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Proposed Draft Principles and Guidelines for the Conduct of Microbiological Risk Management (Agenda Item 8)[11]

91. The Delegation of France introduced the document and pointed out that it had been restructured to take into account the recommendations of the last session and the comments received; a section on the participation of interested parties had been added; the structure of the document reflected the actual chronology followed by risk managers; the issues related to regional differences in prevalence of pathogens in the food chain had been incorporated into Section 5.2.3; the section on food safety objectives was left unchanged as this question would be considered by the Committee on General Principles as part of the general discussion on risk analysis.

92. The Committee expressed its appreciation to the Delegation of France and the countries which had participated in the redrafting for their work on this important document. The Delegation of India proposed to refer to growers in the list of stakeholders and to include as a principle the recommendation of the Commission to consider the feasibility of risk management options in developing counties and the need for flexibility. The Committee noted that this was not a principle but should rather be included in Section 6 (Guidelines for Implementation of Risk Management Decisions).

93. The Delegation of New Zealand pointed out that the structure of the document did not correspond to the recommendations of the FAO/WHO Expert Consultation on Risk Management and Food Safety[12], and made the following remarks. Risk management was not necessarily carried out when a specific problem was identified, but might be used to establish public policy goals or the definition of equivalence; risk managers might not commission a risk assessment but in any case a structured risk approach should be followed; some aspects which were included in Section 5.2 would be more relevant in relation to risk assessment policy. Although food safety objectives would be defined from a general perspective in CCGP, they could be defined in the framework of the document as related to microbiological risk management.

94. The Representative of WHO stated that changes in the general framework described in the FAO/WHO Expert Consultation on Risk Management and Food Safety would cause confusion, and if such major changes were agreed upon, a clear description of the rationale should be provided.

95. The Observer from Consumers International proposed to refer in Principle 5 to the interaction between risk management and risk assessment (for consistency with the Statements of Principle Relating to the Role of Food Safety Risk Assessment), and to add that the goals for microbiological risk assessment should be aimed at preventing or reducing risk in order to protect public health in Section 5.1.4.

96. The Committee had an extensive discussion on Principle 7 referring to a precautionary approach. The Delegation of France indicated that care had been taken not to refer to the precautionary principle since it was under discussion in the CCGP; however it was recognized that risk managers generally followed a precautionary approach to address food safety issues.

97. Some delegations pointed out that this question should not be discussed in detail as the proposal to include a reference to the precautionary principle in the Working Principles for Risk Analysis was under consideration in the Committee on General Principles and there was no consensus at this stage on this question.

98. The Observer from CSPI proposed to refer to decisions adopted “as needed to protect public health” as part of a precautionary approach. Some delegations supported the reference to public health but proposed to retain the “precautionary approach” in square brackets as there was no consensus at this stage. The Delegation of the United States proposed to replace the current text with a requirement that the stringency of control measures should be proportionate to the scientific uncertainty and the extent of the risk; alternatively the reference to public health could be included but the “precautionary approach” should be deleted or kept in square brackets.

99. The Delegation of the United Kingdom, recalling that the precautionary principle was under consideration in CCGP, proposed to put Principle 7 in square brackets as the discussion affected the concept as a whole and no conclusion could be reached at this stage. The Committee agreed with this proposal and noted that this question would be discussed further at the next session.

100. The Representative of OIE referred to the need for cooperation between Codex and OIE in many subjects of common interest in relation to animal health, including risk analysis, especially as they could provide useful regional data in this area.

101. As a general point the Committee agreed that risk management activities and risk assessment activities could be considered simultaneously.

Status of the Proposed Draft Principles and Guidelines for the Conduct of Microbiological Risk Management

102. As the Proposed Draft had not yet been circulated for comments in view of time constraints, the Committee agreed to circulate it at Step 3 for government comments (see Appendix IV), with the understanding that the comments would be forwarded to the Delegation of France for redrafting with the assistance of a Drafting Group, circulation and consideration by the next session.

