Agenda Item 10 CX/PR 13/45/13 March 2013

Transcription

1 E Agenda Item 10 CX/PR 13/45/13 March 2013 INTRODUCTION JOINT FAO/WHO FOOD STANDARDS PROGRAMME CODEX COMMITTEE ON PESTICIDE RESIDUES 45 th Session Beijing, P.R. China, 6-11 May 2013 REVISION OF THE RISK ANALYSIS PRINCIPLES APPLIED BY THE CODEX COMMITTEE ON PESTICIDE RESIDUES (Prepared by the Electronic Working Group chaired by Argentina and co-chaired by Costa Rica) Governments and interested international organizations wishing to submit comments on the above (Appendix 1 Parts A and B) are invited to do so in writing to: Ms. Duang Lifang, Institute for the Control of Agrochemicals, Ministry of Agriculture (ICAMA), P.R China, Fax: , ccpr@agri.gov.cn with a copy to: Secretariat, Codex Alimentarius Commission, Joint WHO/FAO Food Standards Programme, FAO, Viale delle Terme di Caracalla, Rome, Italy, by codex@fao.org by 12 April In order to comply with the mandate of the 44 th session of the Committee on Pesticide Residues, Argentina and Costa Rica, as Chair and Co-Chair, respectively, of the Electronic Working Group on the revision of the of the Risk Analysis Principles applied by the Codex Committee on Pesticide Residues, presents this executive summary of the actions taken by the EWG since the 44 th session of the CCPR. BACKGROUND 2. The background to the discussion on the revision of the Risk Analysis Principles applied by CCPR can be found in the reports of the 24 th session of the Committee on General Principles 1, the 30 th and 31 th sessions of the Codex Alimentarius Commission 2 and the 40 th to the 44 th sessions of the Committee on Pesticide Residues 3. The reports of sessions of the Commission and its subsidiary bodies are available at: FRAMEWORK AND TECHNICAL JUSTIFICATION 3. The work was structured according to the mandate received at the 44 th session of the CCPR, which reads: 163. The Committee noted that, as indicated in CRD 38, Argentina could not participate in the present session but agreed to chair the Working Group if it was re-established. The Committee therefore agreed to establish an electronic Working Group chaired by Argentina, co-chaired by Costa Rica, working in English and Spanish, with the following mandate: to take into account the clarification to be provided by JMPR concerning the toxicological and residue data to be submitted when the chemical is not supported by the manufacturers, regarding Case B of CX/PR 12/44/13 (Rev.); to consider the examples of chemicals (dicofol, fenvalerate) that JMPR has evaluated and that were not supported by the manufacturer; and to clarify issues related to national monographs and equivalence. The work of the EWG should focus on Part I of CX/PR 12/44/13 (Periodic Review / Criteria for Prioritization) and section 7 of Part II (Concern Form and other forms), taking into consideration CRDs 19, 24, 42, 43 and 48, in order to prepare a revised version of these sections for consideration at the next session. 4. Given the need to await the report of the meeting of the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) (11 to 20 September 2012, AGP-716), it was decided to start with the rest of the document. The first part comprising Sections 1-8, except 5.2 to 5.4 was then circulated. The second part (5.2 to 5.4) was circulated after the JMPR report became available. 5. The proposed texts were based on the mandate, the comments of the members of the EWG, the documents indicated in the mandate recently transcribed, and the JMPR report. 1 ALINORM 07/30/33, paras ALINORM 07/30/REP paras , 158 and ALINORM 08/31/REP, Appendix X. 3 ALINORM 08/31/24, paras , ALINORM 09/32/24 paras , ALINORM 10/33/24 paras , REP11/PR paras and REP12/PR, paras , Appendix XIV.

2 CX/PR 13/45/ Thus, the EWG focused its work on the periodic review and the criteria for priority setting document (CX/PR 12/44/13) and section 7 of Part II (form for expressing concerns or other forms). 7. The EWG worked on the inclusion of the proposal in CRD 43 Rev. 1, which was agreed by several countries and included with modifications of form. 8. A the 43 th CCPR session (2011) Brazil presented CRD 28, which was taken into account to elaborate the documents. SUMMARY OF THE TASKS CARRIED OUT 9. For sections 1-8, the amendments and observations made during the 44 th session of CCPR were take into account, in which the document was agreed except for a few points. The EWG included debating issues given in the mandate, to elaborate the draft. This was circulated to the EWG members for comments. The comments received were analyzed and those relevant were incorporated. Particular attention was paid to the concern form which merged proposals from Japan and Germany. 10. For part CX/PR 12/44/13 (Periodic review / criteria for priority setting) the EWG must await the letter of clarification of the JMPR on issues of procedure, and work on it. The JMPR manifested: - the toxicological and residue data to be submitted when manufacturers do not support the chemical in relation to Case B of CX / PR 12/44/13 (Rev.); - the examination of examples of pesticides (dicofol, fenvalerate) that JMPR had evaluated and do were not supported by the manufacturer; - clarification of issues related to national profiles monographs and equivalence. 11. This information was available in late September Upon receipt of the report of that meeting, and to present the same clear procedural scheme, it was turned into almost a textual document and was circulated among members of the EWG to receive and then include their comments. 12. In order to achieve greater transparency in the presentation of the proposals received, comments submitted are included in two tables, one for sections 5.2 to inclusive (Appendix 2), and one for Section 5.4 (Appendix 3). The remaining items, as they had already been analyzed, and they were minor changes, were included in the text. 13. Therefore, two documents are presented: - One with the periodic re-evaluation/criteria for prioritization and the form to express concerns (points 5.2 to 5.4 and 7). Members comments are shown in the abovementioned appendices. - The other relates to the rest of the document, which had been agreed by the 44 th session of the CCPR in These were included in the REP/12/PR, Appendix XIV and have minor changes that are highlight in the text as follows: the new text are underlined, the original text deleted is strikethrough.

