- Harmonization of MRL Setting for Compounds Used Both as Pesticides and as Veterinary Drugs
- Proposed Measures When Dietary Exposure Estimates Exceed the Acceptable Daily Intake
- Feasibility of Establishing MRLs for Genetically Modified Crops and for Metabolite Residues
- Feasibility of Establishing Specific MRLs for Cereal-Based Foods and Infant Formula
- Need for EMRL for Camphechlor in Fish
Draft and Proposed Draft Maximum Residue Limits in Foods and Feeds at Steps 7 and 4
44. The Committee recalled that it had been concerned since its 29th Session about the differences in the way JMPR/CCPR and JECFA/CCRVDF set MRLs. It also recalled that the Codex Alimentarius Commission at its 22nd and 23rd Sessions had requested better harmonization in the MRL setting for compounds used both as pesticides and as veterinary drugs. An informal JECFA/JMPR Harmonization Meeting had been convened in February 1999 to solve differences in residue definitions and related matters and to ensure harmonization and consistency between JECFA and JMPR. The Harmonization Meeting had made a number of recommendations addressed to CCPR, CCRVDF, JMPR and JECFA. The outcomes of the consideration of the relevant recommendations by the 1999 JMPR and 12th CCRVDF were presented to the Session.
Commodity Definitions
45. The Committee agreed to accept the recommendation to amend the term “fatty tissue” to “fat tissue” in the definitions of mammalian meat, mammalian fats and poultry fats in the Codex Classification of Foods and Animal Feeds. The Committee also agreed to accept a new definition of “milk” as contained in the General Standard for the Use of Dairy Terms as a consequence of its adoption by the Commission at its 23rd Session.
46. The agreed texts of the above definitions are contained in Appendix V of this report. The Committee noted that as these revised definitions would eventually be included in the Codex Classification of Foods and Animal Feeds in Volume 2A of the Codex Alimentarius, their elaboration should follow the Codex Elaboration Procedure. As there was consensus, the Committee agreed to use the Accelerated Procedure pending approval of the Executive Committee to initiate new work.
47. The Committee briefly considered whether the revised definition of “muscle” being considered by the CCRVDF could be used as the definition of “meat” for the purpose of this Committee. The Committee was generally of the opinion that MRLs should be recommended for food commodities, such as meat, rather than tissues, such as muscle, and therefore definitions should be established for food commodities. Since both definitions of muscle and meat would be circulated for comments at Step 3, the delegations were invited to coordinate with their counterparts working in the area of veterinary drugs within their own countries when commenting on them.
Veterinary Uses
48. For MRLs arising from the application of certain pesticides on animals, the Committee agreed to discontinue the use of the “V” designation and the explanatory text, “The MRL accommodates veterinary uses”, and decided to use a footnote that states “The MRL accommodates external animal treatments.”
Other Issues
49. The Committee concurred with the recommendation of the CCRVDF that where JMPR and JECFA had recommended MRLs for the same chemical with the same residue/marker definition on the same commodity, the higher MRL should be recommended provided that intake of residues did not exceed the ADI.
50. The Committee noted that in order to avoid the situation where no MRL exists when the higher MRL of two different MRLs for the same chemical with the same residue definition on the same commodity is withdrawn, the lower MRL should be kept as a footnote to the relevant Committee’s list of MRLs. In cases where proposed MRLs were concurrently moving through the Codex Elaboration Procedure, both should be advanced to Step 8 for adoption, to ensure that MRLs would be in place for both uses in case one use was withdrawn in the future.
51. The Committee noted that harmonization efforts should be undertaken on a case-by-case basis where marker residue definition/residue definition differences occur between JECFA and JMPR. The Committee supported the recommendation that for compounds that were common to both, JMPR and JECFA should use the more specific animal commodity descriptions to enhance harmonization.
52. The Committee deferred the consideration of those recommendations specific to certain compounds until it considered these compounds along with MRLs for others. The Committee took note of all other recommendations pertinent to the work of this Committee noting that most of them were in agreement with the current practice or had already been implemented.
53. The Delegation of Australia introduced the discussion paper proposing a number of measures that might be used in situations when the IEDI indicated that the ADI might be exceeded.
