1 MEETING 2 OF THE 3 SCIENTIFIC REVIEW PANEL ON TOXIC AIR CONTAMINANTS 4 CALIFORNIA AIR RESOURCES BOARD 5 6 7 8 9 10 SOUTH SAN FRANCISCO CONFERENCE CENTER 11 SALON B 12 255 SOUTH AIRPORT BOULEVARD 13 SOUTH SAN FRANCISCO, CALIFORNIA 14 15 16 17 18 WEDNESDAY, JUNE 3, 1998 19 9:00 A.M. 20 21 22 23 24 Janet H. Nicol Certified Shorthand Reporter 25 License Number 9764 PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 ii 1 APPEARANCES 2 MEMBERS PRESENT: 3 Dr. John Froines, Chairman Dr. Paul D. Blanc 4 Dr. Craig Byus Dr. Anthony Fucaloro 5 Dr. Stanton Glantz Dr. Peter S. Kennedy 6 Dr. James N. Seiber Dr. Hanspeter Witschi 7 8 REPRESENTING THE CALIFORNIA AIR RESOURCES BOARD: 9 Mr. Lynton Baker, Staff Air Pollution Specialist Mr. Peter Mathews, Office of the Ombudsman 10 Ms. Genevieve Shiroma, Chief, AQMD 11 REPRESENTING THE OFFICE OF ENVIRONMENTAL HEALTH HAZARD 12 ASSESSMENT: 13 Dr. George Alexeeff, Deputy Director for Scientific Affairs Dr. Melanie Marty, Senior Toxicologist 14 15 REPRESENTING THE DEPARTMENT OF PESTICIDE REGULATION: 16 Mr. Douglas Okumura, Branch Chief Dr. Gary Patterson, Branch Chief 17 Ms. Jean-Mari Peltier, Chief Deputy Director Dr. John Ross, Senior Toxicologist 18 Dr. John Sanders, Branch Chief 19 REPRESENTING THE CALIFORNIA ENVIRONMENTAL PROTECTION AGENCY: 20 Dr. William Vance, Special Assistant to the Secretary 21 22 23 24 25 PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 iii 1 INDEX 2 PAGE AGENDA ITEMS: 3 1 Presentation by the Air Resources Board (ARB) 2 4 on its history and role of designing ambient air monitoring of pesticides for the Department of 5 Pesticide Regulation (DPR) 6 2 DPR presentation on it procedures (A, B and C) 36 to address pesticidal toxic air contaminant 7 candidates 8 3 Presentation on a Procedure A pesticide, the draft 68 report: Environmental Fate of Molinate 9 4 Presentation on the Toxic Air Contaminant Program 134 10 Fact Sheet for Benomyl (Procedure B) 11 5 Panel discussion on addressing the anticipated 163 workload of reviewing 12 pesticides this calendar 12 year 13 6 Panel review of Air Toxics Hot Spots Program Risk 163 Assessment Guidelines: Part II: Technical Support 14 Document for Describing Available Cancer Potency Factors 15 Adjournment 172 16 Certificate of Reporter 173 17 18 19 20 21 22 23 24 25 PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 1 1 P R O C E E D I N G S 2 CHAIRMAN FROINES: It's five after 9:00. I think 3 we should begin. We do have a quorum. We are currently 4 missing two members of the panel, who are expected. 5 This meeting is an outgrowth of a March meeting 6 between members of the Scientific Review Panel, the ARB and 7 Department of Pesticide Regulation. 8 Particularly we met with James Wells, the 9 administrator for the department, to discuss procedural 10 issues and try to get on track with respect to addressing 11 pesticides as toxic air contaminants. 12 It was a very positive meeting and I think 13 everybody came out of that meeting feeling energized and 14 ready to go back in and to try to address how we're going -- 15 how we will identify pesticides as toxic air contaminants or 16 how to handle other substances in the alternative where 17 there may be differing levels of evidence. 18 So based on that meeting, this meeting follows, 19 and we're going to be discussing some of the outcome of that 20 earlier discussion. 21 And this is not a day when we're going to address 22 scientific documents in great detail. And Jean-Mari will 23 speak to that. But we're talking about procedural issues 24 and how we are going to be going forward. And DPR has a 25 significant number of compounds that they're interested in PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 2 1 bringing before the panel and so I anticipate a number of 2 meetings in which we'll be quite busy. So that's that. 3 The second issue in developing the agenda, though, 4 since exposure becomes such an important facet of the 5 definition of a toxic air contaminant within the context of 6 pesticides, we decided that we wanted to hear about the Air 7 Resources Board activities with respect to monitoring for 8 pesticides. 9 And so the first speaker is in fact not from DPR, 10 but in fact is Lyn Baker from ARB who is going to be 11 discussing the design and implementation of air monitoring 12 activities around pesticides. So we'll go directly to Lyn 13 Baker. 14 I think that as you can see, Peter and Paul are 15 not here yet. As far as I know, right now the limiting 16 factor is Jim Seiber, who has to leave about 12:00. 17 Limiting only in a transportation context. 18 Does anybody else have any special travel needs? 19 The rate limiting step here is Seiber. 20 So, Lyn, why don't we go ahead and I think the 21 panel is going to be very interested in how you approach air 22 monitoring with respect to pesticides. 23 MR. BAKER: Morning, Dr. Froines, members of the 24 panel. I'm Lyn Baker with the Stationary Source Division of 25 the Air Resources Board. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 3 1 And as Dr. Froines mentioned in his introductory 2 remarks, I was asked to come and give you a little history 3 on our role in designing the air monitoring of pesticides 4 for the Department of Pesticide Regulation. 5 I'll spend just a minute on the purpose and 6 history of our monitoring, and then I'll go into some more 7 detail on the design of our monitoring studies, and then a 8 little on the pesticides that we have monitored to date and 9 then I'll conclude with a few slides to give you an idea of 10 some examples of our actual monitoring locations. 11 In 1985 DPR first requested ARB to conduct air 12 monitoring of pesticides in support of the DPR toxic air 13 contaminant program. 14 Since 1985 we've worked very closely with DPR 15 staff to conduct this monitoring to make sure that it meets 16 their needs. And I think over the years we've developed a 17 very good and effective working relationship with the DPR 18 staff and I think we have a lot of mutual respect for each 19 other and I think we have a very good working relationship. 20 After the first request in 1985 for monitoring, in 21 1986 we started to meet regularly, monthly, sometimes even 22 twice a month between our staffs to come to an agreement on 23 what should constitute a representative air monitoring study 24 for pesticides to meet DPR's needs for their toxic air 25 contaminant reports. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 4 1 We reached agreement on a study design. That 2 study design has evolved over the years. Initially we just 3 conducted ambient monitoring. Over the years we've added 4 application site monitoring around specific applications of 5 our monitoring and I'll go into some specifics on that, as 6 to how our monitoring has evolved over the years to our 7 current study design. 8 Next slide. 9 This is kind of an outline of what constitutes our 10 current study design for air monitoring of pesticides. And 11 I'll just kind of step through it with you. 12 DPR requests monitoring of pesticides to the ARB. 13 Currently, we've been getting requests of about six 14 pesticides per year and that as an example in early 1997 DPR 15 gave us a request for about six pesticides. We scheduled 16 those in late 1997 and throughout 1998. 17 Early this year they gave us a request for six 18 more pesticides, which we will be scheduling for monitoring 19 either late this year or in 1999. 20 Following the request for monitoring DPR gives us 21 a very detailed monitoring recommendation. This is a very 22 important document for us to allow us to really conduct the 23 monitoring effectively. 24 DPR staff puts a lot of time and effort into 25 developing those monitoring recommendation and they have PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 5 1 evolved too over the years. 2 The current monitoring recommendations include 3 information on the physical and chemical characteristics of 4 the pesticides, summary of the toxicological information. 5 They may actually recommend that we also do monitoring for 6 an atmospheric breakdown of the pesticide. For instance, 7 naled breaks down into dicholorvos, so they wanted 8 information on both of those. 9 They also provided information, a desired limit of 10 quantitation in their monitoring recommendations. So that 11 we try to make sure that the monitoring is done in an 12 sensitive enough way to make sure that the levels that are 13 detected are in the same level as the health numbers of 14 significance, so that we don't end up with very high limits 15 of quantitation, but the health numbers would be much lower 16 than that and then the data would be of limited use. 17 Also, the monitoring recommendations also give us 18 information on the peak month and use -- the peak months of 19 use and the peak county of use of the pesticides, and also 20 some kind of historical information on the use of those 21 pesticides. 22 Now, we use this information, the information on 23 the peak month and peak county of use, to figure out where 24 we're going to do the monitoring. We then contact the 25 county agricultural commissioner, who gives us information PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 6 1 on the specific areas within the county where the pesticide 2 is likely to be applied, wherever that crop may be that the 3 pesticide would be used on. 4 DPR supplements this information with use maps, 5 maps showing the historical use of the last few years of 6 where the pesticide was actually applied, what sections 7 within the county. And the information, that information 8 along with the information from the county ag commissioners 9 allows us to get in the right area for areas where we expect 10 the applications to occur. 11 Then for our ambient monitoring then we go out and 12 look for monitoring locations in the vicinity of these 13 expected locations. And it's a point I wanted to make. The 14 ambient monitoring that we do for general public exposure 15 has to be done in the areas where the pesticide is expected 16 to be applied. We don't know prior to doing the monitoring 17 that those applications will take place for sure in that 18 vicinity. It's been used in that area in the past. We have 19 every reason to believe that it will be, but it may be -- it 20 may for some reason not be used in those areas that 21 particular year. 22 In a couple of cases where all of our samples at 23 all of the sites have been below the detection limit, we've 24 actually gone back and talked to the county agricultural 25 commissioner to find out was the pesticide used in the PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 7 1 vicinity of our samplers to find out was it a function of 2 our detection limit or was it just not used in this area. 3 To date -- 4 CHAIRMAN FROINES: You don't have a way ahead of 5 time to learn where an area may be being -- may be planned 6 to be sprayed? 7 MR. BAKER: We do maybe a week before, maybe a 8 couple of weeks, but we usually -- these studies are four to 9 six weeks in duration, so when we're going about picking the 10 monitoring sites some of these applications may not have 11 started in that area, and so without contacting every grower 12 or applicator in that vicinity, we can't be sure of that. 13 The agricultural commissioner will tell us, well, 14 it looks like this is going to a bad year for fungus, so 15 they're going to have to use this fungicide, for example, 16 but they don't know for sure that they will use that 17 particular fungicide. They might use an alternative 18 fungicide on the crops that are near where our samplers are. 19 The applicators, if it's a restricted use 20 pesticide, the applicators have to file a notice of intent, 21 but that's only a couple of days or a day prior to the 22 application. Then we may have been doing sampling for a 23 couple of weeks prior to that. 24 CHAIRMAN FROINES: Well, do I understand, correct 25 me if I'm wrong, do I understand you to be saying that you PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 8 1 go out and you station the monitors and collect data for 2 over, say, 24-hour periods, and that when you actually then 3 go and analyze your results, you don't have knowledge of 4 whether or not the pesticide was actually used during the 5 time frame of your monitoring? 6 MR. BAKER: That's correct. If we find 7 non-detects we go back and check with the county 8 agricultural commissioner to find out was it used within the 9 vicinity of our sampling sites. 