Working Principles for Risk Analysis (Agenda Item 3)
Risk Analysis: Food Safety Objectives (Agenda Item 3.2)
8. The Committee recalled that the last session had discussed the Working Principles for Risk Analysis and had agreed on several amendments to the sections on risk analysis and risk assessment; there had been no consensus on the inclusion of a reference what some Members referred to as the 'Precautionary principle' in the section on risk management.
9. The Committee had agreed to return the proposed Draft Working Principles to Step 3 for further comments, including specific proposals on the precautionary principle or approach and asked the Secretariat to prepare a revised draft and an analysis of the questions related to the precautionary principle or approach, in the light of the comments received[4].
10. The Committee considered the revised Working Principles section by section and made the following amendments
SCOPE
11. The Delegation of Malaysia proposed to include a reference to fair trade practices in the purpose of risk analysis, in addition to the protection of consumers' health, in order to reflect the general objectives of Codex (para. 2). Some delegations pointed out that the application of risk analysis should not result in disguised barriers to trade and that this should be reflected in the text. Other delegations expressed the view that the general objectives of risk analysis were a subset of the overall objectives of Codex, and that the primary purpose of risk analysis was health protection. The Committee recognized that the primary consideration should remain health protection but that fair trade aspects should be taken into account in the process. The text was therefore amended to reflect that the purpose of risk analysis was to protect the health of consumers 'while ensuring fair practices in food trade'.
12. The Committee agreed to delete the reference to 'consistency' and to a 'thorough' risk analysis in paragraph 3[5] since these terms did not provide any further clarification; it was agreed that Codex standards and related texts intended to protect the health of consumers were 'based on risk analysis'.
13. During the debate, the Committee noted that since the draft principles were intended for application in the Codex framework and also by governments where applicable, some confusion arose with the interpretation of specific articles. It nevertheless decided to retain the dual scope of application.
RISK ANALYSIS - GENERAL ASPECTS
14. The Delegation of the United States proposed to specify that in para. 1 it should be made clear that risk analysis should be science-based, and the Committee had an extensive exchange of views on this question. Some delegations expressed the view that science should not be mentioned in relation to risk analysis as a whole since risk management decisions were policy decisions, as reflected in the current definition of Risk Management in the Procedural Manual; in addition the question of 'other legitimate factors' was still under consideration and no conclusion had yet been reached on this question. Other delegations pointed out that risk analysis was based on science since the risk assessment process was based on scientific data. They referred to the first Statement of Principle, whereby Codex texts should be based on scientific analysis and recalled that other factors were mentioned in the second Statement of Principle and they were taken into account in the risk management process as appropriate, however it should be clear that the scientific basis was an essential element of the decision process.
15. The Committee could not come to a definite conclusion and agreed that the words 'soundly based on science' required further consideration and should be included in paragraph 1 in square brackets. The Committee noted that this matter was linked to the wording in the second paragraph of the section on Risk Management (para. 27, now para. 25 - see para. 33 of the report)
16. In the section on documentation (para. 2), the Committee considered a proposal concerning accessibility of documentation to consumers, in addition to the current text referring to 'interested parties'. In order to clarify the text and to make it more general, it was agreed to refer to 'all interested parties'. This was also added to paragraph 3 on communication and consultation.
17. In the section concerning uncertainty and precaution (para. 5), the Committee recognized that precaution was an essential element of risk analysis and agreed to include a statement to this effect at the beginning of the section, as proposed by the Delegation of the United States on the basis of the FAO Conference on International Food Trade beyond 2000 (Melbourne, 1999). It was agreed that this was particularly important when scientific evidence was insufficient and negative effects on health were difficult to evaluate.
