Feasibility of Establishing MRLs for Genetically Modified Crops and Metabolite Residues (AGENDA ITEM 6A)
Appropriateness of the Current ADI and MRL Setting in Relation to Infants and Children (Agenda Item 6 (b))
Consideration of Draft and Proposed Draft Maximum Residue Limits in Foods and Feeds at Steps 7 and 4 (Agenda Item 6c)
63. The last session of the Committee had considered the feasibility of establishing MRLs for GM crops and metabolite residues and focused on matters related to residue definitions for control purposes. The Committee had agreed to seek information from governments on their approach to MRL setting for GM crops, to be compiled by the Delegation of Canada.
64. The Delegation of Canada indicated that the information received reflected the approach followed in Canada, Mexico and the United States since no other country had provided information. It appeared from the comments that the residue definition applied both to tolerant and other crops and that no separate MRLs were established for GM crops.
65. The Delegation of Germany indicated that a similar approach was followed at the national level; new metabolites occurring in GM crops were taken into account in the definition of residues on the basis of their toxicity and the level of residue, for example in the case of glufosinate for relevant commodities.
66. The Committee agreed that a case by case approach should be followed, taking into account national policies on enforcement for toxicity of metabolites, residue definitions and dietary intake estimations, and noted that this was also consistent with the conclusions of the 2000 JMPR (section 2.4) (see also para 13 above).
67. The Delegation of the Netherlands introduced the document based on contributions received in response to the CL 2000/27-PR from the US, New Zealand, the European Community and Consumers International which focused on national policies related to the protection of infants and children. The Delegation indicated that the document provided a set of recommendations to acknowledge a possibility of additional vulnerability of infants and children; the necessity of clear confirmation of the applicability of ADIs and MRLs for all population groups including infants and children while clearly stating uncertainties; to make a primary screening of the lists of pesticides and pesticide/commodity combinations contained in contributions received, to clarify if they could be of concern to infants and children; to encourage the Committee to take an appropriate risk management decision in those cases where health concerns could not be addressed; and consider the need for an expert consultation to address the possible toxicological concerns of extra vulnerability and intake assessment of infants and children.
68. The Observer of Consumers International pointed out that there were four main matters to be addressed and proposed the following solutions as stated in CRD 5:
69. The Delegation of the United States clarified that Table 1 of CRD 11 was a list of pesticides that had been or were being evaluated and did not necessarily mean that they represented a greater risk for infants and children.
70. The Committee had an extensive debate on the recommendations contained in the document CX/PR 01/8. Many delegations agreed that the possible extra vulnerability of infants and children needed to be taken into account when performing risk assessment. However, it was pointed out that the situation should not be exaggerated.
71. The Observer of GCPF indicated that it did not believe that infants and children were generally more susceptible to chemicals, although this could occur occasionally at pharmaco-toxicologically active levels, this should not be the case with usual exposure from pesticide residues. The Observer did not support the concept of using default limits for residues or the use of additional uncertainty factors to ensure a reasonable protection of infants and children, and proposed that until new data become available JMPR continue working according to their current procedures in establishing ADIs and estimating MRLs.
72. Many delegations were of the view that the current process adequately addressed the sensitivity of infants and children and that ADIs and MRLs covered all population groups including infants and children and therefore there was no need to develop a new methodology.
73. The WHO Joint Secretary of JMPR indicated that the 1999 JMPR addressed the issue of susceptibility of infants and children and that the Meeting emphasized that possible differences between adult and developing mammals was currently addressed in the commonly performed studies of reproductive and developmental toxicity in various species. Therefore the Meeting concluded that it had no basis for changing its approach to addressing the susceptibility of developing mammals as compared with that of adult organisms in the toxicological evaluation of pesticides and that the routine use of safety factors in addition to those currently used was not justified on the basis of current information.
74. While it was acknowledged by some delegations that developmental neurotoxicity studies were valuable in assessing risks for infants and children, it was not clear whether the availability of those studies would lead to an adjustment of the ADI or MRLs. Some delegations indicated that additional scientific data in this area were needed, especially on the methodology of cumulative and aggregate risk assessment.