54. The paper recommended two main approaches to such situations. The first relied upon improving the science and estimations of dietary intake calculations at the international level. A set of more detailed recommendations to improve the methodology was outlined. They included among others: better usage of processing studies, levels of residues in edible portions, national monitoring data, proportion of crop treated and consumption data for processed commodities. Other suggestions included the consideration by JMPR of the use of contemporary national reviews and dietary exposure calculations, and seeking advice from national governments in regions where the regional diet estimate had been exceeded as to whether, based upon their own national reviews, they could support advancement of the MRLs in question. It was also suggested that improvement in the science of dietary intake estimates at the international level would provide a more realistic exposure estimate with a view to convening an expert consultation when appropriate.
55. The paper also presented an alternative approach that the Codex should advance MRLs even when the dietary intake estimates might exceed the ADI and leave to national governments the role of risk management in relation to these MRLs.
56. The Committee noted the conclusion of the paper that such situations might be an artificial problem produced by methodology, as calculations at the national level did not demonstrate concern.
57. There was general support from the Committee for the recommendations to continue developing the science related to dietary exposure calculations at the international level and to encourage countries to submit relevant data.
58. There was limited support regarding the proposed alternative approach. It was pointed out that this approach could have implications with respect to the SPS Agreement of WTO and that not so many countries performed dietary exposure assessment regularly. However, the Committee agreed that it highlighted the need to bridge the gap between what could be done at the international level and national level.
59. The Committee recalled that it had agreed at the 29th Session to implement a procedure for dealing with chronic dietary exposure concern and to review its operation after three years[19]. The Committee decided to maintain the agreed current procedure concerning chronic exposure concern. The Committee noted that there was a need to move forward with caution.
60. The Committee also agreed to continue consideration of this issue as a review of the procedure and to solicit government comments on the underlying principles of the recommendations set forth in paragraphs 22, 41 and 42 of the paper via a circular letter. It further agreed that it was premature to request an expert consultation on the improvement of chronic dietary risk assessment. The Committee requested Australia, in collaboration with Canada, New Zealand, Sweden, USA, CI and GCPF, to prepare a paper based on the discussion at this session and comments provided in response to the circular letter for consideration by the Committee at the next session.
61. The Committee recalled that during the consideration of MRLs for AMPA[21] at the last session, several delegations had expressed reservations regarding establishing MRLs for a metabolite arising from the treatment of a genetically-modified crop with glyphosate and requested a clear policy on how to deal with this issue. The Committee had agreed that a short paper should be prepared on the feasibility of establishing MRLs for genetically modified crops and metabolite residues for consideration at the current session.
62. The Delegation of Canada presented the paper prepared in collaboration with Australia, South Africa, USA, Commission of the EC, GCPF and the Codex Secretariat. He explained two scenarios of residues encountered with herbicide resistant crop varieties: following the same metabolic pathway but resulting a shift of dominant metabolite; and following different metabolic pathway resulting in a new/novel metabolite(s). He also explained possible approaches in addressing these scenarios, using the cases of glufosinate-ammonium[22]/NAG[23] and glyphosate/AMPA[24] as examples: (1) where the metabolite is included in the existing residue definition; and (2) where the metabolite is not included in the residue definition. He concluded that no one approach seemed applicable to all situations and therefore a case-by-case approach was needed at present; and proposed options on how to proceed with this issue.
63. Some delegations expressed their views that for control purposes it was not practical to set separate MRLs for conventional and genetically-modified varieties and preferred a single residue definition to cover both. However, one delegation stated that when a new metabolite arising in a genetically modified variety was added to the residue definition, this definition should be applicable only to the genetically modified variety in order to avoid extra cost for the validation of method of analysis for all commodities.
64. The Committee decided to seek information from governments through a circular letter on the following so as to enable this Committee to develop general guidance on the development of residue data and analytical methodology which would facilitate development of residue definitions compatible to traditional and resistant varieties:
65. The Committee agreed to request the 2000 JMPR to consider this paper so that the Committee could consider their opinions together with information submitted in response to the CL above to be compiled by Canada at the next session.
