58. Several delegations stressed the importance of the availability of the Reports and Monographs of JECFA evaluations when considering MRLs, in particular, when both the ADIs and MRLs were amended by JECFA. They requested the timely publication of both documents in order to expedite the elaboration of MRLs. The Committee was informed that the Reports generally took longer to publish than the Monographs.
59. It was suggested that better coordination be established between JECFA and other scientific bodies working in the same area, such as the Committee for Veterinary Medicinal Products (CVMP) of the European Community.
ABAMECTIN
60. The Delegation of Germany, speaking on behalf of the European Community, expressed opposition to the basis of the ADI setting of the 1997 JMPR because the NOEL of the most sensitive species, CF1 mouse, had not been used for the ADI setting and no human data were available on abamectin, as opposed to ivermectin. It was also stated that data on a new avermectin was now available. The Committee requested the EC to provide the data to the JMPR.
61. The Committee decided to retain the draft MRLs at Step 7 (see Appendix IV) with the understanding that if no data or information were received by JMPR by the next session of the Committee, the Committee would consider their advancement to Step 8.
ALPHA-CYPERMETHRIN AND CYPERMETHRIN
62. The Committee noted that there were a number of Codex MRLs adopted for animal products arising from veterinary uses based on the recommendations of the Codex Committee on Pesticide Residues, which had different residue and commodity definitions (see paras. 8-9). The issues raised included, risk assessment policies, different diet patterns and impracticalities in having two different MRLs for substance/commodity combinations. The Committee reaffirmed that there must be only one Codex MRL for a substance/commodity combination. Several delegations stressed that substances used for veterinary purposes must be evaluated by JECFA and MRLs for these uses be elaborated by the CCRVDF.
63. The Committee agreed to advance all draft MRLs to Step 8 (see Appendix II) with the understanding that if the outcome of the informal meeting between JECFA and JMPR (see paras. 9 and 11) required amendments of these MRLs, it would reconsider them at its next Session.
AZAPERONE
64. The Committee agreed to advance all draft MRLs to Step 8 (see Appendix II).
BOVINE SOMATOTROPINS
65. The Committee recalled that the 21st Session of the Codex Alimentarius Commission (July 1995) had adjourned debate on the adoption of maximum residue limits for bovine somatotropins until its 22nd Session[31]. At the 22nd Session of the Commission, the Delegation of the Netherlands, expressing the views within the European Union, presented a proposal to suspend the consideration of the adoption of the MRLs for BST pending the reevaluation of scientific data by JECFA and the CCRVDF and the examination of the application of the "other legitimate factors" in relation to BST by the Committee on General Principles. A roll-call vote was called, and the motion passed[32].
66. In reviewing the application of the statements of principle on the role of science and the extent to which other factors should be taken into account in the case of BST and PST, the 13th Session of the Codex Committee on General Principles (CCGP) (September 1998) recognized that no consensus existed on the application of other factors in the case of BST and that further discussion was needed. It agreed that although the general and specific issues under consideration were related, they should be clearly identified in order to avoid confusion and to facilitate discussion. To this effect, the CCGP agreed that two papers should be prepared by the Secretariat on these issues: 1) consideration of other legitimate factors in the framework of risk analysis as recommended by the Commission, and 2) application of other legitimate factors to the case of BST. The CCGP agreed to return to these matters at its next Session[33].
67. The CCGP noted that the Summary and Conclusions of the 50th JECFA Meeting, which included the complete section on the BST evaluation, had been published and distributed and was available on the Internet. However, the supporting toxicological monographs were not yet available and the final report, following editing, would be published by WHO in the coming months.
68. The Delegation of Germany, speaking on behalf of the European Community, believed that the CCRVDF was obliged to postpone the adoption of MRLs for BST because of the unavailability of the final toxicological monographs and the ongoing consideration of "other legitimate factors" by the CCGP. Several delegations, as well as the observers from the European Community and Consumers International, referred to the recent meeting of the CCGP stressing the need for transparency and consensus in Codex decision making procedures. In the interest of transparent risk assessment and a full and open scientific debate, the CCRVDF in its role as risk managers required the full toxicological monographs and the result of the consideration of "other legitimate factors" by the CCGP before proceeding further, and that neither of these conditions had been met at this time. The Delegation of Germany noted that although the mandate of the Codex Alimentarius Commission allowed the elaboration of standards for reasons of the protection of consumer health and the facilitation of international trade, the EC currently allowed the importation of BST treated animals and the products thereof and therefore, there was no urgent need to elaborate MRLs for BST.