75. Some delegations were of the view that constructing a list of compounds that might give rise to concerns for infants and children would be costly and require extensive evaluation before any conclusive decision could be taken. The Committee agreed not to develop such a list at this time due to the lack of enough support from governments.
76. The Representative of WHO drew the attention of the Committee to the fact that there was not enough actual consumption data for some foods commonly consumed by children (e.g. apple or banana). It was not clear how much they were consuming expressed on a body weight basis which presented problems in conducting chronic risk assessment, at the international level. The Representative indicated that WHO was planning to organize a Workshop on Total Diet Studies in Australia and that might assist countries, especially developing countries, to generate relevant data.
77. The Committee concluded that ADIs and MRLs should cover all population groups including infants and children. The Committee also concluded that the possible increased vulnerability of infants and children was an important issue which needed to be explicitly integrated into the work of the CCPR and JMPR and agreed by means of a Circular Letter to request Member governments to provide information to the JMPR Secretariat on the availability of studies on developmental neurotoxicity that have been submitted to them, along with contact details on the data owners. This information should be submitted by 1 November 2001, which should provide sufficient time for the Secretariat to obtain the data for consideration by the 2002 JMPR.
78. The Committee agreed that the development of cumulative risk assessment required further consideration, especially regarding the development of common understanding of methodology. Therefore, it requested the Delegation of the United States to prepare a paper on this matter for consideration by the next session of the committee. The Committee decided that it was premature to recommend convening an expert consultation on the various issues in relation to infants and children.
General Comments
Chlorfenvinphos (014)
Chlormequat (015)
Chlorpyrifos (017)
Diazinon (022)
Ethoxyquin (035)
Fenitrothion (037)
Fenthion (039)
Folpet (041)
Lindane (048)
Malathion (049)
Mevinphos (053)
2-Phenylphenol (056)
Parathion (058)
Parathion-methyl (059)
Phosalone (060)
Pyrethrins (063)
Thiabendazole (065)
Cyhexatin (067)
Benomyl (069)/Carbendazim (072)/Thiophanate-methyl (077)
Disulfoton (074)
Propoxur (075)
Thiophanate-methyl (077)
Vamidothion (078)
Chlorothalonil (081)
Dichlofluanid (082)
Fenamiphos (085)
Dinocap (087)
Chlorpyrifos-methyl (090)
Carbofuran (096)
Methamidophos (100)
Phosmet (103)
Etephon (106)
Propargite (113)
Triforine (116)
Aldicarb (117)
Permethrin (120)
Amitraz (122)
Mecarbam (124)
Azocyclotin (129)
Methiocarb (132)
Biternatol (144)
Carbosulfan (145)
Dimethipin (151)
Flucythrinate (152)
Pyrazophos (153)
Cyfluthrin (157)
Paclobutrazol (161)
Anilazine (163)
Flusilazole (165)
Oxydemeton-methyl (166)
Terbufos (167)
Hexaconazole (170)
Profenofos (171)
Bentazone (172)
Buprofezin (173)
Glufosinate-ammonium (175)
Abamectin (177)
Clethodim (187)
Fenpropimorph (188)
Fenpyroximate (193)
Haloxyfop (194)
Tebufenozide (196)
Aminomethylphosphonic acid (AMPA) (198)
Kresoxim-methyl (199)
Pyriproxifen (200)
DDT (021)
79. The Delegation of the United States indicated its preference for retaining proposed MRLs for OPs and carbamates at Step 6 until the results of a cumulative risk assessment are available.
80. The Observer from the EC considered it necessary that JMPR residue evaluations should be available at the latest in December the year after the JMPR evaluations. The Joint FAO Secretary of the JMPR indicated that 1999 JMPR evaluation was late; and noted, however, that usually the evaluations are available in time.
81. The Observer from the EC requested the clarification on the criteria used in proposing MRLs for bagged bananas (e.g. chlorothalonil (081)) or unbagged bananas (e.g. fenpropimorph (188)) and expressed the view that GAP in general should not be pooled. A member of the FAO panel of JMPR informed the Committee that JMPR can only propose an MRL on the basis of particular GAP that was supported by sufficient residue data. In most cases the MRL would be based on unbagged bananas since that was considered to be the most critical GAP. However, when data on unbagged bananas was lacking or insufficient and data only available on bagged bananas, then JMPR would only propose an MRL for bagged bananas.
