u.s. codex program draft positions on tfamr...− who integrated surveillance on antimicrobial...

UNITED STATES DELEGATION

TO THE 6th SESSION OF THE AD HOC CODEX INTERGOVERNMENTAL

TASKFORCE ON ANTIMICROBIAL RESISTANCE

10-14 December 2018 Busan, Republic of Korea

DRAFT POSITIONS

AD HOC CODEX INTERGOVERNMENTAL TASK FORCE ON ANTIMICROBIAL RESISTANCE (AMR)

6 T H SES SIO N December 10-14, 2018

Busan, Repu bl ic of K orea

Location: Paradise Hotel Busan, Busan, Republic of Korea Start time: Monday, December 10 at 9:30 am

U.S. Delegation:Donald Prater, Delegate Neena Anandaraman, Alternate Delegate James Adaskaveg, University of California (UC Riverside) Marielsie Avila, Foreign Agricultura Service (USDA-FAS) John Brooks, Agricultural Research Service (USDA-ARS) Michael Costin, American Veterinary Medical Association (AVMA) James Cranney, California Citrus Quality Council Julius Fajardo, USDA Office of Pest Management Policy Nicholas Gardner, U.S. Dairy Export Council (USDEC) Kenneth Lowery, U.S. Codex Office Ron Miller, Food and Drug Administration (FDA) Randall Singer, University of Minnesota Liz Wagstrom, National Pork Producers Council (NPPC) Leah Wilkinson. American Feed Industry Association (AFIA)

Working documents for each agenda item, as well as practical information related to TFAMR will be made available at the session Website meeting page at http://www.fao.org/fao-who-codexalimentarius/meetings/detail/en/?meeting=TFAMR&session=6

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http://www.fao.org/fao-who-codexalimentarius/meetings/detail/en/?meeting=TFAMR&session=6

http://www.fao.org/fao-who-codexalimentarius/meetings/detail/en/?meeting=TFAMR&session=6




Agenda Item 1 CX/AMR 18/6/1 -REV

ADOPTION OF THE AGENDA

DRAFT U.S. POSITION

The United States agrees with the order of the Agenda Items, as proposed.

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6 T H SES SIO N December 10 -14, 2018


Agenda Item 2 CX/AMR 18/6/2

MATTERS REFERRED TO THE COMMITTEE BY THE CODEX ALIMENTARIUS COMMISSION AND ITS SUBSIDIARY BODIES

DRAFT U.S. POSITION

This content of this paper is informational, and the Task Force is invited to note the information.

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Agenda Item 3 CX/AMR 18/6/3

MATTERS ARISING FROM FAO, WHO AND OIE INCLUDING THE REPORT OF THE JOINT FAO/WHO EXPERT MEETING (IN COLLABORATION WITH OIE) ON FOODBORNE

ANTIMICROBIAL RESITANCE

DRAFT U.S. POSITION

This Paper is entirely informational in nature.

The paper contains sections on:

− UN Food and Agriculture Organization (FAO)/World HealthOrganization (WHO) (in collaboration with the World Organization forAnimal Health, OIE) Scientific Advice to Codex Part 1

− FAO/WHO/OIE tripartite activities on foodborne AMR − United Nations Interagency Coordination Group on AMR (IACG) − Global Development and Stewardship Framework to Combat Antimicrobial

Resistance − Tripartite Integrated Surveillance System on AMR/AMU (TISSA) − Monitoring of the Global Action Plan on AMR − Other related matters arising from FAO, WHO and OIE − Awareness raising and development of National Action Plans − WHO Integrated Surveillance on Antimicrobial Resistance in Foodborne Bacteria

and the Global AMR Surveillance System (GLASS) − Use of medically important antimicrobials in the food chain – WHO list of Critically

Important Antimicrobials for Human Medicine (WHO CIA List) − WHO work on AMR in the environment with links to food production − World Organization for Animal Health (OIE)

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AGENDA ITEM No. 4 CX/AMR 18/6/4

MATTERS ARISING FROM RELEVANT INTERNATIONAL ORGANIZATIONS

This Paper contains Information relevant to the work of the Ad HocIntergovernmental Task Force on Antimicrobial Resistance.

