X. Annex A - Transcript of the Joint Meeting with Experts (Cont.)

Chairman

67. So may I ask the experts, have you received the parties' comments to Mr. Taylor's responses? Ok, they have them, yes.

United States (Mr. Hirsh)

68. In that study, with respect to apples, the author states on the final page of the study that the factors affecting different CxT products were not specified in the test. For example, it appears that there were no controls for length of time and storage, maturity of the fruit and fruit size. In addition, we reviewed the CxT product data in Table 3 and in Table 5. In particular, the data for the Mutsu and the Fuji in each table and that data appears to indicate that the two are not statistically different in Table 5, but they are statistically different in Table 3. In light of the uncontrolled factors in this experiment and the inconsistent data, is Japan's conclusion warranted that the differences in CxT values noted in Table 5, quuote, were obviously attributed to varietal differences?

Chairman

69. Ok, I want to give some explanation now. The experts received that document when they arrived in Geneva and they also had other documents which they received yesterday so I think they have not been able to study these documents in detail. So could we agree that we give some time to the experts so that they could answer your question later?

United States (Mr. Hirsh)

70. Certainly. Thank you very much.

Chairman

71. Ok, so we postpone answer to this question to a later stage, ok.

United States (Mr. Hirsh)

72. Those are the only questions which we have right now, Mr. Chairman. We do reserve the right later following Japan's questions to follow up further.

Chairman

73. Ok, thank you. Does Japan have any follow-up questions to those questions United States raised?

Japan (Mr. Yokota)

74. Mr. Chairman, may we confer within ourselves for a few minutes?

Chairman

75. Ok.

[break]

Japan

76. Mr. Chairman?

Chairman

77. Japan you have the floor.

Japan

78. Yes, we have one immediate follow-up question.

Chairman

79. Ok.

Japan (Mr. Saito)

80. I'd like to have one question but in Japanese so I ask to interpret my question.

Japan (Mr. Saito - interpreted)

81. I have a question to Mr. Taylor. Within the response to the US question � [can you hear, can you hear? Can you hear Ok? Let me start again� ] I have a question to Mr. Taylor. In the first question from the United States, Mr. Taylor responded saying that the sorption difference among the cereals are commodity wise and varietal differences insignificant. But we would like to ask what is Mr. Taylor's view with regard to the fruits which are the issue here in this Panel?

Mr. Taylor

82. Thank you for the question. I am not a specialist in the fumigation of perishables, I regret to say. Therefore I find it very difficult to respond in any firm way to give you a definite reply to this. All I could say is that the differences I would think would have to be very significant in order to make it necessary to, for example, adjust dosage rates and/or time periods for the fumigation. If these differences were so significant that the amount of methyl bromide available for the fumigation process was significantly reduced by different varieties, then, in theory, this would be a significant factor, but I think this has still to be demonstrated. Now you could say well why are there no differences between different varieties of cereals? Again, the answer to that I cannot give you. In fact, I think that in practicable fumigation the application rates always have such a margin [excess over and above the minimum dosage] that any small differences would be accounted for by this margin, or excess that is used. I would imagine that where the United States uses a 10-20% buffer, as I think is the term used, this again would account for it [any small differences]. So in practical terms, as I say, I think we would need to find that there is a significant difference between the varieties and that this needs to be demonstrated. I feel that I cannot say any more on this subject from my own personal point of view. Thank you.

Chairman

83. I'd like to ask do the other experts like to add something to this? I don't see. Ok. Then I give the floor to Japan to present your, so to say, own questions.

Japan (Mr. Yokota)

84. Thank you Mr. Chairman. May I first of all, and on behalf of the Government of Japan, specially thank Dr. Ducom, Dr. Heather and Mr. Taylor for agreeing to serve as experts on this Panel and to give us their very valuable opinions on this matter. We have prepared a series of questions and I would like to ask Dr. Kawakami to present them.