66. The Committee agreed that where it was anticipated that the existing residue definition would no longer be applicable, e.g., parent compound no longer represents a measurable component of the final residue, the industry should consider the possibility of developing a common moiety method of analysis as the basis for consistent measurement of the terminal residue regardless of the final composition as per glufosinate ammonium and NAG. This was supported also by GCPF.
67. The Committee recalled that at its last session it had agreed that in response to a request from the Codex Committee on Nutrition and Foods for Special Dietary Uses a paper be prepared on the feasibility of establishing specific MRLs for cereal-based foods and infant formula and on possible unique toxicological concerns to children.
68. The Delegation of Germany introduced the document prepared in cooperation with the USA, CI and the Codex Secretariat, and informed the Committee that the paper covered a wide range of issues relating to whether or not the current procedures of recommending ADIs and MRLs were appropriate to protect the health of infants and children. The Delegation stated that infants and children might be more or less susceptible to some chemicals than adults, and that this needed to be considered in the risk assessment. The Delegation proposed several options if the Committee intended to proceed with the establishment of ADIs for infants and children and MRLs for processed foods. These include: the establishment of a generic common limit for products intended for infant and children and the application of additional safety factor on a case-by-case basis when setting ADIs for pesticides that may have the potential for enhanced toxicity effect for infants and children.
69. The Committee decided to focus the consideration on: (1) the request of the CCNFSDU; and (2) the appropriateness of current ADI and MRL setting practice in relation to the protection of infants and children.
70. Regarding the request of the CCNFSDU, some delegations indicated that the paper did not adequately address the feasibility of establishing separate MRLs for cereal-based products and infant formula and questioned the need for setting MRLs for such products. It was pointed out that the establishment of separate MRLs for a raw commodity, one for adults and the other for infants and children, was neither practical nor feasible.
71. The Observer from the EC informed the Committee that in order to protect the health of infants and young children it had adopted a common limit of 0.01 mg/kg for all pesticides for ready-to-eat foods for infants and children, as temporary precautionary measure, pending toxicological evaluations of the substances.
72. The Committee noted that it had not established MRLs for composite products. It recognized that in order to do this it would be necessary to develop new methodology to estimate MRLs for composite products and it was considered that the methodology would be complex in nature; and it might not form a sound scientific basis for establishing Codex MRLs. The Committee concluded that the establishment of MRLs for these products was not feasible at this time.
73. The Committee did not support the establishment of two MRLs for a raw commodity, one for adults and another for infants and children and could not reach consensus at this time on the establishment of a generic common limit (e.g., at the limit of determination) for these products.
74. The Committee noted that the standard wording for the pesticide residue provision was not applicable to the Proposed Draft Standards for Cereal-Based Foods for Infants and Young Children and for Infant Formula because there had been no MRLs established for those products. In view of the above, the Committee endorsed the proposed CCNFSDU wording for the pesticide residue provision for inclusion in those proposed draft standards to read:
“5.1 Pesticide Residues75. Regarding appropriateness of the current practice, the Observer from CI urged the Committee to consider protection of infants and children from more general perspective especially as the document prepared by Germany covered some issues that might be useful for an expert consultation to consider.The product shall be prepared with special care under good manufacturing practice, so that residues of those pesticides which may be required in the production, storage or processing of the raw materials or the finished food ingredient do not remain, or, if technically unavoidable, are reduced to the maximum extent possible”.
76. As a follow-up to the earlier JMPR consideration and in the light of the development at the national level, the Committee decided to request JMPR, in its evaluation of specific pesticides, to explicitly comment on the adequacy of the database for assessing risks for infants and children. Recognizing the need to consider the question of cumulative intake (common mechanism of action), it agreed to ask JMPR to comment on this issue when information became available to JMPR.
77. The Committee agreed to invite governments by a circular letter to provide information on:
78. The Committee was of the opinion that this information would facilitate establishing a list of pesticides for which special consideration might be needed for the protection of infants and children; determining whether there was a need for an expert consultation; and if there was such a need, identifying specific objectives for consideration by a consultation. The information should be directed to The Netherlands which, in cooperation with the Codex Secretariat, would prepare a paper for consideration by next session of the Committee.