3 CX/PR 13/45/13 3 APPENDIX 1-PART A DRAFT TEXT OF THE RISK ANALYSIS PRINCIPLES APPLIED BY THE CCPR 5.2 SELECTION OF COMPOUNDS FOR JMPR EVALUATION (SECTIONS 5.2 TO AND 7) Each year CCPR, in cooperation with the JMPR Secretariat, agrees on a schedule of JMPR evaluations in the following year and considers prioritisation of other compounds for consideration of future scheduling Procedure for the preparation of the Priority List for Nomination, prioritisation and scheduling of compounds CCPR submits a proposal to the CAC each year, as ongoing work, to re-establish the Electronic Working Group (EWG) on Priorities. The EWG on Priorities is tasked with preparing a Tentative Schedule of Pesticides for JMPR (evaluations for the following year) for the consideration of CCPR and the maintenance of a Priority List of Pesticides for future scheduling by CCPR. The Tentative Schedule of Pesticides for JMPR Evaluation and the Priority List of Pesticides comprise a number of appendices relating to new compounds, periodic re-evaluations, follow-up evaluations and other evaluations. Within two months of the CAC session, the Chair of the EWG issues a broadcast to all CCPR member and observers requesting nominations. Nominations for New compounds are submitted by members to the Chair of the EWG on Priorities and the JMPR Secretariat using the form in the FAO manual. All nominations compounds complying with the specified criteria of priority are incorporated into a list and prioritised. Those received by 30 November are incorporated into the draft agenda paper which is distributed as a circular letter by 1 January. Members and observers are allowed two months for comment, which must be received by the Chair of the EWG on Priorities, copied to the JMPR Joint Secretariat, by 1 March. On the basis of comments received to the circular letter, the Chair of the EWG on Priorities incorporates the compounds into the Tentative Schedule and Priority Lists, and prepares an agenda paper for CCPR. The Tentative Schedule seeks to provide a balance of new compounds, periodic reviews and other evaluations. Following plenary discussions on MRL recommendations, the Chair of the EWG on Priorities revises the Tentative Schedule and Priority List, which is then presented in CRD1 for CCPR s consideration. Following plenary discussion on CRD1, CCPR decides on the JMPR Evaluation Schedule for the following year. At that point, the Schedule is closed for the inclusion of additional compounds. However, with the agreement of the JMPR Secretariat, the inclusion of additional commodities for scheduled compounds may be accepted. Each year, to cover the possibility that a member country cannot meet the JMPR data call-in deadline for new compound evaluations, CCPR will include two reserve compounds Criteria for the elaboration of the Priority List Nomination, Prioritization and Scheduling of Compounds for Evaluation by JMPR New chemicals Nomination Criteria Before a nomination is accepted the following criteria must be met: A completed nomination form; An intention to register the compound for use in a member country; The commodities proposed for consideration must be traded internationally; There is a commitment by the member country of the compound to provide supporting data for review; The use of the compound is expected to give rise to residues in or on a food or feed commodity noting that a compound, for which use does not give rise to residueswill be afforded a lower priority; The compound has not been already accepted for consideration; and Certain number or percentage of minor/speciality crops are included. (New Comment - European Commission) Prioritisation Criteria The following criteria are used by the EWG on Priorities when proposing the priority list for CCPR s consideration:

4 CX/PR 13/45/13 4 The year when the chemical was nominated for evaluation; Timing of data availability; Commitment by the member country of the compound to provide supporting data for review with a firm date for data submission; and Scheduling Criteria The provision of information on the commodities for which CXLs are sought and the number of trials for each commodity. In order for CCPR to schedule a compound for JMPR evaluation in the following year: It must be registered for use in a member country and product labels available for review by the time of JMPR data call-in; The member country must commit to meeting the JMPR data call-in deadline; and Its use must, in general, give rise to residues in or on a food or feed commodity moving in international trade. If the use of the compound does not give rise to detectable residues in foods and feeds, it will be afforded a lower priority than those listed compounds for which use does give rise to measurable residues. Periodic Re-Evaluation Nomination Criteria Chemicals that have not been reviewed toxicologically for more than 15 years and/or not having a significant review of maximum residue limits for 15 years will be listed for prioritisation in the Appendix (Listed but not yet Scheduled). Prioritisation Criteria When prioritizing chemicals for periodic re-evaluation by the JMPR, the Committee will consider the following criteria: Scheduling criteria If scientific data concerning the intake and/or toxicity profile of a compound indicates some level of public health concern; If the chemical have not been reviewed toxicologically for more than 15 years and/or not having a significant review of maximum residue limits for 15 years; If no ARfD has been established by JMPR or if established ADI or ARfD are of public health concern (Except in cases where JMPR has decided an ARfD is not required); The availability of current labels (authorised GAP) arising from recent national re-evaluations; The CCPR has been advised by a member that the residues from a compound has been responsible for trade disruption; The year the compound is listed in the Appendix (Listed but not yet Scheduled); The year the data will be submitted; The year the compound was previously subjected to periodic re-evaluation or, if not previously re-evaluated, the year of new compound evaluation; and If there is a closely related chemical that is a candidate for periodic re-evaluation that can be evaluated concurrently. Noting the Committee s aim to have a balance between new compounds and periodic re-evaluations, the final schedule of periodic re-evaluations is decided by CCPR, taking into account the above criteria and a clear commitment for data submission. Follow-up and Other Evaluations Nomination criteria Compounds previously evaluated by JMPR may be listed for further toxicological and / or residue evaluations by the JMPR as a result of requests from CCPR or members. Noting that members may request, and CCPR may agree to, the application of the four-year rule, the following circumstances will be considered for follow-up or other evaluations: A member seeks to expand the use of an existing compound, ie. to obtain new or revised MRLs for one or more commodities; The CCPR requests a clarification or reconsideration of a recommendation from the JMPR; New toxicological data becomes available to indicate a significant change in the ADI or ARfD, or the need to set an ARFD if none was set in the past. (New comment - European Commission);

