MRLs Kept at Step 7 Due to Dietary Intake Issues
MAXIMUM RESIDUE LIMITS
EXTRANEOUS MAXIMUM RESIDUE LIMITS
40. With the assistance of the ad hoc Working Group on Acceptances, chaired by Dr. D. Lunn (New Zealand), the Committee examined the referenced documents. Following the endorsement of CX/PR 97/10 by the Working Group, the Committee welcomed the principles outlined in this paper as they addressed both consumer protection and trade facilitation in a well balanced manner. It was recognized that a clear distinction was made in the paper between international and national responsibilities and between chronic and acute exposure. The Committee agreed to implement the following proposals immediately with the understanding that it would review their operation in three years time allowing experience to be gained both at the CCPR and national level:
1. (a) when considering draft MRLs, the JMPR/CCPR should concentrate on international dietary intake assessments (using the regional diets) based on the best use of available data;41. After thanking the members of the Working Group for their efforts in completing the assigned tasks the Committee agreed that no further meeting would be necessary.(b) when this estimate of dietary intake does not exceed the ADI in any of the regional diets, the draft MRLs should advance through the Step Procedure. Member countries which cannot accept a particular MRL for national dietary intake reasons, can use the Codex Acceptance Procedure to indicate their non-acceptance of the Codex MRL;2. Recognizing that there was a need to make a clear distinction between chronic and acute exposure, and that there were ongoing initiatives to develop methodology for acute exposure assessments, the CCPR should consider elaborating procedures in this area once the report of the Joint FAO/WHO Consultation on Food Consumption and Exposure Assessment of Chemicals became available;
(c) if this "best estimate" of dietary intake for one or more regional diets exceeds the ADI, and further refinement of the intake estimation at the international level is not possible, the CCPR should not recommend advancement of the draft MRL but should, instead, reflect on possible risk management measures;
3. With respect to the compounds MRLs for which were held at Step 7C, and recognizing the need to avoid imposing an excessive workload on the JMPR, the CCPR should review these compounds on a case by case basis, taking account of the following principles:(a) reviews should utilize the new IEDI methodology recommended by the Joint FAO/WHO Consultation on Revision of the Guidelines for Predicting Dietary Intake of Pesticide Residues;4. For future evaluations, the CCPR should advise manufacturers that data submissions to the JMPR should routinely include best estimates of dietary intake for the regional diets; and
(b) STMRs should normally be estimated on the basis of existing data available to the FAO Panel of the JMPR;
(c) requests by the CCPR to the JMPR to re-examine these MRLs should be subject to confirmation that manufacturers can re-submit the data;
(d) STMR estimations may only need to be conducted for those commodities which contribute significantly to dietary intake concern;
(e) where a periodic review is already scheduled for the near future, the CCPR should normally await the outcome of that review, rather than asking the JMPR to conduct a specific assessment;
5 Whilst recognizing that WHO can provide details of the regional diets, the CCPR should invite FAO/WHO to provide further guidance on estimating dietary intake and estimating STMRs, to manufacturers and other interested parties.
Fenbutatin oxide (109)
Phorate (112) (Annex II, para. 42), Tecnazene (115), Methacrifos (125) (Annex II)
Isofenphos (131), Triadimefon (133), Metalaxyl (138) (Annex II), Triazophos (143) (Annex II, para. 42)
Triadimenol (168), Profenofos (171)
42. Based on the above decision, the Committee agreed to either advance or hold the draft MRLs for the pesticides stated below, which had been held at Step 7C:
MRLs at Step 7
Azinphos-methyl (002), Diazinone (022) and Triazophos
Advanced to Step 8
According to Point 1(b) of para. 40.
Dicofol (026), Diquat
(031), Methidathion (051), Chlorpyriphos-methyl (090) and Phorate
Held at Step 7C; IEDI or
best possible estimates requested from manufacturers; if the ADI is exceeded
only slightly, governments to consider this fact in relation to the IEDI
According to Point 1(c) & 3 of para. 40.
Held at Step 7B
Pending the 1998 JMPR evaluation, including STMR and
No longer supported
43. The Committee advanced all MRLs at Step 7C to Step 8 not awaiting new data (para. 42).
44. The Committee noted the recommendation of the 1996 JMPR to delete all CXLs and future availability of data on several commodities. The manufacturer was requested to advise the Joint Secretaries in writing when and what data would be available to the JMPR. The Committee agreed to full discussion at its next session.
45. The Committee agreed to consider at its next Session an MRL for citrus fruits at 1 mg/kg proposed by the Delegations of USA and Spain.
(Annex II & para. 42)
46. The Committee noted that dicofol should be scheduled for JMPR residue evaluation. Information from the manufacturer, including refined intake estimations, was requested for a full discussion at the next session of the Committee (para. 42).
47. The Committee noted that residue data for all commodities specified in the footnote in CX/PR 97/9 would be available for periodic review by the 1998 JMPR.
48. Since the TMDI exceeded the ADI for 3 out of 5 regional diets the Committee returned the MRLs to Step 6 (para. 42).
49. The Committee postponed the deletion of the CXL for pear pending the JMPR evaluation as it was informed by the United States that new toxicology and residue data on pear would be provided.
50. The Committee decided to retain the CXLs for meat and milk for 4 years according to the Periodic Review Procedure awaiting data on animal feeding studies.