79. The Committee recalled that at its last session the Committee had considered a paper[27] prepared by Germany on the need for EMRL for camphechlor in fish. The Committee had agreed to a circular letter[28] seeking government comments on the paper and requesting information on trade problems and availability of monitoring data. The Committee also recalled that it had agreed on CCPR positions on estimating EMRLs[29].
80. The Delegation of Germany introduced a new paper[30]. The paper contained the German responses to major issues raised in comments provided in response to the circular letter; and concluded that: the source of camphechlor contamination of fish was the former use of camphechlor as a pesticide; and the available data which could be provided to JMPR were sufficient for recommending a PTDI[31] and EMRL.
81. Several delegations questioned the need for establishing an EMRL for camphechlor in fish or the usefulness of such an EMRL, as there were no demonstrated trade problems or significant health concerns experienced in their countries. Several other delegations expressed their opinion that it was premature to make decision to establish an EMRL as monitoring data were too sparse and there would be a need for developing guidance on what congeners to analyze and report.
82. The Delegation of Germany requested that toxicological data, which met the OECD requirements, be reviewed by JMPR for allocating a PTDI. However, the WHO Joint Secretary to JMPR noted that unless it was certain that toxicological studies were applicable to congeners relevant to those found as residues in fish and unless the need for establishing an EMRL was determined, JMPR was reluctant to review the toxicological data.
83. While recognizing the toxicity of camphechlor on one hand and practical problems, such as insufficient monitoring data, to be solved on the other, the Committee could not reach consensus on the need for establishing an EMRL for camphechlor in fish. Taking into account comments made at the session and the heavy workload of JMPR and CCPR, the Committee considered this issue of low priority and decided not to refer this issue to JMPR. Recalling the decision made at its 29th Session in relation to the use of pesticides in aquaculture or environmental contamination of fish[32], the Committee agreed that it might consider this issue in the future when more information became available.
Captan (007)
Carbaryl (008)
Chlorfenvinphos (014)
Chlormequat (015)
2,4-D (020)
Dimethoate (027)/Omethoate (055)
Endosulfan (032)
Ethoxyquin (035)
Fenthion (039)
Lindane (048)
Malathion (049)
Mevinphos (053)
2-Phenylphenol (056)
Quintozene (064)
Thiabendazole (065)
Cyhexatin (067)
Benomyl (069)/Carbendazim (072)/Thiophanate-Methyl (077)
Disulfoton (074)
Vamidothion (078)
Amitrole (079)
Chinomethionat (080)
Chlorothalonil (081)
Dichlofluanid (082)
Dicloran (083)
Fenamiphos (085)
Dinocap (087)
Chlorpyrifos-methyl (090)
Carbofuran (096)
Methamidophos (100)
Maleic Hydrazide (102)
Phosmet (103)
Dithiocarbamates (105)
Iprodione (111)
Phorate (112)
Triforine (116)
Aldicarb (117)
Cypermethrin (118)
Permethrin (120)
Amitraz (122)
Azocyclotin (129)
Methiocarb (132)
Deltamethrin (135)
Procymidone (136)
Bitertanol (144)
Carbosulfan (145)
Cyhalothrin (146)
Flucythrinate (152)
Pyrazophos (153)
Cyfluthrin (157)
Oxydemeton-methyl (166)
Glufosinate-ammonium (175)
Hexythiazox (176)
Abamectin (177)
Myclobutanil (181)
Clethodim (187)
Tebuconazole (189)
Haloxyfop (194)
Fenbuconazole (197)
Aminomethylphosphonic Acid (AMPA) (198)
Kresoxim-methyl (199)
84. The Delegation of the USA indicated that they could not support advancement of the draft MRLs for organophosphate and carbamate pesticides under consideration, pending the outcome of their cumulative risk assessment process. This view was shared by the Observer from CI. The EC opposed advancement of any MRLs above the limit of determination when there were acute and/or chromic intake concerns.