Japan (Mr. Kawakami - interpreted)

85. I would like to speak regarding those questions raised by the Panel and I consider there are five points of importance so I would like to raise them one by one. First of all we should like to express our heartfelt appreciation to the Panel for giving us the opportunity to present our views on the pending issues of today. Also we should like to give our highest respect to the three respectable experts, Dr. Heather, Dr. Ducom and Mr. Taylor for rendering valuable comments from the technical point of view on the methyl bromide situation of perishable products which we think is a highly complicated aspect of treatment technology and in which much more research and investigation are needed for the situation of the issue in question. The Panel sought for expert comments from technical point of view on as many as 18 questions. Of all these questions we consider that the following five issues of argument are particularly important.
86. First issue: Whether or not to be the use of dose response � [interruption]

Chairman

87. Excuse me, excuse me Japan's delegation that I interrupt. But I think that this submission is better suited for tomorrow, because today we are expected to use the expertise of the experts that are present. Your presentation is welcomed, most welcomed to the Panel but I think it is more appropriate to present it tomorrow when we meet between the parties and the Panel, and today we should devote our time and effort to use the expertise of the experts to the greatest extent. So if you could agree with that, I would like to ask you to postpone this presentation for tomorrow. Thank you. But if you have specific questions to the experts you are welcome of course.

Japan ( Mr. Sanatani)

88. Ok. Thank you Mr. Chairman. We have prepared five questions to put to the experts. Maybe we can deliver the written questions to the members in this room? The first question is to Dr. Heather and Mr. Taylor. I will read. Dr. Heather states in response to Question 12, quote: if only one variety has been presented in the initial testing the possibility that other varieties which might be proposed subsequently could have higher predicted minimum dose requirements would be greater. Even so, the likelihood of this exceeding 10-20% buffer appears low, end of quote. Similarly, Mr. Taylor states, quote: any varietal differences affecting the efficacy of MB treatment are unlikely to be so great that the buffer of 10-20% fails to account for these differences. Effective quarantine treatment is therefore to be expected, end of quote. Japan wishes to know the grounds for these assumptions that possible varietal differences in most cases could be covered by the buffer 10-20% surrounding the buffer. So, shall I stop here or continue to finish it?

Chairman

89. I think it's better to take the questions one by one. So, Mr. Taylor and other experts who..?

Dr. Heather

90. Perhaps if I could give the first response on this, please. The grounds for my conclusion were that each of the varieties which had been tested in each of the commodities always met the large confirmatory dose test. There was never any suggestion of failure. Therefore, had the dose been pitched too low in the first place, this would have shown up as survivors from the large scale test. The basis of this problem is partly that we are judging differences at points where they are quite discrete but the effectiveness of the treatment becomes apparent at very, very high efficacies when there are very, very few survivors and this has the effect of bringing together the differences so that they are no longer apparent.

Chairman

91. Mr. Taylor, do you want to respond also? Ok. May I ask Japan to proceed to the next question?

Japan (Mr. Sanatani)

92. Thank you Mr. Chairman. The second question is posed to all the experts. I read, Dr. Heather states in response to Question 13: The broader applicability of a confirmatory test done on samples of one variety over commodity depends on the extent of variation of mortality attributable to varietal characteristics and a large scale test provides assurance for the extension of an existing successful treatment to additional varieties of a commodity, provided that the initial varietal sample is representative of the commodity. In response to Question 16, Dr. Ducom states: Extrapolation to all available varieties is no more scientific than the Japanese's contrary assertion. They seem to concur that there is no valid scientific ground to conclude that a treatment established for a particular variety by confirmatory tests would be efficacious for any additional variety. Is this correct?

Dr. Ducom

93. Yes that is correct. I mean I cannot see any more scientific basis on the Japanese side than on the USA's side to say [that each] variety must be carefully treated � or for one we can have all varieties. I hope you understand. In my opinion it is not scientific to say that one variety is equal to all others, � but [choosing one variety as representative of all is the same sort of argument for me] to say maybe one variety, it's the same for me. Ok.

Chairman

94. Thank you. Other experts, do you want to add?

Dr. Heather

95. Just responding to the first part of the question. The broader applicability of the context of that statement was to start with the basic facts and say yes, technically, if you develop a treatment on one and seek to apply to others. And then I went on to say that there were no real grounds to be concerned, I think you'll find.

Chairman

96. Thank you. Could you now proceed to your third question Japan?

Japan (Mr. Sanatani)

97. Mr. Chairman. Before we proceed, can we take some time to reflect on the answers ...?

Chairman

98. Of course.

Japan (Mr. Sanatani)

99. Mr. Chairman, if you permit us to go back to the question number one, we have some comments to put on our answers to number 1.