The paper is for information purposes only and contains sections work carried out by the:

− Organization for Economic Cooperation and Development (OECD) − World Bank − World Customs Organization (WCO) − World Trade Organization (WTO)




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PROPOSED DRAFT REVISION OF THE CODE OF PRACTICE TO MINIMIZE AND CONTAIN FOODBORNE ANTIMICROBIAL RESISTANCE (CXC 61-2205)

Background

The 5th Session of the Ad Hoc Intergovernmental Task Force on Antimicrobial Resistance (TFAMR05, 2017) agreed to establish an electronic working group (EWG) to further revise the Code of Practice to Minimize and Contain AMR (COP) for comments by Codex membersand observers and consideration at TFAMR06. The EWG was chaired by the United Statesof America and co-chaired by China, Chile, Kenya, and the United Kingdom, and worked in English and Spanish. The terms of reference (TORs) of the EWG are included in Appendix IIof REP17/AMR.

In addition, at the request of the 40th Session of the Codex Alimentarius Commission (CAC40, 2017), the FAO/WHO Expert Meeting on Foodborne Antimicrobial Resistance:Role of the Environment, Crops and Biocides took place in June 2018. The purpose of the expert meeting was to provide scientific advice to inform the work of the Task Force in the aforesaid areas. In July 2018, FAO and WHO published the summary report of the expert ting on their respective websites. The TFAMR is awaiting publication of the finalreport.

Draft U.S. Positions

The United States appreciates the work of the EWG and the co-chairs Chile,China, Kenya and the United Kingdom, in particular with respect to the manycomments received and reconciliation of many suggestions in the revisedtext. We believe the draft continues to improve and contains valuable contributions to minimize and contain antimicrobial resistance.

Mandate of Codex Alimentarius: In order to provide appropriate guidance and focus on the value of Codex to the overall AMR effort, we believe it isimportant to maintain the focus on foodborne AMR. The United States is

One Health Approach while staying within the mandate of Codex. proposing revisions throughout the draft EWG document to help reflect the

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Science-based, risk-based: The Code of Practice (COP) should be science-based and provide guidance that may be applied proportionate to the risk.In several places, we have revised or suggested text that appropriately focuson risk rather than solely on the hazard. This is consistent with the Guidelines for Risk Analysis of Foodborne Antimicrobial Resistance (CXG-077). We have suggested deletion of measures where we believe soundscientific evidence does not support them.

appropriate definition.

Crops vs. plants: This is an overarching issue in both the COP andGuidelines on Integrated Surveillance (GLIS). We note the term “crops” isused in CXG-077 and this is the term that should be used in the COP, with an

Biocides: We concur with the EWG decision to exclude biocides from the scope of work. We further note the FAO/WHO 2018 Expert Group in itssummary report states that while there is a theoretical risk of AMR co-selection, there is an absence of empirical data to indicate that the use ofbiocides drives co-selection under the conditions present in the food production or processing environments (Hardy et al. , 2018; Bas et al. , 2017).

Definitions: We support the inclusion of definitions for: AMR food safetyissue, medically important antimicrobials (as revised), crop advisor andconsultant, and therapeutic use. We believe these are essential terms for the risk management advice contained in the COP.

Principle 2: We support deletion of the footnote because it is not anexhaustive list, some products may not have a clear regulatory pathway, and some products are described above as outside the scope of the document.

Principle 5: We believe this principle could be further revised for clarity.We further believe the definition of medically important antimicrobials isessential for implementation of this principle.

Principle 16: We recommend deletion of this principle. The “RRR” strategy is not broadly understood. As we understand it , many elements of the RRR

from Principle 8 in CAC/GL 77 could be inserted to help address the need tobalance for animal health needs.

strategy are already contained with the document. Alternatively, language

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Responsible and prudent use of antimicrobial agents: We believe thissection should be science-based, practical and feasible, stay within themandate of Codex, and include measures that are proportionate to the risk.We are proposing revised text as appropriate to these aims.