51. The TMDI ranged from 30% to 170% of the ADI (para. 42). Delegations were requested to consider the relatively small excess of the ADI in relation to the new Guidelines and the underlying principles of the IEDI-concept, noting in particular that apple, grape, pear, tomato and olive oil, virgin were the main contributors to dietary intake.
52. The Committee kept the MRL for apple at Step 7B pending the 1997 JMPR evaluation of studies on apples.
53. The IEDI did not exceed the ADI for any regional diets (paras. 29-31). The Committee agreed to consider MRLs for feedingstuffs and associated commodities next year taking into account the relevant sections (animal transfer studies) of the FAO Manual and previous JMPR Reports.
54. The Committee recommended the CXL for banana for deletion as the use for banana was not supported, and retained the other CXLs for 4 years according to the Periodic Review Procedure. The Committee noted that data on lettuce, head and potato would be submitted for evaluation by the 1998 JMPR.
55. The JMPR, in establishing a MRL for citrus fruits, had followed the general policy for group MRLs outlined in the report of the 1996 JMPR. Recognizing that the database was limited, the Committee advanced the MRL to Step 8.
56. The Committee was informed by the Observer from the EC that minimum data requirements for MRL setting were being elaborated in cooperation with the OECD and would be available for the 1998 JMPR.
57. The Committee was informed that additional data would be available (para. 42).
58. The Committee noted that this compound would not be supported beyond 2000 but an alternative compound tolylfluanid (162) would be instead. It was proposed that the current CXLs be retained until the registration of dichlorfluanid expires.
59. The Committee retained the CXLs carrot, lettuce, head, onion, bulb, peach, plums (including prunes), strawberry and tomato as supporting data for these commodities would be available for the 1998 JMPR. The Delegations of the Netherlands and Spain stated that data on strawberry would be available. For grapes, written confirmation on information availability was requested from the manufacturer. The Committee recommended to delete other CXLs.
60. The Committee requested the manufacturer to review all residue and processing studies available on cereal commodities and to estimate IEDI (para. 42). The Committee postponed the decision on cereal commodities pending this review.
61. The Committee maintained the MRL for pome fruits at Step 7 pending the 1997 JMPR evaluation of new trial data.
62. The Committee requested the JMPR to examine whether it was appropriate to use the toxicological correction factor for all dithiocarbamates for the purpose of exposure assessment, since some of them are ETU (or PTU)-formers and others are not (para. 37).
63. As the IEDI in 3 out of the 5 regional diets exceeded the ADI (up to 360%) the manufacturers were asked to send detailed STMR information to WHO, so that they could be taken into account in re-calculation of the intake.
64. Noting that metiram was no longer supported for common beans, the Committee agreed to consider all MRLs at Step 6 and the withdrawal of the MRL for common beans at its next Session.
65. The Committee noted that data on pepper, cantaloupe and grapes would be available to the 1997 JMPR, and that data on pineapple would become available in 1999. The Observer from the EC informed the Committee that data on tomato would be provided to the 1997 JMPR. The Committee kept the MRLs for cantaloupe, pepper and pineapple at Step 7B and amended last years decision on grape, pending the JMPR evaluation.
66. The Committee requested the Delegation of the USA to forward their comments on a higher MRL for pineapple to the 1997 JMPR.
67. Since insufficient data had been available to the JMPR on mandarins, the Committee retained the group MRL for citrus fruits and withdrew the separate MRLs (para. 55).
68. The Committee retained the CXL for tomato for one more year as new data from indoor trials would become available in 1999 and the TMDI did not exceed the lowered ADI.
69. The Committee agreed to consider deletion of the existing CXLs at the next session as the use of the compound might not be supported.
70. The Committee postponed discussion pending the 1998 JMPR periodic review of the compound and the related compound, demeton-S-methyl (073).
71. The Committee requested the JMPR to consider revising the residue definition for plant commodities.
72. The Committee postponed discussion on the MRL for oranges to the next Session as new trial data on oranges would be available to the 1999 JMPR
73. The Committee postponed discussion awaiting the 1997 JMPR evaluation (paras. 9 - 12).
74. The Committee postponed discussion pending review by the 1997 JMPR of questions raised at its 28th session concerning residues in cereals and its impact on animal products.
75. The Committee noted that no new data on cherries were expected.
76. The Committee postponed discussions pending the 1997 JMPR re-evaluation.
77. The Committee noted that animal transfer studies were being developed.
78. The Committee kept the MRL for grapes at Step 7B awaiting the 1997 JMPR review of residue data on grapes and oat.
79. The Committee noted that additional data would be submitted to the 1999 JMPR.
80. The Committee considered whether there was a need to elaborate criteria for setting EMRLs, or to accept the EMRL setting policy of the JMPR stated in the 1995 and 1996 JMPR Reports. The Committee had a brief discussion on acceptable rates of violation and how to treat outlier data points.
81. The Committee accepted the offer of the Delegation of the USA to prepare a discussion paper in collaboration with Australia, Egypt, Netherlands, New Zealand, South Africa, UK and the EC for consideration by the Committee at its next Session. The paper should examine the need for such criteria and what need to be considered if criteria are to be established, e.g., approach taken by the CCFAC. The Reports of the 1995 and 1996 JMPR should also be taken into consideration in the paper.