Agenda Item 4 CX/AMR 17/5/5 September 2017

Transcription

1 E Agenda Item 4 CX/AMR 17/5/5 September 2017 JOINT FAO/WHO FOOD STANDARDS PROGRAMME AD HOC CODEX INTERGOVERNMENTAL TASK FORCE ON ANTIMICROBIAL RESISTANCE Fifth Sessin PROPOSED DRAFT REVISION OF THE CODE OF PRACTICE TO MINIMIZE AND CONTAIN ANTIMICROBIAL RESISTANCE (CAC/RCP ) Prepared by the Electrnic Wrking Grup led by the United States f America and c-chaired by China, Kenya and the United Kingdm Cdex members and Observers wishing t submit cmments at Step 3 n the prpsed draft revisin f the Cde f Practice t Minimise and Cntain Antimicrbial Resistance (Appendix I t this dcument) shuld d s as instructed in CL 2017/83-AMR available n the Cdex webpage/circular Letters 2017: Reprt f the Electrnic Wrking Grup (EWG) n the Revisin f the Cde f Practice t Minimize and Cntain Antimicrbial Resistance (CAC/RCP ) 1. The 40 th Sessin f the CAC (CAC40) apprved new wrk fr the TFAMR and established tw EWGs, wrking in English and Spanish and pen t all Cdex members and bservers, t develp: a prpsed draft revisin f the Cde f Practice t Minimize and Cntain Antimicrbial Resistance (CAC/RCP ) (chaired by the United States f America and c-chaired by China, Kenya and the United Kingdm); and a prpsed draft guidance n integrated surveillance f antimicrbial resistance (chaired by the Netherlands and c-chaired by Chile, China and New Zealand). 2. An EWG, pen t all Members and Observers, was held frm 26 July thrugh 31 August Requests t participate in the EWG n the prpsed draft revisin f the Cde f Practice t Minimize and Cntain Antimicrbial Resistance (CAC/RCP ) were received frm 44 Cdex Members, 1 Cdex Member Organisatin and 18 Cdex Observers. The list f Members and Observers is attached as Appendix II. 3. Thrugh a participatry prcess in the Cdex Frum, the wrking grup reviewed and prpsed revisins t the Cde f Practice t Minimize and Cntain Antimicrbial Resistance (CAC/RCP ). Participants were asked t cmment n the verall structure and rganizatin f the dcument taking int accunt the Reprt f the Physical Wrking Grup n Antimicrbial Resistance (AMR) held 26 Nvember t 2 December 2016 (CX/CAC 17/40/12 Add.2) and in particular Prject Dcument/1 as adpted and apprved fr new wrk at CAC The EWG tk nte that the purpse f the prpsed new wrk is t revise the Cde f Practice t Minimize and Cntain Antimicrbial Resistance by bradening its scpe, and develping risk-based guidance n the management f fdbrne antimicrbial resistance that addresses the entire fd chain, in line with the mandate f Cdex. The bjective is t minimize the risk t public health frm the develpment and spread f fdbrne antimicrbial resistance. The guidance shuld be scientifically supprted and als take int accunt new develpments, including the current and future revisins f lists f critically imprtant antimicrbials, and the wrk f FAO, WHO and OIE in this area. 5. The EWG further tk nte that the scpe f the revisin shuld address the risk t human health assciated with the presence in fd and animal feed, and the transmissin thrugh fd and animal feed, f AMR micrrganisms r determinants. It shuld prvide guidance n relevant measures alng the fd chain t minimize the develpment and spread f fdbrne antimicrbial resistance, including guidance n the respnsible and prudent use f antimicrbial agents in agriculture and aquaculture. 6. Fllwing are key pints f ptential areas f cnsensus.

2 CX/AMR 17/5/5 2 Crss-reference where pssible t ther internatinal texts. There is general cnsensus n crssreferencing relevant texts develped by OIE, WHO and ther Cdex texts. Hwever, the extent f applicatin f these texts and impact n trade in fd will be a matter t be cnsidered later. Strengthened text arund the imprtance f reducing the need t use antimicrbials, such as imprved bisecurity, husbandry measures, nn-antimicrbial disease preventin measures etc. Expanding the detail and clarity f text regarding actins recmmended by the brader range f stakehlders; mst supprted including cnsumers in this expanded cast list. Specifying within the text that antimicrbials shuld nly be available frm veterinarians r trained persnnel. A need fr the Cde f Practice t be sufficiently pragmatic that all Cdex cuntries can make use f it, taking int accunt the wide range f natinal situatins f Cdex cuntries. There is general need t harmnise definitins and nly prvide definitin f terms used in the dcument. The dcument shuld als be aligned t the frmat f the Guidelines fr Risk Analysis f Fdbrne Antimicrbial Resistance (CAC/GL ). There is need t include the rle f ther stakehlders nt captured in the current text (RCP61). 7. The EWG als identified several key areas lacking cnsensus that may benefit frm additinal cmment and/r scientific advice. These areas may benefit frm further cmment and cnsideratin at TFAMR5. 8. Fllwing are key pints describing areas lacking cnsensus that may benefit frm additinal cmment and/r scientific advice. Apprach t the frmat f the dcument: mst cntributrs tk a fairly ad hc apprach, but sme clearly stated that since the remit was t revise rather than re-write the CP, existing text shuld stand and be added t unless gd reasn fr amending. There were many cntributins and different appraches t definitins f treatment/metaphylaxis/cntrl/prphylaxis/preventin. Likewise, there were different reactins t use f the term medically imprtant antimicrbials. Cmments tk nte f the WHO s new psitin, but hw MIAs and nn-mias are dealt with regard t the scpe f the Cde f Practice lks still t be a matter which needs further explratin, whether fr use verall, r hw they relate t the use f antimicrbial grwth prmters. Several Members brught up the text agreed by the G20 Agriculture Ministers n the apprach t antimicrbial grwth prmters as smething which culd be cnsidered by the grup as text is develped. A number f cntributins referred t the Cdex mandate and urged the grup nt t verstep its remit. The use f antimicrbials in crp agriculture is nly mentined in a few cmments, thugh it is an area which likely requires scientific advice frm FAO/WHO in rder t enable the task frce t utline risk management measures. 9. The Chairs f the EWG tk nte f the apprach f several Member Cuntries and Organisatins t preface their cmments with a succinct list f key pririties and tpic areas. This apprach was thught t be valuable taking int cnsideratin the extensive nature f cmments n the text f the dcument. A succinct list f pririties r tpic areas may be a valuable aid in arriving at further areas f cnsensus, identifying tpics that require scientific advice, develping risk-based guidance, and apprpriately addressing the entire fd chain. 10. The EWG identified several areas f ptential cnsensus and incrprated new and revised text in square brackets fr further cmment and ptential adptin at TFAMR5. Similarly, the EWG identified ptential cnsensus arund existing text that culd be deleted. It was suggested that sme prtins f existing text culd be replaced with new infrmatin, language, references, r tls while ther prtins culd be deleted by referencing ther relevant standards. Imprtantly, the EWG nted that certain key cncepts in the existing text cntinue t have value and shuld be retained. All text prpsed fr replacement r deletin is accrdingly nted by strikethrugh fr further cmment and cnsideratin at TFAMR5. The prpsed draft Revisin f the Cde f Practice t Minimize and Cntain Antimicrbial Resistance is cntained in Appendix I. A summary f all cmments received in their riginal language is available with the EWG Chair.

