(a) MAXIMUM RESIDUE LIMITS AND EXTRANEOUS MAXIMUM RESIDUE LIMITS AT STEPS 7 AND 4
(b) GUIDELINE LEVELS
MAXIMUM RESIDUE LIMITS
EXTRANEOUS MAXIMUM RESIDUE LIMITS
Periodic Review Procedure[13]
28. The Committee noted at its 27th Session that questions had been raised on Section 2 of the CCPR periodic review procedure. A revised procedure, proposed by the USA, was accepted by the Committee with minor amendments. The Committee agreed to submit the procedure to the Commission for endorsement[14].
MRLs kept at Step 7C
29. At the last session it had been decided that questions related to MRLs which gave rise to TMDI/EMDI calculations exceeding the ADI should be considered at this session, pending the outcome of the York Consultation. After a first analysis of the data provided, the Committee decided to keep the MRLs at Step 7C and welcomed the elaboration of a full document for discussion at the next CCPR.
Azinphos-methyl (002)
Captan (007)
Chlormequat (015)
Diazinon (022)
Dichlorvos (025)
Dicofol (026)
Dimethoate (027)
Diquat (031)
Ethion (034)
Ethoxyquin (035)
Fentin (040)
Folpet (041)
Bromide Ion (047)
Methidathion (051)
Monocrotophos (054)
Parathion-methyl (059)
Phosalone (060)
Quintozene (064)
Trichlorfon (066)
Bromopropylate (070)
Carbendazim (072)
Disulfoton (074)
Chlorothalonil (081)
Pirimiphos-methyl (086)
Dicloran (083)
Chlorpyrifos-methyl (090)
Acephate (095)
Cartap (097)
Methamidophos (100)
Dithiocarbamates (105)
Ethephon (106)
Fenbutatin oxide (109) (See bromopropylate (070))
Imazalil (110)
Iprodione (111)
Phorate (112)
Tecnazene (115)
Aldicarb (117)
Etrimfos (123)
Methacrifos (125), Isofenphos (131)
Triadimefon (133)
Procymidone (136)
Metalaxyl (138)
Triazophos (143), Flucythrinate (152), Pyrazophos (153), Glyphosate (158), Propiconazole (160), Flusilazole (165)
Oxydemeton-methyl (166)
Triadimenol (168)
Profenofos (171)
Bentazone (172)
Glufosinate-ammonium (175)
Hexithiazox (176)
Abamectin (177)
Bifentrin (178)
Cycloxydim (179)
Dithianon (180), Myclobutanil (181), Penconazole (182), Ethofenprox (184)
Fenpropathrin (185)
Clethodim (187)
Tebuconazole (189)
Tolclofos-methyl (191)
30. The Committee was informed that a full data package would be sent to the JMPR for all commodities MRLs of that were held at Step 7C and for melons and grapes as well as processing data for potato.
31. The Committee returned all proposed draft MRLs to Step 3, pending the evaluation of data by the 1997 JMPR.
32. The Committee was informed that new feeding studies on cattle (residues in milk, meat and edible offal) and on poultry (residues in eggs, meat and edible offal) were in progress. The results of these studies would be available by the end of 1998.
33. The Committee postponed further discussion awaiting the toxicological review by the 1997 JMPR.
34. Estimates by the Delegations of Germany, the Netherlands, Denmark and Japan indicated that national TMDIs and/or EMDIs exceeded the ADI. Pome fruit was the highest contributor.
35. The Committee noted that intake calculations of Japan and Thailand had been sent to the Chairman and WHO. The Committee was informed that although for several diets the TMDI exceeded the ADI, the EMDI exceeded the ADI (170%) only for the African diet.
36. Many delegations expressed their concern about intake relative to the low ADI. The Committee was informed that intake calculations, excluding the general MRLs, would be available for next meeting by the manufacturer.
37. The Committee noted that the compound was scheduled for residue evaluation by the 1998 JMPR where the residues of the metabolites omethoate and formothion would also be taken into account. Several delegations expressed reservations concerning the toxicology and intake of these compounds. A toxicological evaluation available to the European Union Scientific Committee, which resulted in a much lower ADI, should also be made available to the 1996 JMPR.
38. The Committee noted that diquat had been in the periodic review, its TMDI exceeded the ADI, and no reduction factors had been identified. The United Kingdom would conduct refined calculations for oats and wheat to be presented to the next Session.
39. It was noted that results of the EC evaluation of residue data would become available in due course. The Representative of the EC stated that the residue data in 1994 JMPR Evaluation were overly summarized.
40. The Delegation of Japan was requested to submit their intake concern about citrus fruits and to provide intake calculations to the CCPR and WHO, taking into account edible portion and processing factors. The Committee noted that these data were in the JMPR Report. The Committee was informed that the TMDI exceeded the ADI in 3 of the 5 regional diets.
