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					           Consolidated TFAMR GL draft document – French comments


The French delegation congratulates the US for their work in incorporating the various elements discussed at
the last session of the Task force into one document and is pleased to submit its further comments, focusing
on the parts it was involved in drafting at an earlier stage. As advised by the US delegation, it has tried to
address, the “detail and repetitiveness contained in the current text” by concrete suggestions to make the
current draft more focused and consistent.



    LINES                                            FRENCH COMMENTS

Introduction
10-14              Move sentence before line #24 to reorder matters to improve readability.
121-124            The definition covers both purely preventive use and use in animals where the disease has
                   been diagnosed. The two uses should be treated separately as the risk associated to
                   each use may be different, as well as risk management measures.
193-194            In figure 1, the risk ranking step has disappeared. This may be linked to the changes made
                   in to the part related to abbreviated and complete risk profile. See below.
233-235            Principle 7 should be modified to take into account Microbiological risk management, and
                   other general AMR risk management measures:
                   New proposal: “AMR–risk management activities should include consideration of microbiological risk
                   management measures, General AMR risk management should focus on clearly...”

5. Preliminary risk management activities
GENERAL COMMENTS: The WPRAG advise that risk profiling should be performed before ranking food
safety issues. The risk profile must be used as the basis for further risk management activities, starting with
risk ranking or prioritisation. So, the risk profile would be very general. Due to the complexity of the AMR
issue, it is unlikely that the risk profile will be entirely satisfactory.
The suggested elements in line 285- 295 are based on a specific combination (food commodity+antimicrobial
resistant microorganism+antimicrobial use) and the Appendix 1 “Suggested elements for a AMR risk profile” lists
very specific pieces of information.”
The new draft suggests that an abbreviated risk profile is established first, in order to perform ranking, and
then a comprehensive risk profile after the prioritisation process (but what is the purpose of such a
comprehensive risk profile?).
The outcome still seems rather inconsistent: if the risk profile is focussed on a combination, it seems difficult
to see the need for a ranking. If the risk profile is more general, for ranking to be achieved, a more detailed
risk profile may be needed.
The course of events should be explained more clearly. At this stage, it is unclear how in practice risk
managers can use the current document.
273 - 274             Delete the phrase “and for bringing forward newly proposed work within Codex”, as inconsistent
                      with the section about intended users (line # 52-57), which does not mention Codex work.