82. The Observer of CI indicated that they could not support advancement of MRLs for organophosphorous compounds and other pesticides known to act on the nervous system whose database does not include a developmental neurotoxicity study, since there was not an adequate database for assessing their risks to infants and children, and since the CCPR procedures did not adequately account for the risks from multiple exposure to pesticide residues having a common mechanism of action.
83. The Observer of CI also indicated that it could not support the advancement of MRLs whose best estimate of chronic dietary intake exceeds the ADI or whose best estimate of short-term intake exceeds the Acute RfD for any population.
84. The Committee noted that the designation V (allocated for MRLs that accommodate veterinary uses) should be replaced by a footnote according to the decision expressed in paragraph 48 of the 32nd session of the CCPR.
85. Since no new data had become available, the Committee recommended revocation of all existing CXLs.
86. Since several MRLs were re-evaluated by the JMPR 2000, the Committee would consider all proposed MRLs at its next session.
87. The Committee would consider the proposed MRLs and the revocation of the existing CXLs as proposed by the 2000 JMPR at its next session.
88. The Observer of the EC expressed its reservation concerning the proposed MRLs for liver and kidney of cattle, goats, pigs and sheep since the compound is a fat-soluble compound. The EC recommended that the 2001 JMPR reconsider their methodology for setting an MRL for edible offal and fat soluble compounds.
89. The Committee decided to return the MRLs for goat meat, for kidney of cattle, goats, pigs and sheep, for liver of cattle, goats, pigs and sheep and for meat of cattle, goats, pigs and sheep to Step 6. New Zealand expressed concern that this decision was not based on JMPR and CCPR normal procedures and would again delay the progress of these MRLs.
90. Awaiting the evaluation of the acute RfD by the 2001 JMPR, the Committee advanced the proposed draft MRLs for cabbages, head and pome fruits to Step 5.
91. The Committee was informed that the required toxicology data would be available by 2004.
92. The delegations of Spain and France informed the Committee that they have uses on apples and pears as post harvest treatment.
93. The Committee decided to retain the existing CXL for pears for 4 years under the Periodic Review Procedure.
94. The Committee noted that the 2000 JMPR had identified intake concerns.
95. The Committee was informed by the Observer from GCPF that information on which CXLS will be supported would be made available this year. The Committee agreed to consider deletion of commodities no longer supported at its next Session.
96. The Committee decided to consider revocation of the CXLs for meat and milks at the next session, as the new data were insufficient.
97. The Observer from EC requested for acute RfD. The Observer from GCPF indicated that an acute RfD for folpet was not necessary in view of the similar decision by the 2000 JMPR for captan. The Committee requested the manufacturer to provide detailed information on this item before the 1st of May.
98. The Delegation of France expressed reservations for MRLs of apple (GAP), grapes (metabolites in wine), and lettuce, head (insufficient database). The Delegation of Chile expressed reservations on MRL for grape (too high).
99. The Committee decided to advance the proposed draft MRLs to Step 5 and to retain the draft MRL for strawberry at Step 6.
100. The Observer from the EC informed the Committee that they were withdrawing all authorizations for lindane. The Committee was informed that some existing CXLs were supported by the manufacturer. The Committee decided to recommend the revocation of all unsupported CXLs, except for carrot, eggs, poultry meat, rape seed, sugar beet and sugar beet leaves or tops.
101. The Committee decided to recommend withdrawal of the CXLs as recommended by the 1999 JMPR, except for the commodities supported by the manufacturer (apple; broccoli; cabbages, head; grapes; peach; raspberries, red, black; root and tuber vegetables; strawberries; cereal grains; citrus fruits. The Observer of the EC expressed a general reservation (no acute RfD). The Committee decided to advance the draft MRLs to Step 5. The Committee also decided to retain the CXLs for supported compounds for 4 years under periodic review procedure.