69. Other delegations supporting the advancement of the MRLs for adoption by the Commission were of the opinion that both the EC/CVMP and JECFA had agreed on the recommendation of an MRL of "not specified" for BST, and that JECFA had already reviewed additional data in conducting the reevaluation of BST at its 50th meeting. These delegations noted, and the JECFA Secretariat confirmed, that the publication of the full JECFA report and toxicological monographs would not change the result of the evaluation. It was also noted that the CCRVDF had previously advanced other MRLs for final adoption in the absence of the final toxicological monograph report, and that the Commission had instructed the CCRVDF to take account of the scientific factors only, as "other legitimate factors" were to be considered by the CCGP. It was stated that the SPS Agreement allowed importing countries to restrict the importation of BST treated animals and the products thereof if scientifically justified.
70. It was noted that the Commission had requested the CCRVDF to consider the scientific aspects of the issue only. After a lengthy discussion with divergent opinions, the Chairman noted that there was no consensus. However, as no specific scientific objections had been raised on the basis of the summary report of the 50th JECFA, his decision was to advance the MRLs for BST for adoption at Step 8 (see Appendix II) to the 23rd CAC. It was emphasized that this decision was subject to subsequent scrutiny of the final JECFA report and toxicological monographs. Furthermore, the outcome of the discussion on other legitimate factors relevant to BST by the CCGP would have a bearing on the final consideration of MRLs for BST by the CAC. The delegations of Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Norway, Portugal, Spain, Sweden and the United Kingdom objected to this decision on the basis that the Committee should await publication of the final report and toxicological monographs of the JECFA and the CCGP deliberations on other legitimate factors related to BST.
CHLOROTETRACYCLINE/OXYTETRACYCLINE/TETRACYCLINE
71. The Committee noted that the ADI had been increased by the 50th JECFA and MRLs had also been increased to accommodate all uses of these substances and that the estimated intake was well below the new ADI.
72. The representative of WHO explained that the ADI was derived from the microbiological endpoint which was based on the development of resistance in human microflora. As this was especially sensitive and the variation of responses was small, the safety factor of 1 had been used. Recognizing that the methodology was evolving at present, the Committee agreed to review the policy and methodology of the ADI setting based on microbiological endpoints elucidated in the toxicological monograph of the 50th JECFA.
73. Several delegations proposed the advancement of the MRLs to Step 8. However, based on the reasons stated above, the Committee decided to retain (also see para. 83) the draft MRLs for tissues of cattle, pig, sheep and poultry at Step 7 (Appendix IV) pending the publication of the toxicological monograph by the 50th JECFA.
DEXAMETHASONE
74. The Committee noted that while the Commission adopted the MRLs for dexamethasone at Step 5, JECFA at its 48th and 50th Sessions had recommended to withdraw all the draft MRLs due to the lack of appropriate methods of analysis for regulatory monitoring. However, it was recognized that dexamethasone was widely registered and had potential for misuses/abuses which might give rise to health concerns. The Committee decided to retain all the proposed draft MRLs at Step 7 (see Appendix IV).
DICLAZURIL
75. The Committee agreed to advance all draft MRLs to Step 8 (Appendix II).
DIHYDROSTREPTOMYCIN/STREPTOMYCIN
76. The Committee was informed that the MRLs were temporary due to the fact that a validated method was available only for dihydrostreptomycin. Noting that these MRLs were scheduled for reevaluation by the 52nd JECFA, the Committee agreed to advance them to Step 8 (Appendix II).
FEBANTEL/FENBENDAZOLE/OXFENDAZOLE
77. The Delegation of Germany, speaking on behalf of the EC, informed the Committee that the ADI within the EC was the same as that recommended by JECFA and therefore, the EC could accept an increase of the established MRLs in the EC up to the MRLs proposed by JECFA. The Committee agreed to advance (also see para. 85) the draft MRLs for the tissues of cattle, pig and sheep to Step 8 (Appendix II).
GENTAMICIN
78. The Committee noted that the 50th JECFA increased the ADI and MRLs. While it was recognized that the estimated intake was below the new ADI, the Committee decided to retain all the draft MRLs at Step 7 (Appendix IV) as no details of the toxicological evaluation were available (also see paras. 71-73).
NEOMYCIN
79. The Committee agreed to advance all draft MRLs to Step 8 (Appendix II).
SPECTINOMYCIN
80. Noting that the estimated intake was below the ADI, the Committee agreed to advance (also see para. 92) the draft MRLs for the tissues of cattle, pig and chicken (except chicken eggs) to Step 8 (Appendix II).
THIAMPHENICOL
81. Based on the fact that the ADI was temporary, the Committee decided to retain all the draft MRLs at Step 7 (Appendix IV) awaiting their reevaluation by the 52nd JECFA.
TILMICOSIN
82. In response to the question on the use of safety factor of 10, the WHO Secretary to the JECFA explained that the basis of the ADI was the toxicological endpoint and the safety factor of 100 was used. The Committee agreed to advance all the draft MRLs to Step 8 (Appendix II).