85. The Observer of the EC asked that JMPR estimate an Acute RfD and noted that animal feeding studies are required for full evaluation of the compound. The Delegation of Thailand informed the Committee that a summary of GAP data on grape and strawberry had been provided. The Committee returned the draft MRLs to Step 6 awaiting the periodic review by the 2000 JMPR and taking into account the reservations of the USA and the EC on several commodities.
86. The Committee noted that the MRLs for animal feedingstuffs and common bean would no longer be supported. The Committee was informed that the Delegations of Thailand and Mexico would provide new residue data and GAP information to the 2001 JMPR. The Committee retained all temporary CXLs awaiting the toxicological evaluation by the 2000 JMPR and the residue evaluation of the 2001 JMPR, since several uses on crops that were also used as animal feedingstuffs remained in the list.
87. The Committee noted that the compound would not be supported for periodic review by the JMPR, since the GAP in the UK for all commodities in the list had been revoked. The Committee would consider revocation of the existing Codex MRLs at its next session.
88. The Committee returned all draft MRLs to Step 6 awaiting evaluation of new data including feeding studies by the 2000 JMPR.
89. The Committee decided to retain the Codex general MRL for citrus fruits, as the Delegations of South Africa, Uruguay and USA preferred this to accommodate post harvest use. The Delegation of Spain also preferred this to MRLs for individual commodities. The USA and Spain informed the Committee that additional residue trials would become available for the JMPR. The Netherlands and South Africa disagreed with the evaluation of the data for the proposed separate MRLs for oranges and grapefruit.
90. Brazil and Thailand noted that they were prepared to cooperate in the development of residue data to support the MRL for citrus fruits. Noting concerns over the chronic and acute intake, the Committee decided to recommend to the Commission revocation of all MRLs proposed by the 1998 JMPR for withdrawal and not supported. The Committee advanced the proposed draft MRLs to Step 5, indicating that the chronic and acute exposure should be addressed before advancing them any further.
91. The Committee had an exchange of views on whether or not to retain omethoate in the residue definition. It noted that omethoate was no longer in use and its use was not supported. However, the Committee was also aware that omethoate would arise from the use of dimethoate. As no agreement was reached, the Committee decided to keep the present residue definition for dimethoate and to discuss it again at its next Session. It postponed decision on the MRLs for omethoate to its next session.
92. The Committee was informed that new residue trials data would be submitted for a range of commodities from Australia and the USA.
93. The committee returned the draft MRLs to Step 6 and the proposed draft MRLs to Step 3. The Committee maintained all CXLs awaiting the residue evaluation by the 2003 JMPR.
94. The Committee would consider at its next session the revocation of the CXL for pear unless sufficient toxicological data would become available.
95. The Committee was informed that animal feeding studies had been provided to the 2000 JMPR. The Committee agreed to extend the 4-year period under the periodic review procedure for the MRLs for meat and milks pending the review by the 2000 JMPR.
96. The Committee was informed that data would be sent on seed and soil treatment used for a number of cereal and vegetable commodities for residue evaluation by the 2003 JMPR. Detailed information was requested on the specific commodities to be supported well in advance of the next session.
97. The Committee was informed that the use on apple; broccoli; cabbages, head; citrus fruit; grapes; peach; raspberries, red, black; and potato would be supported. The Committee would consider at the next session retention of the CXL for root and tuber vegetables, awaiting information on potato, and revocation of all other CXLs as recommended by the 1999 JMPR. The FAO Joint Secretary informed the Committee that new trial data were available for post harvest uses on wheat bran, unprocessed; wheat flour; and wheat whole meal.
(See Annex II)
98. The Committee would consider at its next session new proposed draft MRLs and retention of the CXL for pears awaiting review by JMPR as the US growers agreed to supply data on pears later this year.
99. The Committee recommended revocation of the CXLs for lettuce head and potato to the Commission as no supporting data had been submitted to the 1998 JMPR. The Committee agreed to extend the 4-year period under the periodic review procedure for all other CXLs awaiting the corresponding MRLs reaching Step 8. The Netherlands expressed concerns about regulatory implications of residues occurring in rotational crops.