10 But if we measure it, we go on the assumption, 11 well, it must have been used because we've measured it. We 12 don't know how closely it was used, but that -- part of the, 13 I guess, the study design agreement that we came up with 14 Department of Pesticide Regulation years ago was that that 15 would be something that DPR would follow up on and that we 16 did not need to address as part of our monitoring. 17 I was just going to make the point, that this is 18 our ambient monitoring for general population exposure. 19 Now, later, Item 6, on that list is our 20 application site monitoring where we surround a field where 21 we know there's -- we do the monitoring coincident with an 22 actual application. 23 CHAIRMAN FROINES: We'll come back to that, 24 because I want to a question about that, because you also, 25 the problem with the application site is your detection PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 9 1 limits go to hell. 2 MR. BAKER: That's right. 3 CHAIRMAN FROINES: So there's a problem of how do 4 you bring your detection limits down when you're having 5 actual observations occurring, so that you can have 6 meaningful results. 7 But Jim wanted to comment. 8 DR. SEIBER: Lyn, if you didn't find anything and 9 then you went back to the commissioner and found that in 10 fact nothing was used, would you then go back out another 11 year and -- 12 MR. BAKER: We have done that for captan, for 13 instance, we went -- we found nothing in any of the samples 14 for four weeks of sampling at four sites. We checked with 15 the county agricultural commissioner and found that no 16 captan was used within a mile of any of our sampling sites, 17 and in fact learned that we somehow had been misdirected to 18 the wrong part of the county, and so we were -- we repeated 19 it a year or two later in a different part of the county 20 where we knew it was being used. 21 CHAIRMAN FROINES: Tony. 22 DR. FUCALORO: When you do detect ambient 23 concentrations because of usage, do you then go back to the 24 supervisor and discover who has used it when and this -- 25 MR. BAKER: No, we don't. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 10 1 DR. FUCALORO: You don't get any meaning out of 2 that ambient background if you don't know if any farmers 3 have used it or just a few or just that you detected 4 something in the background? 5 MR. BAKER: That's correct. As I said, early in 6 the evolution of our monitoring, that issue came up and the 7 DPR staff said they would handle looking into -- 8 DR. FUCALORO: Who used it. In effect, it is 9 done, it's not done by you. Is that your understanding? 10 MR. BAKER: I don't know if they do that or not. 11 DR. SEIBER: I think the point is that it could be 12 done, because then the records are available, as the State 13 has good recordkeeping in that regard, so it can be done. 14 Whether it is or not, I guess we'll have to -- 15 MR. BAKER: In the early year of our monitoring, 16 prior to 1990, there wasn't hundred percent use reporting. 17 So back then it could only have been done if it was a 18 restricted material, but now with 100 percent reporting, it 19 can be done for any pesticide. 20 CHAIRMAN FROINES: I've had lengthy discussions 21 with Don Villarejo up in Sacramento about use reporting and 22 he's generally very positive, but finds that there are, like 23 any data that you collect, there are bound to be errors. 24 And there are. 25 And so when you go back to the ag commissioner, PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 11 1 does the ag commissioner in fact necessarily have correct 2 information about the pesticides that you were just 3 monitoring for? 4 MR. BAKER: We have to assume that he does, yes. 5 We have every reason to believe that the use reporting is 6 quite accurate. 7 And I think DPR staff can speak to that. 8 CHAIRMAN FROINES: I don't know, Jean-Mari, do you 9 want to start mixing and matching here? 10 MS. PELTIER: I don't -- 11 CHAIRMAN FROINES: Why don't we go ahead. I don't 12 want to steal your thunder by having you sort of giving a 13 response where people lose the overall track of the 14 presentation. 15 MR. OKUMURA: I was just going to respond to the 16 use reporting. I'm Doug Okumura, branch chief of the 17 Environmental Monitoring Branch. 18 The county ag commissioner's data, I think the 19 errors that you're speaking to, are more or less reporting 20 errors of potentially like volume or something like that, 21 not the type of pesticide used. So they also have a check, 22 and in the notice of intent and the label rates are a checks 23 system in the file that they have when they're checking 24 their use reports. So if we need to work more closely with 25 the Air Board, we can, in identifying during the sampling PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 12 1 periods more on line or more up to date exactly what amount 2 is being used. 3 The reports are submitted either on a seven-day or 4 a monthly summary, so many applicators, in order to cut 5 their costs down, are submitting it on a monthly summary, a 6 report, and so the data received at the commission's office 7 may be in a block of one month. 8 However, the notice of intents should give you a 9 very good indicator over that period of time as far as what 10 pesticides actually took place, because they're required to 11 turn notice of intent 24 to 48 hours ahead of the 12 application. 13 CHAIRMAN FROINES: Thank you. 14 This is the crucial issue. This is fundamental. 15 And so why don't you go ahead, but I think we need 16 to keep it as something. 17 DR. SEIBER: Let me just comment. 18 It's a crucial issue, I agree, but every toxic air 19 contaminant issue we've ever dealt with, we always have that 20 uncertainty whether our monitors are placed where the actual 21 emission is. 22 And we have -- the point could be is kind of a 23 generic point, I think, it holds for all TAC, not just 24 pesticides, and if anything we have maybe better way to go 25 back and track. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 13 1 And I agree with you, if it can be done, it ought 2 to be done. 3 CHAIRMAN FROINES: Well, I have been thinking 4 about this issue a lot lately, because I'm very deeply 5 involved in the design of the new Mates 2 study in the South 6 Coast on air toxics and the Mates 2 study is going to have 7 two elements. It's going to do more monitoring, traditional 8 monitoring for air toxics, but under the auspices of 2588 9 it's going to do some, quote, hot spot sampling. 10 So the AQMD is trying to design those studies. 11 What you realize is that the people who are 12 traditionally oriented towards monitoring, sometimes -- and 13 this is not a criticism, it's just a statement of fact, I 14 think -- that people who are oriented towards monitoring 15 sometimes don't think effectively about where monitors 16 should be placed, vis-a-vis pathways of exposure. And that 17 becomes a really important issue. 18 And then when you go to the hot spots that becomes 19 even more an important issue, because you really do need, if 20 you're going to monitor for hot spots, you need to have -- 21 which is the equivalent to your application monitoring here. 22 So I think that the issue of it's not just a 23 question of monitoring, it's the question of how do we 24 identify the pathways that result in potential human 25 exposures and how do we quantitate that. And that may also PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 14 1 require a multimedia approach for looking at potential 2 exposure. This is really a quite fundamental issue, I 3 think. 4 MR. BAKER: I agree with you. It's one of the 5 reasons that we've -- back to I guess Item 4, selection of 6 primary monitoring sites and background site, one of the 7 reasons that we've typically tried to have three to five 8 monitoring sites and not just one or two in an expected area 9 so that we try to have better odds of having a sampler near 10 applications of the pesticide. 11 However, I think it's a good point that you're 12 raising and probably something that we should be doing, 13 working with DPR regardless of the results after a study is 14 done, go back and work with the county agricultural 15 commissioner to find out how much was used in the vicinity 16 of the sampling locations. 17 CHAIRMAN FROINES: It seems to me that it's really 18 quite important, because if you finish your monitoring and 19 you haven't found anything, and then the document comes to 20 us and says we didn't find anything, we say did you know 21 whether they used the chemical and you say, no, I don't, you 22 have an obvious problem. 23 MR. BAKER: Like I say, if they were all 24 non-detects, then we have gone back and checked, but if 25 they're all positive, we don't know if that's due to PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 15 1 applications a mile away or four miles away, because we 2 haven't checked. 3 CHAIRMAN FROINES: It seems to me that we need to 4 figure a way to do things that we can be assured that when 5 your are monitoring people, people are using the pesticides. 6 That seems the conclusion that we would -- 7 DR. FUCALORO: Not only using it, but where they 8 use it and how much and all that information, where you're 9 in relation to them, and so on, I think. 10 MR. BAKER: Location is the key. 11 CHAIRMAN FROINES: Location and temporal 12 characteristics, re-entrainment of dust. I mean just a lot 13 of -- 14 MR. BAKER: Right. 15 As I said, we typically use three to five ambient 16 sites for general population exposure, and I'll have a few 17 slides of examples at the end. 18 Then we also have typically an urban background 19 site to look, for instance, Fresno County we would have 20 samplers out in the rural area where the pesticide would be 21 being used, but then we would also put a sampler in downtown 22 Fresno to look for any pesticide that might be migrating 23 into an urban area. 24 We locate the samplers typically on the roofs of 25 buildings, such as schools and fire stations. Having the PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 16 1 samplers on the roofs meets ambient air quality siting 2 criteria for ambient sampling. 3 If we can find a site on the ground in a secure 4 location we have used that as well, but frequently it's 5 schools. Putting samplers on the ground kind of invites 6 tampering. 7 We do duration monitoring is typically four to 8 six weeks, four samples a week and the samples are 24 hours 9 in duration. 10 The application site monitoring that we briefly 11 discussed is done near a known application of a pesticide, 12 of the particular pesticide and that work is done through 13 very close cooperation with the county agricultural 14 commissioner. We have to work with them to find a 15 cooperative grower or applicator, get all the necessary 16 permissions to deploy our samplers on neighboring property 17 so that everyone is aware and notified and doesn't have 18 objection to us doing that. 19 And then we conduct monitoring about 15 or 20 20 meters away from each site of the field in our application 21 site monitoring and take short-term samples to look for 22 acute exposure to simulate what would public exposure be if 23 there was a house or a school adjacent to an application of 24 the particular pesticide. 25 CHAIRMAN FROINES: Let me make this one comment PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 17 1 about that. 2 We're designing a beryllium sampling device for 3 Los Alamos and their beryllium center, and the levels of 4 beryllium are very very low, so we have detection limit 5 problems. 6 What we're doing is designing an automated system 7 where you can collect a sample for a specific task. This is 8 an occupational study. And then you, the next time that 9 task is done you collect another sample and then later you 10 collect another sample. In other words, you create an 11 automated multi-sampling systems. 12 And it seems to me that developing some 13 multi-sampling approaches would help you with your detection 14 limit problem so that you may take a sample for a short 15 period of time and then the next time it's applied take the 16 same sample and so on and so forth, and find a way to 17 increase the amount of material you can collect in a short 18 period of time. 19 Because otherwise you have these very high 20 detection limits and then your values are within them and 21 you're in the notices. 22 MR. BAKER: That's right. With the 24-hour sample 23 we're getting many times more the material than we do in a 24 three-hour sample, like around an application site. That's 25 correct. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 18 1 Item 7 there, the sampling analysis methods of 2 course have to be developed ahead of time. Once we know we 3 have been requested to do monitoring our lab starts to 4 develop the sampling analysis methods. They have to prepare 5 trapping efficiency studies to verify that the sampling 6 media will trap the material, there won't be significant 7 breakthrough. 