3 CX/AMR 17/5/ The fllwing are key pints cntained in the General Cmments and after that are key pints by tpic heading in the draft dcument highlighting areas f discussin and the apprach taken by the Chairs t revise the draft dcument based n cmments f Members and Observers. General Cmments 12. Several Members and Observers prvided general cmments. In mst cases, the cmments highlighted verarching cncepts that applied t their cmments thrughut the draft dcument. In sme cases, the cmments raised new ideas. 13. The Chairs, t the extent pssible, identified areas f cnsensus and made suggested revisins t the draft dcument accrdingly. The Chairs als added new cncepts and ideas as text in square brackets fr further cnsideratin by the TFAMR under relevant sectins in the draft dcument. Fllwing are pints raised amng the general cmments, including thse that the Chairs believe may warrant further discussin t identify cnsensus. Table f Cntents Many Members and Observers supprted the One Health cncept and suggested ways t adapt the text t address the ways human health is cnnected t that f animals, plants and the envirnment. Several Members and Observers emphasized that infectin preventin and cntrl and bisecurity measures are critical in the management f infectius diseases as they reduce the need fr antimicrbials and cnsequently the pprtunity fr micrrganisms t develp and spread resistance. Many Members and Observers supprted the prpsal t reference OIE Terrestrial Animal Health Cde Chapter 6.9 and Aquatic Animal Health Cde Chapter 6.2 t avid duplicatin and the ptential fr ambiguity as the chapters are updated and revised. Members and Observers identified certain sectins f text t be retained and smetimes prvided cndensed summaries f key cncepts t retain. One Member suggested that separate Cdes f Practices culd be develped fr different sectrs, fr example animals and crps, while anther Member suggested that separate sectins within the Cde f Practice culd be develped t address animals and crps. Several Members and Observers suggested additinal actrs that culd be cnsidered fr inclusin in the Cde f Practice, fr example: feed and fd business peratrs, veterinary faculties and agricultural schls, veterinary prfessinal assciatins, industry stakehlder assciatins, farmers assciatins, labratries, animal nutritinists, aquaculture prducers, fd prcessing industry, imprters, apiculturists, and animal handlers. Sme Members suggested a new sectin n Respnsibilities f animal feed manufacturers and nted Chapter f the OIE Terrestrial Animal Health Cde with the same heading. Further discussin n whether t reference the OIE Chapter r develp a new sectin culd be beneficial. 14. In the draft dcument it was nted that the Table f Cntents wuld be revised fllwing the cntent f the final dcument. One Member cmmented n the Table f Cntents suggesting alternate headings - sme f which revised the current headings and thers which were new. The Member suggested new text and prvided suggestins fr deletin f text with reference t the OIE Terrestrial and Aquatic Animal Health Cdes in different sectins that fllwed. 15. The Chairs did nt include the new headings, but did include in square brackets text which intrduced new cncepts in line with the Main Aspects t be cvered in Prject Dcument 1 in the relevant sectins f the dcument that fllwed. The Chairs decided t retain the current tpic headings with small mdificatins because mst Members and Observers prvided new cntent and revisins under the tpic headings prpsed in the draft dcument. The TFAMR shuld revisit the tpic headings at a later stage after evaluating the cntent f the Cde f Practice. Ratinale: The final Table f Cntents shuld reflect the cntent f the Cde f Practice. Intrductin 16. Mst Members and Observers agreed with the new text prpsed fr the Intrductin and ffered minr edits. Several Members and Observers encuraged the EWG t retain imprtant cncepts frm the existing text. 17. The Chairs mdified the new text in Paragraphs 1-3 keeping it in square brackets fr further cmments and ptential adptin at the TFAMR5. The Chairs retained imprtant cntent in Paragraphs 4-6 (previusly numbered as Para 1, 2, 4). Frmerly numbered Para 3 is prpsed fr deletin.

