BACKGROUND
15. The Task Force recalled that at its First Session, a consensus had emerged that general principles for the risk analysis of foods derived from biotechnology should be developed, and established a Working Group under the chairmanship of Japan to prepare an initial draft for consideration by the Task Force. Following the approval of this work by the Executive Committee, the Working Group met in Japan in July and October 2000 for this purpose. The draft text was subsequently sent to Member governments and interested international organizations for comment at Step 3.
16. The Chairperson of the Working Group, Dr Kazuaki Miyagishima (Japan) noted that the draft text contained elements drawn from several existing Codex documents and some documents in the course of elaboration, for example the work of CCFICS on the Principles of Import and Export Certification and that of CCGP on the Proposed Draft Working Principles of Risk Analysis. The Cartagena Protocol on Biosafety had also been used as a basis for some elements, in particular the proposed definition for “modern biotechnology”.
17. Several delegations expressed their appreciation at the progress made by the Working Group and their general satisfaction with the document.
18. The Task Force agreed to consider the draft paragraph-by-paragraph, except that prior to discussing Paragraph 19 (later renumbered as Paragraph 21)[6], it would first consider paper CX/FBT 01/6 on “Traceability”.
TITLE
19. The Task Force agreed to maintain the Title of the document as “Proposed Draft Principles for the Risk Analysis of Foods Derived from Modern Biotechnology.”
SECTION I - INTRODUCTION
20. The Task Force amended Paragraphs 1 and 3 to improve their clarity. In particular, it noted that existing principles for the food safety risk analysis of specific hazards had not been elaborated to take into account the risk analysis of whole foods (Paragraph 3).
21. The Task Force agreed to specify that the Principles should be read in conjunction with the Working Principles for Risk Analysis, currently under development by the Codex Committee on General Principles (Paragraph 5).
SECTION II - SCOPE AND DEFINITIONS
22. In Paragraph 6, the Task Force accepted a proposal to indicate that the purpose of the Principles was to provide a framework for risk analysis, rather than to provide advice. It decided not to make a reference to intended or unintended effects other than safety and nutritional aspects in this statement of scope as these were dealt with at appropriate points in the subsequent text. On the other hand, it agreed to extend the list of factors not covered by the Principles, to cover in particular ethical factors other than safety, and the moral and socio-economic aspects of research, development, production and marketing of these foods. Although the Codex definition of food related exclusively to products for human consumption, the Task Force agreed to include a footnote to indicate that animal feed and animals fed such feed were excluded from the Scope of the Principles, except insofar that these animals had been genetically modified (i.e. all genetically modified animals would be covered).
23. The Task Force noted that the Definition of Modern Biotechnology had been taken from the Cartagena Protocol on Biosafety. Although it noted that the Codex Committee on Food Labelling had developed a separate definition for labeling purposes and that in general consistency between Codex texts was desirable, the Task Force was strongly of the opinion that consistency with other internationally agreed instruments was critically important in this case. It recommended that the Codex Committee on Food Labelling give consideration to using the same definition in its work. However, some Delegations and observers were of the opinion that for labeling purposes, it may be appropriate to use terms and definitions that were easier for consumers to understand. No change was made to the definition.
24. The Task Force had an extended discussion on the definition of Conventional Counterpart, in particular on whether or not a genetically modified food could serve as a “conventional counterpart” for comparison purposes. Several Delegations stated that once a food derived from biotechnology had been approved and in common use for an extended period, there was no scientific reason for not using such a food as the basis for comparison. It was pointed out that the FAO/WHO Expert Consultation had stated in its reply to the Task Force on the question concerning the evaluation of unintended effects, that the comparator used to detect unintended effects should ideally be the “near isogenic parental line grown under identical conditions” which could indicate a food derived from biotechnology. Other Delegations pointed out that the confidence of consumers in foods derived from biotechnology depended on their being able to relate the safety of such foods to un-modified foods that had a well-established history of safe use and that the traditional unmodified food supply provided a sound baseline for this purpose. In their opinion, at the present time and for the foreseeable future, foods derived from biotechnology could not be considered as meeting this criterion.
25. The Task Force agreed to modify the definition by the inclusion of a footnote to the effect that for the foreseeable future, foods derived from modern biotechnology will not be used as conventional counterparts. It also modified the definition to indicate that components or products of foods could serve as a “conventional counterpart” to components or products of foods derived from biotechnology.