5 CX/PR 13/45/13 5 A data deficiency is noted by JMPR during an evaluation and a member country commits to provide the required information. In this case, and when the four-year rule is applied, the JMPR recommendation is held in the Step Procedure for a period not exceeding four years; A Codex MRL is recommended for withdrawal. In this case, and when the four-year rule is applied, the CXL is maintained for a period not exceeding four years. Prioritisation Criteria When prioritizing chemicals for other evaluation by the JMPR, the CCPR will consider the following criteria: Scheduling criteria The date the request was received; Commitment by the member country to provide the required data for review by the deadline of data submission for the evaluation of the toxicological and/or residues studies by the JMPR; Whether the data is submitted under the 4-year rule for evaluations; and The nature of the data to be submitted, and the reason for its submission; for example, a request from CCPR. The final schedule of other evaluations is decided by CCPR, taking into account the above criteria and the available JMPR resources. 5.4 MRLS PERIODIC REVIEW PROCEDURE The periodic Review Procedure consists of two different phases as described below: PHASE I - Identify Periodic Review Chemicals and solicit data commitments (Year 1, CCPR session) 1. Listing compounds for periodic re-evaluation Compounds are listed for periodic re-evaluation according to the process and procedures described in section 5.2. The process provides members and observers a notice of a periodic re-evaluation. When a compound is listed for periodic re-evaluation, manufacturers, members and observers are able to support it, regarding the three following possibilities: A) The chemical and all CXLs are supported by the manufacturers with a complete data package. B) The chemical and all CXLs are not supported by the manufacturers. In this case, interested members or observers may support the re-evaluation of the compound and submit relevant data. For situations where a company no longer sponsors the product (typically older active ingredients), the information available may not comprise a full data package. In these cases, in order to maintain consistency in the quality of its assessments, JMPR has established principles to followfor submissions by others than the manufacturer. 4 C) The chemical is supported but only one (or some) CXL is not supported by the manufacturers. In this case, interested members or observers may support the MRL. If GAPs remain unchanged this only requires the presentation of labels, whereas if the GAPs have been modified interested members or observers must provide new residue data based on current GAPs to the JMPR for a new recommendation. If there is no commitment to support a compound listed for periodic re-evaluation or existing Codex MRLs or new proposed MRL for use of such a compound on particular commodities, this is highlighted in the draft Priority List distributed to members and observers by Circular Letter as well as the priorities agenda paper tabled at CCPR. 2. Commitment to support chemicals or existing Codex MRLs or new proposed MRL The commitment of members to provide data for the periodic review should be addressed to the Chair of the EWG on Priorities and the JMPR Joint Secretariat. Manufacturers and observers, when addressing the commitment to a nominating member, should copy it to the Chair of the EWG on Priorities and the JMPR Joint Secretariat. The following information must be provided in the response: 4 Joint FAO/WHO Meeting on Pesticide Residues (JMPR), Rome, September 2012 (AGP-716) (available in English only).

