50. The Delegation of Japan introduced document CX/FBT 01/5 which had been developed by the Working Group established by the Task Force at its First Session. The Delegation reported that work had begun on the development of the text following the approval of the work by the Executive Committee in June 2000. The Working Group had met in July and October 2000. The working group had given consideration to the preparation of general guidance for all foods derived from biotechnology, but given the experience acquired in Member countries, decided to concentrate on developing guidance for foods derived from genetically modified plants as there seemed to be better prospects for harmonization, at least in the short term. Within this group, it decided to concentrate on recombinant-DNA plants and to exclude plants derived from cell fusion. It noted however, that the guidelines would need to be completed in the future to take into account experience gained in the safety assessment and regulatory approval of the latter.
51. The Delegation noted that the Working Group had introduced a new term, “safety assessment” so as to differentiate the process of evaluation from the risk assessment process used for the evaluation of chemicals or microbiological contaminants. The Proposed Draft Guideline was organized around the concept of substantial equivalence, but in the sense that this concept was a starting point for the safety assessment and not an end-point of the assessment. Section 4 of the Guidelines described the step-by-step evaluation process including the consideration of potential toxicity, allergenicity and nutritional consideration. Section 5 took into account several practical considerations.
52. The proposed draft Guidelines had been circulated for comment at Step 3 and the comments received were available to the Task Force.
53. The Task Force proceeded to examine the draft paragraph by paragraph. The main changes made are described below. Editorial and minor changes made for the purpose of clarity are not reported unless they are of significance in understanding the document.
TITLE
54. In view of the restricted scope of the document, the Task Force agreed to amend to Title so as to refer only to recombinant-DNA plants.
SECTION 1 - SCOPE
55. Consistent with its earlier decision, the Task Force agreed that the Guidelines did not apply to animal feeds or to animals fed these feeds nor did they address environmental risks (Paragraph 2).
56. The Task Force agreed to use the previously defined term “conventional counterpart” when referring to the product against which a recombinant-DNA plant would be assessed. (see paras. 24 and 25 above) It also agreed that the comparative assessment was not, in itself, a safety assessment and therefore deleted a statement that could have been interpreted to this effect (Paragraph 4).
57. The Delegation of China proposed to delete the second sentence of Paragraph 6 to maintain the conformity with the amended title of the Guideline. The Task Force decided to maintain the sentence for future consideration.
SECTION 2 - DEFINITIONS
58. The Task Force decided to retain the same definition of Conventional Counterpart as agreed to in the context of Agenda Item 4. The Task Force did not include a definition of “substantial equivalence” as suggested by Mexico in its written comments.
SECTION 3 - INTRODUCTION TO FOOD SAFETY ASSESSMENT
59. The Task Force agreed to modify the Title of the Section to indicate that the assessment referred to food safety and not to assessment for other purposes. Similar changes were made throughout the document.
60. In the description of the concept of substantial equivalence, the Task Force agreed that reference, in the footnote, should only be made to the most recent statement of the concept, as contained in the 2000 Joint FAO/WHO Expert Consultation (Paragraph 11).
Unintended Effects
61. Some Delegations expressed concern at the reference to unintended effects that arose during the course of conventional plant breeding, and stated that the Guidelines should deal exclusively with recombinant-DNA plants. The Task Force however, was of the opinion that the reference to conventional breeding was appropriate, as it provided additional perspective and insight into the safety assessment process (Paragraph 13).
62. It was pointed out that the treatment of “predictable” and “unexpected” unintentional effects in Paragraph 15 was unbalanced. The Task Force noted however that the safety assessment framework described in the document was intended to detect both types of unintended effects, even though more information would normally be available for predictable effects. The Task Force also agreed to simplify this paragraph by deleting specific reference to a few selected factors that needed to be taken into consideration, in favour of a more general statement and complete description in the following Section.
Framework of Food Safety Assessment
63. It was noted that Good Laboratory Practices were not applicable to all scientific experiments used for the safety assessment of plants, and modified Paragraph 19 accordingly. Consistent with its previous decision, it also deleted reference to the use of validated methods of assessment, but recognised that such methods should be sufficiently sound to withstand scientific peer review.
64. The Task Force agreed that safety assessments needed to take into account the best available scientific knowledge (Paragraph 20).
SECTION 4 - GENERAL CONSIDERATION
Description of the Host Plant and its use as Food/Description of the Donor Organism(s)
65. The Task force agreed that information to be provided should be on traits that might affect human health and that the Points B and C of Paragraph 22 as well as Point D of Paragraph 25 should be modified accordingly.