41. The Committee postponed discussion on deletion of the existing CXLs to its next session.
(See Annex II)
42. The Committee was informed that data on cucumber and strawberry as well as those for the commodities deleted at the last meeting would be ready in February 1997 for evaluation by the 1997 JMPR. The Committee decided to keep the MRL for cucumber at Step 3(a) and to advance the MRL for strawberry to Step 7B.
43. The Committee noted that the USA and Israel had registered uses of methylbromide. The Committee decided that the compound should not be referred to the Working Group on Priorities.
44. The MRLs for grapes and pear were held at Step 7C pending a review of intake. It was suggested that attention be paid to the acute reference dose in this review.
45. The Committee noted that excluding from calculation MRLs recommended for deletion reduced the TMDI from 400% to 60% of the ADI. The Representative of the EC stated that the use on food commodities of such pesticides with very low ADIs was questionable. Comments on chronic and acute intake estimates of this compound would be sought.
46. The Committee was informed about the lowered ADI and the concern of several delegations regarding intake assessment. The Committee postponed discussions awaiting the results of a re-examination of the compound by the 1996 JMPR. The Committee welcomed the proposal that a fully-worked example of intake assessment prepared by the Codex Secretariat be presented at its next session. The draft example would also be reviewed by the 1996 JMPR.
47. The Committee was informed that new supervised trial data would become available in 1999 on apple, citrus fruits, grapes and potato awaiting the toxicological review by the 1997 JMPR. The Committee decided to maintain these CXLs for four years according to the periodic review procedure and to recommend deletion of all other CXLs.
48. The Committee was informed that environmental fate studies necessary for residue evaluation for all CXLs (except banana) would be made available to JMPR. The Chairman suggested that Member countries should also give attention to supporting the CXL for banana, which would otherwise be deleted.
49. Although the Delegations of the UK and Spain reported uses on several crops, the manufacturer did not support this compound anymore. The Committee decided to delete all existing CXLs.
50. The Committee decided to keep the MRL for citrus fruits at Step 7B, awaiting the opinion of the JMPR on its general policy on setting group-MRLs in place of individual MRLs for members of the group.
51. The Committee postponed discussion on individual MRLs not recommended for deletion, awaiting the evaluation by the 1998 JMPR. It noted that the residue definition would be reconsidered on the basis of information provided by the UK and that a risk assessment would be required in relation to any new definition.
52. The Committee amended the MRLs at or about the limit of determination (LOD) to read 0.02 mg/kg and kept them at Step 7B awaiting the outcome of the 1996 JMPR. The MRLs for maize and milk of cattle, goats and sheep at levels below the new LOD were also kept at Step 7B.
53. Several delegations expressed concern at the high levels of estimated intakes relative to the ADI and the possibility of acute effects. It was noted that processing data were not available for refinement of the intake calculations.
54. The Committee decided to keep all other proposals at Step 7C. Revised intake calculations were requested. The 1996 JMPR was invited to consider the acute hazard of this compound and the possible establishment of an acute reference dose.
55. The Committee was informed that additional data would be provided for peach (available to 1997 JMPR) and decided to keep the MRL for peach at Step 7B.
(See Annex II)
56. The Committee was informed that the CXLs for the following commodities would be supported: dry beans, carrot, kiwi, head lettuce, onion bulb, orange, peach, plum and tomato. Other CXLs would be considered for deletion at the next Session.
57. The Committee noted that TMDI exceeded the ADI when existing processing data were not taken into account. The Committee requested refined intake calculations using reduction factors. The MRLs for barley and oats were held at Step 7C pending review of intake data, including intake from all sources.
(See Annex II)
58. The Committee noted that there was no support from the manufacturer for the existing CXLs and that these would be considered for deletion at the next Session.
59. The Committee was informed that new data on broccoli; head cabbages; cauliflower; citrus fruits; egg plant; melons (except watermelon); peach and tomato had been submitted for review by the 1996 JMPR. New studies on metabolism for potato and head lettuce would also be available in 1996. The Delegation of the UK informed the Committee that a further refinement of intake calculations, especially in relation to the acute reference dose, would be available for the 1996 JMPR.
60. The draft MRLs were returned to Step 6 pending evaluation of ferbam, thiram and ziram by the 1996 JMPR. It was noted that the 1996 JMPR would consider the question of applying exposure assessments for different ADIs estimated for different dithiocarbamates.
61. Several delegations stated that consideration would have to be given to the presence of ethylene thiourea (ETU) and propylene thiourea (PTU) when foods which contained dithiocarbamate residues were cooked. The Delegation of Germany stated that the available processing studies were insufficient for a final evaluation. Two delegations indicated that Market Basket Studies showed little or no problem in relation to ETU arising from dithiocarbamate residues.
62. It was noted that a specific analytical method was available for propineb, determined as propylenediamine.
63. The Committee was informed that the EC would provide to the JMPR trial data on tomato following indoor GAP.
64. The Committee decided to keep the MRLs for grapefruit, mandarin and orange (sweet) at Step 7B awaiting the 1996 JMPR evaluation.