100. The Committee noted that the use for avocado, citrus fruit, mango, pome fruits and strawberry were supported.
101. The Committee returned the MRL for mushrooms to Step 3 as a new label based on revised GAP would be considered by the 2000 JMPR. The Committee amended the draft MRLs for cattle meat and cattle milks from 0.05 to 0.1 mg/kg for the sake of harmonization with the existing MRLs for animal products arising from veterinary uses (see para. 49) and advanced them to Step 8. The Committee retained the MRL for edible offal of cattle at Step 7B and requested JMPR to review the MRL as it might be too low in the light of the sum of individual analytes included in the residue definition.
102. The Committee noted that there would be support for apple, citrus fruits, grapes, peach, pear and plums including prunes. GAP for nectarines had been requested. The Committee retained the draft MRLs for peach and plums including prunes at Step 7B. The remaining CXLs and draft MRLs for nectarines at Step 7C would be considered for revocation/withdrawal next year.
103. Regarding whether it was appropriate to have three separate residue definitions or not, the Committee decided to retain the current definitions and to reconsider them next year. The Committee decided to retain the CXLs for carbendazim for asparagus; avocado; celery; coffee beans; common bean (pods and/or immature seeds); lettuce, head; mango; peppers; soya bean (dry); soya bean (fodder); sweet potato; and tree nuts (macadamia) because of commitment to submit data. Written submissions specifying precise information were requested.
104. The Committee decided to recommend to the Commission revocation of the CXLs for broad bean (green pods and immature seeds); cherries; egg plant; hops, dry; melons, except watermelon; peanut; peanut fodder; potato; sheep meat; squash, summer; sugar beet; sugar beet leaves or tops; swede; taro; and winter squash. The Committee withdrew the draft MRL for mushroom, returned all other draft MRLs to Step 6 and advanced all proposed MRLs to Step 5. The issue of extrapolation from peach to other stone fruits and from wheat to rye would be considered at the next Session.
105. The IEDIs exceeded the ADI in all regional diets. Rice and sorghum were the main source of the intake except in the European regional diet. The manufacturer was considering not to support the CXLs for rice and sorghum. The Committee decided to consider revocation of the CXLs for rice and sorghum at the next session. The Committee returned all draft MRLs to Step 6 and would consider them next year.
106. The Committee decided to consider revocation of the CXLs at the next session, as there was no supporting data.
107. The Committee advanced all proposed draft MRLs to Step 5. The Committee noted the concerns of the USA regarding possible cancer risk.
108. The Committee recommended to the Commission revocation of all CXLs as the compound was no longer supported.
109. The Delegation of the USA proposed to increase the draft MRL for banana from 0.01 to 0.05 mg/kg to accommodate residues arising in unbagged bananas because the limit of determination was 0.03 mg/kg. The Committee returned the draft MRL to Step 6 and to reconsider it at its next session along with the proposed amendment at 0.05 mg/kg.
110. As the compound would not be supported beyond 2000 and would be replaced by tolylfluanid, the Committee agreed to consider revocation of the CXLs next year and to request information on the registration of dichlofluanid from governments by a circular letter.
111. The Committee noted that there was support for the use on grapes; lettuce head; peach; plums; strawberry; and tomato. The Committee retained the CXLs for these commodities for four years in accordance with the periodic review procedure.
112. The Committee noted acute intake concerns and that the CXLs for broccoli, cauliflower, coffee beans, coffee beans, roasted, kiwifruit, oranges, sweet, sour, potato, soya bean, dry, sugar beet and sweet potato would be considered for withdrawal at the next session unless new information became available.
113. The Committee requested JMPR: to comment on the Acute RfD, noting that it is based on teratogenic effects and might not be appropriate for children; to conduct an intake calculation, since this had only been carried out for tomato; and to clarify at the time of the 2000 JMPR that the residue definition still includes the isomer and phenols as established by the 1998 JMPR.
114. The Committee advanced the proposed MRLs to Step 5, noting that there was no longer support for the use on glasshouse grown strawberry.
115. The Committee returned the draft MRLs to Step 6, with the understanding that Australia would submit their intake calculations and comments well in advance of the next session for circulation by the Netherlands Secretariat. The Committee decided to ask the working group on priorities to include it in the Priority List for review by JMPR for establishment of an Acute RfD.