6 CX/PR 13/45/13 6 I) In the case provided for in A II) III) A list of chemicals and all CXLs supported by the manufacturer; A draft list of all chemistry (residue, metabolism, animal transfer, processing, analytical sample storage stability, analytical methods etc.) and toxicology studies and other data that they are willing to provide and the data they commit to make complete data package submissions to the JMPR. Comments on the status of registration at the national level are encouraged; A summary of all current Good Agricultural Practices (GAPs) at the time of the notification and any potential new GAPs expected before the JMPR evaluation which they are willing to provide and which is pertinent to residue data they are willing to provide (e.g. commodities and countries for with detailed GAP summaries and representative labels can be provided). In the case provided for in B A list of chemicals and CXLs that members or observers are willing to support; The requesting country should be responsible for providing information on the intended uses, specification of the technical active substance used in the country and a justification for assessment by JMPR; The information required would be such that it would be possible to address the key questions for the human health assessment, including establishment of an ADI and/or ARfD, when required, and the definition of residues for enforcement of MRLs and dietary risk assessment. Furthermore, data on a sufficient number of supervised trials in or on food and feed crops reflecting the current use patterns specified on the relevant labels are required for estimation of maximum residue levels and STMR and HR values. Trial data may be complemented by relevant selective survey residue data; It is the responsibility of the requesting country to provide the available data and other relevant information, such as available assessments by supranational and national authorities and publications from a recently conducted literature search. In the case provided for in C A list of CXLs that members or observers are willing to support; If GAPs remain unchanged only required the submission of labels; If GAPs were modified, supervised residue trial studies conducted according to current GAP, and relevant studies to support new MRLs in animal and processed commodities. 3. Repeat the Invitation and Notification By means of a Codex Circular Letter to accompany the report of the Session the Secretariat will repeat the notification and request. On receipt of the request by the Circular Letter, members and observers will immediately repeat their notification and invitation to identified interested parties who may not have been represented at the CCPR (they would not have received the report of the Session and the accompanying Circular Letter). Interested parties need only respond to one of the requests but should copy addresses listed in the item above PHASE II - Status Report on Data Commitments and CCPR Follow-up (Year 2, CCPR session) 1. Status report on data commitments The EWG on Priorities will provide a report and room document to the CCPR on the status of commitments received to provide data for the chemicals identified in year 1. This information will be used to schedule JMPR reviews: A) Chemicals and CXLs that are supported by the manufacturers with a complete data package; B) Chemicals and CXLs that are supported by members or observers (that is, chemical not supported by the industry); C) CXLs that are supported by current Good Agricultural Practices (GAPs) or new residue data and GAPs (that is, CXLs not supported by the industry, even if the chemical is supported). Note: If there is no commitment, The Priorities EWG report will inform about the potential deleting CXLs. 2. Response to data commitments I) Procedure for Case A If a commitment is made to provide and identify or develop data to support the chemicals and existing CXLs, as foreseen in Case A), the complete data package will be scheduled for JMPR review. The JMPR review will be conducted consistent with one of the following scenarios:

7 CX/PR 13/45/13 7 Sufficient toxicological data (and other studies) are submitted to support the chemical and it is therefore maintained; Sufficient data are submitted to confirm the existing CXL and it remains in placewhile the proposed CXL enters the process at Step 3 and the existing CXL is deleted as soon as the new proposed MRL is adopted by CAC at the latest automatically after no more than 4 years; Sufficient data are submitted to support a new proposed MRL, it enters the process at Step 3 and the existing CXL is deleted as soon as the new proposed MRL is adopted by CAC at the latest automatically after no more than 4 years. II) Procedure for Case B If commitments are made to provide, identify or develop data supporting the chemicals and existing CXLs, as foreseen in Case B), the JMPR review of the data will be scheduled. If literature studies are to be relied upon, JMPR will weigh such studies for their quality and design. Because raw data will not be available, there needs to be sufficient information on methods and results to enable the study findings to be reconstructed; If critical data are missing, then JMPR may still determine whether an assessment is possible; in such cases, however, it is likely that conservative assumptions will be used to address the missing information; If sufficient information is not available to enable the establishment of health-based guidance values, JMPR may provide alternative guidance, such as characterization of the margin of exposure, or may conclude that it is not possible to provide any guidance in the absence of additional information. Note: If the submitted information/data are insufficient, the JMPR may request additional information/data on a case-by-case basis. III) Procedure for Case C If a commitment is made to provide and identify or develop data to support the CXLs, as provided for in Case C), the review of the new data or Good Agricultural Practices (GAPs) is scheduled for review by the JMPR. The JMPR review will result in one of the following scenarios: Good Agricultural Practices (GAPs), which have not changed and are in use, are presented to confirm the CXL, which therefore remains. The proposed CXL enters the process at Step 3 and the existing CXL is deleted as soon as the new proposed MRL is adopted by CAC at the latest automatically after no more than 4 years; Residue data and most recent Good Agricultural Practices (GAPs) are submitted to support the new MRL proposal. It enters the process at Step 3 and the existing CXL will be automatically deleted after four years. Note: If the submitted information/data are insufficient, the JMPR may request additional information/data on a case-by-case basis. 3. Insufficient information to support a CXL If insufficient data have been submitted to support the chemical or the existing CXL or the new MRL, manufacturers, members or observers are so advised by written notification from the relevant Joint Secretary of the JMPR and/or by issuance of the JMPR Report. On being advised of the data inadequacy, manufacturers, members or observers may, by the next CCPR session, provide to the JMPR and the CCPR Secretaries a written commitment to generate and submit a dossier of required data for review within 4 years, under the condition that no unacceptable acute/chronic risks have been identified by JMPR. If an unacceptable acute/chronic risk has been identified by the JMPR, on a scientific base, the additional period to submit the dossier of required data will not be granted and the CXL should be proposed for deletion. The chemical and the CXL is maintained for no more than 4 years following advice of data inadequacy (by direct notification or by issuance of the JMPR Report). The 4 year period may be extended by the CCPR only to the extent necessary for the JMPR to schedule and complete review of the available new data. The new data are scheduled for the second JMPR review and the first part of the PHASE II 2 procedure is repeated. If the committed data are not submitted, or if the data submitted for the initial periodic review are insufficient and no commitment is made by the next CCPR session to generate new data, the CCPR recommends deletion of the CXL. In case a chemical and/or its CXLs failed confirmation or evaluation of new MRLs under the four-year-rule (described in the previous paragraph) to be supported, the CCPR recommends deletion of the CXL.

