Codex MRLs Confirmed by the JMPR under Periodic Review
New ADI/Acute Reference Dose
Animal Transfer Studies
Pesticides of Common Mechanisms/Aggregated Exposure to Pesticides
Acute Intake Concerns
(A) DRAFT AND PROPOSED DRAFT MAXIMUM RESIDUE LIMITS AT STEPS 7 AND 4
(B) DRAFT AND PROPOSED DRAFT EXTRANEOUS MAXIMUM RESIDUE LIMITS AT STEPS 7 AND 4
29. The Committee considered matters of a general nature before the deliberations of MRLs.
30. The Committee considered whether an opportunity should be given to Member countries to comment on those existing Codex MRLs confirmed by the JMPR under the Periodic Review programme. The Committee agreed that Codex MRLs confirmed by the JMPR under the Periodic Review should be included in future circular letters for comments. This would be in addition to those changed and recommended for deletion, as the principle objective of the Periodic Review was to review all existing Codex MRLs which had been recommended more than 10 years ago in the light of the current scientific requirements.
31. The Committee noted that lowering ADIs might give rise to intake concerns and agreed to continue to consider this matter in relation to implications to MRL elaboration and risk analysis. However, on whether it would be appropriate to discuss toxicological aspects of ADIs at the sessions, the Committee was generally of the opinion that governments having comments on ADIs from a toxicological point of view could raise them at the sessions and should be prepared to transmit them in writing directly to the JMPR for further consideration.
32. The Observer from the EC was of the opinion that where no adequate animal transfer studies were available, the JMPR should not recommend MRLs for major feed items except where residue levels in feed items were lower than 0.1 mg/kg, or when no residue transfer into edible tissues of animals was expected. The Committee was informed, however, that if no MRLs existed for feedingstuffs where residues could occur, it might cause trade problems. The Committee noted that it would be difficult for the JMPR to keep track of the evaluations of feedingstuffs and animal transfer studies if it could not recommend MRLs for feedingstuffs due to the lack of adequate animal transfer studies. The Committee agreed that the JMPR would continue to recommend MRLs for feedingstuffs if there were sufficient data to do so regardless of the adequacy of animal transfer studies. However, these MRLs could not advance to Step 8 of the Codex Procedure unless there were adequate animal transfer studies on these commodities.
33. The Committee noted that the USA had initiated examinations of issues relating to pesticides with common mechanisms of action, aggregated exposure and the impact of exposure to pesticides on infants and children in the framework of Food Quality Protection Act. The Observer from Consumers International requested that these issues, especially in relation to organophosphates and carbamates, be also examined by the CCPR/JMPR and that MRLs for organophosphates not be advanced. The Committee noted that the JMPR had considered the issue of interaction on several occasions. The Committee concluded that the issue on aggregated exposure was difficult to address at the international level and that this issue was better dealt with at the national level. It requested the JMPR to consider common mechanism of organophosphates and carbamates in connection with risk assessment.
34. Several delegations expressed concerns about acute exposure relating to certain MRLs. However, the Committee decided that until a methodology for estimating acute exposure had been established, deliberation of MRLs should focus on chronic exposure. The Committee was hopeful that it could submit a progress report on the methodology and its implementation to the Commission at its 24th Session in 2001[19].
Carbaryl (008)
Chlorfenvinphos (014)
Chlormequat (015)
Chlorpyrifos (017)
Diazinon (022)
Dicofol (026)
Dimethoate (027)
Diquat (031)
Fenthion (039)
Lindane (048)
Methidathion (051)
Mevinphos (053)
2-Phenylphenol(056)
Parathion-methyl (059)
Propoxur (075)
Thiometon (076)
Chlorothalonil (081)
Dicloran (083)
Fenamiphos (085)
Chlorpyrifos-methyl (090)
Acephate (095)
Carbofuran (096)
Methamidophos (100)
Maleic Hydrazide (102)
Phosmet (103)
Dithiocarbamates (105)
Ethephon (106)
Iprodione (111)
Phorate (112)
Guazatine (114)
Aldicarb (117)
Cypermethrin (118)
Permethrin (120); Deltamethrin (135); Cyhalothrin (146)
Phenothrin (127)
Phenthoate (128)
Phoxim (141)
Cyfluthrin (157)
Buprofezin (173)
Abamectin(177)
Bifenthrin (178)
Clethodim (187)
Fenpropimorph (188)
Teflubenzuron (190)
Fenarimol (192)
Haloxyfop (194)
Flumethrin (195)
Tebufenozide (196)
35. The Observer from the EC expressed concerns that the TMDIs for the regional diets ranged between 700 and 1420% of the ADI, as the ADI had been lowered, and asked for risk management measures to be considered. Written information on which uses would be supported and when data would be available was requested to be sent to the JMPR Secretaries well in advance of the next Session. If no information was received, the Committee would consider deletion of CXLs at its next Session.