4 CX/AMR 17/5/5 4 Nte: Fr the purpse f this reprt new paragraph numbers are stated as Paragraph xx and frmer paragraph numbers are referred t as Para xx. Ratinale: The new text includes the bjectives in Prject Dcument 1. Imprtant cncepts, identified by Members and Observers, are retained. Para 3 describes the prcess fr develping RCP61 which has been superseded by the mandate f TFAMR and is therefre prpsed fr deletin. Aims and Objectives 18. Mst Members and Observers agreed with the prpsal t replace the Aims and Objectives with new sectins n Scpe and General Principles fllwing the structure f GL77. Several Members and Observers encuraged the EWG t retain imprtant cncepts, particularly thse fund in Para 7 and 8. Sme Members and Observers prvided new text and revised text and suggested text fr deletin. 19. The Chairs marked the current text in the sectin (Para 5-8) fr prpsed deletin and mdified the text in the new sectins n Scpe and General Principles t take int accunt many cmments and prpsals. The Chairs mved and revised certain text as fllws. Para 5: Cncepts mved t Scpe, Paragraph 7. Para 6: Cncepts mved t Intrductin, Paragraphs 4-7 and Scpe, Paragraph 7. Para 7: Cncepts mved t Intrductin, Paragraph 6; Definitins, One Health; General Principle 10; new sectin Respnsibilities f the Regulatry Authrities, Assessment f Envirnmental Impact, Paragraphs 20; and Respnsibilities f the Regulatry Authrities, Develpment f Research; Paragraph 33. Para 8, bullet 1: General Principle 12. Para 8, bullet 2: General Principle 2. Para 8, bullet 3: General Principle 13. Para 8, bullet 4: General Principle 14. Para 8, bullet 5: General Principle 5. Para 8, bullet 6: Intrductin, Paragraph 4 and Scpe, Paragraph 7. Ratinale: Imprtant cncepts in the frmer sectin Aims and Objectives are retained. The text is revised taking int cnsideratin the Objectives, Scpe, and Main aspects t be cvered in Prject Dcument 1. Cherence with GL77 is imprved by fllwing a similar structure. [Scpe] 20. Mst Members and Observers agreed with the prpsal t develp a new sectin n Scpe fllwing the structure f GL77. Several Members and Observers encuraged the EWG t retain imprtant cncepts in the current Aims and Objectives. Sme Members and Observers suggested new text, revised text, and minr edits. 21. The Chairs mdified the sectin n Scpe taking int cnsideratin the different prpsals by Members and Observers. Imprtant cncepts in the Aims and Objectives were mved int the new sectin n Scpe. Sme Members suggested additinal actrs in the fd chain that culd be included within the scpe f this Cde f Practice. Similarly, sme Members suggested separate Cdes f Practice culd be develped fr different sectrs. 22. The Chairs, taking int cnsideratin Prject Dcument 1, made minr edits t Paragraph 7 and added Paragraph 8 frm GL77 as new RCP61 Paragraph 8 t maintain cherence between the tw dcuments. The TFAMR shuld cnsider whether additinal actrs culd be added t the Cde f Practice and the questin f whether separate Cdes f Practice shuld be develped fr different sectrs. Ratinale: Minr mdificatins t the Scpe were made t imprve clarity and cherence. The TFAMR shuld cmment n the develpment f sectins addressing additinal actrs in the fd chain. [Definitins] 23. Mst Members and Observers cncurred with the need t include definitins as part f the Cde f Practice. Many Members and Observers agreed with the prpsal t include definitins at the beginning f the Cde f Practice, rather than at the end, fllwing the structure f GL77. Hwever, sme Members pinted ut that having definitins at the beginning f the dcument culd be distracting. Mst Members and Observers cmmented n the new definitins presented, while fewer cmmented directly n the existing definitins at the end f the dcument.

5 CX/AMR 17/5/ In particular, Members and Observers prvided cmments and questins n antibitic resistance, therapeutic use, treatment, cntrl, preventin, grwth prmtin, and medically imprtant antimicrbials. The cmments demnstrated a range f pinins and shuld be further discussed at the TFAMR. Key areas f cmment included the fllwing. Whether One Health definitins culd be derived that have shared understanding acrss sectrs (humans, animals, crps). When the Cde f Practice shuld use the term antimicrbial resistance r antibitic resistance. Hw t best distinguish therapeutic uses (i.e. related t infectius disease) frm prductin uses (i.e. grwth prmtin). Hw t apply the relatively new term, medically imprtant antimicrbial, t distinguish classes f antimicrbials imprtant fr therapeutic use in human medicine frm antimicrbial classes that are nt used in human medicine. 25. Tw Members reminded the EWG that definitins shuld be relevant t the text f the chapter and shuld be aligned with ther definitins in Cdex, in particular GL The Chairs made mdificatins t the definitins in the draft dcument based n cmments by Members and Observers maintaining them in square brackets fr further discussin. Ratinale: Definitins shuld facilitate the use f the chapter. Definitins shuld be updated and revised based n current scientific knwledge taking int accunt advancement in antimicrbial resistance risk analysis. Definitins in Cdex texts and ther relevant texts under the Wrld Trade Organizatin Sanitary and Phytsanitary Agreement (i.e. OIE Terrestrial and Aquatic Animal Health Cdes, Internatinal Plant Prtectin Cnventin), WHO and FAO shuld be taken int cnsideratin. [General Principles t Minimize and Cntain Antimicrbial Resistance] 27. Mst Members and Observers supprted the prpsal t develp General Principles t prmte cherence with GL77 and t highlight imprtant elements t minimize and cntain antimicrbial resistance. Several Members and Observers prvided suggested revisins and new General Principles. 28. The Chairs mdified the General Principles taking int accunt cmments and added General Principles where new cncepts were prpsed r mved frm ther areas f the text. Ratinale: Revisins t the General Principles prvide clarity and mre detail. Additinal General Principles help address a mre brad scpe and may include valuable cncepts. Respnsibilities f the Regulatry Authrities 29. Many Members and Observers supprted the prpsal t reference OIE Terrestrial Animal Health Cde Chapter 6.9 and Aquatic Animal Health Cde Chapter 6.2 t avid duplicatin and the ptential fr ambiguity as the chapters are updated and revised. Members and Observers identified certain sectins f text t be retained and smetimes prvided cndensed summaries f key cncepts t retain. 30. The Chairs adpted summaries f key cncepts and prvided a reference t relevant sectins f the OIE Aquatic and Terrestrial Animal Health Cdes, Paragraphs. The Chairs identified sme sectins f text fr ptential deletin by the TFAMR, Para 10-11, 13-16, and 18-34, as being duplicative f the OIE Terrestrial Animal Health Cde Chapter The Chairs mdified sme text t make it applicable acrss sectrs. The Chairs included additinal paragraphs based n suggestins f new cncepts by Members and Observers. 31. Mst Members and Observers supprted referencing the OIE Terrestrial and Aquatic Animal Health Cdes fr sectins dealing with the registratin f veterinary antimicrbials. Many members and Observers suggested retaining the sectin n surveillance prgrams and including a reference t the new prpsed draft Cdex guidelines n integrated surveillance f antimicrbial resistance alng with reference t existing texts n surveillance fund in the OIE Cdes and WHO AGISAR. Several Members and Observers suggested the sectins n pharmacvigilance culd als reference the OIE Chapters and therefre be prpsed fr deletin, hwever there were sme Members that seemed t indicate pharmacvigilance shuld be retained. Further discussin n the value f retaining pharmacvigilance culd be beneficial. Ratinale: Streamlining the cntent f this sectin while retaining key cncepts will avid duplicatin and prevent ambiguity with the OIE Terrestrial and Aquatic Animal Health Cdes. Mdifying text t be applicable acrss sectrs will braden the scpe f the guidance. Adding new cncepts and detail will increase the value f the sectin.

