Delegate's Report, 44th Session, Codex Committee on Pesticide Residues
April 23-28, 2012
On April 23-28, 2012, the Codex Committee on Pesticide Residues (CCPR) held its 44th Session in Shanghai, People's Republic of China. Professor Xiongwu Quio, Vice-Director of the Shanxi Academy of Agricultural Sciences, served as Chair, assisted by Dr. Weili Shan, Director of Residue Division of Institute for Control of Agrochemicals, Ministry of Agriculture (ICAMA). The Session was attended by 253 delegates representing 68 Member Countries, 1 Member Organization, and Observers from 6 international organizations. The U.S. Delegation was led by Ms. Lois Rossi of EPA, and Dr. Pat Basu of USDA served as alternate delegate.
The following summarizes issues of particular interest to the U.S. Delegation. Complete details of the 43rd Session (2011 Meeting) may be found on the Codex Alimentarius website at: http://www.codexalimentarius.net/web/archives.jsp
Matters of Interest Arising From FAO and WHO
The FAO Secretariat to Joint FAO/WHO Meeting on Pesticide Residues (JMPR - the risk assessment body for CCPR) announced several initiatives associated with enhancing the participation of developing countries in the residue risk assessment processes, which included the revised FAO Training Manual on Evaluation of Pesticide Residues for Estimation of Maximum Residue Limits (MRLs) and three regional workshops held in Latin America and Africa on residue risk evaluation submissions and reviews.
The FAO Secretariat to JMPR also updated the Committee on the Second Global Minor Use Summit (GMUS-2) held in Rome, Italy in February 2012 , which event was supported by FAO, USDA, EPA, and the IR-4 Minor Crop Pest Management Program and attended by 230 delegates from more than 50 countries. The U.S. Delegation provided an out-of-session briefing of specific activities of the GMUS-2 and presented several action items, including the development of a "global needs" database to share information, the further development of a global minor use portal to facilitate risk communication and materials to benefit communication on minor use issues.
Application of Proportionality in Selecting Data for MRL Estimation
As agreed upon by the CCPR at the last Session, the 2011 JMPR applied the concept of proportionality to estimate MRLs and provided a comparison of results of MRL recommendations with and without the use of the proportionality approach for five compounds and five commodities for which the residue data were not sufficient for a recommendation of a MRL according to Good Agricultural Practices (GAP). The U.S. Delegation, as well as several other delegations, strongly supported the JMPR's use of the concept of proportionality. The U.S. Delegation further noted that the proportionality concept is a useful tool for JMPR to recommend additional MRLs for minor uses.
However, several other delegations noted that further guidance on criteria for this concept of proportionality was still needed and therefore did not support moving forward MRLs based on this concept until such guidance was completed.
After a lengthy discussion and consultation with FAO Secretariat to JMPR, the Committee established an electronic working group (EWG) to develop further principles and guidelines on applying the concept of proportionality and requested that the 2012 JMPR continue exploring examples and comparisons using this concept. The U.S. Delegation expressed interest in participating EWG, which will be co-chaired by Australia and Germany.
MRL (Maximum Residue Limits) Results
This CCPR Session marks the seventh year in which the accelerated procedure and criteria for decision-making were used with great success in advancing MRLs. 271 MRLs based on the consideration of 19 pesticides were advanced to Step 8 for adoption, 251 of which were advanced using the accelerated 5/8 procedure. One MRL each per fruit or berry spices and root or rhizome spices was advanced to Step 8. An additional 23 pesticide/commodity MRLs for 7 pesticides were advanced only to Step 5 for reasons such as the identification of a potential dietary intake concern by the JMPR, the need for the submission of labels for the Pesticide Initiative Programme (PIP) chemicals, a country's expressed concern on the availability of additional information not previously considered by the JMPR, or because the estimation of MRLs was derived from the concept of proportionality.
Fifty-nine pesticide/commodity CXLs for 8 pesticide chemicals were recommended for revocation. These MRLs are typically CXLs being replaced based on additional data, uses no longer supported, or CXLs deemed by JMPR to have potential dietary intake concerns with no alternative GAP. 43 pesticide/commodity MRLs associated with 10 chemicals were retained at Step 7, awaiting further review by the JMPR, either retrospective analysis (alternative GAP) or periodic review. There were also 38 pesticide/commodity MRLs associated with four chemicals, including the pilot project chemical sufloxaflor, that were held at Step 4 due to dietary intake concerns or awaiting submission of data or an acceptable GAP.
