19. The Delegation of United States introduced the draft, which incorporated the amendments agreed to by the ad hoc Working Group that had met prior to the Plenary Session. The Committee was informed that several amendments had been made and that the explanatory notes in the Section, Additional Considerations, in CX/FH 98/3, were transposed into the related sections.
20. The Committee reviewed the proposed text section by section and agreed to make the following amendments as well as many editorial changes.
21. The title of the section Background was replaced by Introduction, in order to be consistent with other Codex texts. Additional text describing the process of Risk Analysis and the primary objective of this draft was added in the section for clarification. The delegation of India, supported by other delegations, stressed the need of developing countries for training on microbiological risk assessment and for a realistic time frame to implement these Principles and Guidelines. The Delegation also drew the attention of the Committee to the issues raised by India in the Committee on General Principles in this respect. The Committee agreed to add sentences at the end of this section to address this concern.
22. The section on Definitions was updated to make it clear that some of the definitions were derived from the definitions adopted at the 22nd Session of Codex Alimentarius Commission, which did not only cover microbiological agents but also chemical and physical agents. A footnote on control options was added to clarify the definition of Risk Management.
23. In the section on General Principles of Microbiological Risk Assessment, the second sentence on Principle 5 was deleted since it covered the implementation of the Principle and not the Principle itself, and transparency was already defined in the Section on Definitions. Principle 1 and the first sentence of Principle 5 were edited.
24. The section on Guidelines for Application was modified. The second sentence regarding the NRC Committee and the Joint FAO/WHO Consultation was deleted since it had been included to facilitate drafting in the earlier steps.
25. A new section on General Considerations based on the text of paragraphs on Limitation of Data, Purpose of the Conducting of a Risk Assessment and Resource Constraints, taken from the section on Additional Considerations in CX/FH 98/3, was inserted. Further amendments were made to those paragraphs. In addition, new sentences were added to address the importance of the involvement of interested parties in the process of Risk Assessment.
26. The text of the paragraph on Purpose of the Conducting of a Risk Assessment in the section of Additional Consideration in CX/FH 98/3 was transposed into the section on Statement of Purpose of Risk Assessment. Several sentences that were not related to the purpose of Risk Assessment were deleted.
27. In the section on Hazard Identifications, some amendments were made for clarification purposes.
28. In the section on Exposure Assessment, several factors, such as regional differences, seasonality of products, role of food handlers, and environmental time/temperature relationship were incorporated as factors to be considered for Exposure Assessment.
29. In the section on Hazard Characterization, several factors such as pregnancy, nutrition and access to medical care were added as these may affect the severity of illness. The term “population behaviour” was deleted as this was covered in Exposure Assessment.
30. In the section on Risk Characterization, the first paragraph was amended to make it clear that the goal of Risk Characterization is to obtain a Risk Estimate.
31. The text of the paragraph on Understanding Limitations of a Risk Assessment with Respect to Transparency in the section on Additional Considerations was transposed into the section on Documentation. The Committee noted that risk managers' understanding of any limitations that influence Risk Assessment such as expert judgement was essential in decision making and that those limitations should be clearly documented and the text was amended accordingly.
32. The Committee, recognizing the importance of reassessment, included a new Section for Reassessment based on the text of the paragraph on Reassessment of Risk Assessments in the section on Additional Considerations.
33. The section on Additional Consideration proposed in CX/FH 98/3 was deleted. The first seven additional considerations in the document were moved to other sections with some modification, as indicated above, and the additional consideration regarding Default Assumption was deleted from the document.
Status of the Draft Principles and Guidelines for the Conduct of Microbiological Risk Assessment
34. The Committee advanced the Draft Principles and Guidelines for the Conduct of Microbiological Risk Assessment to Step 8 for adoption by the 23rd Session of the Commission (see Appendix II).