6 CX/AMR 17/5/5 6 Respnsibilities f the Veterinary Pharmaceutical Industry/[Respnsibilities f Manufacturers] 32. Several Members and Observers prvided suggestins fr minr editing f this sectin. 33. The Chairs mdified sme text t make it applicable acrss sectrs and made small changes based n suggestins f Members and Observers. Ratinale: Mdifying text t be applicable acrss sectrs will braden the scpe f the guidance. Respnsibilities f Whlesale and Retail Distributrs 34. Several Members and Observers prvided suggestins fr minr editing f this sectin. 35. The Chairs mdified sme text t make it applicable acrss sectrs and made small changes based n suggestins f Members and Observers. Ratinale: Mdifying text t be applicable acrss sectrs will braden the scpe f the guidance. Respnsibilities f Veterinarians [and Plant Health Prfessinals] 36. Members and Observers supprted the prpsal t reference OIE Terrestrial Animal Health Cde Chapter and Aquatic Animal Health Cde Chapter 6.2 t avid duplicatin and the ptential fr ambiguity as the chapters are updated and revised. Members and Observers identified certain sectins f text t be prpsed fr deletin. 37. The Chairs identified sme sectins f text fr ptential deletin by the TFAMR, Para 48, 53. The Chairs mdified sme text t make it applicable acrss sectrs. The Chairs included additinal paragraphs based n suggestins f new cncepts by Members and Observers. Ratinale: Streamlining the cntent f this sectin while retaining key cncepts will avid duplicatin and prevent ambiguity with the OIE Terrestrial and Aquatic Animal Health Cdes. Mdifying text t be applicable acrss sectrs will braden the scpe f the guidance. Adding new cncepts and detail will increase the value f the sectin. Respnsibilities f Prducers 38. Members and Observers supprted the prpsal t reference OIE Terrestrial Animal Health Cde Chapter and Aquatic Animal Health Cde Chapter 6.2 t avid duplicatin and the ptential fr ambiguity as the chapters are updated and revised. 39. The Chairs mdified sme text t make it applicable acrss sectrs. The Chairs included additinal paragraphs based n suggestins f new cncepts by Members and Observers. Ratinale: Mdifying text t be applicable acrss sectrs will braden the scpe f the guidance. Adding new cncepts and detail will increase the value f the sectin. [Respnsibilities f Cnsumers] 40. Sme Members and Observers prvided new cntent fr this area. 41. The Chairs added the new cntent in square brackets fr further cmment and cnsideratin by the TFAMR making small revisins fr cnsistency and clarity. [Advcacy and Cmmunicatin] 42. A Member prpsed a new sectin n Advcacy and Cmmunicatin. 43. The Chairs included the new sectin in square brackets with minr revisins t braden the scpe in line with the ther sectins. Ratinale: The prpsed new sectin intrduced a cncept nt currently cntained in the draft dcument. Cnclusins 44. Sme Members and Observers cmmented that cncepts in the Cnclusins shuld be retained, while thers indicated they culd be prpsed fr deletin. 45. The Chairs prpsed Para 60 and 62 fr ptential deletin. The Chairs mved Para 61 t General Principle 11. Ratinale: Cncepts in Para 60 and 62 are cntained in the preceding text. The cncept in Para 61 was nt cvered elsewhere and was cnsidered t be imprtant fr verall implementatin f the Cde f Practice.

7 CX/AMR 17/5/5 7 End Ntes 46. Few Members and Observers cmmented n these references. 47. The Chairs prpsed the references fr deletin. Ratinale: While the references may still cntain relevant material, they are likely t be amng many ther references that culd be accessed as part f a library n antimicrbial resistance. List f Abbreviatins Used in This Cde 48. Mst Members and Observers cncurred with the inclusin f abbreviatins/acrnyms in the Cde f Practice. Many cncurred with the prpsal t mve them t the beginning f the text fllwing the structure f GL The Chairs mved the sectin t the beginning f the dcument. The final list f abbreviatins/acrnyms shuld be reviewed after the final cntent f the text is develped. Ratinale: The use f abbreviatins/acrnyms can imprve the efficiency f the text, hwever they shuld be clearly stated and used cnsistently. Glssary f Definitins and Terms 50. Fewer Members and Observers cmmented n the definitins at the end f the text. Mst agreed with the prpsal t list them earlier in the text fllwing the structure f GL77. The definitin f grwth prmtin seemed t have mre cnsensus than the ther definitins. Sme Members preferred t retain the current definitins. 51. The Chairs mved the definitin f Grwth Prmtin t the preceding sectin n Definitins. The Chairs prpsed fr deletin the definitins f Veterinary Antimicrbial Drug nting a similar definitin included abve taken frm GL77. The Chairs prpsed fr deletin the definitins f Disease Treatment/Therapeutic Use and Disease Preventin/Prphylactic Use nting that similar definitins are included abve. Substantial cmments were received n definitins and this is an area fr further cmments and discussin by the TFAMR. Ratinale: Definitins prmte cmmn understanding f cncepts in the Cde f Practice and prmte cherence with ther Cdex texts and standards. Cnclusins 52. Members and Observers generally agreed the Cde f Practice shuld be revised by bradening its scpe, and develping risk-based guidance n the management f fdbrne antimicrbial resistance that addresses the entire fd chain, in line with the mandate f Cdex. 53. Members and Observers generally agreed that the structure f the revised Cde f Practice shuld fllw that f GL77, including Intrductin, Scpe, Definitins, General Principles. 54. Members and Observers generally agreed prtins f the existing text cntinued t have value and shuld be retained; while sme sectins relating primarily t specifics arund a veterinary medicines dssier fr fd-prducing animals culd be deleted as they are duplicated in the OIE Aquatic and Terrestrial Animal Health Cdes. 55. Members and Observers supprted the additin f new text prviding additinal risk-based guidance and new sectins describing the respnsibilities r additinal actrs in the fd supply chain. Recmmendatins 56. The TFAMR shuld cnsider the adptin f new text and text prpsed fr deletin as cntained in Prpsed Draft Revisin f the Cde f Practice t Minimize and Cntain Antimicrbial Resistance, Appendix I. 57. The TFAMR shuld cnsider the range f actrs that culd reasnably be included in the Cde f Practice taking int accunt numerus participants in the fd chain, as described in Paragraph 13 abve. 58. The TFAMR shuld cnsider the Definitins presented t ensure they are relevant t the Cde f Practice, aligned with ther Cdex texts, based n current scientific knwledge, and take int accunt advancement in antimicrbial resistance risk analysis. 59. The TFAMR shuld cnsider the General Principles t ensure they cntain thse principles related t the cntent f the chapter and avid unnecessary duplicatin with ther Cdex texts r references.