102. The Committee requested JMPR to conduct intake calculation for cabbages, head, common bean, (pods and/or immature seeds) and leek. The Committee decided to consider revocation of the remaining CXLs as recommended by the 1997 and 2000 JMPR at the next session.
103. The Committee invited the Delegation of the Netherlands to send their specific and general comments on the necessity of establishing an acute RfD to the JMPR. The Delegation of Germany expressed a reservation on the extrapolation to all citrus fruits. The Committee had an exchange of view on the use of this pesticide and citrus producing countries indicated that is was used as a post harvest treatment on fruit intended for direct consumption; however in some cases, such fruit might be ultimately used for processing. The Committee noted that new residue data would be supplied by US growers organization in 2001.
104. The Committee noted the views of some delegations that for orange juice, as a processed commodity, normally no MRL should be established.
105. The Committee decided to add Po to citrus fruits and PoP to citrus pulp (dry) and orange juice. The Committee decided to advance all proposed draft MRLs to Step 5 and to retain the CXL for pear.
106. The Committee decided to consider revocation of most CXLs at the next session as recommended by the 2000 JMPR, unless data are submitted.
107. The Observer from the EC informed the Committee that all uses had been withdrawn. The Committee agreed to consider an amended MRL for apple and a new MRL for barley, where JMPR 2000 had identified intake concerns, at it next session.
108. The Committee decided to consider revocation of most CXLs and MRLs, as recommended by the 2000 JMPR, at the next session. CXLs for beans, dry; cabbages, head; peas (dry); potato, and sugar beet will be maintained and MRLs for beans forage (green); hay or fodder (dry) of grasses; sugar beet leaves or tops; wheat; wheat bran unprocessed; and wheat straw and fodder, dry would be discussed at the next session.
109. The Committee decided to advance the proposed draft MRLs for pome fruits to Step 5 and stone fruits to Step 5. The 2001 JMPR will establish an acute RfD. Almonds, hazelnuts and walnuts were advanced to Step 5/8 with the omission of Steps 6 and 7 for adoption by the 24th Session of the Commission.
110. The Observer from the EC expressed its reservation about advancement of MRLs for pome fruits and stone fruits (lack of acute RfD).
111. The Committee decided to consider revocation of all CXLs except dried fruits at its next session.
112. The Delegation of Spain informed the Committee that thiabendazole was also used in tropical fruits and will request the manufacturer to provide data. The Delegation of France drew the attention of the Committee to residue definition problems for animal products.
113. The Committee decided to advance the proposed draft MRL for eggs to Step 5/8 with the omission of Steps 6 and 7 for adoption by the 24th Session of the Commission.
114. The Committee decided to maintain the MRL for mushrooms at Step 3 as GAP was modified by the USA. The USA indicated that it would submit its new GAP to JMPR.
115. The Committee recommended revocation all CXLs, except CXLs for apple, citrus fruits, grapes, meat (from mammals other than marine mammals), milk products, milks, and pear. The Committee recommended withdrawal of the CXLs for common bean, cucumber, egg plant, gherkin, melons, except watermelon, peppers (sweet), strawberry and tomato.
116. All CXLs and MRLs being retained will be subject to full review in 2003 or 2004.
117. The Observer from the EC expressed concern about the residue definition for enforcement purposes. The Committee agreed to change the definition to 1998 JMPR wording. The Committee decided to consider the issue of the residue definition next session.
118. The Committee was informed that US GAP and GAP in the European Community for the use of benomyl in peaches, nectarines and apricots are identical. Extrapolation from peach to apricots and nectarines was supported by several delegations. The Committee therefore decided to change the MRL from 0.1 to 2 mg/kg for apricot and to advance the MRLs for apricot, nectarine, peach, plums (including prunes), pome fruits and tomato to Step 8.
119. The Committee agreed to return the proposed draft MRLs for berries and other small fruits, cereal grains, lettuce, head and peppers to Step 6.
120. The Observer from CI, referring to the written comments of the USA and the EC, supported the view that MRLs should not be advanced until it is clearly demonstrated that they do not pose chronic or acute intake risks. The manufacturer informed the Committee that due to intake concerns MRLs for rice, sorghum and sorghum forage (green) will not be supported and that the Committee will be informed which uses will be supported before next year meeting.