8 They do storage stability studies up front and we 9 have extensive quality assurance and quality control with 10 spikes and blanks in the field and in the laboratories as 11 part of our standard procedures. 12 The sampling is typically done by the Air 13 Resources Board Monitoring Laboratory Division. The 14 analysis sometimes is performed by them and sometimes it's 15 contracted out, typically to University of California, 16 Davis. 17 And those when we do -- whether we contract these 18 out or not, the costs of these, well, they're contractual 19 costs with for instance UC Davis typically run 25 to 50 20 thousand dollars per study, for hundred ambient samples and 21 about 50 applications site samples, just to give you an idea 22 of our costs. 23 And once we have all this information together and 24 the quality assurance report in on the results, then we put 25 it all together in a report, which is then submitted to the PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 19 1 Department of Pesticide Regulation. 2 Next overhead, please. 3 This is a list of a couple of the sampling methods 4 that we've commonly used. Some of the absorbent resins, the 5 XAD resins or charcoal or filters if the pesticide is being 6 applied as a dust. 7 Our sampling flow rates are typically 2 to 15 8 liters a minute and we do try to use a higher flow rate 9 around the application site monitoring to try to increase 10 that sample volume, but still if it's only a couple-hour 11 sample we're still definitely sacrificing the limited 12 quantitation. 13 The lab analysis is whatever ends up being 14 appropriate to detect the pesticide. 15 Next overhead, please. 16 This is a list of kind of our status of monitoring 17 to date. The list has grown. I was amazed that it had 18 grown all the way to 44 when I put this together. But since 19 1985 DPR has requested monitoring for 44 pesticides and that 20 is broken down as follows. 21 CHAIRMAN FROINES: Since when, '95? 22 MR. BAKER: Since 1985. They have requested 44 -- 23 monitoring for 44 pesticides. 24 That's broken down as follows. 25 We've done monitoring for 35 pesticides to date. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 20 1 Final reports have been submitted to the Department of 2 Pesticide Regulation for 26 of those. 3 Monitoring is completed and the reports are being 4 prepared for nine. 5 As we speak, monitoring is underway for two. It's 6 just being completed for one and just getting underway for 7 another. 8 And we have monitoring scheduled for either late 9 this year or 1999 for seven. 10 Next overhead, please. 11 And this is a list of the 35 pesticides that we've 12 conducted monitoring for already. 13 I think this list is not unfamiliar to you all. 14 As an example of how will you go about doing the 15 monitoring, I thought I would kind of use one of the 16 pesticides the DPR is going to be talking to you about in a 17 minute. 18 The fact sheet that they're going to be presenting 19 to you is about the fungicide benomyl, so I thought just as 20 a kind of a case study I would show you a little about 21 benomyl. 22 Next overhead, please. 23 This is a map of the monitoring sites that we used 24 for your benomyl monitoring. As you can see, we had 25 samplers here in the town of Pond, two samplers in the town PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 21 1 of McFarland, and one in the town of Wasco. These are in 2 the northwest part of Kern County in the rural areas. 3 And then we would a sampler in the heart of 4 downtown Bakersfield at an ARB air monitoring station and 5 that was our urban background site. 6 DR. SEIBER: Lyn, getting back to John's question, 7 why was this area selected? 8 MR. BAKER: That area was selected -- thank you -- 9 that area was selected because benomyl is a fungicide 10 applied to almonds. This is the county of peak use for 11 benomyl. Almonds were the peak crop of use. And this was 12 the almond growing region of Kern County. 13 So we drove around, after talking with the county 14 agricultural commissioner, we drove around and found schools 15 or a fire station in the vicinity of almond orchards where 16 we expected benomyl to be applied, and then made our sales 17 pitch, you can say, to the school administrators to ask for 18 permission to do the monitoring on their rooftops. 19 So that's the reason for those locales. 20 That concludes the overheads. I have a couple of 21 slides. 22 I think the lower knob. Thank you. 23 Just a couple of slides just to give you an idea 24 of what some of these sampling sites look like. 25 This is a little bit darker than I expected it to PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 22 1 look like. 2 This is the northwest part of the town of 3 McFarland we did the benomyl monitoring. This is obviously 4 an aerial photo. 5 There is a building here that is the learning 6 center, a special learning center for the schools of 7 McFarland. And you can't really see it, but these are all 8 almond orchards just here to the northwest of this learning 9 center. 10 So this would be a typical example of a monitoring 11 site where we would first find the crop and then we would 12 look for the closest public building where we could do 13 monitoring to represent that exposure. 14 But again the question is was benomyl actually 15 used on those orchards. 16 This is another site that we used for the benomyl 17 monitoring. This is the school, the Pond School. You see 18 the school, you don't see the town. The town isn't much 19 larger than the town, actually. The town is just here off 20 the photo. It's a very small town, but the school is 21 surrounded to the east and southeast and southwest by almond 22 orchards, and we had a sampler there. 23 This is what a typical air monitor would look 24 like. 25 Hold on. I didn't mean to advance that. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 23 1 The pump is located down here. It's attached to a 2 flow meter and then the sampling device in this case, an 3 XAD-2 is connected to the end. The tubes are either wrapped 4 with aluminum foil or a little shield to shield the sampling 5 media from sunlight so that the sun doesn't breakdown the 6 pesticide. 7 This one, as you can see, is on the roof of a 8 school, as would be typical. 9 Here's a similar sampler. Here we were able to 10 find a fenced area at a school, so we were able to have a 11 sampler on the ground. 12 This is a co-located sampling site. Here we've 13 got two samplers. This was for both XAD samples for methyl 14 parathion. And again you can see this is on the roof of a 15 school situated close to rice fields where the methyl 16 parathion was expected to be applied. 17 This is a close-up of our sampling device for 18 methyl parathion and chloropicrin. This is kind of a unique 19 situation. This XAD resin bed here was for the chlorpicrin, 20 but in the lab studies prior to going out in the field where 21 for trapping efficiency the methyl bromide was spiked on to 22 the charcoal for trapping efficiency, it was found that they 23 needed two charcoal tubes in series and a third as a backup 24 tube to prevent breakthrough, because the material is so 25 volatile it would go right through if you just had one PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 24 1 charcoal tube. 2 It shows the value of the collection efficiency or 3 trapping efficiency studies ahead of time. 4 This is a sampler on the roof of a background site 5 in Fresno. Shows the ARB's other sampling going on and we 6 just situated a sampler on that roof. 7 And I just have one other example of again another 8 background site. Co-located samplers, co-located with other 9 monitoring going on in El Centro. 10 That concludes my presentation, and I'd be happy 11 to answer any questions. 12 DR. BLANC: I have a few questions. 13 How, for example, since you brought up the 14 question of this one particular substance that you were 15 monitoring in Kern County, and I know we're going to be 16 talking about that later in the day, how for example, did 17 you decide that what you were going to monitor was benomyl 18 and one of its breakdown products, the MBC, but that you 19 weren't going to monitor for example for n-butyl isocyanate, 20 which based on the information provided may be more 21 volatile, less volatile and certainly could be as a big as 22 health issue? 23 MR. BAKER: For my recollection the DPR monitoring 24 request was for just for benomyl and the one breakdown 25 product, not for any other breakdown products. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 25 1 DR. BLANC: So it was based on a request from -- 2 MR. BAKER: From DPR, that's correct. 3 DR. BLANC: So basically it's you're following 4 their orders? 5 MR. BAKER: We follow their request. There have 6 been a couple of cases where an atmospheric breakdown 7 product came to our knowledge and we asked DPR about it and 8 they said, yes, that's a good idea, why don't you look for 9 that as well. 10 There's one case I can think of where they asked 11 for a breakdown product which we concluded would not be an 12 atmospheric breakdown product and then we did not look for 13 that. 14 DR. FUCALORO: Was this the case where the 15 breakdown product, broke down equal amounts, so if you get 16 one, it's essentially -- 17 DR. BLANC: Not necessarily. Because one of them 18 may not be volatile and the other may. 19 DR. FUCALORO: I see. 20 DR. BLANC: For all I know. Certainly based on 21 the data presented I would certainly say that one might have 22 more concerns about -- health concerns about the isocyanate 23 component based on structural similarities to sensitizing 24 agents, for example. 25 DR. SEIBER: But my observation would be, having PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 26 1 looked at a lot of these reports and been somewhat involved 2 in it, that generally the toxic breakdown products such as 3 the oxones of the parathion and methyl parathion have been 4 included. 5 And some breakdown products that you might say 6 would be nice to look for, for whatever reason, either 7 they're very difficult to analyze for, there may be no 8 analytical method, or as you alluded to they may simply not 9 survive, expected to survive from point of formation to 10 release. 11 So I'm not answering your question. I'm just 12 saying these are some factors that occurred in making that 13 decision. 14 DR. BLANC: Unfortunately, for example, when later 15 today we're asked to comment on the fact sheet for benomyl, 16 the answer that we didn't sample for the n-butyl isocyanate 17 because we weren't told to is not going to be sufficient to 18 allow me to pass on the fact sheet, for example. 19 MR. BAKER: I don't remember, it's been ten years 20 since we did that monitoring, I don't remember any 21 discussion back then of the isocyanate. I don't remember. 22 CHAIRMAN FROINES: There are a couple of things 23 that we know. 24 One, that compound is likely to be more volatile 25 than the others. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 27 1 And, secondly, it is likely to be considerably 2 more toxic. Isocyanates are problematic from a standpoint 3 of noncarcinogens and cancer and so it becomes an issue. 4 DR. BLANC: One other question in terms of the 5 list of pesticides monitored to date. 6 MR. BAKER: Yes. 7 DR. BLANC: What's pending, what are you in the 8 development phase of monitoring for? 9 MR. BAKER: Getting ready to do monitoring for? 10 Well, we're just finishing monitoring for the soil 11 fumigant ethoprop in Siskiyou County. 12 We've done monitoring now from the Oregon border 13 all the way down to the Mexican-California border for 14 different pesticides. 15 But we're just starting monitoring for alachlor, 16 which is an herbicide used on corn and bean fields in Solano 17 County. 18 And then the monitoring for next year, the 19 seven -- you want to know for next year? We would be -- 20 we've asked -- been asked to do monitoring for atrazine, 21 bifenthrin, cycloate, diquat dibromide, methamidophos, and 22 phosmet. 