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    LINES                                      FRENCH COMMENTS
271 – 284   The issue of incomplete information is mentioned several times in this part of the
            document and the draft could be streamlined to avoid repetition. The “implementation of a
            risk-profile” is a confusing phrase and deletion of the corresponding sentence(s) is also
            suggested.
            “Whenever possible, a comprehensive risk profile should be conducted to minimize the chances of
            important data or information being missed that might influence risk management decisions. In certain
            situations, however, It may be is necessary to develop an abbreviated risk profile that could be used as a
            basis for further preliminary risk management activities. These include prioritizing the development of
            more comprehensive risk profiles or determining the need for commissioning a risk assessment. An
            abbreviated risk profile may be particularly useful for resource challenged countries in determining
            priorities for further activities. Caution should be exercised in implementing these abbreviated risk
            profiles, as they may not provide as complete a picture of the food safety issue as needed for effective
            decision making by the risk managers. The fundamental elements that should comprise an abbreviated
            risk profile include:”
285-295     Line 285-295 should describe the indispensible elements of an abbreviated risk profile ;
            however, one of them is the identification and the characterisation of a combination. which pertain
            to a comprehensive risk profile.
296-308     These two paragraphs are not about risk profile at all: They give an overview of the range
            of possible risk management decisions and they imply a prior judgment on the seriousness
            of the problem; it is suggested to move them down into section 5-5 (possibly after
            line # 315).
310-315     Most of this paragraph essentially repeats what the basic content of a risk profile is
            (compare with lines # 285-295 above) and could be deleted while retaining the first and
            last sentences in order to provide a brief introductory statement for section 5.5. It is
            questionable whether a risk profile provides “criteria” for further decision; it is rather a
            convenient means of presenting available data on the issue at hand.
            The current text could be revised as follows :
            “Given the potentially high resource costs associated with conducting risk assessments and/or implementing
            risk management goals, a risk ranking or prioritization process is important in placing the risks from a
            specific food commodity + antimicrobial resistant microorganism + antimicrobial use combination in
            context with other risk scenarios that require the attention of risk managers. The output from the risk
            profile provides the principal criteria resource that should be used by risk managers in this risk ranking or
            prioritization process.”
316-324     These issues are not to be used in ranking the food safety issues and setting
            priorities for risk assessment, they are to be considered in the evaluation of risk
            management options – see section 7.4; at this early step in the process of risk analysis, it
            seems premature to allows the full range of issues risk managers should consider after they
            have had access to a outcome of the risk assessment, to bear on their decisions at this
            stage. It is suggested to delete these lines.
325-350       GENERAL COMMENT: The notion of “risk management goal” is not found in the
              WPRAG adopted by the CAC. It is questionable whether this section should be
              retained in the text:
326 -340    The beginning (lines # 326 -340) rehearses one more time in slightly different language the
            fact that, at this stage, the risk profile is the critical resource to be used by risk managers
            and that to plug gaps in information is essential. The “other criteria” to be taken into
            account are repeated from the end of the previous section (line # 316-324) and the same
            objection (see comment about lines # 316-324) as to their placement here is relevant.
            Furthermore, the whole section fails to articulate any concrete “broad” goal (and rightly so!
            Initially, the point is always “to protect human health” and remains a critical one
            throughout). This part can be deleted entirely.


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    LINES                                            FRENCH COMMENTS
341-350            The latter part (lines # 341-350) is obviously about policy on commissioning risk
                   assessment (whether or not to commission a risk assessment? And what answers are
                   expected from its outcome?). There is considerable overlap with section 5.8
                   (Commissioning the AMR assessment).
                   Furthermore, this text conveys the impression that preliminary RM activities (which
                   include decision on commissioning a risk assessment) depends on the outcome of a future
                   risk assessment.
                   Furthermore, one has doubts about the relevance of some of the “factors” listed: for
                   instance, how can “the nature and the magnitude of the risk be well characterized” (1st bullet) in
                   advance of the completion of a risk assessment? Overall, these bullets points seem to dilute
                   the basic requirement for a decision on performing risk assessment (and taking the risk
                   management decisions which it would entail), i.e. the protection of human health by
                   ensuring food safety.
                   Deletion of this part would improve the content of this section.
360-362            It is not necessary to insert such a reference, as readers have been already advised to
                   read these GL “in conjunction with” other texts. Moreover, the General principles provide no
                   specific direction about AMR risk analysis, as the wording seems to imply here.
365-367            This sentence about uncertainty is not specific to AMR risk assessment, but similar
                   language is found in Codex WPRAG1. It is suggested to delete the leading clause (“for
                   example”) and to move the sentence up after the end of the text, on line # 359. In
                   this way, the section would comprise now 2 para., one about general requirements and the
                   other about those specific to AMR.
388-392            The 1st sentence is a general requirement for the conduct of risk assessment, which features
                   already in WPRAG; it can either be deleted or added to the para. beginning on lines
                   # 359. The rest of the para. is a reminder of the importance of communication, which is
                   superfluous at this point in view of the insertion in lines # 38-40 (introduction) and the
                   current wording of section 7-10, which specifically addresses communication at this step in
                   the process and can also be deleted..