121. The EC informed the Committee of a possible future revocation of all MRLs in the EC.
122. The Committee agreed to recommend revocation of the CXL for rice, and withdrawal of the proposed draft MRLs for sorghum and sorghum forage (green).
123. The Committee decided to return all remaining draft MRLs to Step 6 and would consider them at the next session. The Committee requested WHO to undertake intake calculations, especially acute intake for next years meeting.
124. The Committee would consider the revocation of all CXLs, as the compound was no longer supported at its next session.
125. The representative of the manufacturer informed the Committee that new residue data would become available for review by the 2002 JMPR including apricots, beans (dry), beans snap, beans forage & hay, celery, cherries, melons, peanuts, peanuts forage & hay, peppers, potatoes (seed treatment), sheep meat, soya beans, squash, and sugar beet roots & tops.
126. Since no data had become available, the Committee recommended revocation of the existing CXLs.
127. The Delegation of the USA expressed the view that a higher limit of determination was necessary for banana. As the proposal was based on residue data on bagged bananas the Committee invited the banana producing countries to submit data on unbagged bananas. The Committee decided to advance the draft MRL for banana to Step 8.
128. The representative of the manufacturer informed the Committee that the dossier of tolylfluanid would become available earlier for evaluation by the 2002 JMPR. The Committee requested the manufacturer to submit an overview on the registered uses of dichlofluanid. Based on this information the CCPR at its next Session would consider the revocation of CXLs for the commodities for which there are no registered uses. The Delegation of France pointed out that dichlofluanid had not been evaluated toxicologically since 1985 and that GAP were obsolete, and proposed to revoke the CXL as soon as possible for consistency with the earlier decision on vamidothion.
129. The Committee decided to maintain the existing CXLs, nothing that the use of this compound will be replaced by tolylfluanid.
130. The Committee noted acute intake concerns due to the low acute RfD.and that JMPR 2000 had revised the IESTI calculations. For several commodities, the acute RfD was exceeded even for commodities with residue levels at the LoD.
131. The representative of the Manufacturer informed the Committee that a new acute study in dogs would become available for evaluation of the Acute RfD by the end of this year.
132. The Committee decided to advance the proposed draft MRLs to Step 5 and decided not to advance the draft proposals beyond Step 7 until intake concerns were resolved.
133. The Committee recommended revocation of the CXLs for broccoli, cauliflower, coffee beans, coffee beans, roasted, kiwifruit, oranges, sweet & sour, potato, soya beans (dry), sugar beet and sweet potato as recommended by the 1999 JMPR.
134. The Committee decided to postpone further discussion on the draft MRLs and existing CXLs until its next Session and invited the Delegations to express their views on possible solutions.
135. The JMPR 2000 has reconsidered the acute RfD and established an RfD for the general population (excluding the subpopulation of women of child bearing age) and a separate acute RfD for women of child bearing age. New intake calculations were performed which showed that the IESTI is exceeded for grapes for children and for woman of childbearing age.
136. The representative of the manufacturer disagreed with the intake calculations based on the MRL/STMR for grapes because these were based on data on wine grapes grown in Northern Europe, which result in high residue levels. The residue levels of table grapes should have been used which are grown in Southern Europe, which result in lower residue levels. The Committee, noting that the proposed draft MRL for grapes was based on European GAP, agreed to consider this compound at its next session.
137. The Delegation of Australia introduced Addendum 2 to document CXPR01/9. Results of an estimated national daily intake (NEDI) showed that the Australian use according to GAP did not pose an intake concern. International dietary intake estimate for the 5 regional diets of the GEMS Food also showed that the intake of chlorpyrifos-methyl was below the ADI for all diets. Several delegations expressed concern, since an acute RfD was not established. The Delegation of the Republic of Korea expressed intake concerns (rice), Morocco expressed intake and trade concerns (cereal grains). The Committee decided to return all draft MRLs to Step 6, pending a full review by the JMPR.
138. The Committee noted the written comments of the EC (general reservation as no acute RfD had been established) and of Spain which supported extrapolation from mandarin and oranges, sweet and sour to citrus fruits. The Committee decided to advance the draft MRL for mandarin to Step 5.