23 And we had planned to do monitoring this year for 24 amitraz, which is an insecticide used on a couple of crops, 25 but we were not able to -- our lab was not able to develop a PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 28 1 method that was sensitive enough to detect the pesticide at 2 the requested limited of quantitation. So rather than 3 coming up with results that were of limited value, we 4 postponed it a year. 5 DR. BLANC: And in terms of the list of 6 Agricultural Code Section 14021, chemicals considered toxic 7 air contaminants, that rather than some of these are just 8 chemicals which are not specifically pesticides, they may be 9 formulations of pesticides, but the ones that are 10 pesticides, but don't appear on your pesticides monitored to 11 date, are there -- is there a system wherein even without 12 Department of Pesticide Regulation requests you are 13 proactive in terms of saying, hey, here's something that we 14 need to look at? 15 MR. BAKER: We haven't addressed that yet. We 16 have discussed with DPR and they want to address this as 17 part of their presentation. They, I believe, plan to enter 18 those pesticides that were federal hazardous air pollutants 19 that became toxic air contaminants, they plan to evaluate 20 those for possible need for mitigation, and if they feel 21 there's a need, then they would ask us to do monitoring to 22 get exposure information on those. 23 CHAIRMAN FROINES: So that there's no decision 24 been made up to now to in a sense automatically look to 25 determine whether or not one can conduct monitoring for the PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 29 1 existing HAPs? 2 MR. BAKER: Not the pesticide HAPs, no. We have 3 done monitoring for two, the 1,3-dicloropropene and the 4 methyl bromide, but we haven't considered doing any 5 monitoring for any of the other ones. 6 CHAIRMAN FROINES: A lot of these compounds aren't 7 being used as pesticides though. 8 DR. BLANC: I think, for example, something like 9 maneb, let's say, which doesn't appear on your list of 10 something that you've monitored to date. 11 MR. BAKER: That's correct. 12 DR. BLANC: But does appear on list of toxic air 13 contaminants and is something which is specifically an ag 14 chemical. 15 MR. BAKER: Right. 16 DR. BLANC: I just use one that as an example 17 because it was one of the clearer ones to me if something 18 would be -- one would be exceedingly interested to know 19 about any ambient air contamination. 20 MR. BAKER: That may be something that DPR asks to 21 do monitoring for in the future, for them to evaluate it to 22 determine since it's already been identified for them to 23 determine whether there's a need for mitigation. 24 But as you know, the Air Resources Board doesn't 25 have authority to regulate pesticides, so we wouldn't do PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 30 1 monitoring for a pesticide, for its pesticidal use, without 2 request from Department of Pesticide Regulation. 3 DR. SEIBER: There's two related, mancozeb and 4 ziram, that have been monitored and sometimes it's good to 5 see how compounds that are in the same class would behave. 6 And I don't know the answer, but at least there's 7 some basis already in the record maybe for judging what the 8 exposures might be. 9 CHAIRMAN FROINES: Peter. 10 DR. KENNEDY: Seems sort of basic, but are we 11 going to be given the information regarding the database 12 from which DPR makes its determination about what they want 13 monitored? Seems to be sort of fundamental question. 14 MR. BAKER: I can speak to that briefly. 15 The DPR developed a document in October of 1996, a 16 candidate list for prioritization of pesticides for 17 consideration under the 1807 program, and that document 18 prioritizes pesticides based on use, toxicity of the chronic 19 noncancer, as well as cancer, and volatility. 20 So that each pesticide gets a score for the 21 different parameters, use, toxicity, volatility and they 22 have a ranking system based on that and they are using that 23 for prioritizing pesticides for their consideration and for 24 our requesting monitoring for those pesticides. 25 CHAIRMAN FROINES: I thought Peter was asking PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 31 1 about the results of the monitoring studies. 2 DR. KENNEDY: I just wanted to understand how the 3 targets under study are chosen. 4 CHAIRMAN FROINES: Other comments? Tony? Peter? 5 Jim? 6 I just have one, which is the obvious one from 7 sort of the way you described everything, what is your level 8 of confidence that the values that you determined in the 9 benomyl air monitoring reflected pesticides, benomyl use, 10 during the periods of time you were actually doing the 11 monitoring? 12 MR. BAKER: I think that the ambient data, I think 13 we are pretty confident, represents the exposure that would 14 be out there, considering we did monitoring for four weeks 15 at four different sampling sites in that area. There may be 16 a point somewhere in that Kern County area that would have 17 had a higher sampler, or a higher concentration, but 18 obviously there's a limit to the number of samplers that we 19 can deploy. 20 CHAIRMAN FROINES: But do you know, this might 21 sound like a lawyer here, and I don't want that, but do you 22 know as a factual matter that that particular pesticide was 23 being used on crops during that period of time? 24 MR. BAKER: We detected it in the ambient 25 sampling, so I presume that it was being used. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 32 1 CHAIRMAN FROINES: Well, I don't want to prolong 2 this. But you detected 13 parts per trillion in Bakersfield 3 also. And the highest I think you got in your actual 4 sampling was six. And you had four and six, and so you were 5 operating right within your detection limit of four to six. 6 MR. BAKER: Yes. 7 CHAIRMAN FROINES: You had some values that you 8 thought that were there, as opposed -- even though it was 9 right in the signal noise ratio where you have problems, but 10 you have a 13 part per trillion level in Bakersfield. 11 MR. BAKER: And that's a good point that you're 12 making. 13 It is, I believe, a nonrestricted material or it 14 was back at the time so it could be used by homeowners and 15 it is not a -- there are two or three pesticides that we 16 have seen higher concentrations at our urban background site 17 than we did out in the rural area and we concluded that it 18 must have been due to a homeowner use very close to our 19 urban background site, that led to those concentrations, 20 versus agricultural use somewhat removed from the sites in 21 the rural areas. 22 CHAIRMAN FROINES: But it points out some of the 23 ambiguity about this whole issue that we say on the one 24 hand, well, we didn't find very much when we went out and 25 monitored for four weeks and 24 hours a day and so on and so PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 33 1 forth, so there's not much of a problem. That's the 2 conclusion. But, by the way, in Bakersfield we find 13 3 parts per trillion. 4 Now, what do we do with that? We can ignore that 5 or we can say, yes, there is that pesticide showing up in 6 our monitoring and we need to find out why that occurs. 7 So the issue is, I don't think the issue is 8 entirely clear. I think it points out some of the vagueness 9 of what we're trying to deal with, because if public is 10 using benomyl and it produces ambient concentrations of 13 11 parts per trillion, is that significant in the City of 12 Bakersfield? I don't know. But I know that it's not 13 something you can ignore. 14 MR. BAKER: Right. I don't know what the health 15 significance is of it, so. 16 CHAIRMAN FROINES: Does everybody know what I'm 17 talking about? The 13 parts per trillion is the control 18 number. 19 MR. BAKER: I think you raised a good point. And 20 that I think we, as I said early on, we, I think, have 21 always been assuming that DPR would check with the 22 agricultural commissioner staff if they wanted to find out 23 how close spatially and temporally the pesticide was applied 24 to our sampling. 25 And I can't say for sure that that was done in PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 34 1 every case and it's probably -- definitely something that we 2 should start, but it's probably something that we should 3 have been doing in every case all along. 4 DR. SEIBER: Nevertheless, just to repeat again, 5 there is an application site monitor and you know it was 6 applied then and you know where your samplers were and how 7 the wind was blowing. 8 MR. BAKER: That's correct. 9 DR. SEIBER: That's an excellent check I think. 10 If benomyl doesn't show up under those circumstances, I 11 guess one would be led to conclude that it's not a very 12 good -- its entry into the air or its stability in the air, 13 one or the other, is just not great enough to get exposures 14 at whatever above what your detection limit is. 15 MR. BAKER: During that one -- 16 DR. SEIBER: The real question is whether that 17 detection limit is low enough to dovetail with the health 18 data and say, yeah, there's at least a thousandfold or a 19 10,000 and I guess we'll get into that on the fact sheet. 20 CHAIRMAN FROINES: I think that the issue of the 21 detection limit on short-term sampling becomes really quite 22 crucial. If your detection limit is 150 or 200 or 100 23 and -- 24 MR. BAKER: The level of health significance is 25 well below that then we're -- PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 35 1 CHAIRMAN FROINES: We know -- 2 MR. BAKER: Inconclusive. 3 CHAIRMAN FROINES: You need as a sampling 4 methodology issue figure a way to get the detection limit 5 down so that we can -- you need to know, for example, what 6 important levels of compound might be and look at that in 7 terms of your level of detection. If your level of 8 detection is very high, then in these reports that you write 9 you have to make that clear that you were -- your level of 10 detection was outside the range that had health 11 significance. 12 MR. BAKER: We don't address the health 13 significance in our reports. That would be something that 14 DPR should address. 15 CHAIRMAN FROINES: I understand. But you're here 16 and you're the guy doing the monitoring so you're the one 17 who's the window. 18 And Jean-Mari comes in a second and so the window 19 will get larger. 20 Because what you do is so crucial these kinds of 21 things need to be raised. I think DPR will have lots more 22 information on these other issues. 23 So unless there's more questions, thanks. 24 MR. BAKER: Thank you. 25 CHAIRMAN FROINES: I think what we'll try and do PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 36 1 out of something like this is take the transcript and define 2 a series of action items that we might want to talk about 3 and follow up later with, so that we -- it doesn't just have 4 to be a nice discussion and get lost. 5 Jean-Mari, welcome. 6 MS. PELTIER: Thank you, Dr. Froines. My name is 7 Jean-Mari Peltier, and I'm the chief deputy director of the 8 Department of Pesticide Regulation. 9 And I have to say, I'm not exactly sure how I 10 would respond to the idea that I need a larger window than 11 Lyn Baker, but I guess I'll take it sort of as a compliment 12 because I have along with me today a number of other staff 13 members from the Department of Pesticide Regulation as well. 14 To my immediate right is Dr. John Sanders, who is 15 now the branch chief of the Worker Health and Safety Branch, 16 and was previously branch chief of Environmental Monitoring 17 and Pest Management Branch, which is actively involved in 18 our monitoring program. 19 To his right, sort of, is Doug Okumura, who is our 20 new branch chief of Environmental Monitoring and Pest 21 Management, and he previously to this was the branch chief 22 of the Information Services Branch, and so is very familiar 23 with our pesticide use reporting and the availability of 24 using that data, those data, to review more detailed 25 information about actual applications that may have been PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 37 1 made. 2 And to the far right, my far right, is Dr. Gary 3 Patterson, who is the branch chief of Medical Toxicology 4 Branch. 5 To my left is Dr. John Ross, from the Worker 6 Health and Safety Branch, who is available to discuss with 7 you questions that we may be anticipating with regard to 8 making a call of insignificant exposures. But we can get 9 into that a little bit further. 10 As was probably raised in the questioning that 11 just took place of Lyn Baker, in the prior operation of the 12 department's program and its priorities for monitoring for 13 materials as toxic air contaminants, there's been a basic 14 disconnect between varying statutes that require the 15 Department of Pesticide Regulation to commit risk 16 assessments. 17 Specifically, those include the 1807 statutes, 18 toxic air contaminant statutes, and those of the Birth 19 Defects Prevention Act, or SB 950. 