Update on the Sulfoxaflor Pilot Project and the Progress of the National Global Joint Review
During the 2010 CCPR Session, the Committee approved the U.S. proposal for a pilot project, whereby JMPR would evaluate a chemical before finalization of any national review/registration. The 2011 JMPR reviewed sufloxaflor as a pilot and established an Acceptable Daily Intake (ADI) and recommended MRLs considering both regional zones (the method historically used) as well as the global dataset method for estimating MRLs. The JMPR provided a comparison of those MRL results. The U.S. Delegation supports the use of the global dataset method, as MRLs can be recommended for several commodities which otherwise could not have been established.
The U.S. Delegation updated the Committee on the pilot project and explained that the national global joint review associated with the pilot was not yet complete, but regulatory decisions were expected before the next CCPR Session. The Committee agreed to evaluate the pilot project at the next Session of CCPR in April 2013 when the global joint review is complete and agreed to retain all MRLs recommended for sulfoxaflor at Step 4 until authorized GAPs were available for JMPR consideration. The Committee showed general support for the pilot project and welcomed using the same process for another chemical evaluation.
Revision of the Codex Classification of Foods and Animal Feeds
The EWG co-chaired by the Netherlands and the United States presented the amendments and revisions to the Revision of the Codex Classification of Foods and Animal Feeds. CCPR's completion of this Classification represents an important tool to facilitate the establishment MRLs and trade harmonization generally.
The Committee reviewed the proposed amendments agreed to forward all "fruit type" revisions (Citrus fruits, Pome fruits, Stone fruits, Berries and Small fruits, and Tropical and Subtropical fruits- edible and inedible peel) to Step 8 for inclusion in the Classification. The Committee also agreed to retain the revisions for edible flowers at Step 7, pending finalization of the revision of the Herbs group.
The Committee considered and forwarded the proposed amendments to the Revision of the Codex Classification of Foods and Animal Feeds for Brassica (cole or cabbage) vegetables, Head cabbages and Flowerhead cabbages; Leafy vegetables (including brassica leafy vegetables); and Stalk and stem vegetables to Step 5.
The Committee agreed to re-establish the EWG, co-chaired by the United States and the Netherlands to continue work on the Classification of Foods and Animal Feeds.
Proposed Draft Principles and Guidelines for the Selection of Representative Commodities for the Extrapolation of Maximum Residue Limits for Commodity Groups
CCPR has devoted a significant effort in developing a document Classificationss of Foods and Animal Feed, AC/MISC 4 1-93) that provides uniform nomenclature and establishes group maximum residue limits for groups and/or sub-groups of commodities with similar characteristics and residue potential. At this Session, the Committee updated and amended the Classification of Foods and Animal Feeds for fruit types and the Draft Principles and Guidelines and Table 1 on fruit commodities and agreed to forward these documents to Step 8 for adoption by the Commission, along with the revocation of the corresponding provisions in the existing document. This completion of the Classification for fruit type crop groups as well as the guidance on the selection of representative commodities represents a significant step towards establishing additional MRLs. especially for minor fruit crops.
The United States also presented a proposed draft table 2, which included the selection of representative commodities for a number of different vegetable crop groups and subgroups, including Brassica (cole or cabbage) vegetables, Head cabbages and Flowerhead cabbages; Leafy vegetables (including brassica leafy vegetables); and Stalk and stem vegetables.
The Committee agreed to reconvene the EWG on the Revision of the Codex Classification of Food and Feed to identify other commodity groups for consideration by CCPR, to continue to amend the draft table 2, and review and revise, where needed, existing Codex commodity group MRLs.
Working Group to Facilitate the Establishment of Codex MRLs for Minor Use and Specialty Crops
A physical working group on Minor Uses and Specialty Crops met prior to the Session to review the EWG conclusions on the criteria for the minimum number of field trials needed to support minor use MRLs. Co-chairs United States, Thailand, and Kenya presented before the Committee a discussion paper which outlined the proposed criteria in four categories.
To develop these criteria, the EWG used a two-tiered approach, whereby global diet data (FAOSTAT Food Supply Quantity (g/capita/day)) and a fixed percentage (0.5%) was used as the first tier and GEMS/Foods 13 Cluster Diets data was used to further refine the criteria at the second tier. From this approach, the EWG developed four categories to determine the appropriate number of residue field trials.
After much discussion, the Committee could not reach agreement on any specific criteria and re-established the EWG to continue refining the criteria and a list of commodities and number of field trials based on a proposed criteria. France, Kenya and Thailand agreed to co-chair this EWG for the next Session. The United States will participate in this EWG and will continue to support exploring the development of a simple database to identify residue data needs for minor crops.
