Report of the U.S. Delegate to the 32nd Session of the Codex Committee on Methods of Analysis and Sampling
The Codex Committee on Methods of Analysis and Sampling (CCMAS) held its 32nd Session from March 7-11, 2011 in Budapest, Hungary. The 32nd Session was attended by 141 delegates and observers representing 46 Member Countries, one Member Organization (EU), and 9 international organizations. The United States was represented by the Delegate, Dr. Gregory Diachenko and Dr. Gregory Noonan, U.S. Food and Drug Administration; Mr. Larry Freese, Grain Inspection, Packers and Stockyards Administration, USDA; and Ms. Marie Maratos, U.S. Codex Office, USDA.
The United States fully participated on all agenda items and was successful in achieving its objectives during this Session. The Committee, recognizing that substantial progress had been made on the Draft Revised Guidelines on Measurement Uncertainty, agreed to advance the Revised Guidelines, as amended during the session, for final adoption at Step 8 by the 34th session of the Codex Alimentarius Commission (CAC).
Below is a summary of the discussion at this meeting. The full report of the 32nd CCMAS session can be found in ALINORM REP 11/MAS. It will be posted on the Codex Website at www.codexalimentarius.net.
Draft Revised Guidelines on Measurement Uncertainty
The Guidelines on Measurement Uncertainty (CAC/GL 54-2004) were revised by CCMAS by adding an Annex that was intended to provide simple explanatory notes to clarify the significance and implications of measurement uncertainty. The Draft Revised Guidelines had been adopted at Step 5 by the 33rd Session of the Commission and circulated for comments at Step 6. The Committee went line by line through the document and made many editorial and a few technical changes. CCMAS agreed to insert a new paragraph to reflect that in many cases sampling uncertainty is as large as or larger than analytical measurement uncertainty, but these guidelines only relate to analytical measurement uncertainty. Text was also amended to reflect that some sources of uncertainty are partly covered by validation studies and another source of uncertainty from "imprecision in estimating method or laboratory bias" was added to the list. Following the rewriting, the Committee agreed to advance the Proposed Draft Guidelines, as amended during the session, for adoption at Step 8 by the 2011 session of the CAC.
Proposed New Work on Principles for the Use of Sampling and Testing in International Food Trade
At the last session, the Committee had discontinued consideration of uncertainty of sampling as a separate item and had agreed to develop a discussion paper on procedures for conformity assessment, resolution of disputes, and related issues through an electronic working group led by Brazil with the assistance of New Zealand. During the discussion of this paper, several delegations stressed the need to avoid duplication of work with other committees, especially the Committee on Food Import and Export Inspection and Certification Systems (CCFICS) and generally to ensure consistency between Codex texts addressing questions related to conformity assessment and resolution of disputes. The Committee agreed that new work should concentrate on the issues that were clearly the mandate of CCMAS and that items of work should be clearly prioritized in order to address the various issues in a timely manner.
After the general discussion, the CCMAS established an in-session working group chaired by the delegations of Brazil and New Zealand, to prepare a project document. It was also agreed that the proposed principles would not provide detailed guidance to governments, but would provide a framework for the development of guidance on the choice of an appropriate sampling and testing procedure taking into account sampling variability, considerations on measurement uncertainty; consideration of preventive measures in exporting countries to ensure exported foods meet requirements, and reducing the probability of a subsequent dispute occurring through pre-market procedures. CCMAS agreed that an electronic working group chaired by New Zealand, with the assistance of the Netherlands and the United States, would develop Proposed Draft Principles for the Use of Sampling and Testing in International Food Trade for circulation at Step 3 and consideration by the next CCMAS session, if approved as new work by the Commission.
Endorsement of Methods of Analysis for Provisions in Codex Standards
A report of the ad hoc Working Group on endorsement of methods was presented by the Chair, Dr. Roger Wood (United Kingdom). The Committee endorsed several methods of analysis in Codex Standards at different steps of the Procedure as proposed by the ad hoc Working Group with only a few minor amendments and comments.
Proposed New Work on Provisions for Proprietary Methods in Codex Standards to be Included in the Codex Procedural Manual
The Delegation of the United Kingdom introduced a discussion paper, which proposed that the Committee consider including in the Codex Procedural Manual criteria for the selection of proprietary methods. Some delegations, while noting that a proprietary method was often easier to use, were of the opinion that several potential problems resulted from the endorsement of proprietary methods in Codex such as availability to end-users, potential risk to stop developing new methods of analysis, a "black box method" in which key information would not be disclosed, and significant financial advantages for some manufacturers, which would distort competition.
Several delegations thought that CCMAS should define a procedure for endorsing proprietary methods that might include criteria to assess the need for the method, information requirements about the method such as performance characteristics, validation status, and cross reaction, and that these could be included in the Procedural Manual. CCMAS agreed to initiate new work on the development of provisions for proprietary methods to be included in the Procedural Manual and agreed that an electronic working group led by the United Kingdom and Germany would define the term "proprietary method" and prepare a draft version of the criteria that would be circulated to Members and Observers and discussed at the next meeting.
Time and Date of Next Meeting
The 33rd Session of CCMAS is scheduled to be held March 5-9, 2012, in Hungary.