20 And what has happened, we have had sometimes a 21 disconnect between pesticides for which we have been 22 monitoring and priorities within the Medical Toxicology 23 Branch for materials that are going to be upcoming for risk 24 assessment, which are prioritized because of concerns over 25 exposures, most typically to workers. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 38 1 And what we're trying to do is in essence merge 2 these two processes that we have in place for risk 3 assessment within the department and come up with a workable 4 way to assure the steady flow of documents to the Scientific 5 Review Panel for your review as toxic air contaminants. 6 In March we had a meeting with several members of 7 the Scientific Review Panel that was pulled together by the 8 Air Resources Board and we felt that that was a very very 9 helpful exchange and we think is the start of what we hope 10 to be a rather aggressive agenda for movement of pesticides 11 through this panel in the upcoming 12 months. 12 Let me outline what we have proposed, and I 13 believe that there were a series of documents that were sent 14 to the panel from the Department of Pesticide Regulation 15 within the last several weeks. 16 Let me clarify that at this point it's our 17 intention that our discussion today focus not on the 18 specific scientific questions raised in the individual 19 documents, including the DEF document, the document on 20 molinate, and the fact sheet on benomyl, but rather to use 21 those as samples of prototypes of the kinds of the format 22 that you'd be seeing in documents that will be forthcoming 23 to the SRP this year. 24 Specifically, what we're -- what we have 25 traditionally done is followed the format that the Air PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 39 1 Resources Board has established with the SRP in preparation 2 of the documents. That included preparation of the 3 four-part document, including an executive summary, the 4 environmental fate, a risk characterization document, and 5 finally an ambient air exposure document. 6 What ended up happening was that preparation of 7 those documents was done on a separate track from what we 8 were doing under our risk characterization documents that 9 under the regular 950 process, the Birth Defects Prevention 10 Act. 11 In the interest of moving documents through to 12 you, what we are proposing to do, and if you follow through 13 along on the left-hand side of the chart here, is that we 14 would take the risk characterization documents that are 15 completed for purposes of the 950 risk assessment and add to 16 those an addendum that would cover both an exposure 17 assessment and an environmental fate assessment as a 18 separate addendum to that traditional risk characterization 19 document that we filed. 20 At that point we would be sending the addendum to 21 a OEHHA and to ARB for review. 22 When those are returned to DPR from OEHHA, that 23 will trigger the 90-day process to complete our draft for 24 public review, which would then ultimately -- we would 25 forward to the public for review and along with a PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 40 1 complimentary copy to SRP at that point. 2 Then we would send a final draft document to the 3 SRP which would trigger the 45-day review on your part to 4 determine whether or not our science was seriously 5 deficient. 6 And then depending on what the findings are there, 7 the director of the Department of Pesticide Regulation would 8 make the call whether this material should be listed as a 9 toxic air contaminant and whether it required additional 10 steps of mitigation. 11 That's the process that we would see flowing 12 through from this point forth for those circumstances where 13 we've conducted ambient air monitoring, and will be 14 completing the new process with you with the risk 15 characterization document and the addendum. 16 There are some materials that were originally 17 identified as candidate toxic air contaminants, which are 18 either no longer registered in California, are used in very 19 insignificant quantities. In many cases we've had 20 situations where as we've walked through this process, uses 21 have been severely curtailed from where they were when we 22 originally created the original list of candidate toxic air 23 contaminants. 24 Or there are situations where the ambient air 25 monitoring resulted in no detections. In those cases, we PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 41 1 would propose going with a much streamlined process where 2 instead of the complete risk characterization document, 3 along with the full addendum, on exposure assessment and 4 environmental fate, we would propose instead to have a 5 four-page document, a prototype of which you have before 6 you, with, as was previously discussed, this was the benomyl 7 document. 8 Finally, there is actually a third process that 9 also will be in place, and that is for those documents which 10 we have already started down the path of creation of what 11 I'm calling the classic set of documents, those four that I 12 described earlier, with a executive summary, EV fate, the 13 risk characterization document and ambient air exposure, and 14 there are two materials that the Department of Pesticide 15 Regulation plans to submit to the SRP this year for your 16 consideration. 17 One of those is DEF, a cotton defoliant, and the 18 other is methyl parathion, a material that was submitted to 19 this body about two and a half years ago, maybe longer, that 20 we will be at the end of this summer sending you the final 21 draft report on. 22 So in summary what we're looking to do is create a 23 streamlined process that will allow us to use documents that 24 are already being prepared for purposes of the Birth Defects 25 Prevention Act, but highlight those exposures in the ambient PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 42 1 air, since in order to be classified as a toxic air 2 contaminant, we're looking at ambient air exposure patterns, 3 and then also a more streamlined process for those products 4 which don't seem to meet the criteria for listing as a toxic 5 air contaminant rather clearly. Either they're no longer 6 being used, minimally being used or there were no 7 detections. 8 We have set forth and have committed and plan to 9 commit to you to submit a total of 12 pesticides for 10 consideration by the Scientific Review Panel between now and 11 this time next year. 12 And I think that it would be helpful to us if we 13 can talk with you about how best we could manage the flow of 14 those documents to you, so that they can be handled in an 15 expeditious way, and in a way that allows them to be 16 considered most fully. 17 What I might suggest is the categories of 18 pesticides that we have before us fall into a couple of 19 different areas. 20 First, we have the DEF document and methyl 21 parathion, both of which will be available to submit to you 22 by the end of this summer, and we can talk about 23 establishing a meeting sometime in September for 24 consideration of those two materials. 25 Beyond that, there are three pesticides which fall PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 43 1 into the category of fumigants that are going to be 2 submitted for your review. 3 Two of those, methyl bromide and telone have 4 already been listed as toxic air contaminants. 5 The third, MITC, or metam-sodium, has not yet been 6 listed as a toxic air contaminant, but all three are 7 materials that are used as pre-plant soil fumigants and may 8 have application as well as post-harvest fumigants, and we 9 may want to consider the possibility of exploring handling 10 those within a different format. Perhaps you might be 11 interested in considering using the format of a workshop for 12 considering those materials, and we can discuss that with 13 you. 14 The other materials that are going to be coming 15 forth to you, if we can have the next slide. 16 DR. SEIBER: I'm fumbling on the job. 17 MS. PELTIER: Well, mine is such a formal 18 presentation, I have a total of two overheads, and no 19 formulas. 20 As I mentioned before, we have the DEF and methyl 21 parathion document, both of which are going to be in the 22 format that you're traditionally used to receiving. 23 We have the benomyl which we would be preparing a 24 fact sheet on. 25 Let me have one point of clarification. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 44 1 The prototype fact sheet that we sent to you has 2 not yet gone -- or has only recently gone to the Office of 3 Environmental Health Hazard Assessment for their review, so 4 our submission of it to you today was not for your full 5 scientific review, but rather to give you an idea of what we 6 would propose that to look like. 7 Anyway, so we do have at least two materials that 8 we think are going to fall into the category of a fact 9 sheet, at least at this point. One is benomyl, the other is 10 thiabendazole, and that one is still in the category of 11 decision pending, but we're thinking that's a material thats 12 use has been curtailed back to really just being a 13 post-harvest fungicide and it may well end up falling into 14 the category of just a fact sheet. 15 Then beyond that we have a number of materials 16 that we believe will fall into the category of full report. 17 We have the molinate document that will be ready to submit 18 to you very shortly. We have naled, azinphosmethyl, 19 chlorothalonil and endosulfan. 20 So before us are what we would like some reaction 21 from the panel is, one, an agreement that first that this 22 idea of reformatting of the materials for submission to you 23 would be an acceptable and effective way for you to review 24 the documents. And then, secondarily, I think it would be 25 helpful from our perspective to walk through what would be PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 45 1 the most practical way to try to manage the flow of these 2 documents through to you for your consideration over the 3 next 12 months. 4 Let me have one final point of clarification with 5 regard to the comments that were made previously about 6 materials that have already been listed as a toxic air 7 contaminant by virtue of the fact that they were listed as a 8 hazardous air pollutant federally. 9 We are proposing that we prioritize those 10 documents -- those pesticides for monitoring, if monitoring 11 has not already taken place. We will be prioritizing those 12 for additional monitoring, based on our schedule for risk 13 assessment under SB 950. 14 There is a panel that is created consisting of a 15 representative from the department's Medical Toxicology 16 Branch, its Worker Health and Safety Branch, as well as a 17 representative from the Office of Environmental Health 18 Hazard Assessment, that would be setting up a priority list, 19 agreeing to a priority list, of materials that are listed as 20 hazardous air pollutants, toxic air contaminants, and 21 setting up a priorities system for moving those into 22 monitoring as well. 23 DR. BLANC: Could we go back to the previous 24 overhead? I'd like to get to one of the questions you were 25 asking. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 46 1 It's unclear to me in this flow diagram. Let's 2 take a scenario where a draft document in the A category is 3 presented to us, a document which has been prepared under 4 the Birth Defects protocol with appendices relevant to air 5 exposure, and this Scientific Review Panel has serious 6 content problems with it. 7 Where is it that we review it and send it back to 8 you in need of serious revision? 9 MS. PELTIER: If you look at the one, at least 10 it's on this, that is directly above the bottom line, the 11 one that says that DPR director determines materials are 12 toxic air contaminant, right before that it says the 13 Scientific Review Panel makes a finding that material is -- 14 if you make a finding that it's seriously deficient -- let 15 me turn this on. I'm really good at these technical -- is 16 that on? 17 I apologize. I lost my glasses somewhere between 18 Washington, D.C. and Chicago last week, so if I look like 19 I'm squinting, I am. 20 At that point if you submit statements to us that 21 a report is seriously deficient, I believe the department 22 has a 30-day period for return of that document to the SRP. 23 John? I believe that's correct. 24 So that loop flows through back at that point. 25 And, you're right, the flow chart doesn't capture PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 47 1 that. But we do have a responsibility to respond to the 2 SRP. 3 DR. BLANC: Is that a different scheme than how 4 non-pesticides are handled? I mean, it seems to me for 5 example with the lengthy back and forth on the diesel 6 exhaust document, there were many steps at which material 7 came forward to the SRP and we could ask for clarifications 8 rather than at the very end of the process either accept or 9 reject. 