139. The Committee decided to return the proposed draft MRLs to Step 6 pending the 2000 review of the JMPR.
140. The Committee noted written comments of the EC requesting the setting of an acute RfD and estimation of the acute risk for all relevant consumer groups, before MRLs could be advanced beyond Step 6 and that the EC could not accept an MRLs for peach, pome fruits and tomato. The Committee also noted written comments of the USA requesting that the MRLs be held at Step 6 pending review by JMPR 2002 with special care for acute dietary intake. The Committee was informed that the CXLs or draft MRLs for pome fruits, peach, tomato, peppers (chili and sweet), cucumber, cauliflower, cabbages, head; potato, sugar beet, sugar beet leaves or tops, soya bean (dry), cotton seed are supported by the manufacturer and that there was no longer support for the CXLs or draft MRLs for celery, tree tomato, watermelon, lettuce, head; brussels sprouts, rape seed, and hops (dry).
141. The Committee decided to return the draft MRLs for peach, pome fruit and tomato to Step 6, pending review by the JMPR. The Committee also decided to retain the CXLs for cabbages, head, cauliflower, cotton seed, cucumber, peppers (chili and sweet), potato, soya bean (dry), sugar beet, sugar beet leaves and tops. Cattle fat and meat, sheep fat and meat, goat fat and meat, milks, alfalfa forage (green), lettuce, head; and tree tomato are being retained for two reasons, animal feed use and/or links to acephate uses.
142. The Committee decided to return the draft MRL for apricot to Step 6 pending review by JMPR. The Committee invited the US to submit written comments concerning combining apricot and nectarine residue data to support the CXL for nectarine and demonstrate that an MRL of 5 mg/kg is sufficient, taking into account written comments of the EC and Germany (acute dietary intake concern).
143. The Observer of the EC expressed reservations on MRLs grapes (lack of processing studies), peppers, pineapples and tomato (inadequate data base). The Delegations of France and Germany expressed their reservation on the MRL grapes (lack of processing studies).
144. The Committee decided to advance the draft MRL for dried grapes to Step 8 with omitting Step 6 and 7.
145. The Committee invited the delegation of the Netherlands to submit their written comments concerning the acute RfD to the JMPR.
146. The Committee decided to revoke the CXL for tree tomato, as it was not supported by the manufacturer.
147. The Committee decided to return the draft MRL for potato to Step 6 pending the review by the 2001 JMPR.
148. The Committee invited the Delegation of the Netherlands to submit their written comments concerning the acute RfD to the JMPR. The Observer of GCPF informed the Committee that thirty to forty commodities would be supported. The Observer of the EC informed the Committee that all registered uses would be withdrawn.
149. The Committee decided to retain all CXLs pending review at its next session.
150. The Observer of the EC informed the Committee that acute RfD in EU did not significantly deviate from JMPR evaluations.
151. The Committee decided to consider revocation of the CXLs at the next session
152. The Committee decided to retain the draft MRLs for apple; nectarine; peach; pear and plums (including prunes) and maintained the CXLs for citrus fruits; grapes; meat (from mammals other than marine mammals); milk products and milks. The Committee also decided to recommend revocation of the CXLs for common bean (pods and/or immature seeds); cucumber; egg plant; gherkin; melons, except watermelon; peppers, sweet; strawberry and the draft MRL for tomato.
153. The Delegation of Germany expressed a reservation (data base concerns). The Observer from GCPF informed the Committee that studies on storage stability will be made available at the end of 2002 and data will be provided to support artichoke globe; rape seed; sugar beet and sweet corn (cornon-the-cob).
154. The Committee advanced the draft MRL for strawberry and decided to recommend revocation of all CXLs.
155. The Committee decided to maintain the CXL for apricot for 1 year in order to consider the extrapolation from peaches to apricots and the CXLs for banana; cucumber; nectarine; peach; plums (including prunes); pome fruits and to recommend withdrawal of CXLs of bean forage (green); common bean (pods and/or immature seeds); peanut and peanut forage (green). The Committee advanced the proposed draft MRLs to Step 5/8 with the deletion of the present CXLs except for tomato which was advanced to Step 5.