Practices during production, processing, storage, transport, retail anddistribution of food: We believe the two paragraphs in this section should

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be further revised as they currently state conclusions instead of providingguidance.





PROPOSED DRAFT GUIDELINES ON INTEGRATED MONITORING AND SURVEILLANCE OF FOODBORNE ANTIMICROBIAL RESISTANCE (GLIS)

The 5th Session of the Ad Hoc Intergovernmental Task Force onAntimicrobial Resistance (TFAMR05, 2017) decided to establish anelectronic working group (EWG) chaired by The Netherlands and co-chairedby New Zealand, Chile and China. The EWG would further develop the Guidelines, based on the general guidance and comments received during the session, in order to provide a revised document for comments and

In addition, at the request of the 40th Session of the Codex AlimentariusCommission (CAC40, 2017), the FAO/WHO Expert Meeting on Foodborne Antimicrobial Resistance: Role of the Environment, Crops and Biocides tookplace in June 2018. The purpose of the expert meeting was to provide scientific advice to inform the work of the Task Force in the above-mentioned areas. In July 2018, FAO and WHO published the summary report of the expert meeting on their respective websites. The TFAMR is awaitingpublication of the final report.

The conclusions of the initial summary report of the Expert Meeting indicate that there is insufficient knowledge on the amounts and types ofantimicrobials applied to crops and those used in terrestrial andaquaculture and that research is required to fil l these gaps. The report further states that surveillance for antimicrobial use (AMU) andantimicrobial resistance (AMR) in primary food production environmentsshould be implemented in order to obtain the additional data that isrequired for risk assessment and risk management. Terrestrial and aquatic

Background

consideration at the TFAMR06 (2018).

primary food production system environments and products used post-

surveillance programs. harvest should be considered for inclusion in integrated AMU and AMR

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Draft U.S. Position

The United States appreciates the work of the Netherlands and its co-chairsChile, China, and New Zealand in considering and incorporating the manycomments received through the EWG into the draft Guidelines on IntegratedMonitoring and Surveillance of Foodborne Antimicrobial Resistance (GLIS)for consideration at the December 2018 session of the TFAMR. We believe the draft continues to improve and look forward to the full report of the FAO/WHO Expert Meeting.

therefore support deletion of the Chart in 7.3 which categorizes countriesbased on artificially created steps. We believe that the guidelines shouldprovide a basic framework for foodborne AMR surveillance that isachievable globally. We propose using the term “incremental” instead of“stepwise” and note the term “incremental” is also used by the WHOAdvisory Group on Integrated Surveillance of Antimicrobial Resistance(AGISAR).

Some areas that the United States would like to continue to consider with other delegations to the TFAMR include: inclusion of a stepwise approach, inclusion of areas outside the scope of Codex and the TFAMR mandate to address foodborne AMR, and aspirational versus practical and scientificallysound language. The United States recognizes that AMR covers broad areasof concern, that the science and resources available to address certain sectors may be more advanced than others, and that some areas are outsidethe scope of Codex to address. It will be important for Codex to developguidelines that help countries to identify and develop capacities withflexibility to address those areas of greatest foodborne AMR risk as nationalpriorities and resources permit.

The current draft of the GLIS describes a stepwise approach for implementation. After much consideration, the U.S. continues to be concerned that steps, phases, and any other terms that categorize countriesis inappropriate for Codex and outside the Task Force’s mandate. We

While the GLIS EWG summary report concludes that crops should beincluded in an integrated monitoring and surveillance program forfoodborne AMR, this conclusion does not reflect comments submitted by the United States in the EWG. The United States believes it is premature toinclude crops in a harmonized Codex guideline for national integratedsurveillance programs.