8 CX/PR 13/45/ Summary of Periodic Review Procedure for Codex MRLs PESTICIDE SELECTED FOR PERIODIC REVIEW A LIST IS SUBMITTED CCPR INVITE TO COMMITMENT COMMITMENT TO SUPPORT DATA CASE A) or B) or C) JMPR EVALUATION AND PROPOSALS NO COMMITMENT FOR DATA SUBMISSION CXL RECOMMENDED FOR DELETION BY CCPR SUFFICIENT DATA ARE SUBMITTED TO CONFIRM CXL SUFFICIENT DATA ARE SUBMITTED TO SUPPORT NEW MRL INSUFFICIENT DATA ARE SUBMITTED TO CONFIRM CXL OR TO SUPPORT NEW MRL THE CXL IS MAINTAINED THE NEW MRL IS CIRCULATED AT STEP 3 EXISTING CXL DELETED AFTER NO MORE THAN 4 YEARS COMMITMENT IS MADE BY THE TIME OF THE NEXT CCPR TO PROVIDE DATA NO COMMITMENT IS MADE TO PROVIDE DATA CXL MAINTAINED FOR NO MORE THAN 4 YEARS FOLLOWING AVAILABILITY OF JMPR REPORT OR WRITTEN NOTIFICATION RESULTS CXL RECOMMENDED FOR DELETION BY CCPR 2 ND JMPR EVALUATION AND PROPOSALS SUFFICIENT DATA ARE SUBMITTED TO CONFIRM CXL SUFFICIENT DATA ARE SUBMITTED TO SUPPORT NEW MRL INSUFFICIENT DATA ARE SUBMITTED TO CONFIRM CXL OR TO SUPPORT NEW MRL CXL IS MAINTAINED NEW MRL CIRCULATED AT STEP 3 CXL IS RECOMMENDED FOR DELETION BY CCPR

9 CX/PR 13/45/ PROCEDURE FOR SUBMITTING CONCERN 7.1 CONCERNS WITH ADVANCEMENT OF AN MRL OR THE EVALUATION OF A COMPOUND JAPAN/GERMANY PROPOSAL ACCEPTED ( Considering proposals made by Japan, Germany, and Australian opinion, we include in the Japan proposal the wording made by Germany about a Request for clarification as number 7.3) If members or observers intend to express concerns with advancement of an MRL or the evaluation of a compound, they should complete and submit the Annex A to the CODEX and JMPR Secretaries accompanied by scientific data at least one month before the CCPR session; The JMPR will evaluate the concerning scientific data provided with the form. The CCPR will decide whether JMPR should address the concern and schedule it based on the JMPR recommendations and workload; When a concern form was not submitted within the specified deadline, the JMPR would consider the concerns at a future meeting and the CCPR would subsequently decide on the status of the MRL; When considering concerns expressed by members, the CCPR has agreed: CCPR should recognize the position taken by the JMPR as the best available science (applicable at the international level) until and if a different position is indicated; Science based concerns based on the same data/information should be considered only once by the JMPR in relationship to any specific compound, MRL or CXL; If the same information is submitted, JMPR should simply note that this information has already been reviewed, no other change has occurred which would affect the outcome of a new review, and therefore no review is warranted at this time. While MRLs should not be prevented from advancement because of concerns related to concerning current JMPR procedures, it is imperative that CCPR appropriately address any continuing concerns, i.e. repeated concerns related to the same sciencebased issue. This may also be relevant to issues closely associated with risk management. Appropriate action must be: referring the issue to JMPR if there is additional or new information, or if the CCPR wishes to provide risk management input to JMPR on the conduct of risk assessments; referring the issue to national governments or regional authorities for input with a discussion and decision at the next CCPR; and/or where justified by the nature of the issue, referring the issue to a scientific consultation if the budget is available from FAO and/or WHO, with JMPR and/or CCPR to make adjustments based on the recommendations of that consultation. Members recommending any such action by CCPR should provide documentary information supporting their recommendation for the consideration of the Committee; in the interim, according to the above recommendations, subject MRLs should be advanced; if desired by the objecting member, concerns should be officially recorded in the CCPR report and CAC informed through the CCPR report. 7.2 CONCERNS WITH PUBLIC HEALTH ON A COMPOUND FOR PRIOTIZATION OF PERIODIC RE-EVALUATION If members or observers intend to express concerns with public health on a compound for prioritization of periodic reevaluation, they should complete and submit Annex B accompanying the scientific data to the Chair of EWG on Priorities, in order that the EWG can propose a list of 2 to 3 chemicals every year, from the full list of substances candidate for periodic reevaluation, based on their potential higher concern regarding public health; The EWG on Priorities will, in consultation with the JMPR if necessary, consider whether the submitted information indicates some level of public health concern and present proposals to the subsequent CCPR session; If the concern in regard to a compound listed in periodic reevaluation schedule is supported by CCPR, the compound will be assigned a high priority and scheduled for the next available year; However, if a member or observer disagrees with the proposal by the EWG on Priorities, it must lodge additional scientific data to the Chair of the EWG on Priorities one month before the CCPR session. At the following CCPR session, the EWG on Priorities will report its proposals. CCPR will make its final decision on prioritization.