Characterization of the Genetic Modification(s)
66. The Delegation of Belgium, supported by many Delegations, stated that the sequence data of the inserted material and also of surrounding regions should be always provided as they were considered essential for safety assessment. The Delegation of the United States was of the opinion that only those sequence data related to possible impact on human health should be required. This view was supported by many Delegations, and the Task Force noted that other techniques were available to determine whether insertion sequences had been preserved or rearranged. The Task Force agreed to modify Point D to read “identification of any open reading frames within the inserted DNA or created by the insertions with contiguous plant genomic DNA including those that could result in fusion protein.” The Task Force agreed that the number of copies of the inserted gene should be also provided (Paragraph 30).
Safety Assessment of Expressed Substances (Non-Nucleic Acid Substances)
67. The Task Force agreed that safety assessment should be conducted on expressed substances rather than introduced substances and changed the wording accordingly throughout the text.
Assessment of possible toxicity
68. The Task Force noted the proposal of the Delegation of Canada for reorganization of this Section; it decided, however, that this should be considered at a later stage. The Task Force agreed that the words “conventional processing techniques” would describe the nature of the techniques that may deactivate anti-nutrients or toxicants found in the donor organisms (Paragraph 36).
Assessment of possible allergenicity (proteins)
69. The Task Force observed that the section on allergenicity was an important part of the Guideline document and that the report of the Joint FAO/WHO Expert Consultation on the Evaluation of Allergenicity of Genetically Modified Foods[11] offered considerably useful information. It observed further that the report introduced a new approach for the assessment of allergenicity of genetically modified foods, different significantly from that used as the basis for the drafting of the current wording. The Task Force agreed therefore that the section on allergenicity needed to receive a considerable amount of changes. Some Delegations regretted that there had not been sufficient time to consider the contents of the report in detail.
70. In order to proceed, the Task Force agreed to develop a separate annex containing detailed procedures for the allergenicity assessment. It also agreed to establish an open-ended Working Group on Allergenicity to develop such an annex and accepted the offer of the Government of Canada to host the Working Group. The Working Group was also invited to prepare a reorganization of the section on toxicology (see para. 68 above) and to ensure the scientific accuracy.
71. Under the understanding that detailed procedures for the allergenicity assessment should be removed from the body of the Guideline, the Task Force agreed to replace the whole section on allergenicity (Paragraphs 38 to 42). The paragraphs dealing with gluten-sensitive enteropathy were retained without change. The Task Force agreed further that the transfer of genes from commonly allergenic foods should be “avoided” rather than “discouraged”, but retained the restriction that such genes should not code for an allergen or a protein involved in gluten-sensitive enteropathy.
Evaluation of metabolites
72. The Task Force agreed that the title should read “Evaluation of metabolites” rather than Metabolic evaluation.
Nutritional modification
73. The Task Force agreed that attention should be paid also to the particular physiological characteristics and metabolic requirements of population groups with compromised immune systems.
SECTION 5 - OTHER CONSIDERATIONS
USE OF ANTIBIOTIC RESISTANCE MARKER GENES
74. The Task Force agreed that use of alternative transformation technologies not resulting in antibiotic resistance marker genes in foods should be more strongly promoted in the text (Paragraph 53).
75. The Delegation of Sweden on behalf of the Member States of the European Union present at the session welcomed the inclusion in the Guideline of the restriction of the presence of antibiotic resistant marker genes in foods. It proposed that the restriction should be applied not only to clinically important antibiotics but to all kinds of antibiotics in use in medical and veterinary treatments. This view was supported by many Delegations (Paragraph 56). The Delegation of the United States, supported by other Delegations, stated that the restriction should be limited to clinically important antibiotics. The Delegation of Australia noted that the language used in Paragraph 56 was in conformity with the relevant section of the report of the 2000 FAO/WHO Expert Consultation.
76. The Task Force agreed that antibiotic resistance genes used in food production that encode resistance to clinically used antibiotics should not be present in widely disseminated foods.
STATUS OF THE PROPOSED DRAFT GUIDELINE FOR THE CONDUCT OF FOOD SAFETY ASSESSMENT OF FOODS DERIVED FROM RECOMBINANT-DNA PLANTS
77. The Task Force advanced the Proposed Draft Guideline, as presented in Appendix III of this report, to Step 5 of the Procedure for the consideration of the 24th Session of the Codex Alimentarius Commission. It was noted that the Proposed Draft Guideline required rearrangement in the Section dealing with Toxicity, and several editorial amendments to improve the scientific accuracy.
78. The Annex (Allergenicity Assessment) would be circulated for comments at Step 3.
