South-East Asia
OIE PVS Pathway including Veterinary Education
OIE PVS Pathway including Veterinary Education OIE Global Conference on the Prudent Use of Antimicrobial Agents for Animals: International Solidarity to Fight against Antimicrobial Resistance Paris (France)
Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(b) thereof,
14.10.2003 L 262/17 DIRECTIVE 2003/74/EC OF THE EUROPEAN PARLIAMT AND OF THE COUNCIL of 22 September 2003 amending Council Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain
Building Competence and Confidence. The OIE PVS Pathway
Dr. Alain Dehove (OIE) Coordinator of the World Animal Health and Welfare Fund Building Competence and Confidence The OIE PVS Pathway OIE Global Conference on Wildlife Animal Health and Biodiversity -
OIE international standards on Rabies:
Regional cooperation towards eradicating the oldest known zoonotic disease in Europe Antalya, Turkey 4-5 December 2008 OIE international standards on Rabies: Dr. Lea Knopf Scientific and Technical Department
COMMISSION OF THE EUROPEAN COMMUNITIES
COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 22 December 2005 COM (2005) 0684 REPORT FROM THE COMMISSION TO THE COUNCIL ON THE BASIS OF MEMBER STATES REPORTS ON THE IMPLEMENTATION OF THE COUNCIL RECOMMENDATION
REGULATION (EC) No 854/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004
30.4.2004 EN Official Journal of the European Union L 155/206 REGULATION (EC) No 854/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 laying down specific rules for the organisation
Introduction to Biorisk and the OIE Standard
Introduction to Biorisk and the OIE Standard World Association of Veterinary Laboratory Diagnosticians 18 th International Symposium, Sorrento, Italy 7 th -10 th June 2017 2015 Dr. Anthony Fooks Member,
Guidance Document. Veterinary Operating Instructions. Guidance re: Requirements for Authorising Veterinarians Notice.
Guidance Document Veterinary Operating Instructions Guidance re: Requirements for Authorising Veterinarians Notice 28 August 2015 A guidance document issued by the Ministry for Primary Industries Title
Government Initiatives to Combat Antimicrobial Resistance (AMR)
Government Initiatives to Combat Antimicrobial Resistance (AMR) in the Philippines Ma. Virginia G. Ala, MD, MPH, CESO III Director IV and Program Manager National Center for Pharmaceutical Access and Management,
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
2003L0099 EN 01.01.2007 001.001 1 This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents B DIRECTIVE 2003/99/EC OF THE EUROPEAN PARLIAMENT
International approach for veterinary medicinal products: OIE and Codex alimentarius
Dr Catherine Lambert OIE, AFSSA/ANMV Collaborating Centre for Veterinary medicinal products BP 90203-35302 FOUGERES CEDEX, FRANCE c.lambert@anmv.afssa.fr International approach for veterinary medicinal
OIE SUB-REGIONAL TRAINING SEMINAR ON VETERINARY LEGISLATION FOR OIE FOCAL POINTS
OIE SUB-REGIONAL TRAINING SEMINAR ON VETERINARY LEGISLATION FOR OIE FOCAL POINTS The OIE Terrestrial Animal Health Code, Quality of Vterinary Services, PVS Pathway and Global Veterinary Legislation Initiative
RESEARCH ETHICS UCD. Use of Animals for Research & Teaching POLICY. Version: 5
Use of Animals for Research & Teaching POLICY Version: 5 TABLE OF CONTENTS 1. INTRODUCTION..3 2. PURPOSE & SCOPE...3 3. STATUTORY REQUIREMENTS...3 4. INSTITUTIONAL ETHICAL REQUIREMENT.4 5. CORE PRINCIPLES
YOU YOU WE NEED. To implement the new Antimicrobial Resistance campaign TO HANDLE ANTIMICR BIALS WITH CARE. October Veterinary Services
Veterinary Services To implement the new Antimicrobial Resistance campaign October 07 OIE-AMR-Veterinary-Services-8P-V.indd 4/0/07 3:47 To implement the new AMR communication campaign Misuse and overuse