10 CX/PR 13/45/ REQUEST FOR CLARIFICATION If members or observers intend to seek some clarification they are asked to clearly describe the problem based on the JMPR evaluation when asking to comment this evaluation by Circular Letter or when commenting on Circular Letters or other Codex papers provided for the entire CCPR session and mark this as a matter for clarification. Also for this purpose the form provided in Annex A should be used. The JMPR will take this on board during its next JMPR meeting and provide an answer to the next CCPR session. The CCPR will take note on the answer or may change its decision taken if necessary. If the JMPR cannot provide the clarification requested during the CCPR session the entire MRLs can not be used for Step 5/8 procedure.

11 CX/PR 13/45/13 11 Annex A FORM FOR EXPRESSING CONCERNS WITH ADVANCEMENT OF AN MRL/OR REQUEST FOR CLARIFICATION OF CONCERNS

12 CX/PR 13/45/13 12 Annex B FORM FOR EXPRESSING CONCERNS WITH PUBLIC HEALTH ON A COMPOUND FOR PRIORITIZATION OF PERIODIC RE-EVALUATION

13 CX/PR 13/45/ SCOPE APPENDIX 1-PART B DRAFT TEXT OF THE RISK ANALYSIS PRINCIPLES APPLIED BY THE CCPR (EXCEPT SECTIONS 5.2 TO AND 7) 1. This document addresses the respective applications of risk analysis principles by the Codex Committee on Pesticide Residues (CCPR) as the risk management body and the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) as the risk assessment body and facilitates the uniform application of the Working Principles for Risk Analysis for Application in the Framework of the Codex Alimentarius. This document should be read in conjunction with the Working Principles for Risk Analysis for Application in the Framework of the Codex Alimentarius. 2. GENERAL ASPECTS SUMMARY OF THE MRL-SETTING PROCESS In addressing pesticide residue issues in Codex, providing advice and taking decisions on risk management is the responsibility of the Codex Alimentarius Commission (CAC) and CCPR, while conducting risk assessment is the responsibility of JMPR. The MRL-setting process begins with a member or other interested party nominating a pesticide for evaluation by the JMPR. In considering the nomination, the CCPR, in consultation with the JMPR Joint Secretaries may then prioritize and schedule the pesticide for evaluation. The WHO Core Assessment Group consider available data encompassing a wide range of toxicological endpoints with the aim of estimating an acceptable daily intake (ADI) and an acute reference dose (ARfD) where sufficient data are available. The FAO Panel of Experts on Pesticide Residues in Food and the Environment considers data on registered use patterns, fate of residues, animal and plant metabolism, analytical methodology and residue data derived from supervised residue trials in order to propose residue definitions and MRLs for the pesticide in food and feed commodities. The JMPR risk assessment includes the estimation of both short-term (single day) and long-term dietary exposures and their comparison with the relevant toxicological benchmarks. MRLs in or on food commodities and animal feeds are based on Good Agricultura Practice (GAP) information, taking into consideration information on dietary intakes, and foods derived from commodities that comply with the respective MRLs are intended to be toxicologically acceptable. The CCPR, considers the recommendations of JMPR in the light of information provided in the relevant JMPR reports and monographs. MRLs recommendations accepted by the CCPR are submitted to the CAC for adoption as Codex MRLs. An active periodic review program complements this process. CCPR and JMPR should ensure that their respective contributions to the risk analysis process result in outputs that are scientifically based, fully transparent, thoroughly documented and available in a timely manner to members RISK ASSESSMENT POLICY CCPR shall consider the following when preparing its priority list of compounds for JMPR evaluation: CCPR s Terms of Reference; JMPR s Terms of Reference; The CAC s Strategic Plan; The Criteria for nomination, prioritization and scheduling of compounds; The Criteria for nomination, prioritization and scheduling of compounds.(*) The Criteria for establishment of work priorities The Criteria and Procedures for Proposing Pesticides for Codex Priority Lists; The Criteria for Selecting Food Commodities and Animal Feed for which Codex MRLs or Extraneous Maximum Residue Limits (EMRLs) should be Established; The Criteria for Evaluation of New Chemicals; The Criteria for the Prioritization Process of Compounds for Evaluation by JMPR; A commitment to provide the necessary data for the evaluation in time. (*) Proposal CCPR See REP12/PR Point 146 EWG analysis 5 Submission and evaluation of pesticide residues data for the estimation of maximum residue levels in food and feed, FAO Plant Production and Protection Paper, 197, 2009, ISBN (available in English only).