36. The Committee noted that the proposals of the 1996 JMPR included in its Evaluations for several commodities were not included in its Report. This should be clarified by the JMPR Secretaries. The Committee noted that additional residue data on Brussels sprouts, cabbages, head, cauliflower and carrot would become available and residue data on onion, bulb, parsnip and rapeseed were currently available. The Committee should consider deletion of the CXLs for those commodities not being supported at its next Session.
37. The Committee noted that animal transfer studies in poultry and cattle would be available in late 1998. The Committee advanced all proposed draft MRLs to Step 5. Written confirmation was requested of the availability of residue data on pear and cereals.
38. As proposed by the Delegations of USA[21] and Spain last year, and supported this year by the Delegation of South Africa, the Committee amended the draft MRL for citrus fruits from 2 mg/kg to 1 mg/kg and advanced it to Step 8.
39. The Committee noted that animal transfer studies would become available in 1999.
40. Since several delegations and the Observer from Consumers International had reservations about the way STMRs were estimated by the manufacturer, especially for pome fruits, and their uses in deliberations, the Committee postponed further discussion pending the outcome of the refined calculations by the manufacturer in consultation with JMPR experts.
41. The UK would submit summary data on residue and toxicology, which had been reviewed by the UK and the EC, to the 1998 JMPR. The residue data on the more toxic metabolite omethoate resulting from dimethoate use would also be evaluated by the 1998 JMPR.
42. Since the TMDI reached 170% of the ADI, it was proposed that the Committee rely on the observation that the STMR-approach generally reduce the exposure estimate by a factor of 3. The Committee noted that new residue trials were being carried out on asparagus, broad bean, runner bean, cabbages, cottonseed, cucumber, olives, strawberry, tomato and wheat. Diquat was also used on maize, rice, alfalfa and clover, but only for seed production. The Delegation of the UK stated that STMR data would be available soon. The Committee advanced all draft MRLs to Step 8.
43. The 1997 JMPR estimated that ingestion of up to 200 ml of virgin olive oil containing residues at the MRL level would not lead to exposure exceeding the acute RfD of 0.01 mg/kg bw. The Committee noted that new GAP was being developed in the EC and consequently new data were to be expected. As fenthion was scheduled for evaluation by the 2000 JMPR, the data should be available in 1999. The Committee returned all MRLs to Step 6.
44. The Committee supported scheduling lindane for a Periodic Review as the TMDI ranged from 300% to 1200% of the ADI. It would consider the deletion of the existing CXLs, except those accompanied by the letter “E”, at its next Session if lindane was not supported. If this is the case, the Committee should consider transferring those CXLs annotated “E” to the EMRL section.
45. Based on the refined intake estimation submitted in response to the request of the Committee made at the last Session[22], which demonstrated that the estimated intakes were below the ADI, the Committee advanced the draft MRLs for grapes and pear to Step 8.
46. The Committee should consider at its next Session deletion of those CXLs recommended by the 1997 JMPR for withdrawal, if no information became available on the availability of new data.
47. The Committee noted that supporting data for citrus fruits and pear had been submitted and the compound was scheduled for Periodic Review by the 1999 JMPR. It would consider deletion of the CXL for apple at its next Session if not supported.
48. The Committee advanced the draft MRLs for broccoli, cabbages, head, and rice, husked to Step 8. The Committee postponed discussion on the MRLs for feedingstuffs pending the review of animal feeding studies and Periodic Review (residues) by the 2000 JMPR.
(Annex II)
49. The Committee noted that thiometon would no longer be supported. The Committee should consider deletion of all CXLs at its next Session.
50. The Committee recommended the deletion of the CXLs for blackberries, citrus fruits, lima bean (dry) and raspberries, red, black, as the period of “4 years” in accordance with the Periodic Review Procedure had expired.
51. The Committee noted that residue data for all crops in the CXL list would be available for the 1998 JMPR.
52. The Committee noted that the TMDI only slightly exceeded the ADI.
53. Initial calculations by the manufacturer showed that the IEDIs exceeded the ADI for all regional diets. The Committee was informed that the use on maize would no longer be supported and that new processing studies on cereal commodities would be reviewed to refine the IEDI for consideration by the Committee at its next Session. The Committee returned the MRLs for barley, oats and rice to Step 6.
54. It was noted that acephate was scheduled for a Periodic Review by the 2000 JMPR where an acute RfD would be established. The Committee advanced the proposed draft MRLs to Step 5 omitting Steps 6 and 7 for adoption at Step 8, as concerns were only on acute exposure. The EC would submit data to the JMPR for the establishment of the acute RfD.