8 CX/AMR 17/5/ T evaluate prpsed new text and t further develp risk-based guidance fr the Cde f Practice, the TFAMR shuld cnsider updated scientific infrmatin n imprtant factrs influencing fdbrne AMR, taking int cnsideratin animals, crps, envirnment, and als manure, bicides, waste and packaging, prductin systems and practices (including animal husbandry f nmadic herds and ethn-veterinary use f plants), fd prcessing, retail handling and cnsumptin.

9 CX/AMR 17/5/5 9 PROPOSED DRAFT REVISION OF THE CODE OF PRACTICE TO MINIMIZE AND CONTAIN ANTIMICROBIAL RESISTANCE (CAC/RCP ) (fr cmments at Step 3 thrugh CL 2017/83-AMR) Appendix I This dcument cntains cntributins frm Cdex Members and Observers, including ptential areas f cnsensus, identified in the Electrnic Wrking Grup (EWG) held 26 July t 31 August New and revised text in [square brackets] is prpsed fr further cmment and ptential adptin at TFAMR5. Similarly, the wrking grup identified ptential cnsensus arund existing text that culd be deleted. All text prpsed fr replacement r deletin is accrdingly nted by strikethrugh fr further cmment and cnsideratin at TFAMR5. Table f Cntents [Intrductin] [Scpe] [Definitins] [General Principles t Minimize and Cntain Antimicrbial Resistance] [Respnsibilities f the Regulatry Authrities] [Respnsibilities f Manufacturers] [Respnsibilities f Whlesale and Retail Distributrs] [Respnsibilities f Veterinarians and Plant Health Prfessinals] [Respnsibilities f Prducers] [Respnsibilities f Cnsumers] [Advcacy and Cmmunicatin] [List f Acrnyms Used in the Dcument] ADI AMR AMU CAC CAC/RCP CCRVDF FAO MRL OIE VICH VMP WHO Acceptable Daily Intake Antimicrbial Resistance Antimicrbial Use Cdex Alimentarius Cmmissin Cdex Alimentarius Cmmissin/Recmmended Cde f Practice Cdex Cmmittee n Residues f Veterinary Drugs in Fds Fd and Agriculture Organizatin f the United Natins Maximum Residue Limit Office Internatinal des epizties/internatinal Office f Epizties, Wrld Organisatin fr Animal Health Internatinal Cperatin n Harmnizatin f Technical Requirements fr Registratin f Veterinary Medicinal Prducts Veterinary Medicinal Prduct Wrld Health Organizatin

10 CX/AMR 17/5/5 10 Intrductin [1. Antimicrbial resistance pses a cmplex, glbal public health challenge. Within the fd prductin t cnsumptin cntinuum, there is a need t address the selectin and disseminatin f resistant micrrganisms and resistance determinants. The develpment f strategies fr gd practices in agriculture (crps), aquaculture and animal husbandry including the respnsible and prudent use f antimicrbials in all sectrs fllwing a One Health apprach will frm a key part f multi-sectral natinal actin plans t address risks f fdbrne antimicrbial resistance.] [2. This Cde f Practice is an integral part f risk analysis fcusing n risk management ptins and shuld be read in cnjunctin with ther Cdex texts including the Prpsed Draft Guidelines n Integrated Surveillance (CAC/GL xx-xxxx) and Guidelines fr Risk Analysis f Fdbrne Antimicrbial Resistance CAC/GL In additin, the Cdex Cde f Hygienic Practice fr Fresh Fruits and Vegetables (CAC/RCP ) and the Cde f Practice n Gd Animal Feeding (CAC/RCP ), and Principles and Guidelines fr the Cnduct f Micrbilgical Risk Management (CAC/GL ) are particularly relevant fr use f agricultural chemicals n crps and animal feed, respectively. WHO guidelines n Integrated surveillance f antimicrbial resistance in fdbrne bacteria, Applicatin f a One Health Apprach (2017) and Critically Imprtant Antimicrbials fr Human Medicine (2016) and relevant chapters f the OIE Terrestrial and Aquatic Animal Health Cdes and the List f Antimicrbials f Veterinary Imprtance shuld als be referenced.] [3. Where available, natinal and lcal guidelines t minimize and cntain antimicrbial resistance shuld be taken int cnsideratin. Best practices and guidelines n the respnsible and prudent use f antimicrbials develped by gvernmental and prfessinal rganizatins shuld als be cnsidered.] 1. [4.] This dcument prvides additinal guidance fr [n relevant measures alng the fd chain t minimize the develpment and spread f fdbrne antimicrbial resistance, including guidance n] the respnsible and prudent use f antimicrbials in [the] fd [chain]-prducing animals, and shuld be read in cnjunctin with the Recmmended Internatinal Cde f Practice fr Cntrl f the Use f Veterinary Drugs CAC/RCP It s bjectives are [part f a One Health apprach] t minimize the ptential adverse impact n public [and animal] health resulting frm the use f antimicrbial agents in [the] fd [chain]-prducing animals, in particular the develpment f antimicrbial resistance. It is als imprtant t prvide fr the safe and effective use f veterinary antimicrbial [agents]drugs in veterinary medicine by maintaining their efficacy. This dcument defines the respective respnsibilities f authrities and grups[relevant stakehlders] invlved in the authrizatin, prductin, cntrl, distributin and use f veterinary antimicrbials such as the natinal regulatry authrities, the veterinary pharmaceutical industry[manufacturers], veterinarians [and plant health prfessinals], [whlesale and retail] distributrs[,] and [fd] prducers[, and cnsumers] f fd-prducing animals. 2. [5.] The marketing authrizatin prcedure has a significant rle in establishing the basis fr [the respnsible and] prudent use f veterinary antimicrbial drugs [agents] in fd-prducing animals thrugh clear label indicatins, directins and warning statements. 3. A number f cdes f practice relating t the use f veterinary antimicrbial drugs and the cnditins theref have been develped by different rganisatins. These cdes were taken int cnsideratin and sme elements were included in the elabratin f this Cde f Practice t Minimize and Cntain Antimicrbial Resistance. 4. [6.] In keeping with the Cdex missin, this Cde [f Practice] fcuses n antimicrbial use in [the] fd prducing animals[chain]. It is recgnized that [the use f antimicrbial agents in the fd chain may result in expsure in the envirnment. As part f a One Health strategy t minimize and cntain antimicrbial resistance, the use f authrized prducts and best practices in the prductin sectr shuld be fllwed t minimize the risks assciated with the selectin and disseminatin f resistant micrrganisms and determinants.] antimicrbial resistance is als an eclgical prblem and that management f antimicrbial resistance may require addressing the persistence f resistant micrrganisms in the envirnment. Althugh this issue is mst relevant fr CCRVDF with respect t fd-prducing animals, the same principles apply t cmpanin animals, which als harbr resistant micrrganisms.