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At this point, AMR effects related to crops or the environment and impact onfoodborne AMR is too difficult to discern. Guidance from the TFAMR should focus on the more direct interface between consumers and food products ofknown risk, that is meat products, while working to fi ll data and knowledge

focusing on areas of greater risk concern.

gaps with respect to AMR surveillance on crops and in the environment. That would allow countries to focus limited resources on clinically relevant foodborne AMR bacteria. For example, we note many countries are not even collecting AMR and use data in humans and animals, and the current draft document suggests they move to surveying for AMR and use data in cropsand environment. This could be confusing and distract countries from

Based on the summary report of the FAO/WHO Expert Meeting on FoodborneAntimicrobial Resistance, Role of Environment, Crops and Biocides (Rome,11-15 June 2018), it appears that data gaps exist regarding the fundamental elements of AMR surveillance in crops and in the environment. Questionsremain on the appropriate sample sources, bacteria, and antimicrobialagents to monitor. In addition, there appears to be a lack of standardizedmethods for the range of matrices involved. Additional research and methods development are needed in these sectors prior to the development of guidance in Codex Alimentarius on incorporating crops into national,integrated surveillance systems. We suggest that a next step for integratedsurveillance of foodborne AMR due to crops in the environment is to fil l dataand knowledge gaps on fundamental surveillance system components anddevelop appropriate, validated methods to ensure results are scientificallysound and sufficient for risk management.

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The United States believes it is important to help countries understand howto set priorities, based on information on human foodborne il lness due toAMR in their countries. There is l ittle in the way of attribution data toimplicate crops and the environment as leading to foodborne AMR illness inhumans, compared to meat and poultry, so advising countries to incorporate these into a national surveillance system is inconsistent with helpingcountries to prioritize in targeting limited resources on those areas of

report states that while there is a theoretical risk of AMR co-selection, there

environments (Hardy et al. , 2018; Bas et al. , 2017).

We note that “antimicrobial use” (AMU) and “antimicrobial sales” are usedinterchangeably throughout the document. Acknowledging that most

definition for AMU for the purposes of this surveillance guidance:

known risk. We further note that the WHO Advisory Group on IntegratedSurveillance of Antimicrobial Resistance (AGISAR) guidelines only describe integrated surveillance of AMR in humans, food-producing animals, andretail food and AMU in humans and animals. (https://www.who.int/foodsafety/publications/agisar_guidance2017/en/)

The United States is proposing a new section in 9.3 on “research needs tobetter understand potential of foodborne AMR from use of antibacterials in crops” to help countries identify the information they need to betterevaluate and prioritize foodborne AMR risk.

We concur with the EWG decision to exclude biocides from the scope ofwork. We further note the FAO/WHO 2018 Expert Group in its summary

is an absence of empirical data to indicate that the use of biocides drives co-selection under the conditions present in the food production or processing

countries are better able to collect sales data than on-farm use data, offer a

Antimicrobial use (AMU): For the purposes of this document, while allsources of data may not be strictly reflective of actual use, the termAMU here refers to estimates of total usage based on collecting salesdata, prescribing data, manufacturing data, import and export data orany combination of these. Although antimicrobial sales anddistribution data have limitations and may not accurately reflect actual use, such data provide valuable information for understandingthe initial scope of antimicrobial drug markets and how those marketschange over time.

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https://www.who.int/foodsafety/publications/agisar_guidance2017/en




We note that metrics for antimicrobial use data collection are stil l under consideration in many countries and discussion and agreement on methodologies are not mature enough to be a part of global Codex guidance.We recommend deletion of the metrics section. We also note that inclusion of sales/use data in an integrated national surveillance system for AMR,though aspirational, is not yet practical in many countries.

Finally, under the risk communication section, the current language appearsto be very limited. We have provided language summarized from the riskcommunication section of WHO AGISAR 2017 that describes the process ofrisk communication on foodborne AMR for consideration by the TFAMR(http://apps.who.int/iris/bitstream/handle/10665/255747/9789241512411-eng.pdf?sequence=1 )as suggested new text.

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http://apps.who.int/iris/bitstream/handle/10665/255747/9789241512411-eng.pdf?sequence=1

http://apps.who.int/iris/bitstream/handle/10665/255747/9789241512411-eng.pdf?sequence=1

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