Update on the Codex Committee on Pesticide Residues

1. Update on the Codex Committee on Pesticide Residues Kathy Monk March 22, 2007

2. Outline of Presentation • Reducing the Time to Establish Codex MRLs • MRL Results • Revision of Crop Groupings • Use of Statistical Approach for MRL Estimation • Work Sharing

3. Roles and Responsibilities • CAC- Codex Alimentarius Commission (or Codex) makes the final decisions on Codex MRLs and oversees all of the various Codex Committees • CCPR- Codex Committee on Pesticide Residues performs the risk management functions regarding pesticide MRLs and recommends MRLs to the CAC • JMPR- Joint Meeting on Pesticide Residues performs the risk assessment functions regarding pesticide MRLs and recommends MRLs to the CCPR, the toxicology evaluations are done under the auspices of the WHO and the residue evaluations under the FAO

4. Reducing the Time to Establish Codex MRLs • Interim MRLs • Developing a process to reduce the time it takes to establish an MRL when there are no issues • Criteria for Decision-Making on MRL Advancement • Developing a process to reduce the time it takes to establish an MRL when there are issues raised in the CCPR

5. Interim MRLs • The U.S. had for the last several years promoted establishment of interim MRLs • For reduced risk compounds (narrow scope) • Involved governments reviewing other governments assessments (labor intensive) • Would result in MRLs designated as interim for 4 years until the JMPR review was completed (rework)

6. Outcome of Work and Discussion on Interim MRLs • CCPR agreed to use the already established “accelerated procedure” on a regular basis • Allows establishment of new MRLs coming out of JMPR as Codex MRLs at the first available opportunity (the next CAC meeting) • A 9-month process

7. Outcome of Work and Discussion on Interim MRLs • Accelerated procedure considered for any MRL that meets the criteria: • It is a new MRL • The JMPR report is available electronically by early February • No intake concerns are identified by JMPR

8. Outcome of Work and Discussion on Interim MRLs • Accelerated procedure is preferable to the interim MRL procedure • Applies to all new MRLs (not just MRLs for new compounds) • Applies to all compounds (not just reduced risk compounds) • Results in immediate establishment of Codex MRLs with no special (interim) designation and no further review

9. Outcome of Work and Discussion on Interim MRLs • Concern that the accelerated procedure would not be used as extensively as the proposed interim MRL process precisely because it does not (explicitly) allow for any continued review • Secretariat repeatedly affirmed that established MRLs can be reconsidered at any point in time • Concern unfounded in 2006—the procedure was used at every available opportunity

10. Outcome of Work and Discussion on Interim MRLs • Concern that the accelerated MRLs would be objected to at the CAC meeting (as a round-about way of subverting the procedure) were unfounded this year • Need to work to ensure that extensive use of the accelerated procedure continues at this years CCPR meeting where the leadership has changed

11. Criteria for Decision-Making on MRL Advancement • Delays in the finalization of MRLs occur in the CCPR for a variety of reasons • U.S. lead working group formed in 2005 session to address this issue • Working group proposed processes and procedures for making objections to MRLs that have been evaluated and recommended by JMPR

12. Criteria for Decision-Making on MRL Advancement • Committee approved, without any serious dissent, the procedures proposed • Procedures will greatly speed up the process when there are objections to an MRL

13. Criteria for Decision-Making on MRL Advancement • In the case of MRLs that would otherwise be eligible for the accelerated procedure, the process should result in no more than a 1 year delay in establishment of the MRL—unless it turns out that there is a documented and recognized safety concern

14. Criteria for Decision-Making on MRL Advancement • In the case of other MRLs, the procedure should ensure that the only MRLs “stuck” in the process have documented and recognized safety issues • The committee began to immediately implement the procedures, resulting in: • Some MRLs advancing which otherwise would not have • A much more orderly, structured, and transparent meeting

15. Criteria for Decision-Making on MRL Advancement • There will need to be vigilance to ensure that the procedures are vigorously followed and continue to be used before and during the next (2007) meeting

16. MRL Results • Use of the accelerated procedure and the criteria for decision making on MRL advancement resulted in what was recognized by the Chairman and many other participants as the most successful meeting in memory

17. MRL Results • MRLs Advanced Using the Accelerated Procedure • 207 MRLs from 13 compounds • These proposed MRLs moved through the process to become Codex MRLs in 9 months

18. MRL Results • MRLs advanced using the Normal (i.e. not accelerated) procedure • 238 MRLs from 15 compounds • Included the Interim MRLs for 2 compounds from the pilot interim MRL process which are now losing their “interim” designation • Some of the MRLs progressed only due to the use of the “Criteria for Decision-Making”

19. MRL Results • MRLs “Stuck” in the CCPR Process • As a result of all of this work, a review of the MRLs “stuck” in the process, i.e. at Steps 6 and 3, now contains, almost exclusively, a listing of chemicals with real problems that are causing national governments concern as well

20. Revision of Crop Groupings • The CAC approved new work on an extended revision of the Codex Classification of Foods and Animal Feeds • In the CCPR there was tremendous support for this work, especially among developing countries • Will allow continued coordination/ harmonization on the international level of the on-going work on crop groupings which is being done by IR-4/EPA, Codex, and others

21. Use of Statistical Approach for MRL Estimation • The statistical procedure (i.e. the MRL “calculator”) supported by the U.S. and Canada to derive MRLs, will be included in the next update of the “FAO Manual for the Submission and Evaluation of Pesticide Residues Data for the Estimation of MRLs in Food and Feed” • This is equivalent to requesting the JMPR to use this procedure in its work

22. Work Sharing • Progress on work sharing in the JMPR was reviewed by the CCPR and support expressed • Plans were made for the continuation of the effort in JMPR-- to include: • Use of another case study • Continued use of toxicology summaries showing the endpoints selected by each national government for all of the new compounds for which multiple international reviews are available

23. Work Sharing • The Quinoxyfen 2006 case study resulted in: • A 50-70% time saving for the toxicology evaluation • A 15-20% time saving for the residue evaluation • It was noted that these estimated time savings are likely upper bounds on what is possible (due to the relatively straightforward issues for this chemical)

24. Work Sharing • Toxicology summaries showing endpoints selected by each national government (where available) were provided by the U.S. for the following new chemicals: • Aminopyralid • Bifenazate • Boscalid • Thiacloprid

25. Summary • Several years of hard and difficult work is coming together in many areas, resulting in: • Significant reduction in the time to establish Codex MRLs • Greater harmonization in such pivotal areas as the calculation of MRLs (to reach the same conclusion from the same data) and crop groupings • More extensive use of work sharing to allow more chemicals through the process with less expenditure of resources