156. The Delegations of France and Germany expressed a reservation on the MRL for tomato (processing studies).
157. The Committee noted the written comments from the EC expressing a reservation (lack of acute RfD).
158. The Committee requested the Delegation of Spain to provide GAP information on citrus fruits to the JMPR and advanced the proposed draft MRL for mandarin to Step 5. The Committee returned the draft MRLs for citrus pulp, dry and oranges, sweet, sour to Step 6.
159. The Committee requested the Delegation of The Netherlands to refer its written comments relating to the estimation of the ADI to the JMPR.
160. The Committee decided to recommend revocation of all CXLs.
161. The Committee decided to recommend revocation of all CXLs.
162. The Committee noted that the ADI established by JECFA was not agreed by the Observer from the EC at CCRVDF and that the Committee wold consider this compound again at its next session.
163. The Committee noted that support had not been confirmed.
164. The Committee noted that this compound would not be supported and would consider revocation of all CXLs at the next session.
165. The Committee noted the request for supportive data and decided to consider this compound again at its next session.
166. The Committee noted the written comment from the EC expressing a general reservation (lack of an acute RfD) and specific reservations on MRLs for grapes, lemon and oranges, sweet, sour (acute risk) and decided to return the draft MRLs to Step 6.
167. The Committee decided to consider withdrawal of CXLs for barley; and straw and fodder (dry) of cereal grains as these uses were no longer supported at its next session.
168. The Committee noted the request for supportive data and decided to consider this compound again at its next session.
169. The Committee noted the absence of supportive data for brussels sprouts; cabbages, head; cauliflower; common bean (pods and/or immature seeds); oranges, sweet, sour; soya bean (dry); soya bean oil, refined; sugar beet and decided to consider the withdrawal of these CXLs at its next session.
170. The Committee requested the Delegation of The Netherlands to refer its written comments on Acute RfD to the JMPR.
171. The Committee noted written comments of Germany (insufficient processing data) and decided to advance the CXLs for oranges, sweet, sour to Step 8.
172. The Committee advanced all draft MRLs to Step 5.
173. The Committee noted comments of the Delegation of Germany regarding the new residue definition for all crops and advanced all draft MRLs for commodities of animal origin to Step 8.
174. The Committee was informed that the corrected version of the intake calculation would be published in the report of JMPR 2001.
175. The Committee was informed that the corrected version of the intake calculation would be published in 2001 report and that results did not exceed ADI. The Committee noted the absence of a suitable method of analysis and advanced all proposed draft MRLs to Step 5 and returned all draft MRLs Step 6. The Committee also decided to reconsider this compound at its next session with respect to the methodology of residue analysis with the understanding that without the method of analysis MRLs would not be advanced further.
176. The Committee noted the written comments from the EC expressing a reservation on the MRL for banana (lack of an acute RfD) and advanced the draft MRL for banana to Step 5 and all other proposed draft MRLs to Step 5/8 or Step 8.
177. The Delegation of France expressed a reservation on the MRL for grapes because of the possible transfer into wine. The Delegation of the Netherlands expressed its reservation on the MRL for apple as no acute RfD had been established.
178. The Committee decided to advance all MRLs to Step 5.
179. The Committee noted the JMPR’s review of this compound in 2001 and would consider this compound at its next session.
180. The Committee noted that the 2001 JMPR would consider establishment of an acute reference dose and returned the draft MRL for grapes to Step 6.
181. The Committee decided to delete the MRLs because they were no longer relevant.
182. The Committee requested the Observer from the EC to refer its written comments on animal products residue definition to JMPR.
183. The Committee decided to change the draft MRL for citrus fruits from 1 to 0.5 on the basis of the USA database for grapefruits and extrapolation from present data for oranges and decided to advance the MRL to Step 8. The Committee also decided to delete cotton gin trash.
184. The Committee advanced all other proposed draft MRLs to Step 5.
185. The Delegation of Germany expressed its reservation for cotton seed oil, crude and cotton seed oil, edible (because of insufficient data on processing studies). The Delegation of France supported this view and indicated that no recovery factors should be applied to trial results.