55. The Committee noted that the 1997 JMPR had recommended withdrawal of a majority of existing CXLs. New residue data on field corn, sweet corn, oat, rice, soya bean, carrot, sugar beet, turnip, onion, pepper, sunflower, cotton, rapeseed, tomato, eggplant, grapes and peanut would be submitted to the JMPR, and an acute RfD should be established at the time of the next JMPR review.
56. A Periodic Review (toxicology) was scheduled for 2000 and establishment of an acute RfD was requested. The Committee noted that data on tomato were available and would be submitted. The new data might support a lower limit.
57. The Committee noted that the 1996 JMPR lowered the ADI and that a Periodic Review (residues) was scheduled for 1998.
58. The Committee noted that the 1997 JMPR had recommended withdrawal of a majority of CXLs and that a toxicological review was scheduled for the 1998 JMPR. The Committee should consider deletion of MRLs at the next Session if phosmet was no longer supported.
59. The Committee noted that manufacturers had supplied a number of the STMR estimates requested by the 29th Session to address intake concern that the IEDIs in 3 out of the 5 regional diets had exceeded the ADI. The Committee agreed to use these estimates as a basis for a more refined intake calculation.
60. The Committee was informed of the methodology used for the IEDI calculations by the manufacturer, which was consistent with the procedure of the JMPR[23]. The Committee noted that all calculations resulted in intakes significantly below the ADI for the 5 regional diets. However, concern was expressed that some processed products such as wine and processed apple products were not taken into account. It was recognized that their consumption data at the international level were currently lacking. Delegations were requested to submit national intake calculations for consideration at the next Session. The Observer from the Office international de la vigne et du vin (OIV) was invited to submit consumption data on wine. The manufacture would submit revised calculations taking into account the consumption data of wine and apple juice.
61. The Committee noted that it might be possible for the JMPR to establish MRLs for individual groups of dithiocarbamates.
62. The Committee noted that additional residue trials data on banana, barley, barley straw and fodder, cabbages, head, lettuce, maize fodder, papaya and pepper would be made available to the 1999 JMPR, and suggested that data on melons and cucumber could be used to support pumpkin. A complete list of the data to be submitted was requested to be sent to the JMPR.
63. The Committee returned all draft MRLs to Step 6 for consideration at the next Session, where the MRL for meat at the limit of determination could be aligned with the MRLs for other animal commodities at the limit of determination (0.05 mg/kg).
64. Written information was requested to be sent to the JMPR Secretaries on when data would become available for JMPR review and what data might be anticipated. The Committee returned the draft MRLs at Step 7B to Step 6.
65. The Committee retained the CXL for tomato as new residue data would become available in 1999.
66. The refined intake estimates provided by the manufacturer in response to the request of the Committee made at the 29th Session demonstrated that the IEDIs were below the ADI. The Committee advanced the MRL for potato to Step 8. The Committee noted that the GAP for carrot in the UK had been revoked and those for barley, rapeseed and tomato in the USA withdrawn. The Committee should consider deletion of the CXLs of barley, rapeseed and tomato and the draft MRL for carrot at the next Session.
67. The Committee requested priority scheduling of a full review of the compound because of acute intake concern.
68. The 1997 JMPR had withdrawn the ADI and recommended withdrawal of 5 CXLs. The Committee would consider their deletion at its next Session.
69. The Committee was informed that the compound was under review in the EC particularly in respect to dietary intake concerns. The Committee noted that new data on banana and potato, based on amended GAP, would become available for evaluation by the 2000 JMPR. The Committee was informed that an example of a probabilistic method for estimating acute dietary intake would be provided to the JMPR. The Committee advanced the MRL for potato to Step 5.
70. The Committee noted that the CCRVDF had been elaborating MRLs for cypermethrins arising from veterinary uses with different residue definitions, proposed levels and commodity definitions. It was recognized that further coordination would be needed between the JMPR and the JECFA and the CCPR and CCRVDF, as well as at the national level, for elaborating MRLs for compounds used as both pesticides and veterinary drugs. The Committee requested the EC to send their comments on those MRLs arising from veterinary uses directly to the CCRVDF.
71. The Committee noted that these compounds were on the agenda of the 52nd JECFA (1999) and that permethrin also on the 1999 JMPR agenda for Periodic Review (toxicology).
72. The Committee recommended deletion of all CXLs, as phenothrin was no longer supported.
73. The Committee should consider deletion of all CXLs at its next Session as phenthoate was no longer supported.
74. The Committee should consider deletion of the CXLs at its next Session as phoxim would not be supported.
75. The Committee noted that a number of MRLs for cyfluthrin arising from veterinary uses had been proposed by the JECFA for consideration by the CCRVDF. The Committee also noted that it might consider a new MRL for milk (0.04 mg/l) proposed by the JECFA at its next Session as the current CXL for milk was 0.01 mg/kg. (See para. 70)
76. The Committee noted that buprofezin would be reviewed by the 1999 JMPR and that additional residue trials on oranges would be submitted.