Chairman

100. I think the place of the comments are tomorrow, but if you have follow-up questions, if your follow-up questions, if you want to seek further clarification from the experts, you are welcome.

Japan (Mr. Saito)

101. OK. Thank you Mr. Chairman. So let us go back to question number one and this time in Japanese.

Japan

102. (Interpreted) Concerning the question one in the replies from experts Dr. Heather stated as follows� we asked in our question whether this buffer of 10-20% could cover all these differences in the varieties, among the varieties, are based on scientific grounds and if this buffer has the scientific grounds and in response to our question we, as far as we can understand, after the various confirmatory test, the efficacy did not show a significant difference and that this is the data of empirical of nature. What we are questioning here is that in all cases whether the buffer 10-20% could absorb all this varietal difference and if that buffer would have the scientific grounds in this manner. And if possible I would like to invite the comments from, or replies from all the experts. Thank you.

Chairman

103. OK. I give the floor to the experts.

Dr. Heather

104. I am a little anxious if I understood the question clearly enough, but as far as I understand, Japan is questioning where the 10 per cent or 20 per cent buffer came from. It is difficult to project with certainty, by regression analysis, the [dose required for] efficiency and effectiveness of a certain fumigant. By analysing the data, examining a certain range of doses of the fumigant (if the fumigant has 100 per cent effectiveness, or effectiveness of killing insects), by adding to the fumigant some amount, which one actually does in practice, in the actual research, we have examined all varieties under a series of trials. Then we obtain the data from there. A normal procedure then is to confirm the data by a larger-scale confirmation test. However, one can attain this objective by somewhat different means; one is by taking a "single replicate", which Japan is demanding currently. Another would be by setting "confirmatory loss" to as low a level as possible, based on research among them. If there are surviving insects, we conduct such trials repeatedly. We call this the "repeated iterative approach". In other words, it is the idea to seek for, to the extent possible, the lowest value to attain confirmation of effect on a certain target. I think, therefore, that this can be regarded as a somewhat different approach. Both, I think, are means to meet the very difficult problems we have to solve. To be practical does not mean it is unscientific.

Chairman

105. I would like to give the floor to Dr. Ducom.

Dr. Ducom

106. I would like to add a question: why is the buffer 10 or 20 per cent? This may be accidental and so why not 5 per cent? It is difficult to say these are enough for the variety, because we cannot recognize them as a fait accompli [what is needed]. It implies to hypothesize, to some extent, how much the sorption level is for each variety.

Chairman

107. OK. Thank you. Japan.

Japan

108. [Microphone not on. Probably Japan asking Dr. Taylor to respond as well]

Mr. Taylor

109. I agree with the opinion of the two experts, in particular, with Dr. Ducom's. In other words, we have no data on sorption. There are no data indicating the difference of sorption between varieties. So, the 10 to 20 per cent buffer was set arbitrarily (at random); it was not based on scientific examination. However, such numerical difference [is the one which could absorb the difference enough]. A 20 per cent [buffer] would be a substantial increase in volume. I cannot add anything more, but I agree with the opinions so far expressed by my colleagues, the two specialists. We have no data as to what constitutes the rate of sorption of each variety. If we do, we could possibly decide whether this 10 or 20 per cent is too high or too low, and a 5 per cent buffer may well be enough. But we can present no scientific evidence other than that.

Chairman

110. Thank you Mr. Taylor. Japan?

Japan

111. Thank you, Mr. Chairman. Since we have finished questions number one and two, we would like to move on to question number three, which is a question for Dr. Heather and Mr. Taylor.

Japan (Mr. Sanatani)

112. �.. Dose-response testing is a tool commonly used for the purpose of comparing reactive resistance to a treatment such as between development stages of insects. Results of the tests are statistically analyzed using probit analysis, normally by way of comparison of LD50 values. This is supported by Exhibits 19 and 20 of the Japanese submission. There is no disagreement among on this point; in particular, Dr. Heather and Mr. Taylor explicitly acknowledges the effectiveness of dose-response testing and probit analysis. Japan solicits the experts' opinion as to possible application of dose-response data and probit analysis to a comparative inquiry into differential effects of fruit on mortality. Thank you.