186. The Committee recalled that the 31st Session had considered the establishment of an EMRL for DDT on the basis of the 1999 JMPR evaluation. The Committee noted that JMPR had reevaluated DDT and established a new PTDI of 0.01 kg/kg bw.
187. The Committee had an exchange of views on the appropriate level for the MRL for meat (from mammals other than marine mammals). There were two different approaches within the Committee.
188. The delegation from New Zealand was in favor of an EMRL of 5 mg/kg. The Delegation advised that it had a pasture based economy, where under specific conditions, like droughts or floods, in certain years a level of 5 mg/kg is needed to accommodate the higher concentrations in an small percentage of animals resulting from such conditions. The Delegation stressed that this level did not represent any adverse effect on health as was confirmed by 2000 JMPR evaluation and was consistent with CCPR’s policy on MRL setting and that lower level would create barriers to trade. The Delegation of Australia strongly supported the New Zealand’s position stressing that an EMRL 5 mg/kg was justified by data evaluated and consistent with Codex procedure.
189. The Delegation of Sweden, speaking on behalf of the member states of the European Union, supported by Norway, Slovak and Switzerland, was in favour of an EMRL of 1 mg/kg. These delegations pointed out that their national monitoring data showed very low levels, which do not exceed 1 mg/kg and therefore there was no need for a higher EMRL, as 1 mg/kg corresponded to a violation rate of 0.5% based on Australia, Germany, Norway, Thailand,the United Kingdom and the USA data. The Delegation of Canada supported this view and informed the Committee that its position was based on a full national dietary risk assessment, including fish and that higher levels could result in a hazard to its consumers.
190. The Delegation of Sweden, speaking on behalf of the member states of the European Union, indicated that new monitoring data was available. The Delegation requested that more recent data than those used in the 1996 JMPR evaluation should be collected and evaluated in order to set an appropriate EMRL for DDT, however in order to find a solution at this stage the Delegation was willing to accept a level of 2 mg/kg. The Delegation of New Zealand stated that most up to date data was submitted at the time of request of 1996 JMPR evaluation.
191. The WHO Representative drew the attention of the Committee to the discussion on mycotoxins in the CCFAC and indicated that mycotoxins, and DDT both had a log normal distributions. JECFA had given the opinion that lowering of maximum levels on the tail of such distributions would only result in a very marginal risk reduction on exposure. The Representative indicated that it was primarily a risk communication issue rather then a health problem.
192. The Observer of the AOAC, supported by some delegations proposed to split the residue definition into two parts in order to distinguish between misuses and environmental contamination. The Committee concluded that it would not be appropriate to undertake such a change during the meeting, as it required further consideration.
193. Some countries emphasized the negative implications higher levels of DDT could have for breastfeeding, and the desire to reduce contamination to the lowest level achievable. The Delegation of Australia was of the view that it was primarily risk communication issue which should be addressed at the national level.
194. The Chairman recalled that the monitoring data provided to JMPR originated partly from New Zealand and partly from other countries, and the data from New Zealand showed higher concentrations of residues. The Chairman also noted that the 2000 JMPR confirmed that from the intake calculation a level of 5 mg/kg was unlikely to present a hazard to the consumers and proposed a compromise level of 3 mg/kg, corresponding with a violation rate of 0.5% based on New Zealand data. The Committee also noted the comments from the USA recommending that a level of 3-5 mg/kg would be appropriate and should serve both to facilitate trade and to protect public health. This proposal was supported by Australia, the USA and South Africa although for Australia 5 mg/kg was preferred option. However the Committee could not come to a compromise.
195. The Committee decided to propose to the Commission an EMRL level of 5mg/kg and a level of 3mg/kg in square brackets and to ask the Commission to take a decision regarding the level, taking into account that the Committee would not be able to reach consensus by deferring consideration of this matter to a later session. The Committee also decided not to request a new evaluation of the monitoring data by the next meeting of JMPR.
196. The Delegation of Sweden, speaking on behalf of the member states of the European Union, expressed its strong reservation on this decision for the reasons indicated above. The delegations of Canada, Norway, the Slovak Republic and Switzerland opposed the decision, since they also supported a level of 1mg/kg.