77. The Committee noted that the CCRVDF, which had a different residue definition, would consider the MRLs for kidney, liver and fat of cattle.
78. The Committee advanced the MRLs for barley and maize to Step 8 but returned those for cattle fat and cattle milk to Step 6, taking into account the observations of the 1997 JMPR on animal transfer studies and post-harvest uses on cereals. It decided to consider the latter MRLs, together with the other draft and proposed draft MRLs at the next Session. The Delegation of Australia informed the Committee that new residue data and processing studies on wheat would become available to the JMPR.
79. Written information was requested to be sent to the JMPR Secretaries on: (1) what studies on which commodities were being conducted; and (2) when new data would be available to the 1999 JMPR.
80. The Committee noted that animal transfer studies would be available to the 1999 JMPR and that the draft MRL for sugar beet should be 0.05 mg/kg (*). The Committee postponed discussions, pending evaluation by the 1999 JMPR.
(Annex II)
81. The Committee advanced all draft MRLs to Step 8 and the proposed draft MRL for hops, dry, to Step 5, with omission of Steps 6 or 7, for adoption at Step 8.
82. The Delegation of Australia informed the Committee that new animal transfer studies would be available later this year. The Delegations of Germany, France and The Netherlands were requested to submit their detailed written comments to the Codex Secretariat for consideration by the Committee next year. The Committee advanced all proposed draft MRLs to Step 5.
83. Although a maximum residue level for honey had been proposed by the 1996 JMPR, the Committee agreed that at present the establishment of an MRL for honey for flumethrin was of low priority.
84. The Committee advanced the proposed draft MRL for grapes to Step 5 and requested the Delegation of Germany to send the JMPR its GAP for grapes. It also requested the Delegation of France and the manufacturer to submit data and written comments on processing studies of grapes into wine. The Committee advanced the MRLs for pome fruits, rice, husked, and walnuts to Step 5 with omission of Step 6 and 7 for adoption at Step 8.
Criteria for Setting EMRLs
DDT (021)
85. The Delegation of the United States introduced document CX/PR 98/8 which had been prepared upon the request of the 29th Session of the Committee to examine the need for criteria and, if criteria were to be established, what needed to be considered.
86. The Committee considered the section on potential elements for inclusion in a set of criteria for estimation of EMRLs point by point. The Committee generally supported the suggested CCPR positions as contained in the document and was of the view that there should be flexibility in the application of criteria or potential elements. The Committee also generally agreed that EMRLs should be established only for those compounds whose registration for agricultural uses had been revoked and which were persistent in the environment with potential to result in residues in food and feed likely to cause problems in health and trade.
87. The Committee had an exchange of views regarding the use of monitoring data, whether they should be only random monitoring data or whether targeted monitoring data could also be used; treatment of outliers; and appropriate violation rate (2-5% or 0.2-0.4%) in relation to cost and health implications and possible disputes caused by using different violation rates. The Committee agreed that the suggested position emphasizing the use of random monitoring data was adequately worded to accommodate exceptions.
88. The Committee was of the view that harmonization was necessary between the approaches of this Committee in the area of EMRL setting and of CCFAC in setting maximum levels for other contaminants. However, it was noted that the CCFAC had just started implementing the procedure and would gain experience in the future. The Committee received a brief report on the activity of the UNEP in the area of persistent organic pollutants. It was noted that among nine pesticides being considered by that organization, 6 compounds had been given Codex EMRLs and that the Committee would consider toxaphene in fish at its next Session[24]. This activity highlighted the need to develop clearly defined consistent approach for establishing maximum levels for chemical contaminants between the CCPR and CCFAC.
89. It was decided that comments should be sought from Member governments on their current practices in treating outliers and on what violation rates were used. The Committee agreed that a concise paper should be prepared, based on CX/PR 98/8, by the USA in collaboration with Australia, New Zealand, the Netherlands and South Africa with a coordination role by the Codex Secretariat. The paper would contain the compilation of the suggested CCPR positions, comparison of the approaches of the CCPR and CCFAC, and government comments on outliers and violation rates. The Committee noted that Sections of the FAO Manual had already addressed certain issues relating to EMRL setting at the international level. It further agreed that it would not initiate a full exercise of criteria elaboration for the time being despite some delegations’ proposals to do so.
Extraneous Maximum Residue Limits
90. Many delegations supported the proposed draft EMRL for meat. Some other delegations expressed their reservation, proposing an EMRL of 1 mg/kg. The Committee decided to advance the EMRL to Step 5 and to discuss it again next year in view of the new approach for EMRLs.
