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Food safety standards undergo revisions to protect consumers from antimicrobial resistance
Codex Alimentarius Member States are reviewing existing guidance to minimize and contain foodborne antimicrobial resistance. The Intergovernmental Task Force on Antimicrobial Resistance (TFAMR) in December 2019 moved forward with the review of the Code of Practice to contain foodborne antimicrobial resistance. The revision of the Code reached a partial agreement to be sent to the Codex Alimentarius Commission. However, outstanding issues remain, including the definitions and principles. These will be further discussed through an Electronic Working Group and presented at the next TFAMR in December 2020 to be finalized. The revised Code of Practice will be the new Codex standard for ensuring food safety related to the spread of antimicrobial resistance.
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The Codex Alimentarius Commission ad hoc Intergovernmental Task Force on Antimicrobial Resistance (TFAMR) held its Seventh Session in Pyeongchang, Republic of Korea, from 9 to 13 December 2019 with the participation of 43 Member States.
The Codex Alimentarius is a collection of internationally adopted food standards and these standards aim at protecting consumers’ health and ensuring fair practices in the food trade. The publication of the Codex Alimentarius is intended to guide and promote the elaboration and establishment of definitions and requirements for foods to assist in their harmonization and facilitating international trade. It is under this mandate that Codex has started its work on revising current guidelines related to antimicrobial resistance (AMR).
The Code that is currently under revision has eight sections starting with the scope, definitions and general principles. The Code also outlines responsibilities related to the prudent use of antimicrobial agents, duties for competent authorities and manufacturers, including marketing authorization holders. The Code also provides guidelines for veterinarians, plant/crop health professionals, producers and practices for production, processing, storage, transport and distribution of food.
During the deliberations, the Task Force advanced the revision of the Code of Practice to Minimize and Contain Foodborne Antimicrobial Resistance (CXC 61-2005) as part of the mandate for which it was set up in 2017[1]. The original Code of Practice was adopted by Codex in 2005 and covered only antibiotic use in veterinary medicine. The current Task Force was directed to update the Code of Practice and to expand its scope to the whole food chain, not just primary production of food animals with the result that the document has new sections on plant/crop production and the food production environment. The TFAMR was also tasked with the development of the Guidance on Integrated Surveillance of Antimicrobial Resistance. The 7th meeting did not manage to have enough discussion time for the guidance on surveillance. Therefore, the document will be discussed through an Electronic Working Group (EWG) that will continue revising and advancing the text before the next TFAMR to be held at the end of 2020.
The primary focus of TFAMR7 was advancing the revisions on the Code of Practice to Minimize and Contain Foodborne Antimicrobial Resistance. After intense discussion, the TFAMR7 agreed to send the current draft to the Codex Alimentarius Commission (CAC) as a document in step 5 of the procedure for elaborating Codex standards. The paper that the Commission will receive will have the parts of the text that contain reservations by member states and bracketed text on the parts with no agreement. The TFAMR7 also agreed on setting up another Electronic Working Group to work through the bracketed text and report back to the next meeting with the hope of achieving consensus. See below the figure with the procedure steps to adopt standards at Codex.
Figure 1: Step procedure for Codex standards
Source: Codex[2]
The EWG working on the Code of Practice will be chaired by the United States and co-chaired by Chile, China, Kenya and the United Kingdom. The only unresolved issues were whether to include a definition for “Therapeutic use” and the associated principle 6 which states that medically important antibiotics should only be used for therapeutic purposes[3]. The EWG will need to determine whether to include the definition, what the definition will be and to refer to it in the associated principle.
Proposed definition: [Therapeutic use: Administration or application of antimicrobial agents for the treatment, control/metaphylaxis or prevention/prophylaxis of disease]
During the discussions of the TFAMR7, there was no agreement on whether or not to include a definition of therapeutic use and what that definition should be. Some countries argued for deletion of the definition since it contradicts other Codex texts, blurs the important distinction between the use of antimicrobials for disease treatment and the use for disease prevention or prophylactic use, and does not add anything to the document. Other countries suggested using the World Organisation for Animal Health (OIE) term “veterinary medical use” since it is the term used by OIE. The definition contained in the Codex texts on food borne antimicrobial resistance, 2015[4] has two separate definitions, one specifically for therapeutic use, and one for disease prevention or prophylactic use:
Disease Treatment/Therapeutic Use Treatment/Therapeutic Use refers to use of an antimicrobial(s) for the specific purpose of treating an animal(s) with a clinically diagnosed infectious disease or illness.
Disease Prevention/Prophylactic Use Prevention/Prophylactic Use refers to use of an antimicrobial(s) in healthy animals considered to be at risk of infection or prior to the onset of clinical infectious disease. This treatment includes: ■ Control of the dissemination of a clinically diagnosed infectious disease identified within a group of animals, and ■ Prevention of an infectious disease that has not yet been clinically diagnosed.
[Principle 6: Medically important antimicrobial agents should only be used for therapeutic purposes (treatment, control/metaphylaxis or prevention/prophylaxis of disease).]