116. The Committee advanced the draft MRLs for alfalfa forage (green); citrus pulp, dry; sorghum forage (green); and sorghum straw and fodder, dry to Step 8, noting reservations of the Delegation of the USA and of the Observer of the EC. The Committee returned the other draft MRLs to Step 6 in view of intake concerns.
117. The Committee noted that methamidophos and acephate (095) were scheduled for toxicological evaluation by the 2002 JMPR under the periodic review. The Committee requested detailed information on support for methamidophos/acephate. The Observer from GCPF indicated that they would submit the requested information regarding support for the related compound acephate. The Observer from the EC indicated that they would provide information on support for methamidophos before the next session.
118. The Committee returned the draft MRLs to Step 6 in view of intake concerns. The Committee indicated that the MRLs for commodities, which would not be supported by the USA and EC, would be proposed for deletion at the next session.
(See Annex II)
119. The Committee decided to recommend to Commission revocation of the CXLs for alfalfa fodder; alfalfa, forage (green); cattle meat; maize; maize fodder; maize forage; milks; nectarine; pea hay or pea fodder (dry); pea vines (green); peas (dry); peas (pods and succulent=immature seeds); sweet corn (corn-on-the-cob) and sweet potato. As there was support indicated for blueberries, citrus fruits, nectarine, pear and tree nuts, the CXLs for these commodities were retained for four years under the periodic review procedure.
120. The Committee advanced the draft CXLs for cottonseed and potato to Step 8 and returned the draft MRL for apricot to Step 6. The Committee agreed that acute intake estimates should include not only the proposed MRLs but the CXLs as well. The Committee further agreed that this approach should be followed for all compounds having acute intake concerns.
121. The Committee advanced the draft MRLs for pecan, stone fruits and strawberry to Step 8 noting comments of the Observer from the EC.
122. The Committee decided to extend the four-year period under the periodic review procedure for tomato in view of residue evaluation by the 2001 JMPR.
123. The Committee noted that there would be support for its Periodic Review (2003 and 2004).
124. The Committee would consider revocation of the CXL for tree tomato at the next session as all commodities, except tree tomato, were supported.
125. The Committee returned the draft MRL for potato to Step 6 pending JMPR review in 2000.
126. The Committee was informed that the 12th CCRVDF decided to withdraw all temporary draft MRLs at Step 8 arising from veterinary uses, as the requested data were not submitted to the 54th JECFA.
127. The Committee decided to consider at its next session revocation of all Codex MRLs for commodities which would not be supported. The Committee requested detailed information on support for permethrin (See para. 160).
128. The Observer from the EC advised that they could not accept the ADI and Acute RfD proposed by the 1998 JMPR. The Committee requested the EC to submit their toxicological evaluations and results of the new mechanistic study to the WHO Joint Secretary to JMPR. The WHO Joint Secretary informed the Committee that if this information so indicated, the compound could be scheduled for a re-evaluation of the ADI and the Acute RfD.
129. The Committee retained the draft MRLs at Step 7C until its next session, as there was no confirmation on the commodities supported. Written information on specific commodities supported was requested to be provided well in advance of the next session. The support for apple and grapes was confirmed.
130. The Committee agreed to consider revocation of all CXLs at its next session if no information was provided on commodities being supported.
131. The Committee was informed that the 12th CCRVDF decided to retain the proposed draft MRLs arising from veterinary uses at Step 4.
(see Annex II)
132. The Committee would consider revocation of Codex MRLs for apricot; bean forage (green); common bean (pods and/or immature seeds); peanut and peanut forage (green) at its next session.
133. The Committee returned the draft MRLs for citrus pulp, dry; and oranges, sweet, sour to Step 6 for consideration at its next session.
134. The Committee was informed that the 54th JECFA allocated an ADI, which is lower than the previous ADI established by JMPR. The intake estimates, including both MRLs proposed by JECFA and the adopted Codex MRLs elaborated by the CCPR, did not exceed the ADI.
135. The Delegation of Germany noted that most Codex MRLs resulted from the use of lambda-cyhalothrin and that cyhalothrin would not be supported for periodic review.
136. The Committee noted that flucythrinate was no longer supported and it would consider revocation of all CXLs at its next session.