Risk Assessment
26. The Task Force agreed that the Principles should be “consistent” with the proposed draft Working Principles under development by the CCGP, rather than “in compliance” with them (Paragraph 9). The Task Force generally agreed that the notion of “safety assessment” was characterized by an assessment of a whole food or component thereof relative to an appropriate conventional counterpart for the purpose of the identification of new or altered hazards taking into account both intended and unintended effects. In this regard, the Delegation of the United Stated noted that in the current draft there was no indication of how to proceed if a new or altered hazard was identified by the safety assessment. The Task Force agreed to amend Paragraph 10 to deal with this situation.
27. The Task Force agreed to adopt a rewording of Paragraph 11 for clarity, using a proposal of the European Commission.
28. The Representative of WHO noted that within the present concept, safety assessment could only be conducted when an appropriate conventional counterpart existed and recommended that consideration should be given to situations where a conventional counterpart was absent, for example in the case of modified micro-organisms used in food production and processing. The Task Force recommended that this matter be considered by a future joint FAO/WHO Expert Consultation.
29. The Task Force made several minor changes to Paragraphs 12 to 15 to improve their clarity. In particular, it noted that risk assessment should be based on scientific data and information (Paragraph 13); that methods used for risk assessment should be scientifically sound (Paragraphs 12 and 15); and that assessment methods need not be limited to internationally agreed methods although they should be scientifically sound and use parameters that allow comparison (Paragraph 15).
Risk Management
30. The Task Force agreed that both the outcome of the risk assessment and other legitimate factors would be the basis for risk management. A proposal was made to include examples of other legitimate factors such as the protection of the environment, consumer choice, ethics, fair trade practices and sustainable developments. Different views were exchanged on whether other legitimate factors should be considered by the Task Force, whether or not they should be enumerated or they should be left to the discretion of the CCGP. The Task Force recalled that its terms of reference limited its consideration to “other legitimate factors relevant to the health of consumers and the promotion of fair trade practices”. It agreed that the wording used in paragraph 2 of the Statements of Principle Concerning the Role of Science in the Codex Decision-Making Process and the Extent to Which Other Factors are taken into Account should be used to describe the nature of other legitimate factors and that reference would also be made to the Working Principles on Risk Analysis under development by the CCGP which would provide more detail on the application of these Statements of Principle (Paragraph 16).
31. For the purpose of conformity of terminology the Task Force agreed to replace the words “risk management decisions” with “risk management measures” (Paragraph 16). It also agreed that risk management measures may include conditions for marketing approvals (Paragraph 19).
32. The Task Force had an extended discussion concerning the need for the development of analytical methods for detection or identification of foods derived from modern biotechnology, including the possibility of requiring that such methods be available as a condition for pre-market approval. It agreed that the wording of Paragraph 19 provided sufficient guidance in this matter by generally allowing conditions for pre-market approval and removed the square brackets surrounding this text.
33. The Task Force agreed that post-market monitoring (Paragraph 20) may be an appropriate risk management measure. Some Delegations expressed their concern about the practicability and financial implications in relation to the use of post-market monitoring. The Task Force agreed that the need and utility of post-market monitoring should be considered during risk assessment and practicably in addition during risk management. The Delegation of Thailand expressed its concern about the possibility that relying on post-market monitoring might lead to the reduction of efforts to perform efficient risk assessment for the pre-market approval of foods derived from modern biotechnology, with the subsequent release into the market of foods that were not properly tested and approved. This concern was supported by all Delegations that spoke and the Task Force agreed that the purpose of post-market monitoring should be to verify the conclusion about the absence or the possible occurrence, impact and significance of potential consumer health effects.
TRACEABILITY (PARAGRAPH 21)
34. As agreed during the Adoption of the Agenda, the Delegation of France introduced its discussion paper[7] on the issue of traceability prior to consideration of this paragraph. The Delegation stated that the issue was linked to risk management, especially in regard to product recall, post market monitoring, the right of consumers to choose the foods that they wish to eat and also on the obligation of vendors to meet the labelling requirements applied in many countries. The Delegation noted that Traceability was defined in standard ISO 8402 in general terms as being “the ability for the retrieval of the history and use or location of an article or an activity through a registered identification”.
35. The Delegation of France stated that within this context traceability in the food system provided mechanisms of continuous flow of relevant information that allowed the retrieval of the history and of the origin of a product at any point in the food chain, based on record keeping and documentation. The Delegation stated that traceability was less costly and more reliable than using systematic analysis of product throughout the food chain. The Delegation further noted that many aspects of traceability were common to all foods, but that because of consumer interest in foods derived from biotechnology, special consideration for the application of traceability to these foods was needed.