6. Risk assessment
               GENERAL COMMENT: obviously, there is duplication of texts between section 5.9
               and the intro (untitled) of section 6 and part of section 6.1. A decision should be made
               about which occurrence to retain and which to delete.
405-406        This sentence is unclear: does it allow the risk managers to ignore the outcome of the risk
               assessment they have formally commissioned? Or can they require assessors to evaluate the
               consequences of risk management options in order to facilitate decision on what options
               are to be selected? Only the latter is consistent with WPRAG. The sentence could be
               deleted, because the rationale of risk assessment has been fully described in previous
               sections.
412-413 & 415- “Uncertainty” is mentioned here for the 3rd time (previously in sections 5.7 and 5.9); the
416            “format” for publishing the results of the risk assessment and the “risk estimate” feature
               again here for a second time (see also 5.9).
420-423        This statement duplicates (with improvements) the similar one in line 403-406 and should
               be retained (the 1st para. under Scope could then be deleted).
437-441        This is a requirement for risk managers to follow when commissioning a risk assessment.
               It should be moved up to section 5.7 (possibly after line # 369, as it is specific to AMR
               risk assessment).

1   WPRAG = GL 62/2007

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    LINES                                               FRENCH COMMENTS
527-531           It is suggested to shorten the para., most of its content has already been presented (in some
                  cases, several times):
                  “At the beginning of the work, the specific purpose of the particular AMR-risk assessment being carried
                  out should be clearly stated. The output form and possible output alternatives of the AMR-risk assessment
                  should be defined. The microbiological risk assessment may require a preliminary investigation phase to
                  define and map the work to be undertaken within the framework of the AMR-risk assessment.”
532-541           The reference texts are all mentioned (sometimes twice) in the introduction – see lines #
                  17-23 & lines # 41-48) and reference to specific provisions are made, as appropriate, in the
                  rest of the section. The intent of this introductory paragraph could be adequately
                  captured by a shorter text:
                  “According to the established Working Principles for Risk Analysis for Food Safety for Application by
                  Governments (CAC/GL 62-2007FAO/WHO, 2007), The process of an AMR-risk assessment is
                  composed of Hazard Identification, Exposure Assessment, Hazard Characterization, and Risk
                  Characterization. Exposure Assessment and Hazard Characterization can be conducted in parallel. This
                  proposed process utilizes the Codex microbiological risk assessment guidelines [Canada] (FAO/WHO,
                  1999) and integrates the structured approach described in the OIE guideline (i.e., hazard identification,
                  release assessment, exposure assessment, consequence assessment, and risk estimation) (OIE, Terrestrial
                  Animal Health Code, Chapter 6.8).”
606               Shouldn’t the “microorganisms” be changed to “resistance determinants”? Transfer of a
                  microorganism to a pathogen seems to make little sense.

7. Risk management
736-743       The reference texts are all mentioned (sometimes twice) in the introduction – see lines #
              17-23 & lines # 41-48) and reference to specific provisions are made, as appropriate, in the
              rest of the section. The paragraph should be deleted.
778-781       “As a minimum, existing Codes of Practice should be followed.” The requirement expressed in this
              sentence is not really clear, recalling that Codex CoP should only be implemented to the
              largest extent possible and that, obviously, what is possible ranges widely across time and
              place; further down (line # 807-808), the provisions of CoP are mentioned side by side
              with “additional RMOs” (in Appendix 6) as simply providing a resource for risk managers
              to pick from ; the draft seems to allow for an inconsistency in its articulation between
              provisions in already adopted CoPs and “additional” recommendations in Appendix 6.
              One solution could be to amend the above sentence as follows: “As a minimum, existing
              Codes of Practice should be followed fully implemented.”
814-816       The list of RMOs was established with the understanding that the management measures
              proposed are additional RMOs that are not already contained in existing guidelines. They
              are is no longer identified as such, and this may suggest, incorrectly, that these are the
              preferred RMOs.
              Suggestion to add. “The list of RMO in appendix 6 are RMO that are not already quoted in other
              guidelines.”

