111. The Committee accepted the proposal of some delegations and Observers to consider this agenda item in conjunction with Agenda Item 3 in order to identify the risk management questions to be put forward to the Expert Consultation on microbiological risk assessment. The Delegation of Germany introduced the document and indicated that it was prepared in accordance with the Proposed Draft Principles and Guidelines for the Conduct of Microbiological Risk Management (CX/FH 00/6). The document reflects a consideration of the preliminary report of the Joint FAO/WHO Expert Consultation on Risk Assessment of Microbiological Hazards in Foods, particularly in Section 5.1, Initial Risk Management Activities.
112. The Delegation of Germany pointed out that the completion of the work of the FAO/WHO Expert Consultation on risk assessment of Listeria monocytogenes in ready-to-eat foods would add substantial data to the document, and that the proposed tolerable level of risk would need to be assessed in light of the results of risk assessment. The Delegation also indicated that the risk management options presented in Section 5.2 included measures at primary production, food processing, and distribution, as well as the use of microbiological criteria.
113. The Committee expressed its appreciation to the Delegation of Germany and the drafting group for their valuable work and had an exchange of views regarding types of risk management options and related risk management questions to be considered by the Joint FAO/WHO Expert Consultation. The results of the discussion on this subject are shown in paragraphs 18-19 under Agenda Item 3 regarding the risk management questions on the three pathogen commodity combinations. With regard to the comparison of the cost effectiveness of various management options, the Committee concluded that it was the task of the risk managers.
114. Some delegations and the Observers from IDF and the EC questioned the concept of the Tolerable Level of Risk (TLR) in Section 5.1.8 and suggested the following points 1) the relationship between TLR and the Appropriate Level of Protection was not clear; 2) the identification of TLR would not necessarily be done prior to the completion of risk assessment: 3) since pathogens can multiply, TLR as reflected by the number of pathogens at the point of consumption could not be fully predicted by the number of pathogens during production or at the point of importation; 4) preventive measure such as HACCP were more important than setting certain levels. These concerns were to be communicated to the drafting groups on risk assessment.
115. Replying to a question, the Representative from WHO clarified that the objective of the Expert Consultation was not to define TLR but to provide advice on the most efficient measures to control Listeria monocytogenes in foods with the aim of lowering the disease incidence in the population. The Committee recognised the need for further discussion on the concept and application of tolerable level of risk
116. Some delegations pointed out that differences in nutritional conditions and food consumption patterns were not properly reflected in the document and that the data presented in the Annex of the document were relatively old and did not include data from developing countries.
117. The Delegation of the United States noted that the format of Agenda Item 9 was based on the document, Proposed Draft Principles and Guidelines for the Conduct of Microbiological Risk Management, which was at Step 3 of the Procedure, represented a departure in format from other Codex documents. Since CX/FH 00/6 was a concept document that was likely to change as a result of further deliberations the Delegation suggested that the ad hoc Drafting Group consider whether this was the best format for conveying the information covered by Agenda Item 9.
118. The Delegation of Argentina expressed concern regarding the use of the term,precautionary principle, and was of the view that it could not be used until the matter is resolved in the Committee on General Principles.
119. The Committee concurred with the general approach of the document and agreed that the Delegation of Germany, with the assistance of drafting partners, would prepare a revised document that would incorporate comments provided at the Session and the results of risk characterization to be finalized by the Joint FAO/WHO Expert Consultation in April 2001. Member countries and interested International Organizations were invited to submit additional comments on the current document CX/FH 00/9 to the Delegation of Germany by 1 April 2001. The revised document would be circulated at Step 3 for comments prior to the next session of the Committee, pending a Commission decision to approve this as new work.