14 CX/PR 13/45/13 14 When referring substances to JMPR, the CCPR shall provide background information and clearly specify the reasons for the request when chemicals are nominated for evaluation. When referring substances to JMPR, the CCPR may also refer a range of risk management options, with a view toward obtaining JMPR s guidance on the attendant risks and the likely risk reductions associated with each option. CCPR shall request JMPR to review any risk assessment policies, methods and guidelines being considered by CCPR for assessing maximum residue limits levels (*) for pesticides. (*) Proposal Swiss - EWG analysis When establishing its standards, CCPR shall clearly state when it applies any considerations based on other legitimate factors in addition to JMPR s risk assessment and recommended maximum residue levels and specify its reasons for doing so. JMPR applies a transparent, science based risk assessment process for establishing Acceptable Daily Intakes (ADIs) and Acute Reference Doses (ARfDs) where appropriate. JMPR, in consultation with CCPR, must continue to explore developing minimum data requirements necessary for JMPR to perform risk assessments. The JMPR Secretariat shall consider whether these minimum data requirements have been met when preparing the provisional agenda for meetings of JMPR. 3.1 MRLS FOR SPECIFIC COMMODITIES GROUP MRLs for commodities of animal origin Farm animal metabolism studies are required whenever a pesticide is applied directly to livestock, to animal premises or housing, or when significant residues remain in crops or commodities used in animal feed, (e.g. forage crops, plant parts that could be used in animal feeds, by products or coproducts of industrial productions). The results of farm animal feeding studies and residues in animal feed serve also as a primary source of information for estimating maximum residue levels in animal products. If no adequate studies are available, no MRLs will be established for commodities of animal origin. MRLs for feeds (and the primary crops) should not be established in the absence of animal transfer data. Where the exposure of livestock to pesticides through feeds leads to residues at the limit of quantitation (LOQ), MRLs at the LOQ must be established for animal commodities. MRLs should be established for animals for food production where pesticides on feeds are present *[concerned]. Where direct treatments of pesticides are related [concerned] to specific species (e.g cattle, sheep), MRL should also be established. (*New proposal on wording: Present instead of Concerned )- EWG analysis (*New proposal on wording: Related instead of Concerned )- EWG analysis Where the recommended maximum residue level or limits (**) for animal commodities resulting from direct treatment of the animal, regardless of whether they are recommended by JMPR or JECFA, and from residues in animal feed do not agree, the higher recommendation will prevail. (*) (*) Complete paragraph accepted See REP12/PR Point 147 EWG analysis (**) Japan Proposal accepted - EWG analysis MRLs for spices CCPR agreed that MRLs for spices can be established on the basis of monitoring data in accordance with the guidelines established by JMPR MRLs for fat-soluble pesticides If a pesticide is determined as fat soluble after consideration of the following factors, it is indicated with the text The residues are fat soluble in the residue definition: When available, information concerning the partitioning of the residue (as defined) in muscle versus fat in the metabolism studies and livestock feeding studies that determines the designation of a residue as being fat soluble ; In the absence of useful information on the distribution of residues in muscle and fat, residues with logpow>3 are likely to be fat soluble. For milk and milk products, two maximum residue levels would be estimated for fat-soluble pesticides, if the data permits. One MRL for whole milk and one for milk fat. For enforcement purposes, a comparison can be made between either the residues in milk fat with the MRL for milk (fat), or the residue in whole milk with the MRL for milk (*) with the MRL for whole (**) milk. When needed, MRLs for milk products can then be calculated from the two values, by taking into account the fat content of the milk product and the contribution from the non-fat fraction. (*) Duplicated text eliminated (**) Ecuador Proposal accepted - EWG analysis

15 CX/PR 13/45/13 15 For regulation and monitoring of residues of fat-soluble pesticides in milk, where MRLs have been established for both whole milk and milk fat, whole milk should be analysed and the result should be compared with the Codex MRL for whole milk (FAO Manual, 2009) MRLs for processed or ready-to-eat foods or feeds The JMPR evaluates processing studies to derive processing factors used to estimate residues concentrations in processed commodities for dietary risk assessments and, if necessary, recommended maximum residue levels for processed commodities. The CCPR agreed to: establish MRLs for important processed commodities from its consumption; (*) (*) Ecuador proposal accepted EWG Analysis establish MRL for the processed commodities only if the resulting value is higher than the MRL established for the corresponding raw agriculture commodity (RAC) 6 (PF>1.3); continue the practice of establishing MRLs for processed commodities where, due to the nature of the residues during some specific process, significant amounts of other relevant metabolites appear or increase; and support the current JMPR practice of evaluating all processing studies provided and including in each Evaluation/Review a summary table of all validated processing factors Establishment of EMRLs The Extraneous Maximum Residue Limit (EMRL) refers to a pesticide residue or a contaminant arising from environmental sources due to former agricultural uses other than the use of the pesticide directly or indirectly on the commodity. It is the maximum concentration of a pesticide residue that is recommended by the Codex Alimentarius Commission to be recognized as acceptable in or on a food, agricultural commodity or animal feed. Chemicals for which EMRLs are most likely to be needed are persistent in the environment for a relatively long period after uses have been discontinued and are expected to occur in foods or feeds at levels of sufficient concern to warrant monitoring. All relevant and geographically representative monitoring data (including nil-residue results) are required to make reasonable estimates to cover international trade 7. JMPR has developed a standard format for reporting pesticide residues monitoring data. The JMPR compares data distribution in terms of the likely percentages of violations that might occur if a given EMRL is proposed to the CCPR. Because residues gradually decrease, CCPR evaluates every 5 years, if possible, the existing EMRLs, based on the reassessments of the JMPR. 4. RISK ASSESSMENT 4.1 ROLE OF JMPR The Joint FAO/WHO Meeting on Pesticide Residues (JMPR) consists of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Core Assessment Group. It is an independent scientific expert body convened by both Directors General of FAO and WHO according to the rules of both organizations, charged with the task to provide scientific advice on pesticide residues. This document applies to the work of JMPR in the context of Codex and in particular as it relates to advice requests from CCPR. JMPR is primarily responsible for performing the risk assessments and proposing MRLs upon which CCPR and ultimately the CAC base their risk management decisions. JMPR proposes maximum residue levels based on Good Agricultural Practices (GAPs)/registered uses or in specific cases, such as EMRLs and MRLs for spices based on monitoring data. JMPR provides CCPR with science-based risk assessments that include the four components of risk assessment as defined by CAC, namely hazard identification, hazard characterization, exposure assessment and risk characterization that can serve as the basis for CCPR s discussions. JMPR should identify and communicate to CCPR in its assessments any information on the applicability and any constraints of the risk assessment in regard to the general population and to particular sub-populations and shall, as far as possible, identify potential risks to populations of potentially enhanced vulnerability (e.g. children). JMPR communicates to CCPR possible sources of uncertainties in the exposure assessment and/or in the hazard characterization of the compound that, if resolved, would allow a refinement of the risk assessment. 6 Submission and evaluation of pesticide residues data for the estimation of maximum residue levels in food and feed; FAO Plant protection and Protection Paper, 197, 2009, ISBN (available in English only). 7 Submission and evaluation of pesticide residues data for the estimation of maximum residue levels in food and feed; FAO Plant protection and Protection Paper, 197, 2009, ISBN (available in English only).