18. The Committee considered the section on developing countries (para. 6) and agreed that in addition to their needs, the situation prevailing in these countries should be taken into account. This was especially important in order to obtain relevant data, such as exposure assessment from all regions of the world. The Delegations of Zimbabwe and Morocco expressed the view that this section should clarify the responsibilities for addressing the needs of developing countries, whether this applied to developed countries or international organizations. The Committee noted that all recommendations in the text were worded in a general manner, since they were intended to apply to FAO, WHO, Codex Committees, Expert Groups responsible for risk assessment, and to governments at the national level. The Committee included a general reference to 'the responsible bodies' in the text, as proposed by the Representative of WHO.
19. The Delegation of Chile referred to the recommendation of the Commission that Codex Committees should appoint a co-author from a developing country for position papers, where the main author was from a developed country. The Committee noted that this recommendation of the Commission was not in the nature of a principle for risk analysis and should not be included in the present text; however it should be followed by relevant Committees when considering matters related to risk analysis.
20. The Committee noted that the various language versions of the text required harmonization, in particular with reference to the use of the words 'should', 'shall' and 'must'.
RISK ASSESSMENT
21. The Committee agreed that the text of the first Statement of Principle Relating to the Role of Food Safety Risk Assessment should be used to define the purpose of risk assessment (para. 8, now para. 7), as proposed by the Delegation of Portugal and in order to achieve consistency.
22. The Committee agreed to rearrange and reword the paragraphs concerning the four steps of risk assessment, the identification of uncertainties and the need for documentation (paras. 11 to 13, now paras. 10 to 12) for clarification purposes, as proposed by the Delegation of Malaysia. The Committee agreed that the constraints affecting the quality of the risk estimate should be identified, and that expression of uncertainty or variability should be clearly documented, and the corresponding text was retained.
23. The Committee agreed with the proposal of the Delegation of India to use the text of the recommendation made by the Commission on global data for exposure assessment (para. 16, now para. 15). The Delegation of the United States questioned the use of the term 'global data' since it was not clearly defined. The Committee noted that when food safety risk analysis was initially developed, it tended to be more focused on chemical contamination but the concepts were somewhat different where microbiological hazards were concerned. The Committee agreed to refer to 'exposure assessment data from different parts of the world', as proposed by the Delegation of Sweden.
24. The Committee had an exchange of views on the need to provide further detail on the different stages of the food chain taken into account in risk assessment (para. 17, now para. 16). The Committee agreed to include a general reference to 'production and handling processes' since this covered all aspects of the food chain from the primary producer to the consumer, and to include a specific reference to traditional practices. 25. As regards the records of risk assessment, (para. 19, now para. 18), the Committee agreed to include a reference to minority opinions, and noted that the rules for the conduct of expert groups specifically required such a record.
RISK ASSESSMENT POLICY
26. The Delegation of Norway recalled that a definition of risk assessment policy had been discussed at the last session and proposed to include this definition, although it had not been finalized, in the text for clarification purposes. The Committee agreed that a description of the process based on the earlier definition should be included as a separate section (new para. 20) and that the sections on the establishment of risk assessment policy and on communication (paras. 21 and 22, now para. 21) should be combined since they both referred to the same process. The text was amended in order to clarify that risk assessment policy should be established by risk managers in consultation with risk assessors and all interested parties, and that the proposals of interested parties should be analyzed as necessary.
27. The Committee agreed to delete the requirements concerning the scope and purpose of risk assessment, as well as the selection of the assessors (para. 23) since they were already covered in the sections on risk assessment.
28. The Committee had an exchange of views on the section addressing the mandate given to the assessors (para. 24, now para. 22). It was proposed to delete this section since its provisions were already addressed in the section on risk assessment. The Representative of WHO stressed the importance of interaction between risk assessors and risk managers, which might result in a need to redefine the mandate given to risk assessors, especially where microbiological hazards were involved. The Committee agreed that the relevance of this section as regards risk analysis policy would need further discussion and it was retained in square brackets.
29. The Committee agreed that risk managers could ask risk assessors to evaluate the potential risk reduction resulting from different risk management options (para. 25, now para. 23). The Committee noted that this was not currently covered elsewhere in the document and agreed to retain the current text.