11 CX/AMR 17/5/5 11 [Scpe] [7. This Cde f Practice addresses the risk t human health assciated with the presence in fd and animal feed, and the transmissin thrugh fd and animal feed, f antimicrbial resistant micrrganisms r determinants. It prvides [risk-based] guidance n relevant measures alng the fd chain t minimize the develpment and spread f fdbrne antimicrbial resistance, including guidance n gd practices in agriculture (crps) and animal husbandry and guidance n the respnsible and prudent use f antimicrbial agents in agriculture (crps), animal husbandry, and aquaculture. Its bjectives are t minimise the ptential adverse impact n public health resulting frm the use f antimicrbial agents. All actrs invlved in the authrisatin, manufacture, sale and supply, prescriptin and use f antimicrbials in the fd chain tgether with thse invlved in the handling, preparatin, distributin and cnsumptin f fd have a rle t play in ptimizing the use f antimicrbials and limiting the spread f resistant micrrganisms and determinants.] [8. As there are existing Cdex r internatinally recgnized guidelines, the fllwing areas related t antimicrbial agents r AMR are utside the scpe f this dcument: residues f antimicrbial agents in fd; AMR marker genes in recmbinant-dna plants and recmbinant DNA micrrganisms 1 ; nngenetically mdified micrrganisms (fr example, starter cultures) intentinally added t fd with a technlgical purpse 2 ; and certain fd ingredients, which culd ptentially carry AMR genes, such as prbitics 3.] 1. Aims and Objectives 5. It is imperative that all wh are invlved in the authrisatin, manufacture, sale and supply, prescriptin and use f antimicrbials in fd-prducing animals act legally, respnsibly and with the utmst care in rder t limit the spread f resistant micrrganisms amng animals s as t prtect the health f cnsumers. 6. Antimicrbial drugs are pwerful tls fr the management f infectius diseases in animals and humans. This Cde and existing guidelines fr the respnsible use f antimicrbial drugs in fd- prducing animals include recmmendatins intended t prevent r reduce the selectin f antimicrbial resistant micrrganisms in animals and humans in rder t: Prtect cnsumer health by ensuring the safety f fd f animal rigin intended fr human cnsumptin. Prevent r reduce as far as pssible the direct and indirect transfer f resistant micrrganisms r resistance determinants within animal ppulatins and frm fd- prducing animals t humans. Prevent the cntaminatin f animal derived fd with antimicrbial residues which exceed the established MRL. Cmply with the ethical bligatin and ecnmic need t maintain animal health. 7. This Cde des nt address envirnmental issues related t antimicrbial resistance frm the use f veterinary antimicrbial drugs but it encurages all thse invlved t cnsider the eclgical aspects when implementing the Cde. Effrts shuld be made t ensure that envirnmental reservirs f veterinary antimicrbial drugs, antimicrbial resistant rganisms and resistance determinants are kept t a minimum. In particular: Regulatry authrities shuld assess the impact f prpsed veterinary antimicrbial drug use n the envirnment in accrdance with natinal guidelines r recgnized internatinal guidelines 4 Research shuld be cnducted n resistant micrrganisms in the envirnment and the magnitude f resistance determinant transfer amng micrrganisms in the envirnment. 8. The respnsible use f veterinary antimicrbial drugs in fd-prducing animals: is cntrlled by the veterinary prfessin r ther parties with the required expertise. is part f gd veterinary and gd animal husbandry practice and takes int cnsideratin disease preventin practices such as the use f vaccinatin and imprvements in husbandry cnditins. 1 [The fd safety assessment n the use f antimicrbial resistance marker genes in recmbinant-dna plants is addressed in the Guideline fr the Cnduct f Fd Safety Assessment f Fds Derived frm Recmbinant-DNA Plants (CAC/GL ).] 2 [The fd safety assessment n the use f antimicrbial resistance marker genes in recmbinant-dna micrrganisms is addressed in the Guideline fr the Cnduct f Fd Safety Assessment f Fds Prduced Using Recmbinant-DNA Micrrganisms (CAC/GL ).] 3 [The fd safety assessment n the use f prbitics in fds is addressed in a Reprt f a Jint FAO/WHO Wrking Grup n Drafting Guidelines fr the Evaluatin f Prbitics in Fds (FAO/WHO, 2002).] 4 VICH (2000). Guidelines n Envirnmental Impact Assessment fr Veterinary Medicinal Prducts, Phase I.

