21. The Committee recalled that at its 29th Session it had agreed to modify the title, introduction and scope of the document originally contained in the discussion paper prepared by the United States.[6] It also noted that the definitions adopted at the 22nd Session of the Commission had been incorporated in its Definition Section. The Delegation of the United States introduced the proposed draft text[7] incorporating further amendments agreed to by the Ad Hoc working group that had met prior to the Plenary Session and had considered the government comments received.
22. The Committee agreed that definitions for common medical terms such as infection, clinical infection, pathogenicity and virulence need not to appear in the document. The Committee also agreed to the clarification of the definitions for Hazard Characterization and Risk Estimate and agreed that the definition for "default" was moved to the Explanatory End Notes.
23. Regarding the General Principles of Microbiological Risk Assessment, it was agreed that Principles 7 and 9 be slightly amended and Principle 8 further expanded and that Principles 7 and 8 be inverted.
24. With regard to the Guidelines for Application, the Committee agreed to make several amendments for clarification and add reference to regulatory control and surveillance systems in the section on Exposure Assessment. Further explanation on the establishment of a dose-response relationship was added in the section on Hazard Characterization.
25. While noting the usefulness of the document, the Delegation of India, supported by several delegations, stated that microbiological risk assessment was an emerging discipline that still required certain flexibility in its implementation and that technical assistance in the area of training would be crucial in promoting microbiological risk assessment in developing countries. The Committee was reminded that FAO and WHO were offering technical assistance to those countries in need.
26. The Committee also noted that the Explanatory End Notes contained some useful information which might well be moved to the body of the document and agreed that this should be considered at a later stage.
STATUS OF THE PROPOSED DRAFT PRINCIPLES AND GUIDELINES FOR THE CONDUCT OF MICROBIOLOGICAL RISK ASSESSMENT
27. The Committee advanced the Proposed Draft Principles and Guidelines for the Conduct of Microbiological Risk Assessment to Step 5. The Proposed Draft Principles and Guidelines are attached to this report as Appendix IV.