7.4. Evaluation of AMR-risk management options – 7.5. Selection of AMR-risk
management options – 7.6. Implementation of AMR-risk management options
GENERAL COMMENT: The redraft on this part of the document, which had been originally prepared by
the French delegation, has followed a more conservative approach than the one suggested by this delegation
in response to the discussion held during the 2nd session of the Task force (2008) the 8); the new version is
now longer than it could have been, but its content is generally acceptable, except in one instance mentioned
below (section 7.5).


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    LINES                                                   FRENCH COMMENTS

7.4. Evaluation of AMR-risk management options
828-832 & 866- Essentially repeats and/or complements text in lines # 828-832; the two could be merged
869            as follows and the issue of risk communication at this step could be addressed by a
               reference to section 7-10. The following text could be replace the introductory
               paragraph of this section :
               “After a range of RMOs have been identified, the next step is to evaluate one or more options should be
               evaluated with respect to their ability to reduce risk and thereby achieve an “appropriate level of protection
               (ALOP)”. The process by which options are evaluated may vary depending on the specific RMOs and their
               impact on different control points in the production-to-consumption continuum. Risk managers should
               establish a process for evaluating RMOs consistent with recommendations in section 7-10 risk
               communicati. A desirable characteristic at all levels is an open process that provides opportunities for
               industry, consumers and other interested parties to provide information, to comment on proposals, and to
               suggest criteria for choosing preferred options. The process by which options are evaluated may vary
               depending on the specific RMOs and their impact on different control points in the production-to-
               consumption continuum.”
               The last paragraph of this section should then be deleted.
870-872        It is questionable whether such a requirement is specific to AMR risk. This sentence
               should be deleted to prevent a contrario readings of other Codex texts, which certainly
               never call for “inflexible” requirements toward industry.

7.5. Selection of AMR-risk management options
It is the strong view of the French delegation that this section misses its point entirely by not providing any
criterion for ranking and selecting among the risk management options, previously identified. In order to
remedy this situation, it will suggest to insert an additional piece of text to this effect :
“An important means of reducing human exposure to antimicrobial resistant organisms through the food chain is to ensure as far
as possible that good hygienic practice and HACCP are being followed (Codex Recommended International Code of Practice –
General principles of food hygiene).
Over and above what can be put in place as good hygienic practice, specific Risk Management Options can address antimicrobial
resistance issues.
It is difficult to define strict rules about how to select the best risk management options. A combination of measures may be
necessary. These measures should be adapted to the level of risk as defined by the risk assessment.
Regarding specific measures about antimicrobial resistance, cross-resistance, co-resistance issues should be considered.
 In case of high level of risk, the following measures may be considered:
    (a) Do not use these drugs at all
    (b) Restrict the use of the antimicrobial drugs in some species or some route of administration or specific production processes
    (c) Use only in individual animals based on culture results and lack of alternative drugs
    (d) Use only in individual animals
    (e) Restrict extra and/or off-label use”
895-902                  Out of place in section 7.5: Setting an ALOP or defining “public health goals” are not part
                         of this step, although they are certainly a prerequisite for it, and indeed for the risk analysis
                         framework as a whole. Furthermore, the existence of an ALOP is already taken for granted
                         at the beginning of section 7.4. This part should be deleted.
909-911                  This paragraph is about risk communication and duplicates what is drafted in the relevant
                         section, further down in the document. It can be deleted.
939-941                  This reference is repeated in lines 950-952. Occurrence in lines #939-941 should be
                         deleted.


                                                                                                                                5/6
    LINES                                          FRENCH COMMENTS
948-952          Although the last of its section, this paragraph presents the rationale for the whole section;
                 it should be move up before line # 936.

Risk communication
Title        The number 8 should be inserted (risk communication being the third component in the
             risk analysis paradigm) and the subsections 7.8 to 8 should be renumbered 8.1 to 8.7

8. Documentation
              This section could be deleted as it duplicates other languages (uncertainty, involvement
              of interested parties…), on issues which are more fully and appropriately discussed
              elsewhere in the document.




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