10 DR. GLANTZ: From a formal point of view, the 11 diesel report was only formally presented to us once and had 12 we found it seriously deficient, they would have 30 days or 13 60 days, whatever the length is, to fix the deficiencies. 14 Now, it happened that what we did, given the 15 complexity of diesel, was we had several informal 16 discussions and presentations to raise the issues, so we 17 could avoid a finding of serious deficiency when it formally 18 came to us. 19 But I think, and correct me if I'm wrong, I'm 20 looking at this process when the complimentary copy is 21 forwarded to the SRP that we could, if we wanted, have a 22 meeting and discuss it and forward suggestions and comments 23 to DPR, just as we did with diesel. So that these issues 24 could be ventilated before the formal presentation of the 25 document for a vote. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 48 1 I mean is that -- 2 MS. PELTIER: That's exactly right, Dr. Glantz, 3 and that's one of the details that we would like to work out 4 with you today in consideration of how we might accommodate 5 those flows of questions that inevitably are going to come 6 forward. 7 DR. SEIBER: Maybe complimentary copy is not a 8 good term. Maybe it ought to be informal copy or something 9 of that type. 10 But in the past, as a panel we have assigned 11 people, lead people, to look at different parts of the 12 documents. 13 And I guess my question would be, assuming that we 14 can continue to do that, would there be an opportunity and 15 how would you see this operating where the lead people might 16 get some preliminary documents, look and have a question, 17 could they go back and talk to the appropriate DPR people to 18 get those clarified? 19 And I think that's the way the panel has liked to 20 operate in the past. 21 MS. PELTIER: I think from our perspective we 22 would like to be able to accommodate that as well. We've 23 been talking amongst ourselves about how to handle that most 24 efficiently and I'm sure we can accommodate that. 25 I understand that traditionally there has been a PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 49 1 point person on exposure assessment and on toxicity 2 assessment, and we have a similar situation here with our 3 branch chief of Worker Health and Safety that does the 4 primary work and exposure assessment, and then the branch 5 chief with Medical Toxicology, which could serve as a 6 conduit for bringing together the right staff to talk with 7 you. 8 DR. GLANTZ: I think that would be very -- I think 9 that's proven to be a very efficient mechanism. 10 The way we did it or do it is to have the chair 11 designate two, usually two, sometimes more, lead people and 12 then they have been -- had access to the drafts as they were 13 redeveloped and served as sort of informal consultants to 14 the OEHHA and ARB in producing the documents to make sure 15 that at least the more obvious problems got addressed before 16 the document came forward. 17 And I think that has proven to be very useful, I 18 mean for the compounds I've been connected with. I mean, 19 we've seen the preliminary drafts and been able to say, 20 yeah, this looks good, or, you know, or Witschi will go 21 crazy when he sees this part of it and you better fix it, 22 something like that. 23 CHAIRMAN FROINES: Just one point of 24 clarification. 25 One of the things, at least I don't know what PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 50 1 other's experience have been, but on the health effects 2 side, I tended to interact directly with George Alexeeff 3 when he was the head of that unit. 4 Now, there are times when I met with four and five 5 staff people as well. Methlyene chloride toxicokinetics, 6 for example. 7 But basically there was a point person for the 8 agency who the lead person interacted with. That didn't 9 preclude working with other staff members, but it's, I 10 think, it's useful to have two point people who relate to 11 each other and then identify other resources as they need to 12 be identified. 13 MS. PELTIER: And I think that would be the same 14 parallel process that we'd looking at with DPR. 15 We, in addition to this undertaking with the 16 Scientific Review Panel and the 12 materials that we plan to 17 be submitting through to you, we've also committed to the 18 Legislature that we're going to be completing 35 risk 19 characterization documents under SB 950, the Birth Defects 20 Prevention Act, this year. 21 And so we have a very ambitious schedule, a lot 22 underway and certainly going through the coordination of 23 having as a point of contact in particular our branch chief 24 of Medical Toxicology would be helpful to us so that we can 25 make sure that we have an efficient way to respond to you PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 51 1 without slowing down our process and getting those RCDs 2 completed. 3 CHAIRMAN FROINES: I think that one thing is 4 important. We are used to a certain kind of document. For 5 example, the health effects document always tells us what's 6 EPA position on the document, what's the National Toxicology 7 Program, what's IARC doing, and so on and so forth. So you 8 get a sense in those documents of what other federal and 9 international agencies are doing. So we're used to that. 10 That wasn't in the molinate document, at least I 11 didn't find it. 12 So we have a way of looking at things and it may 13 be that we want to take a document like molinate, go through 14 it with some care and say use it as a model and then say we 15 would prefer to see things look this way and this way and 16 this way and then come to some agreement as to how they 17 would look. 18 And without going into detail I had a number of 19 comments that I think are just -- they're issues of how one 20 presents information. 21 And the question I guess is do you want to do that 22 in a formal session? We can do that informally. 23 Or I think we do need to take an example and work 24 through it in a way so we all agree what -- so we know what 25 we're getting in a sense. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 52 1 MS. PELTIER: I think we can probably handle that 2 informally, I think might be preferable. 3 With regard to the idea of what other bodies have 4 said about the material, any of the risk characterization 5 documents that you will be receiving will have been peer 6 reviewed by US EPA and we can certainly make their comments 7 available. 8 They also have been peer reviewed by OEHHA and 9 their report of their comments would necessarily be a part 10 of the package that would be submitted to you. 11 We could also extract for you, I understand that 12 in the past materials, the key scientific questions have 13 been extracted and if that would be helpful. And unless I 14 misunderstood that. We can work with you to outline how we 15 might pull together those kinds of information as well. 16 DR. BLANC: I'm a little confused at this time. 17 When we have time on our schedule today for 18 discussing, as the agenda reads, for discussing let's say 19 the prototype molinate document, we're still going to be 20 having that discussion. 21 I've heard you say that one thing that you'd like 22 to get out of that discussion would be our feedback on 23 structure and process, more than context. 24 But what I've heard John say is that it is 25 difficult to separate out process and structure from PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 53 1 content, because without discussing some of the contents 2 it's difficult to bring home the problems, potential 3 problems, or potential strengths of the structure and 4 process. 5 Is that correct? 6 So now I need to hear some -- these two statements 7 are not necessarily consistent with one another. 8 DR. GLANTZ: No, I don't agree with you. I think 9 they're completely consistent. I mean, I think the way you 10 talk about the structure and process of the report, we're 11 talking about the content of it at the same time. What 12 content we expect to see in the report. 13 I mean, isn't that what you said, John? 14 CHAIRMAN FROINES: Say it again. 15 DR. GLANTZ: I think my understanding is when 16 we're talking about the structure and the process of how we 17 were going to proceed, part of that issue is what's going to 18 be in the report, how are the reports going to be 19 structured. So I don't see there -- I don't see a 20 difference between these two points. 21 CHAIRMAN FROINES: I feel that one of the 22 principle issues is the transparency, and that is when we 23 read the report we need to know how one ended up deriving 24 whatever conclusions are derived. The two need to be 25 related. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 54 1 So if I read a whole series of toxicologic 2 studies, or I look at the conclusions about toxicologic 3 studies, then the data on those studies needs to be in the 4 document so I can look at it and see if it makes sense to 5 me. I need to know that in the control there were five 6 cancers out of 50, there were 25 cancers in the first dose 7 level and 50 cancers out of 50 in the high dose level. That 8 kind of information it needs to be in here so that we have 9 the scientific basis for the conclusions. 10 So that's not going to the substantive issue of 11 molinate, but it's a procedural issue. 12 In other words, we need to have the information in 13 the document that doesn't require us to go back and read the 14 primary literature, prior to making decisions. The more we 15 can read the primary literature, I think the better, but the 16 document has to in a sense stand on its own face. 17 MS. PELTIER: Dr. Froines, if I might, I believe 18 that Dr. Patterson could speak specifically to that point. 19 DR. PATTERSON: I think in most cases what with 20 the 950 style, we do include tables and incidence rates in 21 there. 22 CHAIRMAN FROINES: I've been through these 23 carefully. There are problems from my standpoint of the 24 document. They're not unresolvable. They are just things 25 to work through and come to some agreement about. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 55 1 And the issue is what's the best form for that. 2 Some of that should be done informally. Some of it can be 3 discussed today and see where we get to. 4 MS. PELTIER: I might suggest further that as we 5 have discussions with you when we have the two point people 6 established, we can even walk through it and it can be kind 7 of an evolving process as well. 8 DR. SEIBER: Maybe this is a good time to go back 9 to your comment about a workshop. Is this a good time to 10 talk about that? 11 CHAIRMAN FROINES: One of -- there's ways, there 12 are things in the document which represent the way the DPR 13 folks think about some of these issues. They are not 14 necessarily the way we think about them. And at some point 15 we need a little bit of a roadmap to understand some of 16 those differences more clearly. 17 I don't know that that's the way to do it. 18 And I'm -- I don't want to give you some examples, 19 because it will slow everything down, but there are 20 differences in the ways the data is presented that we're 21 used to and we need to sort of -- we need to come to some 22 common language and expectation, I think. 23 DR. SEIBER: We went over that a little bit with 24 the DEF. Remember, the DEF document went through a change 25 to get into the format that we were more used to looking at. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 56 1 We had this elements of this discussion before. 2 But I thought Jean-Mari's comment about a 3 workshop, particularly focused around the three fumigant 4 materials, was worth discussing. 5 And from my point of view I think that is an 6 efficient way to handle, particularly when we've got 7 chemicals with some similar aspects like the three 8 fumigants. So I would support that. 9 I'm not sure how that workshop would take place, 10 so I guess I would ask the question, can you be a little 11 more specific in what you had in mind and how that would fit 12 into the 12-month process? 13 MS. PELTIER: I might suggest that the way we 14 would handle it is sometime in the middle to late fall that 15 perhaps what we would do is handle, first, those two 16 documents which have been formatted in a way you're most 17 accustomed to, the DEF document and the methyl parathion 18 document. 