12 CX/AMR 17/5/5 12 aims t limit the use f veterinary antimicrbial drugs accrding t their apprved and intended uses, and takes int cnsideratin n-farm sampling and testing f islates frm fd-prducing animals during their prductin, where apprpriate, and makes adjustments t treatment when prblems becme evident. shuld be based n the results f resistance surveillance and mnitring (micrbial cultures and antimicrbial sensitivity testing), as well as clinical experience. des nt include the use fr grwth prmtin f veterinary antimicrbial drugs that belng t r are able t cause crss resistance t classes f antimicrbial agents used (r submitted fr apprval) in humans in the absence f a risk analysis. This risk analysis shuld: be undertaken by the apprpriate natinal regulatry authrity; be based n adequate scientific evidence; and. fcus n the ptential t impact resistance t antimicrbials used in human medicine. is aimed at all the relevant parties, such as: [Definitins] regulatry and scientific authrities; the veterinary pharmaceutical industry; distributrs and thers handling veterinary antimicrbial drugs; veterinarians, pharmacists and prducers f fd-prducing animals. [Antimicrbial agent: Any substance f natural, semi-synthetic, r synthetic rigin that at in viv cncentratins kills r inhibits the grwth f micrrganisms by interacting with a specific target. The term antimicrbial is a cllective fr antiviral, antibacterial, antifungal, and antiprtzal agents.] [Antimicrbial Resistance (AMR): The ability f a micrrganism t multiply r persist in the presence f an increased level f an antimicrbial agent relative t the susceptible cunterpart f the same species.] [Antimicrbial Resistance Determinant: The genetic element(s) encding fr the ability f micrrganisms t withstand the effects f an antimicrbial agent. They are lcated either chrmsmally r extrachrmsmally and may be assciated with mbile genetic elements such as plasmids, integrns r transpsns, thereby enabling hrizntal transmissin frm resistant t susceptible strains.] [Antibitic: A naturally derived substance that acts against micrrganisms, specifically bacteria.] [Antibitic resistance: The ability f a micrrganism, specifically bacteria, t multiply r persist in the presence f an increased level f an antibitic relative t the susceptible cunterpart f the same species.] [Antibacterial: A substance that acts against bacteria.] [Medically imprtant antimicrbials: Antimicrbial agents imprtant fr therapeutic use in humans.] [Therapeutic use: Administratin f antimicrbial agents fr the treatment, cntrl/metaphylaxis and preventin/prphylaxis f disease.] [Treatment f disease: Administratin f antimicrbial agents t infected individuals r ppulatins t reslve clinical signs, infectin r illness.] [Cntrl f disease/metaphylaxis: Administratin f antimicrbial agents t ppulatins which cntain healthy and infected individuals t minimize r reslve clinical signs, infectin r illness.] [Preventin f disease/prphylaxis: Administratin f antimicrbial agents t healthy individuals r a ppulatin at risk f a specific disease, prir t the nset, with apprpriate versight, dse, and duratin.] Grwth prmtin: Administratin f antimicrbial agents t increase the rate f weight gain and/r the efficiency f feed utilizatin in animals by ther than purely nutritinal means. The term des NOT apply t the use f antimicrbials fr the specific purpse f treating, cntrlling, r preventing infectius diseases, even when an incidental grwth respnse may be btained. [Crss-Resistance: The ability f a micrrganism t multiply r persist in the presence f ther members f a particular class f antimicrbial agents r acrss different classes due t a shared mechanism f resistance.] [Marketing Authrizatin: Prcess f reviewing and assessing a dssier t supprt a medicinal prduct t determine whether t permit its marketing (als called licensing, registratin, apprval, etc.), finalized by granting f a dcument als called marketing authrizatin (MA) (equivalent: prduct license).]

13 CX/AMR 17/5/5 13 [One Health: A cllabrative, multisectral, and trans-disciplinary apprach - wrking at the lcal, reginal, natinal, and glbal levels - with the gal f achieving ptimal health utcmes recgnizing the intercnnectin between peple, animals, plants, and their shared envirnment.] [General Principles t Minimize and Cntain Antimicrbial Resistance] [Principle 1: A One Health apprach shuld be cnsidered, wherever pssible and applicable, when identifying, evaluating, selecting, and implementing AMR risk management ptins.] [Principle 2: Bisecurity, adequate nutritin, vaccinatin, imprved prductin practices, and alternatives t antimicrbial agents 5 shuld be cnsidered t reduce the need fr use f antimicrbial agents.] [Principle 3: Species r sectr-specific respnsible and prudent antimicrbial use guidelines shuld be develped, implemented, and reviewed n a regular basis t maintain their effectiveness in reducing the risk f fdbrne antimicrbial resistance. Such guidelines culd be included as a part f natinal actin plans n antimicrbial resistance with develpment and disseminatin shared amng cuntries and rganisatins.] [Principle 4: The WHO list f Critically Imprtant Antimicrbials, the OIE List f Antimicrbials f Veterinary Imprtance, and natinal lists, where available, shuld be used t set pririties fr risk assessment and risk management. The lists shuld be regularly updated.] [Principle 5: Respnsible and prudent administratin in fd-prducing animals des nt include the use fr grwth prmtin f antimicrbial drugs that are cnsidered medically imprtant r are able t cause crss resistance t ther antimicrbial drugs, r classes f antimicrbial drugs, that are cnsidered medically imprtant in the absence f a risk analysis. This risk analysis shuld: be undertaken by the apprpriate natinal regulatry authrity; be based n adequate scientific evidence; and include a publically available summary.] [Principle 6: Medically imprtant antimicrbial agents shuld nly be used fr therapeutic purpses (treatment, cntrl/metaphylaxis r preventin/prphylaxis f disease); r in certain circumstances fr research and cnservatin (e.g. skeletal marking in fish).] [Principle 7: Antimicrbial agents shuld nly be used in well-defined circumstances fr the preventin f a specific disease and fllw apprpriate versight, dse, and duratin.] [Principle 8: Only legally authrized antimicrbial agents shuld be used and all applicable label directins shuld be fllwed; except where specific legal exemptins apply.] [Principle 9: Fdbrne AMR risk management measures shuld be implemented in a way that is prprtinate t the risk and reviewed n a regular basis as described in CAC/GL77. Risk managers shuld cnsider ptential unintended cnsequences t human and animal health f recmmended risk management measures.] [Principle 10: Mnitring and surveillance f the use f antimicrbial agents and the incidence r prevalence, and in particular trends, f fdbrne antimicrbial resistant micrrganisms and determinants are amng the critical factrs t cnsider when evaluating and determining the effectiveness f implemented risk management measures. Use f medically imprtant antimicrbial drugs in humans and animals, and transmissin f pathgens and resistance genes between humans, animals, and the envirnment are additinal factrs t cnsider.] [Principle 11: This dcument is designed t prvide a framewrk, fr the develpment f measures t mitigate the risk f fdbrne AMR, that cuntries may implement, as part f their natinal strategy n AMR, in accrdance with their capabilities, based n their natinal situatin/capacities, and within a reasnable perid f time. A stepwise apprach may utilized by sme cuntries t prperly implement all f the elements in this dcument.] [Principle 12: Medically imprtant antimicrbials shuld be administered r applied nly by veterinarians, plant health prfessinals r ther suitably trained persn authrized in accrdance with natinal legislatin.] [Principle 13: Administratin f antimicrbial agents shuld take int cnsideratin sampling and susceptibility testing f islates frm the prductin setting, where apprpriate, and make adjustments t the administratin when prblems becme evident.] 5 [Culd include ethnveterinary appraches, e.g. herbal medicine.]