RISK MANAGEMENT
30. The Committee had an exchange of view on the need for a section referring to the structured approach of risk management and describing its components (para. 27, now para. 25). The Delegation of Portugal, speaking on behalf of the Members of the European Union present at the Session, supported by other delegations, expressed the view that the components of risk management introduced new concepts which were not defined and that they should not be included in the text. The Delegation of Singapore expressed the view that the approach to be followed in risk management should not be prescriptive and should be left to the responsibility of governments at the national level.
31. The Delegation of New Zealand, supported by other delegations, recalled that the need for a structured approach was generally recognized and was currently being applied in the Committee on Food Hygiene, and that the components of risk management had been defined by the FAO/WHO Expert Consultation on Risk Management and Food Safety (1997). Some delegations proposed to include definitions in the text or to reference them in a footnote for clarification purposes.
32. The Committee discussed these proposals and recognized that the structured approach described the steps in the process: evaluation of risk, assessment of risk management options, implementation, monitoring and review. These were not actually new concepts and they should not be presented as titles or concepts in the text. Some delegations pointed out that the term 'risk evaluation' still needed some clarification, especially to avoid confusion with risk assessment, and to address translation difficulties. The Committee agreed to retain the current text and to put 'risk evaluation' in square brackets for further consideration.
33. The Committee discussed the proposal of the Delegation of the United States to specify that risk management should be 'grounded on science-based risk assessment'. Several delegations objected to this proposal since risk management took into account other factors than science, as appeared from the recently revised definition of Risk Management. Some of these delegations proposed to add a reference to other factors if the reference to science was introduced, in order to reflect the difference between risk assessment and risk management. Some delegations also pointed out that since risk analysis terms were already defined in the Procedural Manual, additional explanations might not be necessary in the current text.
34. The Committee considered an amended text indicating that risk management was 'grounded on science-based risk assessment' and took into account 'other legitimate factors as appropriate', and agreed to retain it in square brackets for further discussion, since consensus could not be reached at this stage.
35. The Delegation of Portugal, supported by several delegations, expressed the view that risk management should be focused on agreed outcomes as well as on processes (para. 28, now para. 26). Other delegations and the Representative of WHO stressed that the current concept of outcome-based risk management was essential, and noted that the following sentence made it clear that all relevant processes were taken into account throughout the food chain. The Committee agreed to the proposal of the Delegation of New Zealand that 'in achieving agreed outcomes' risk management should take into account relevant processes throughout the food chain, and amended the text accordingly.
36. The Committee agreed to delete the reference to 'repeatability' in paragraph 29 (now para. 27). 37. The Committee agreed that risk management options should be evaluated in terms of the overall reduction of risk, to replace the current text referring to hazards (para. 30, now para. 28), and deleted the sentence referring to the risk management framework as it was already covered in paragraph 27 (now para. 25) (structured approach).
38. As regards the outcome of the process (para. 31, now para. 29), reference was made to the 'assessment of available risk management options' (rather than their 'evaluation') and in the second sentence, it was clarified that the 'risk management decision' was addressed, and that 'other legitimate factors' were considered as appropriate.
39. In the section on other legitimate factors (para. 32, now para. 30), the sentence on economic analysis was deleted since the current text adequately covered all relevant factors taken into account in the process. The Committee noted that this question would be specifically considered under Agenda Item 6.
40. The reference to communication was deleted (para. 33) since this aspect was covered more generally under Risk Communication. The provisions on consistency were amended to clarify that trade barriers should be avoided and that the section applied to the consideration of other legitimate factors (para. 34, now para. 31).
41. The Committee agreed that paragraph 36 (now para. 32) would include the text of the recommendation made by the Commission concerning the consequences of risk management options for developing countries, as proposed by the Delegation of India.
RISK COMMUNICATION
42. The Committee agreed that information and opinion should be 'exchanged between interested parties' in order to reflect the need for interactive communication (second paragraph). The rest of the section was left unchanged.