19 Then we could use the workshop to both walk 20 through the process that we go through and the way that DPR 21 typically conducts its risk assessments and, if you will, 22 kind of walk through our lexicon and the way we approach 23 risk assessment, with an idea of both about talking about 24 our process and about the specific documents as fumigants. 25 We could -- you could then make a decision to PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 57 1 formally review those three documents, separately or as part 2 of that workshop process. 3 DR. BLANC: I think we should perhaps see a little 4 bit how the discussion goes on the documents, the 5 prototypical documents that we have in terms of how that 6 shows how close we are to needing that part of it, the 7 walking through the process again. 8 MS. PELTIER: Our interest here, once again, is 9 that we've had an unfortunate situation in dealing with the 10 SRP where the typical risk characterization document that we 11 conduct that we have been working on harmonizing both at the 12 national level and internationally through NAFTA 13 harmonization discussions, that typical format didn't follow 14 what you were accustomed to seeing and so what we're trying 15 to accommodate here is a way to use the existing risk 16 characterization document and then highlight once again the 17 exposure component and the ambient air monitoring studies so 18 that we can, to the extent possible, use the regular format 19 that we've worked out with US EPA and others in risk 20 characterization to fit your needs. 21 DR. BLANC: Again, this may become clearer in the 22 discussion of molinate, but my take on the draft molinate 23 document is, although there are some problems potentially 24 with the structure of it, I'm not particularly invested in 25 the format of the document, and I'm sure that the format PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 58 1 that you used for whatever purposes for the reproductive 2 with very focused appendices related to air exposure data, 3 will be more than sufficient. 4 What I am very concerned about having seen this 5 document is in fact that the science and the conclusions are 6 very troubling in certain key areas. 7 So that's why I raised the question earlier about 8 where is the feedback happen, and it may be in fact that 9 whatever review process you have been getting for the 10 reproductive regulatory process that you've had has not been 11 coming at the questions from the same point of view that 12 this panel may come at. I don't know. 13 But I certainly have real content questions about 14 what's here. 15 And I don't care if something has a section 16 heading called X or Y, so much. 17 So that's where I'm coming from. 18 MS. PELTIER: If I can ask, Dr. Blanc, is that in 19 the area of -- are your concerns primarily in the way that 20 we've characterized the toxicity of the material or rather 21 in the area of exposure? 22 DR. BLANC: It really has to do with toxicity, 23 from my point of view, and how you've handled what you're 24 treating as the lowest -- the low and some other matters. 25 I do have some questions about how the document is PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 59 1 organized, but I can still plow through that. I prefer to 2 save this discussion for when we get to the document itself. 3 It certainty does taint my take of what we should 4 be having workshops on and what the process is. 5 I don't know. I'll defer to the chair on this. 6 CHAIRMAN FROINES: Quiet crowd today. Are there 7 other comments? 8 DR. FUCALORO: Well, I thought I understood you 9 to, when you first made your comments, Paul, to mean just 10 what you just said. I think I understood you right away. 11 You had problems clearly with the content of this molinate 12 document. 13 The question obtains then still with the SB 4 are 14 we to consider the content today, or are we just looking at 15 we're looking at the structure in the form of the 16 presentation? I mean, I think that question has to be 17 answered. 18 CHAIRMAN FROINES: My sense is that we are kind of 19 operating at two levels, one of which is it seems to me to 20 be not -- we don't want to bury DPR in technical comments 21 today, because I don't think they saw that as the goal of 22 this, and so I think we should respect that. 23 I think that to the degree that criticisms or 24 comments are made about the document should be seen in the 25 context of how can we improve the documents that we're going PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 60 1 to have come forward to us and we can go back later and 2 revisit the technical, more technical issues. 3 But raising technical comments is informative, I 4 think, in terms of helping DPR then think about how they 5 want the documents to look, and having that be a separate 6 issue to some extent from the specific scientific issues. 7 Am I being clear? 8 MS. PELTIER: I think so. From our perspective, 9 let me just respond on the issue at the molinate document. 10 What you have before you is a risk 11 characterization document that has gone through peer review. 12 It was reviewed by US EPA and by OEHHA. 13 The second component of it, the ambient air 14 monitoring -- excuse me, the environmental fate component of 15 that molinate document didn't undergo peer review. 16 And so where we are in that process is that this 17 is a document that was truly given to you for purposes of 18 looking at format. 19 DR. SEIBER: I think, John, I understood that they 20 were prepared to make a presentation. I think a lot of 21 these things will fall into line if we let them go ahead 22 with their presentation on molinate. 23 And I guess you have one on benomyl as well. 24 CHAIRMAN FROINES: I'd like to go ahead too. 25 But I would like to get a agreement among the PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 61 1 panel that we move ahead to plan a workshop on the telone 2 and methyl bromide and the third compound, what is it, MITC. 3 DR. FUCALORO: As long as it's in Southern 4 California. 5 CHAIRMAN FROINES: And I think on this one, unless 6 there's some persons who have a very strong interest in 7 these two compounds, I would propose that Jim and I be the 8 lead persons on that, because I'm very interested in the 9 fungicide issue and so is Jim, and I'll do the health and he 10 does the exposure. 11 DR. SEIBER: On what? 12 DR. GLANTZ: Everything. 13 CHAIRMAN FROINES: Tell him to be a lead on 14 exposure one, we know what your -- 15 Jim and I will meet with your staff to work out 16 how we proceed with that workshop. You know, this panel has 17 had its own workshop for the first time in history, and 18 based on what Craig Byus said this morning feels that was 19 very successful. 20 We've also had workshops where 90 percent of the 21 panel didn't show up and so the panel never necessarily saw 22 those as their own. 23 And so we have some -- we're still figuring out 24 what our sort of policy on these is in fact. 25 But I think that we would -- I would seriously be PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 62 1 interested in deciding who are the scientists who could 2 provide useful information at a workshop of that kind. I 3 don't think it needs to be limited to the people at DPR or 4 OEHHA. I think to the degree we can identify strong outside 5 scientists, we want to include them. 6 Tony? 7 DR. FUCALORO: No, fine. 8 CHAIRMAN FROINES: Stan? 9 DR. GLANTZ: Okay. 10 CHAIRMAN FROINES: So we're agreed that we move 11 ahead on the workshop. 12 DR. SEIBER: Just to finalize that, so the two of 13 us would work with DPR staff in planning the workshop, is 14 that the idea? 15 MS. PELTIER: And the focus of that workshop would 16 be to look primarily at the three fumigants that will be 17 moving through to you, with the idea both of walking through 18 the detailed information, both the science there and process 19 wise, what those materials -- the format those materials 20 would be coming through to you on. 21 DR. SEIBER: And the science. 22 MS. PELTIER: And the science. 23 DR. BYUS: The science is the most important. I 24 think we're all willing to change our format. We're not 25 totally creatures of habit, but we're willing to change PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 63 1 format. At least I certainly am. It's simply the science 2 is the main question. That's what you really have to be 3 sure that we can make judgments based on the information 4 we're provided. That's the main issue always. I would be 5 surprised if that wasn't. 6 CHAIRMAN FROINES: We also have to deal with 7 context too, because methyl bromide has effects on ozone, so 8 it's undergoing a whole process separate from what we're 9 talking about here. So we need to be cognitive of the fact 10 that some of these things there are a number of factors that 11 are operating that we need to be aware of as we move 12 forward. 13 DR. BYUS: I just have one question about the 14 public comments. I mean you say you're going to submit 15 them. Will you write them up the way that OEHHA has done 16 and respond to them formally or is that your procedure or -- 17 MS. PELTIER: We would intend to do that. I'm not 18 sure how you received the copy of the information on the DEF 19 document. In that particular case it has gone through a 20 public comment phase and we received only one comment which 21 was from the registrant. And I had thought a copy of that 22 letter had been sent along to you, but in speaking with 23 another one of the panel members, I'm not clear that that -- 24 DR. FUCALORO: I believe it was. At least I 25 recall it. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 64 1 DR. GLANTZ: I think that as the process is going 2 to -- if you only get one comment, that's fine. If you want 3 more comments, do tobacco or diesel. 4 But I think that actually having -- there's a Part 5 C of the report in the ARB format, which actually either 6 presented directly or summarized the public comments and 7 provided a point-by-point response. I think it's very very 8 helpful, because the public usually reads these reports much 9 more carefully, the interested public, than anybody else and 10 I think hearing what they have to say and how you respond to 11 it is very helpful. 12 DR. FUCALORO: You mean the economically 13 interested public? 14 DR. GLANTZ: Well, no. But last time the diesel, 15 the environmental groups actually put in some public 16 comments too, which I thought were very helpful also. 17 So I would say as part of your -- if we're talking 18 about the procedural issues, I'd like to see a Part C or 19 Part D, whatever, that would fit into this which either 20 presents the public comments directly or in the case of like 21 with diesel and secondhand smoke they were so voluminous 22 that they were summarized and responded to the salient 23 points. I think that should be part of the process. 24 And if you only get one comment then, fine. If 25 you get no comments, fine. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 65 1 CHAIRMAN FROINES: I want to raise a sticky issue, 2 because what we're doing here is in fact slightly different 3 that we've done before, and that is that you've sent your 4 draft document to OEHHA and ARB for review and 5 recommendation. We don't have that in the 1807 process with 6 ARB and OEHHA. There's no third party in this case, as 7 there is here. 8 So I'm assuming that the draft, that the comments 9 from OEHHA and ARB become part of the document that the 10 panel would receive. 11 MS. PELTIER: That's correct. 12 CHAIRMAN FROINES: So we're not trying to create 13 interagency fratricide, but it's useful to have comments 14 from the other agency, since they play such an important 15 role. If that's okay with you, I think we prefer that. 16 MS. PELTIER: We would anticipate doing that. In 17 addition, if you're interested in it, we also, since we're 18 sending it out to US EPA, we could also provide you copies 19 of their comments as well. 20 CHAIRMAN FROINES: Yeah. Given EPA's track record 21 lately, I'd just as soon go to the State folks, but in 22 principle that's a good idea. 23 All due respect to Mr. Chiverra from EPA. 24 Is George here? 25 Is Melanie back there? PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 66 1 George, you didn't hear what was just said, but do 2 you agree? 3 DR. ALEXEEFF: I don't know. Am I supposed to 4 agree? 5 MS. PELTIER: The answer would be yes, George. 6 CHAIRMAN FROINES: The yes word. 7 DR. ALEXEEFF: Yes. No, I don't know. 8 CHAIRMAN FROINES: Before we move to the next two 9 documents, can we take a ten-minute break. 10 (Thereupon a short recess was taken.) 