16 CX/PR 13/45/ DIETARY INTAKE JMPR is responsible for evaluating exposure to pesticides. JMPR must strive to base its exposure assessment and hence the dietary risk assessments on global data, including that from developing countries. In addition to GEMS/Food data, monitoring data and exposure studies may be used. The GEMS/Food diets are used to assess the risk of chronic exposure. The acute exposure calculations are not based on those diets, but on the available high percentile consumption data as provided by members and compiled by GEMS/Food. In undertaking dietary exposure risk assessments to assist the CCPR, the JMPR uses the WHO Guidelines 8 and other documents 9. The JMPR recommends Supervised Trial Median Residues (STMRs) and Highest Residues (HRs) for dietary intake purposes. When the ADI is exceeded in one or more cluster diets, the JMPR further refines the dietary intake estimates at the international level. If further refinement is possible the CCPR should advance the MRLs to Step 8 provided that the MRLs give no longer rise to intake concerns. If further refinement is not possible or the refinement still give rise to intake concern, the JMPR flags this situation when recommending maximum residue levels and the CCPR will decide on which MRLs could be advanced and which ones should be deleted. The JMPR establishes acute reference doses (ARfDs), where appropriate, and indicates cases where an ARfD is not necessary. Since 1999, the JMPR calculates the International Estimate of Short-term Intake (IESTI), following a procedure described previously (FAO, 2003). This procedure allows for the estimation of the IESTI for the General Population and for Children (less than 6 years old). Where the ARfD is exceeded for a compound/commodity, the JMPR report should describe the particular situation that gives rise to that acute intake concern. The JMPR shall examine available information on alternative GAPs and associated residue trials where the ARfD is not exceeded and recommends an MRL associated with this alternative GAP. This procedure has been referred to as the "prospective alternative GAP analysis". Under this procedure, having analyzed the situation, if an acceptable alternative GAP is not available at the moment of the evaluation, interested parties should be able to supply both labels and field trial data that support an alternative GAP within the next year. If a GAP is provided but no field trial data according to this GAP, JMPR may consider a rough estimate on the safety of the use using the proportionality principle according the agreed criteria in which case the proposed MRL may be returned to Step 6 three times. The data will be evaluated by JMPR on request of CCPR as soon as they become available. If no data are supplied the CCPR should proceed to withdraw the draft MRL. The estimate of the short-term dietary intake requires substantial food consumption data that currently are only sparsely available. Governments are urged to generate relevant consumption data and to submit these data to the WHO. 5. RISK MANAGEMENT 5.1 ROLE OF CCPR CCPR is primarily responsible for recommending risk management proposals, such as MRLs, for adoption by the CAC. CCPR shall base its risk management recommendations to the CAC on JMPR s risk assessments of the respective pesticides, considering, where appropriate, other legitimate factors 10 relevant for health protection of consumers and for the promotion of fair practices in food trade. In cases where JMPR has performed a risk assessment and CCPR or the CAC determines that additional scientific guidance is necessary, CCPR or CAC may make a specific request to JMPR to provide further scientific guidance necessary for a risk management decision. CCPR s risk management recommendations to the CAC shall take into account the relevant uncertainties as described by JMPR. CCPR shall consider only maximum residue levels recommended by JMPR. CCPR shall base its recommendations on the GEMS/Food diets used to identify consumption patterns. The GEMS/Food diets are used to assess the risk of chronic exposure. The acute exposure calculations are not based on those diets, but available consumption data provided by members and compiled by GEMS/Food. If no validated methods of analysis are available for enforcing MRLs for a specific compound, no MRLs will be established by CCPR. (*) (*) Complete paragraph accepted See REP12/PR Point 154 EWG analysis 8 WHO Guidelines: WHO/FSF/FOS/97.7 (available in English only). 9 FAO Pesticide Residues in Food Report. FAO Plant Production and Protection Paper No. 176 FAO, Rome. Chapter 3 (available in English only). 10 Statement of Principle Concerning the Role of Science in the Codex Decision-Making Process and the Extent to Which Other Factors are Taken into Account, Codex Procedural Manual, 18th Edition, page 171 (available in English only).