36. Many Delegations and Observer Organizations supported the conclusions of the discussion paper and recommended that reference be made to traceability in the context of Risk Management in the present document. Several of these Delegations also pointed out that traceability should be considered in the general context of risk management for all foods as it was pointed out that traceability had a role to play in post-market monitoring. Reference was made to the future identification requirements under the Cartagena Protocol for living modified organisms intended for direct use for food or feed or for processing[8]
37. Other Delegations were of the opinion that reference to traceability was not appropriate for inclusion in the current Principles since the issue at stake was not one of food safety risk analysis, but rather a matter of consumer choice or labelling. Although they agreed that the ability to trace defective products that had entered the food chain was an integral part of food control and risk management, it was not appropriate to require traceability for products that had received pre-market approval. Moreover, these Delegations pointed out that the cost of traceability was significant and that the economic impact of such a requirement could fall heavily on developing countries wishing to export food products. They agreed that traceability should be considered as a general issue within Codex and looked forward to the guidance of the Commission on this matter.
38. The Task Force noted that aspects of traceability were being treated in several other Codex Committees, notably the Codex Task Force on Animal Feeding, the Codex Committee on Fish and Fishery Products, the CCFICS, the CCFL and the Codex Committee on Food Hygiene (CCFH). It also noted that the traceability was different from the concept of “Identity Preservation (IP)”. Referring to the work of ISO, the Task Force noted that in addition to the definition in ISO 8402, the Draft ISO Standard ISO/DIS 17161.2 “Guidelines on the application of ISO 9001:2000 for the food and drink industry” contained reference to traceability.
39. In view of the divergence of opinion surrounding the issues of traceability, an open-ended Ad Hoc Working Group, chaired by Japan, was convened to provide a further text for the consideration of the Task Force.
40. The Ad Hoc Working Group tabled a report indicating that the concept of traceability, a system which guarantees a continuous flow of appropriate information at all stages of placing on the market of foods, was a broad, horizontal issue and should be discussed on a Codex-wide basis. The report contained the following proposals:
It was recognized that discussion on the applicability of traceability or other equivalent approaches as a tool in support of risk management measures is under consideration by the Codex Alimentarius Commission and its subsidiary bodies. The Task Force encouraged an early completion of this discussion.
41. The Task Force agreed that the traceability was a broad, horizontal issue and should be discussed on a Codex-wide basis. While several Delegations supported the proposal submitted by the Ad Hoc Working Group, a large number of Delegations asked that Paragraph 21 be retained in the Proposed Draft Principles, albeit in brackets. The Task Force agreed to retain Paragraph 21 in brackets and to attach to it the footnote. The Task Force did not address further the report of Ad Hoc Working Group with respect to traceability or its meaning.
42. The Task Force expressed its appreciation to the Ad Hoc Working Group for its efforts in resolving this and other issues referred to it.
Risk Communication
43. The Task Force agreed that risk communication was essential at all phase of risk assessment and risk management and that academia should be also involved in risk communication.
Harmonization
44. The representative of WTO observed that, in the context of the SPS Agreement, Codex guidelines were to be used as the basis for national sanitary measures, presumably including risk analysis systems for foods derived from biotechnology rather than as an element of these measures, in the context of the SPS and TBT Agreements. Others preferred that these guidelines be considered only as an element of national systems. The Task Force noted that the question of the status of Codex guidelines was not specific to work of the Task Force and that deletion of the paragraph would be without consequence.
45. The Task Force agreed that remaining provision should be placed better under the introduction part of the Principles (where it appears as Paragraph 5) and accordingly this section was deleted.
Consistency
46. The Task Force agreed to the current wording included under this section.
Capacity Building and Information Exchange
47. The Task Force had requested the Ad Hoc Working Group to discuss the relationship between this Section and Paragraph 19 concerning the development and application of methods of detection and identification. It agreed to separate the two issues into separate paragraphs (Paragraphs 27 and 28) and agreed to strengthen the paragraph dealing with the exchange of information on analytical methods by making a special reference to Codex Contact Points. It also agreed that capacity building for enforcement should be referred to.
Review Process
48. The Delegation of the United State, while recognizing the importance of taking into account the newest scientific information for safety assessment, expressed its concern about the practicability should a routine review be required. This view was generally supported and the Task Force agreed to solve this problem by modifying Paragraph 30. An additional sentence was introduced to ensure that the assessment be reviewed to incorporate new relevant information and, if necessary, risk management measures be adapted when such information became available.
STATUS OF THE PROPOSED DRAFT GENERAL PRINCIPLES FOR THE RISK ANALYSIS OF FOODS DERIVED FROM MODERN BIOTECHNOLOGY
49. The Task Force advanced the Proposed Draft Principles, as presented in Appendix II of this report, to Step 5 of the Procedure for the consideration of the 24th Session of the Codex Alimentarius Commission.