Revision of the Risk Analysis Principles
At the last Session, the Committee agreed to focus on alternative proposals for the revision of the periodic review and have a physical working group meeting prior to the Session of the CCPR.
The physical working group, which included participation from the United States, reviewed and revised several sections of the risk analysis principles document, which includes such matters as the processes to ensure avoiding the deletion of MRLs for which there are no risk issues- for example, due to a lack of support by the manufacturer. The Committee agreed to re-convene the EWG, to be co-chaired by Argentina and Costa Rica, to focus on remaining sections, including sections on the periodic review and criteria for prioritization and section 7 of part II on the processes surrounding the concern form and other forms. The United States will continue to participate in this EWG and will urge the importance of upholding the integrity of the concern form process to allow the establishment of Codex MRLs.
Nomination and Prioritization of Compounds to be Considered by the FAO/WHO Joint Meeting on Pesticide Residues (JMPR)
The Committee considered the nominations of compounds for evaluation in 2013 as listed in the report of the EWG on Priorities. The Chair of the EWG noted that two new compounds were moved to the 2014 priority list at the request of the U.S. Delegation. All U.S. nominations for new compounds and additional uses of existing compounds were scheduled; however, the nomination for fenpropathrin was moved to the 2014 priority list at the request of the manufacturer. In all, 8 new compound evaluations, 4 periodic re-evaluations, and 18 follow-up evaluations for additional uses of existing compounds are scheduled for review by JMPR in 2013.
The Committee noted that the new compound evaluations priority list for 2014 is currently overbooked and 2015 already has 4 new compound evaluation nominations. However, the 2014 priority lists will be evaluated during the 45th Session of CCPR.
JMPR Resource Issues in the Provision of Scientific Advice to CCPR
The United States prepared and presented an updated discussion paper on the issue of JMPR resources and the need for capacity building of the JMPR to accommodate the increased demand for the review of compounds for the establishment of Codex MRLs. The U.S. Delegation noted that the issue of JMPR capacity was discussed at the 2011 JMPR, as well as during the last Session of the Codex Alimentarius Commission. As a result of discussions during the 2011 JMPR, several constructive recommendations were put forth to help resolve the JMPR's capacity issues including: extending the meeting, utilizing electronic communications and teleconference capabilities to perform work and resolve issues ahead of meeting, establishing consistent data package submission requirements, screening chemicals to determine the need to evaluate full dossier, and resolving issues with industry prior to JMPR meeting.
The U.S. Delegation noted that the U.S. EPA's Director of the Office of Pesticide Programs sent a letter to the FAO and WHO Secretariats of JMPR that highlighted the recommendations and reiterated the importance of implementing recommendations to increase capacity of JMPR. The letter further noted the importance of the role of the FAO and WHO Secretariats in providing leadership and guidance in implementing recommendations. Several additional ideas to increase capacity were discussed, including holding an additional JMPR meeting between 2013-2014 and/or to add another day to the 2013 JMPR Meeting.
Although the increase in demand for Codex MRLs has exceeded the capacity of JMPR to review MRLs, it is also indicative of the success of the process improvements that have been implemented over the past several years by the CCPR for the scheduling and review of chemicals by the JMPR and the improved decision-making processes in proposing MRLs. Because the work of the JMPR and CCPR serves an important role for the safety of the consumer and facilitates the international trade of food commodities, the United States supports the implementation of recommendations provided during the 2011 JMPR, as well as further recommendations to increase the capacity of the JMPR.
The JMPR Secretariats welcomed the ideas presented by the U.S. Delegation and the Committee; however, they noted that funding for JMPR was not available and the JMPR meeting would not be organized for 2013 unless funding was secured by January of that year. The United States stresses the need for funding of the JMPR to continue the important work to establish Codex MRLs.
Methods of Analysis for Pesticide Residues
The U.S. Delegation participated in an in-session working group to further discuss the methods of analysis for pesticide residues, including the maintenance or revocation of Analysis of Methods: Pesticides Residues (CODEX STAN 299-1993). After much discussion, the in-session working group recommended and the Committee agreed to revoke but maintain an archive CODEX STAN 229-1993, Rev. I-2003, and to establish a EWG to develop performance criteria for the assessment of methods of analysis.
The 45th Session was tentatively scheduled to be held in China, in 2013. The final arrangements were not announced at the meeting.