THE APPLICATION OF PRECAUTION: PRECAUTIONARY PRINCIPLE OR APPROACH
43. The Committee considered an amended text prepared by the Delegations of the United States, the member countries of the European Union, the European Community and several other delegations and describing the use of precaution, with a footnote indicating that this was referred to as the 'Precautionary Principle' in certain member countries (para. 38, now para. 34).
44. The Delegation of Australia expressed the view that the content of the proposed footnote could be adequately covered in the report of the meeting together with the alternative views of other countries. 45. The Delegation of Malaysia, referring to its written comments, proposed that when precaution was exercised as an interim measure, additional information should be sought and the measures should be reviewed within a reasonable time frame in order to achieve consistency with Article 5.7 of the SPS Agreement. Several delegations supported this proposal and pointed out that the reference to a limited time frame was essential in order to prevent the establishment of unjustified barriers to trade, and was in conformity with the obligations of member countries under the SPS Agreement.
46. The two proposals referred to above are presented as alternative texts in paragraph 34 of Appendix III, the proposal from Malaysia appearing first as the other proposal should be read in conjunction with para. 35. 47. Some delegations and observers pointed out that the concept of a precautionary principle, which originated in discussions related to the environment, was not generally recognized or defined in relation to food safety, and that precaution was inherent to the risk analysis process, as recognized in the current Working Principles (para. 5 of the revised text). In this perspective, the definition of an additional concept was not necessary.
48. Several other delegations, observers and the Representative of WHO stressed that it was essential to address the uncertainties in risk assessment; in some cases, there were inherent difficulties to establish an adequate scientific basis due to the nature of the health hazard; risk assessment might take a long time to complete, or might still contain a wide range of uncertainty after it was carried out. In such cases, risk managers had to take action to protect consumers' health on the basis of precaution. The Delegation of Egypt expressed the view that when there was a doubt concerning scientific evidence it was the duty of risk managers to protect consumers; this was demonstrated clearly by such examples as the use of pesticides which were eventually prohibited, and the case of BSE.
49. The Delegation of the United Kingdom, supported by several delegations and observers, expressed the view that the reference to a principle was important and should be retained, at least in a footnote and that a definition of the 'Precautionary Principle' as used for risk assessment in Codex was essential, since this term was used in several countries in order to enhance consumer confidence in sanitary measures at the national level. These delegations however noted that in order to facilitate consensus, the reference to 'precaution' in the revised text would be acceptable.
50. In reply to a question, the Delegation of the United States clarified that the reference to 'robustly' assessing risk corresponded to the terminology used in statistics when data were adequate, but other terms like 'objectively and fully' could be used. The Delegation pointed out that the use of the precautionary principle was not generally recognized or defined and that further discussion on this issue was necessary to clarify how precaution was applied.
51. The Delegation of Uruguay pointed out the precautionary approach, as described in the text proposed by several delegations (see para. 46 above), could apply to risk management decisions taken by governments but was not pertinent in the framework of Codex, where a scientific basis was essential to establish international recommendations. Other delegations expressed the view that this was primarily an area for national governments rather than Codex and stressed the need for clarification of this important issue. 52. Several delegations stressed that the recommendations on precaution in risk management should be applicable both to governments and in the framework of Codex. The Delegation of Sweden indicated that precaution was reflected in the development of Codex codes of practices when the risk assessment of certain contaminants was not completed, but it was necessary to address public health problems through preventive action 53. The Delegation of New Zealand indicated that the text did not adequately address all aspects of uncertainty in risk assessment. The Delegation further noted that while interim measures applied by national governments were provided for under the SPS Agreement, they were very unlikely to be used in elaborating Codex standards when risk assessment was not available.
54. The Delegation of Morocco indicated that the responsibility for identifying uncertainty would need to be clarified, since it was not specified in the amended text, although the original text (para. 38) had indicated that risk assessors would identify such uncertainty.