14 CX/AMR 17/5/5 14 [Principle 14: Administratin f antimicrbial agents shuld be based n sund clinical judgement and where feasible n the results f integrated resistance surveillance and mnitring (bacterial cultures and antimicrbial susceptibility testing), as well as relevant experience.] [Principle 15: The reduce, replace and rethink (RRR) strategy shuld be actively prmted within all sectrs.] [Principle 16: On a cntinuus and stepwise implementatin f risk management measures alng the fd chain t minimize the pssible risks assciated with fdbrne AMR, pririty shuld be given t the mst relevant elements as frm a public health perspective.] Respnsibilities f the Regulatry Authrities 9. The natinal regulatry authrities, which are respnsible fr granting the marketing authrisatin fr antimicrbials fr use in fd-prducing animals[the fd chain], have a significant rle in specifying the terms f this authrisatin and in prviding the apprpriate infrmatin t the veterinarian [and plant health prfessinals] thrugh prduct labelling and/r by ther means, in supprt f [the respnsible and] prudent use f veterinary antimicrbial drugs[agents] in fd-prducing animals [the fd chain]. It is the respnsibility f regulatry authrities t develp up-t-date guidelines n data requirements fr evaluatin f veterinary antimicrbial drug[agent] applicatins. Natinal gvernments in cperatin with animal [plant,] and public health prfessinals shuld adpt a practive[one Health] apprach t prmte [the respnsible and] prudent use f antimicrbials in fd-prducing animals[the fd chain] as an element f a natinal strategy fr the cntainment f antimicrbial resistance. Other elements f the natinal strategy shuld include gd animal husbandry [and prductin] practices, vaccinatin [and bisecurity] plicies and develpment f animal [and plant] health care at the farm level, all f which shuld cntribute t reduce the prevalence f animal [and plant] disease requiring antimicrbial treatment. Use f veterinary antimicrbial drugs fr grwth prmtin that belng t classes f antimicrbial agents used (r submitted fr apprval) in humans and animals shuld be terminated r phased ut in the absence f risk-analysis, as described in Paragraph It is the respnsibility f the pharmaceutical cmpany r spnsr 6 t submit the data requested by the regulatry authrities fr granting marketing authrisatin. 11. The use f antimicrbial agents in fd-prducing animals requires a marketing authrisatin, granted by the cmpetent authrities when the criteria f safety, quality and efficacy are met. The examinatin f dssiers/drug applicatins shuld include an assessment f the risks t bth animals and humans resulting frm the use f antimicrbial agents in fd- prducing animals. The evaluatin shuld fcus n each individual veterinary antimicrbial drug but take int cnsideratin the class f antimicrbials t which the particular active principle belngs. The safety evaluatin shuld include cnsideratin f the ptential impact f the prpsed use in fdprducing animals n human health, including the human health impact f antimicrbial resistance develping in micrrganisms fund in fd- prducing animals and their envirnment assciated with the use f veterinary antimicrbial drugs. 12. [10.]. If dse ranges r different duratins f treatment are indicated, the natinal authrities shuld give guidance n the apprved prduct labelling regarding the cnditins that will minimize the develpment f resistance, when this infrmatin is available. [11. Fr mre infrmatin n antimicrbial drugs fr fd-prducing animals see the OIE Aquatic Animal Health Cde Chapter Respnsibilities f cmpetent authrities and Terrestrial Animal Health Cde Chapter Respnsible and prudent use f antimicrbial agents in veterinary medicine sectin 1. Marketing authrizatin.] 13. The relevant authrities shuld make sure that all the antimicrbial agents used in fd- prducing animals are prescribed by a veterinarian r ther suitably trained persn authrized in accrdance with natinal legislatin r used under cnditins stipulated in the natinal legislatin. (See OIE Guidelines fr Antimicrbial Resistance: Respnsible and Prudent Use f Antimicrbial Agents in Veterinary Medicine (Terrestrial Animal Health Cde, Appendix 3.9.3) 14. N veterinary antimicrbial drug shuld be administered t animals unless it has been evaluated and authrized fr such use by the relevant authrities r the use is allwed thrugh ff-label guidance r legislatin. Regulatry authrities shuld, where pssible, expedite the market apprval prcess f new veterinary antimicrbial drug frmulatins cnsidered t have the ptential t make an imprtant cntributin in the cntrl f antimicrbial resistance. 6 As defined in the VICH Gd Clinical Practice Guideline,