137. The Observer from the EC noted that pyrazophos was no longer supported in the EC and that the CXLs are based on the EC GAP. The Committee agreed to consider revocation of all CXLs at its next session.
138. The Committee was informed that the 12th CCRVDF decided to retain the draft MRL for milk arising from veterinary uses, which this Committee had agreed to support at the last session, at Step 7 along with all other draft MRLs, as the ADI was not agreed upon.
139. The Committee withdrew the draft MRLs for several commodities, as there was no existing GAP for them. The Committee advanced the proposed draft MRLs to Step5 and returned the draft MRLs to Step 6 due to intake concerns. They would be considered at the next session. The Committee requested detailed information on support for oxydemeton-methyl.
140. The Committee had an exchange of views on the residue definition which had been confirmed by the 1999 JMPR. It was stated that as demeton-S-methyl was no longer supported and there was no GAP; and therefore, in order not to allow its use, this compound should be removed from the residue definition. However, it was pointed out that demeton-S-methyl could not be distinguished from oxydemeton-methyl in analysis and it could be generated from oxydemeton-methyl during analytical process. As no agreement was reached, the Committee agreed, as a compromise solution, to maintain the present residue definition and to clarify that the residue definition and MRLs applied only to residues resulting from the use of oxydemeton-methyl by adding the following note to the residue definition as follows: “The residue definition and MRLs are based on the use of oxydemeton-methyl only”.
141. The Committee advanced the proposed draft MRLs for almond hulls, assorted tropical and subtropical fruits-inedible peel, and tree nuts recommended by the 1998 JMPR to Step 5 awaiting the follow-up of the discussion on the policy regarding the residue definitions for genetically modified crops (see paras 62-66).
(See Annex II)
142. The Committee was informed that the 12th CCRVDF retained all draft MRLs at Step 7 due to the two different residue definitions for animal products proposed by JECFA and JMPR. The Committee decided to refer the question of the residue definition for animal products to the 2000 JMPR with a view toward removing avermectin B1b and 8,9-Z-avermection B1b from the definition for the sake of harmonization. Awaiting the results of this discussion by the 2000 JMPR, the Committee returned all draft MRLs for animal products to Step 6.
143. The Committee advanced all draft MRLs for plant products to Step 8.
(See Annex II)
144. The Committee was informed that the ADI would not be exceeded for any regional diet when the value of 10 mg/kg for soya bean (dry) was included in the calculation. The intake calculations would be amended in the 2000 JMPR report.
145. The Delegations of France, Germany and The Netherlands expressed their concern about the availability of analytical method for regulatory purposes and the rather high and variable limits of determination (LODs) for clethodim and its metabolites in several commodities. The Committee decided to request governments and other interested organizations through a circular letter to submit available information and relevant comments on analytical methods and LODs to be considered by the ad hoc Working Group on Methods of Analysis and Sampling.
146. The Committee returned all draft MRLs to Step 6.
(See Annex II)
147. The Delegation of The Netherlands was of the opinion that the compound should be classified as (partially) fat soluble. The Delegation preferred uniform MRLs, at the LOD for plant products which could be easily enforced and the establishment of MRLs for cattle products. The Delegation of Australia informed the Committee that new residues data for haloxyfop in several crops had recently been evaluated in Australia, including new transfer and depletion studies in beef and dairy animals, and that several new MRLs for animal feed commodities and animal products were proposed. The new studies would be made available to the 2001 JMPR.
148. The Committee returned the MRLs for commodities which could be used as feedingstuffs, and for animal products to Step 6 pending animal transfer studies.
(See Annex II)
149. The Delegation of the USA informed the Committee that the GAP upon which the 1997 JMPR based its recommendation for maize, maize fodder and maize forage had been changed and that AMPA was now a very minor portion of the residue for the new variety of genetically-modified maize. The Committee returned the draft MRLs to Step 6.
150. The Observer from the EC informed the Committee that a proposal for a directive with MRLs for products of plant and animal origin was in preparation and should be adopted within the next months and disagreed with the residue definition for animal products, preferring a more differentiated definition depending on the product in question.