55. Some delegations indicated that the criteria proposed in the current text (para. 39, now para. 35) could be used as a starting point for further discussion. The Delegation of the Philippines proposed that the need for a time frame to review provisional measures should be included in this section. Some delegations proposed that the criteria should be discussed first in order to clarify the conditions for the application of precaution, while other delegations stressed the need to describe the nature of the principle or approach before selecting the criteria. The Committee did not discuss the criteria in detail and recognized that both parts of the section would require further consideration at the next session.
56. The Representative of WTO, recalling the provisions of SPS Article 5.7, indicated that guidelines on the application of precaution could facilitate common understanding of risk analysis but should not contradict the rights and obligations of member countries under the SPS Agreement.
57. The Committee recognized that no consensus existed at this stage on the different proposals put forward on the application of precaution, and discussed how to proceed further. The Chairperson proposed to establish a drafting group, which would work by electronic mail, and prepare revised proposals for consideration by the next session. A Working Group could also be held prior to the next session if necessary in order to facilitate discussion. Some delegations objected to such a discussion in a Working Group since issues of principle should be addressed in the plenary session of the Committee.
58. Some delegations proposed that FAO and WHO should convene a workshop to consider matters related to precaution, uncertainty and the interaction between risk management and risk assessment, in order to facilitate a common understanding of these issues. The Representatives of FAO and WHO indicated that they would consider the possibility of holding such a workshop, if this was the wish of member countries and the participation of Members from developing countries should be as large as possible. The Delegation of Chile asked FAO and WHO to consider convening a similar workshop at the level of the Regional Coordinating Committees.
59. Some delegations emphasized the responsibility of the Committee to address the issue of the application of precaution, as agreed in the FAO Conference on International Food Trade beyond 2000, and stated that this responsibility could not adequately be addressed in another meeting like an expert consultation or a workshop. It was also pointed out that a drafting group would need a clear mandate and an initial text as a basis for discussion.
60. The Committee agreed that the two proposals referred to as alternative texts (see para 46 and Appendix III, para. 34) would be circulated for comments, as part of the Proposed Draft Working Principles at Step 3, and agreed that a drafting group, coordinated by the French Secretariat, would work by electronic mail in order to prepare a revised text for consideration by the next session. All member countries and international organizations were invited to participate in this electronic drafting group. The Committee noted that the French Secretariat would ensure prompt distribution of material to all members and observers, including replies to the Circular Letter sent at Step 3. The Committee agreed that a Working Group could be held to finalize a revised proposed text on the day preceding the Plenary Session, if required.
61. The Committee noted that significant progress had been made on most sections of the Working Principles; however, the application of precaution in risk management still needed additional discussion, and it was preferable to retain the text at Step 3 for further consideration
STATUS OF THE PROPOSED DRAFT WORKING PRINCIPLES FOR RISK ANALYSIS
62. The Committee agreed to return the Proposed Draft, as amended at the current session, to Step 3 for further comments and consideration by the next session (see Appendix III).
63. The Committee noted that it had agreed at its last session[7] to consider the general aspects of the development and application of "food safety objectives" following discussions at the 7th Session of the Codex Committee on Food Import Export Inspection and Certification Systems (CCFICS) and the 45th Session of the Executive Committee.
64. The Committee discussed whether there was a need to define "food safety objectives" and how it would proceed to consider the concept in relation to risk analysis specifically. The Committee noted that the 32nd Session of the Codex Committee on Food Hygiene (CCFH) had discussed the Proposed Draft Principles and Guidelines for the Conduct of Microbiological Risk Management that included a section on food safety objectives. It also noted that the 8th Session of the Codex Committee on Food Import Export Inspection and Certification Systems decided to develop the Guidelines on the Judgement of Equivalence of Sanitary Measures Associated with Food Inspection and Certification Systems pending approval as new work by the 47th Session of the Executive Committee.
65. The Committee was of the opinion that the application of "food safety objectives" concept was of a technical nature and it was premature to generalize the concept with a specific definition.
66. The Committee agreed that the concept of "food safety objectives" could be further developed by other relevant Committees in order to identify how it could be applied to specific food safety issues, and that the Committee should continue to oversee the consistency in the definition and application of the concept.