OTHER LEGITIMATE FACTORS IN THE FRAMEWORK OF RISK ANALYSIS

103. The Committee considered the request from the Committee on General Principles concerning the role of other legitimate factors in the framework of risk analysis and had an exchange of views on the factors which were taken into account in its work (see Agenda Item 2). The Committee recalled that the request concerned “other legitimate factors relevant for the health protection of consumers and for the promotion of fair practices in food trade”.[13]

104. The Delegation of New Zealand referred to the role of economic feasibility, an example of which could be found in the provisions on dedicated transport in the Draft Code of Hygienic Practice for the Transport of Food in Bulk and Semi-Packed Food; technical feasibility as discussed in relation to primary production (faecal contamination in pre-harvest areas); the practical aspects of control measures in view of the specific situation of small growers, as recognized in the discussion on primary production.

105. The Delegation of Ireland referred to the importance of sampling considerations in relation to testing for compliance with microbiological criteria, as appeared from the discussion on bottled waters. The Delegation of France also noted that consideration of water reuse was related to environmental concerns and water conservation and proposed to include such environmental aspects. The Delegation of China pointed out that the availability of expertise in developing countries was a limiting factor in the application of hygiene control measures. The Committee agreed that the above proposals reflected the factors taken into account in its decision process.

106. The Delegation of India proposed to include a reference to susceptibility to risk and eating habits; other delegations however pointed out that consideration of regional diets and susceptible population groups was part of the normal process of risk assessment.

107. The Delegation of Sweden referred to Good Agricultural Practice and Good Manufacturing Practice, and emphasized the need to minimize the use of chemical substances as a general requirement. The Observer from Consumers International supported the inclusion of consumer information, consumer concerns, environmental issues and cultural aspects in the list of other factors taken into account by CCFH in its work and proposed to include also the weight given to uncertainty in the decision process.

108. The Committee had an exchange of views on the reference to consumer information and consumer concerns. The Committee agreed that consumer information was a legitimate factor which had been taken into account in its work. as reflected in the Introduction of the Draft Code of Practice for Bottled/Packaged Drinking Waters where provisions on consumer information were included. The Committee however could not reach a conclusion on the consideration of consumer concerns at this stage. Several delegations considered that consumer concerns had been taken into account by CCFH, for example in the development of the Draft Code for Bottled/Packaged Waters. The Delegation of the United States, supported by the Observer from COMISA, pointed out that these concerns were not clearly defined.

109. The Committee could not come to a conclusion on the opportunity to consider cultural factors, as proposed by some delegations, and on the examples which could illustrate this aspect. There was no consensus on the relevance of the provisions for milk and milk products as an example; some delegations pointed out that cultural considerations had significantly delayed progress in this area and that hazard analysis was the correct approach. The Observer from ICMSF noted that the reference to food suitability in the General Principles of Food Hygiene reflected the fact that certain foods, albeit safe, were not acceptable to consumers for cultural or religious reasons.

110. The Delegation of the United States noted that there was a difference between factors that may be taken into consideration when deciding upon initiating work on a Codex standard or related text and the appropriate other legitimate factors that should be considered when actually developing the document.

111. The Committee agreed that economic and technical feasibility, practical aspects of measures (especially for small businesses), the availability of expertise, sampling, consumer information, environmental impact and Good Agricultural Practice (GAP), Good Manufacture Practice (GMP) were legitimate factors, which had been or were being taken into account in the decision process. The Committee could not come to a conclusion at this time on the reference to cultural aspects and consumer concerns.


[11] CX/FH 99/8, CRD 6 (comments of Finland), CRD 14 (Comments of the European Community), CRD 15 (ALA-Asociacion Latinoamericana de Avicultura)
[12] Risk Management and Food Safety, Report of a Joint FAO/WHO Consultation, FAO Food and Nutrition paper No.65, Rome, 1997
[13] Statements of Principle Concerning the Role of Science in the Decision-Making Process and the Extent to which Other Factors are Taken into Account (Procedural Manual, 10th Edition, Appendix: General Decisions of the Commission)

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