Dr. Heather

113. It would be a very interesting study, but in such study, from my experience, variation will [originate from both the] fruits and their harmful insects, and it will depend, I think, on how such a treatment is indirectly given. Therefore, it would be difficult to obtain practically useful data from such a study.

Chairman

114. Mr. Taylor.

Mr. Taylor

115. I agree with the opinion of Dr. Heather. It would be very interesting to know how useful the data will be that comes out as a result. Of course, if Japan is really thinking of doing this, it would be useful. If Japan could make public the result, it will shed light on the issues for which the answer is unknown, or there is no data. Thank you.

Chairman

116. Japan.

Japan (Dr. Nakakita)

117. I am not good at English and would like to intervene in Japanese. Dr. Ducom, I believe you mentioned that LD50 cannot be used for these kind of purposes and as a basis of your saying that, the Journal of Economic Entomology submitted by the United States, the 1987, and which refers to six varieties of nectarines, they are indicating the comparative tests and ... codling moth eggs ... 6.3 grammes per cubic metres. This is the LD50 and this was the lowest value obtained among those six varieties. However, with regard to the efficacy at the higher concentration level Summer Grand, is the variety that indicated the highest resistance. So Dr. Ducom seems to be saying that the LD50 does not really have the validity, I believe that's what you said. But looking at this report this does indicate the difference between the varieties. And I believe that in this regard this is a report that should command lots of attention. So I believe that this report should attract attention in that regard. But in 1997, in the United States, another report published in the United States which refers to the Summer Grand's test results of 1987 and it came up with a newer data that replaces the old data of '87 and in this new report the value of LD50 was not that small. And LD95 also indicated the value that is not that much different from the LD95 of other varieties. So, the data obtained in the testing done in '87 with regards to the Summer Grand's resistance was in a way negated. And also, May Grand, the variety called the May Grand, the LD50 and the LD95 are listed next to each other and when you look at those in May Grand LD50 and also LD95 both indicate a higher resistance than that of Summer Grand but the 100% mortality values is lower by 25% than that of the Summer Grand, so I am somewhat dubious with regards to the reliability of this report. What is your observation on this report Dr. Ducom?

Dr. Ducom

118. It is very difficult to answer, to know what happened. For myself we have carried out a lot of trials like that and sometimes we have found black and sometimes white. I don't know why, although I should. I would appreciate it if I could know what happened. But, no, I have no answer. I don't know why. That's the only thing. It's when you do trials like this one with LD50 or Probit 9 analysis. Like Dr. Ito says, it depends, sometimes it works. When we say it works, it is logical with what we want to get, but if the results are not what we want, then we say it doesn't work. I don't know what the truth is. I have no more comment about that. I am sorry Kawakami-san.

Chairman

119. OK. Thank you.

Japan (Dr. Nakakita)

120. Thank you. I would like to ask Mr. Taylor, do you regard this as a scientifically reliable data?

Mr. Taylor

121. Could you just refresh my memory as to which, are we comparing the 1987 report with the more recent one? Is this what you are asking me to report on, or to give my opinion on? Please could you just, when you say you would like me to give opinion on to...

Mr. Nakakita

122. The report. 1997, sorry. That's the year the Americans submitted report. And '87 which was on general insect product research.

Mr. Taylor

123. Thank you Dr. Nakakita. I find it difficult to make any firm statement. I mean I have read these two papers but it's very difficult to know why there is this difference and to actually give with any affirmity which of the two is correct and why there is a difference. I mean Dr. Ducom has already stated that sometimes you get one set of results and sometimes you get another set of results when you may be expecting similar results. I'm sorry, I cannot with any confidence give you any other answer than to say that unless there are any differences that have not been accounted for in these two experimental programmes which we might have to re-examine to see whether there was anything about the two experiments which leads to that conclusion. I don't know whether Dr. Ducom would like to make any comment as whether he thinks there might have been some possible experimental difference which has not been taken into account?

Chairman

124. OK. I think you cannot extract more from our experts.

Japan (Mr. Nakakita)

125. Thank you very much Mr. Taylor and Dr. Ducom.

Chairman

126. OK. Can we move now to your fourth question?

To continue with Annex A - Transcript of the Joint Meeting with Experts