The TFAMR7 decided to place the Principle 6 in brackets, pending the discussions on the definition of therapeutic use to analyze whether it will be kept or should be removed.
Member countries are invited to send their comments through the EWG for consideration.
Other discussions on the principles
The TFAMR discussed various principles for the Code of Practice (COP). In addition to the bracketed definition and Principle 6, several member states expressed reservations about other principles. The concerns were based on the document limiting recommendations that antimicrobials not be used for growth promotion (Principle 5) and require professional oversight (Principle 12) only to medically important antimicrobials. In addition, some member states sought stronger language that recommended against the routine use of antimicrobials for disease prevention/prophylaxis (Principle 7) consistent with existing recommendations from OIE. If the Task Force is to address these concerns further it will have to be done at the CAC meeting this July in Rome since they are outside the mandate of the EWG and there likely will not be time to address them at the next and final session of the Task Force in December.
Principle 12: Medically important antimicrobials should be prescribed, administered, or applied only by, or under the direction of, veterinarians, plant/crop health professionals, or other suitably trained persons authorized in accordance with national legislation.
The Task Force agreed to this principle with objections from Norway and the Russian Federation being noted. Discussions related to principle 12 centered around whether the current text means that oversight should only apply to medically important antimicrobials and that other antimicrobials, not on this category, could still be used without supervision. Some countries observed that the prescription and/or administration of antimicrobials should always be done under the direction or control of a professional or designated authority. Therefore keeping the principle to only medically important antimicrobials limits the scope of this principle and could result in the administration of other antimicrobials without proper oversight. Consumers International, the only consumers’ organization participating in the discussions, stressed that the principle should aim at strengthening current provisions so that it would increase protection for consumers and noted that the agreed-upon Principle is weaker than the 2005 COP, which covered all antimicrobials used in food-producing animals.
Principle 5: Responsible and prudent use of antimicrobial agents does not include the use for growth promotion of antimicrobial agents that are considered medically important. Antimicrobial agents that are not considered medically important should not be used for growth promotion unless potential risks to human health have been evaluated through procedures consistent with the Guidelines for Risk Analysis of Foodborne Antimicrobial Resistance.
The TFAMR7 agreed to keep Principle 5 but noted the reservations of the Russian Federation, Egypt, Thailand and India, and the statement of the European Union (EU) and its Member States and Norway related to concerns on the current wording. The discussions related to principle 5 focused on whether the current text leaves the possibility open of using antimicrobials that are not considered medically important, as growth promoters. This possibility was of concern to a few countries and therefore, it was agreed that more discussion would need to ensure to assess the implications of that possibility. It is important to note that all countries that are members of the World Health Organization (WHO) have already agreed through the WHO Global Action Plan on Antimicrobial Resistance in objective 4 to “phasing out of use of antibiotics for animal growth promotion and crop protection in the absence of risk analysis; and reduction in nontherapeutic use of antimicrobial medicines in animal health.”[5]
Principle 7: Medically important antimicrobials should only be administered or applied for prevention/prophylaxis where professional oversight has identified well-defined and exceptional circumstances, appropriate dose and duration, based on clinical and epidemiological knowledge, consistent with the label, and in line with national legislation. Countries could use additional risk management measures for medically important antimicrobials considered highest priority critically important as described in the WHO List of Critically Important Antimicrobials for Human Medicine, the OIE List of Antimicrobial Agents of Veterinary Importance, or national lists, where available, including restrictions proportionate to risk and supported by scientific evidence.
The TFAMR7 agreed to keep Principle 7 but noted a statement from the Russian Federation, EU and its Member States, and Norway expressing their position that medically important antibiotics should not be for prophylaxis and pointing out that the current recommendation is inconsistent with existing guidance from the OIE, WHO, and the Food and Agriculture Organization (FAO). Consumers International and the OIE also supported language that would prohibit the use of the Highest Priority Critically Important Antimicrobials from being used for disease prevention in feed or water consistent with OIE recommendations.
Other inputs to the Code of Practice text
The draft text also benefited from some additions related to marketing to veterinarians and wholesalers. Consumers International proposed to add the following language in paragraph 42: “manufacturers and marketing authorization holders should not provide incentives that have a financial value to prescribers or suppliers for the purpose of increasing the use or sales of medically important antimicrobials.” This addition was welcomed by many of the member states and was included as proposed in the current draft.
The draft text of the Code of Practice, with the bracketed text, will be presented to the Codex Commission for consideration this July. At the same time, the electronic group will be working on the outstanding issues to achieve consensus as to have the text almost ready for the session of the TFAMR scheduled for December 2020. This would allow the TFAMR to move towards steps 7 and 8 of the process for its final approval.
The outstanding issues will continue to be discussed with multiple considerations. These include the implementation of the global commitments to address AMR with a one health approach, strengthening food safety measures to protect consumers’ health and to ensure fair practices in the food trade, and the acknowledgment that developing countries require time and resources during a transitional period to have the capacity to implement such measures.
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SOUTH CENTRE NEWS ON AMR is an e-newsletter service of the South Centre providing news and information on issues relating to Antimicrobial Resistance.
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