(See Annex II)
65. The Committee decided to maintain the existing CXL for tomato for another year, awaiting confirmation from France that new data would be available. The Representative of the EC stated that the proposed MRL for common beans was too low for indoor use based on the existing data.
66. The Delegation of the United Kingdom reported that on-going studies on the heterogeneous distribution of residues in composite samples of commodities such as carrots, showed greater variability than previously supposed. Should these initial results be confirmed, there would be a significant impact on field trial protocols, compliance sampling and intake assessments. The distribution of triazophos (143) residues was also being examined.
67. The Committee agreed to consider deletion of the MRLs for head lettuce and witloof chicory at its next Session, since these commodities would no longer be supported. The Committee noted proposals of France and Germany that MRLs should be established for animal products for this compound because potatoes might be used as feed.
68. The Committee was informed that data were being generated on banana and decided to maintain the existing CXL pending evaluation by the 1998 JMPR.
(See Annex II)
69. The Committee noted that these compounds were not supported by the manufacturer and decided to consider withdrawal of the existing CXLs at its next session.
70. It was noted that in EC legislation the residues for both triadimefon and triadimenol were expressed as the sum of these compounds since most of the residue data had been presented in this manner.
(See Annex II)
71. The Delegation of Spain and France informed the Committee that data were available to support a higher MRL for strawberry.
(See Annex II)
72. The Committee postponed discussion awaiting the 1997 JMPR where the compound, together with the related compounds, would be evaluated. The TMDI and EDI exceed the current ADI considerably.
(See Triadimefon (133))
73. The Committee decided to consider deletion of the MRL for teas (tea and herb teas) at the next session.
(See Annex II)
74. The Delegation of the Netherlands was requested to send their comments on the residue definition to the JMPR.
75. The Committee was informed that data on hops would become available for a future evaluation. The reservation of France referred to the use of very short PHI for a highly stable compound.
76. The Committee was informed that residue data were available for restricted uses on lettuce and tomato in glasshouse, and that residue and GAP data were available on uses on almonds, apple, celery, hops, lettuce, potato and walnut. The Representative of the EC stated that insufficient trial data on tomato and cucumber in glasshouses in short light period could lead to an underestimate of intake.
77. The Committee requested countries to comment on the use of the 2 ADIs established by the 1995 JMPR when performing intake calculations. The Committee was also informed that the limit of determination (LOD) of 0.01 mg/kg might need to be increased to 0.02 mg/kg.
78. Taking into account the reservations expressed by several delegations regarding intake concern, inclusion of MRLs for veterinary uses in intake calculations and questions about the LOD, the Committee decided to advance the MRL for strawberry to Step 5, keep the MRL for tomato at Step 7B and return all other MRLs to Step 6, awaiting evaluation in future JECFA and JMPR meetings.
79. The MRLs for barley, cattle fat, cattle milk, maize and wheat were kept at Step 7B awaiting the 1996 JMPR review of modified GAPs for barley, wheat and maize. The CXLs for animal products might also be affected.
80. The Delegations of Germany and the Netherlands expressed reservations because of the incomplete information on GAP.
(See Annex II)
81. The Delegations of France and The Netherlands requested consideration of lower maximum intake levels for animals via feed than the levels on which the MRLs were based. Such data would support an MRL for cattle milk of 0.05 F mg/kg.
82. The Committee noted the opinions of some delegations that data in the evaluations were insufficient or unclear and that the evaluation and decision of the 1994 JMPR were only partially comprehensible. The Committee noted that the supervised trials were based on data which included clethodim metabolites which are the same as sethoxydim metabolites. Reservations were expressed as there were no data on quantities of metabolites in plants; no data on the nature and quantities of metabolites in the goat study; the limit of determination of 0.05 mg/kg for two compounds was questionable; and that the method of analysis could not distinguish sethoxydim from clethodim. The Committee decided to refer these matters to the JMPR for consideration at the earliest opportunity.
83. Residue data were available for pome fruits (apple, pear), stone fruits (cherry, peach), grapes, banana and onion; and processing data for grape and apple. Data would be available in February 1997 for beans, cotton seed, cucumber and pecan; and in 1998 for squash.
(See Annex II)
Aldrin/Dieldrin (001)
DDT (021)
Endrin (033)
84. The Committee noted a recommendation that criteria for EMRL setting should be developed. It also noted that the JMPR would regularly re-evaluate these compounds.
(See Annex II)
85. The Committee decided to advance all EMRLs to Step 8, except that for meat, which was to be evaluated by the 1996 JMPR. Monitoring data had been sent by several countries to the JMPR in support of lowering the EMRLs even further for some commodities. These data would be taken into account in subsequent evaluations.
(See Annex II)
PROPYLENE THIOUREA (PTU) (150)
(see Annex III)