11 CHAIRMAN FROINES: I'd like to reconvene. We're 12 set to go. 13 DR. GLANTZ: I just had, I wanted to clarify a 14 point about the public comments and the comments from the 15 other agencies. 16 When I was talking about having the public 17 comments and the responses to public comments come forward 18 to the committee, the way that's been done in the past is 19 the comments have come into OEHHA and ARB from other 20 government agencies and those were just presented to us with 21 the public comments, which I think EPA, things, or local 22 government districts. 23 What I would suggest you do is since you're going 24 to be getting comments from ARB and OEHHA that you just 25 handle it that way, so that we can actually see what their PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 67 1 comments were and how you responded to them. 2 And I think that was implicit, but during the 3 break in talking to some people there are some concern about 4 that. 5 And also just again what I had assumed is that for 6 the documents that are coming forward where you're doing 7 your risk characterization document with addendum, that we 8 would get all the comments that were submitted on the whole 9 thing, not just the addendum. 10 So is that -- I just want to clarify that. 11 MS. PELTIER: Let me take the first question 12 second and the second question first. 13 With regard to the peer review and the rest of the 14 comments, we would intend to give them to you on the entire 15 document. 16 And certainly with regard to your first question, 17 we could certainly include one section that covers both the 18 comments of OEHHA, EPA and the public. 19 I would just point out that we would plan to give 20 you a document and early copy that wouldn't necessarily have 21 all the public comments in it yet. So you'd have an earlier 22 draft that is not a complimentary draft, but whatever it is 23 we decide to call it, informational draft, would have the 24 section in it that would already have OEHHA's comments and 25 EPA's. And the public comments come later in the process. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 68 1 DR. GLANTZ: And that's the way it has worked with 2 the other documents. 3 I just wanted to make sure that because some 4 people I talked to were concerned that we were just talking 5 about the addendum. And I had understood that we would be 6 talking about the comments on both the RCD and the addendum. 7 MS. PELTIER: Absolutely. 8 CHAIRMAN FROINES: The RCD will tend to emphasize 9 reproductive and developmental toxicology. Is that correct? 10 MS. PELTIER: If I may, Dr. Froines, what I'd like 11 to suggest is that the way we would like to walk through the 12 next portion of the agenda is to call on Dr. Gary Patterson 13 to walk through what elements you should expect and our 14 risk -- our traditional risk characterization document. 15 Then I'll be calling on Dr. Sanders to give you 16 further information about the elements of the environmental 17 fate component that would be in the addendum. 18 And then on to John Ross to characterize the 19 exposure assessment component of our document that we'd be 20 putting forth. 21 If I could, then I would call on Dr. Patterson, if 22 that's acceptable to you. 23 CHAIRMAN FROINES: Fine. 24 DR. PATTERSON: Basically the answer to your 25 question is it does not focus solely on reproductive and PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 69 1 development. We go across the full gamut of the toxicology 2 spectrum. 3 And basically what the RCD contains is we go 4 through a background information on the chemical. We look 5 at the history, the regulatory history, formulations that 6 may be registered in California, once that may no longer be 7 registered. We look at physical chemical characteristics, 8 report on the illness reports. 9 And then we roll into the toxicology profile from 10 the studies that we have on file in the department and also 11 within the public literature. Those would be on acute 12 toxicity, subchronic toxicity, chronic toxicity, 13 reproductive, developmental neuro tox studies, metabolic 14 studies. 15 And at that point then we move to synthesized to 16 look at the NOELs, the effects that are out there, and move 17 it into what we would call our hazard identification 18 section. 19 And then it's at that point that it goes over to 20 the exposure assessment is brought into it. 21 DR. ROSS: This is John Ross with the Worker 22 Health and Safety Branch, DPR. 23 For the exposure assessment portion we utilize 24 exposures or calculated exposures dependent on the end 25 points of concern and those typically are acute, subchronic PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 70 1 and chronic. And we will calculate exposures for the acute 2 scenario from the highest ambient air concentrations, using 3 child's breathing rate typically. 4 Molinate was an exception, because for that end 5 point it was reproduction specifically, and children don't 6 reproduce. 7 So there are exceptions to the rule in terms of 8 what we typically use for breathing rate. 9 We'll calculate chronic exposure for an adult 10 using the average ambient air concentration over the 11 four-week period that's been monitored by ARB, and using 12 typical body weight and breathing rates as specified by US 13 EPA exposure factors. 14 DR. SEIBER: May we ask questions? 15 Let me just ask you, Dr. Ross, the average 16 four-week, you mentioned you use the average exposure rate. 17 Do you consider, say, the 90 or 95th percentile? Do you 18 take -- also look at a, let's say at the high exposure end 19 as well as the average? Is it only the average? Is there 20 any guidelines on how you proceed with that? 21 And I guess I could ask the same question about 22 adult body weights. Is there some sliding scale there as 23 well to kind of get at this idea of maximumally-exposed 24 individual and kind of worst case scenario. Is that part of 25 it or is it strictly averages? PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 71 1 DR. ROSS: For subchronic and chronic we use 2 averages and that's because over an extended period of time 3 we expect there to be an average air concentration. 4 If you're looking at a subchronic or chronic end 5 point it's over 90 days to a year. 6 And the average is probably the most appropriate 7 in terms of air concentration. 8 As far as the maximally exposed individual, by 9 utilizing a child's breathing rate, we're using the maximum 10 respiration rate per body weight, basically for a 11 six-year-old child. 12 And we typically use the maximum adult breathing 13 rate for the adult male. 14 So I think those are generally taken into account. 15 Lyn pointed out that we used the average for the 16 highest site. We don't use the average of all four or five 17 locations. 18 DR. SEIBER: Okay. 19 DR. SANDERS: John Sanders with the Worker Health 20 and Safety Branch. 21 I'll just briefly go over what's included in the 22 environmental fate document. 23 We generally include a description of the 24 application methods. In other words, is this primarily 25 applied by air or by ground? That can have some effect PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 72 1 about whether it's actually into the atmosphere or the 2 ambient air. 3 We talk about the historical use patterns over the 4 last few years, where it's used, what counties have the 5 highest use, and what the number of pounds that are used. 6 We also talk about the populations that occur, 7 where the highest use occurs of the compound. 8 And then there's a description of the persistence 9 and fate in the environment in the various media. 10 And then a discussion of the airborne 11 concentrations that were -- that ARB had monitored for or 12 other monitoring studies that might be available in the open 13 literature, other sources. And those airborne 14 concentrations are then fed into the exposure assessment. 15 CHAIRMAN FROINES: Just in terms of understanding, 16 this is in the context I think of the molinate document? 17 DR. SANDERS: Yes. 18 CHAIRMAN FROINES: So everything you just said is 19 that what's contained in the human pesticides exposure 20 assessment section? 21 DR. SANDERS: No. Environmental Fate of Molinate. 22 CHAIRMAN FROINES: I'm sorry. Is that -- 23 DR. SANDERS: Draft addendum. 24 CHAIRMAN FROINES: I'm sorry. Is that -- 25 DR. FUCALORO: It's not dated, which is somewhat PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 73 1 difficult. I believe it's this document. Correct? 2 MS. PELTIER: Yes, it is. 3 And let me just comment. 4 This represents a draft addendum. It specifically 5 goes into environmental fate. Because we already had 6 monitoring data available when we completed the risk 7 characterization document, the exposure assessment, 8 including exposure and ambient air, was actually embodied in 9 the risk characterization document, which with some of these 10 it would be a separate addendum, like this environmental 11 fate section. 12 If there was a risk characterization document that 13 had already been completed, for which ambient air monitoring 14 wasn't available at the time the RCD was done, that 15 component would be an addendum similar to this and would 16 include those elements that Dr. Ross just covered. 17 DR. FUCALORO: May I follow up on that just for a 18 second? 19 I mean, this is a draft addendum; is that correct? 20 Presumably there will be another? 21 MS. PELTIER: Yes, it is. This is a draft 22 addendum. 23 DR. FUCALORO: It would be helpful to have a date 24 on it, because drafts change with time and you want the 25 latest one. Number one. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 74 1 And number two on page one you mention work done 2 by Ware, W-a-r-e. And I know this is not -- I just want to 3 make this clear. And it's -- and then it's not referenced. 4 Ware is not referenced in the references, so maybe that's an 5 omission. 6 CHAIRMAN FROINES: Tony, where are you? I'm 7 sorry. 8 DR. BLANC: He's looking at page one of the 9 Environmental Fate of Molinate document where there is a 10 parenthetical reference to Ashton and Craft 1981, and Ware 11 in 1982. And perhaps the references were cut off before the 12 W's. 13 DR. FUCALORO: It has happened. 14 DR. BLANC: Although Ashton and Craft isn't there 15 either. 16 DR. FUCALORO: They are. Well -- 17 MS. PELTIER: You're right. The reference list 18 certainly doesn't look complete. 19 DR. FUCALORO: It's either Crafts or Crofts. And 20 the reference is Crosts, and Crafts in the document, so 21 that's a typo. Yeah. 22 MS. PELTIER: We'll endeavor to make sure that the 23 references match those cited in the document. 24 DR. BLANC: So one of the things that is a 25 structural question about how you organize these documents, PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 75 1 and I don't know whether it's something that flows out of 2 the requirement of the preparation format for the 3 reproductive regulatory apparatus, but it's a little bit 4 strange to have a category which is chronic toxicity, and 5 then to have, for example, a category which is 6 neurotoxicity, which is repetitive with category, which is 7 chronic toxicity. 8 If, as in this case, the neurotoxicity is one of 9 the principle chronic toxicities, and the two sections in 10 fact differ in what they emphasize, and yet it doesn't in 11 any way say over and above what we've already stated about 12 neurotoxicity, chronically, the following additional things 13 are relevant or it's -- this is the structural criticism as 14 to how this is organized. 15 I don't know if you struggle with this also and 16 it's because of some reporting requirement that you have. 17 MS. PELTIER: Gary, perhaps you can comment on 18 that. 19 DR. PATTERSON: It is basically a reporting type 20 situation that we're in. Basically what we try to do is do 21 a complete overview and then try to go back like in the case 22 with neurotoxicity where it is a main concern to emphasize 23 it again. 24 DR. BLANC: Well, it doesn't make any sense, I'll 25 just say that. It would make much more sense if you had a PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 76 1 section called chronic toxicity, and then within that you 2 said chronic neurotoxicity, chronic reproductive toxicity. 3 Unless there's a reporting requirement of your 4 other system, then I wouldn't -- I don't -- just doesn't 5 make any sense. 6 And also that's not actually what you do in your 7 neurotoxicity section, you don't actually go back and 8 recapitulate. There's some stuff which only appears in the 9 neurotoxicity section. It doesn't appear in the other. 10 DR. PATTERSON: I think what it is, we go in much 11 more depth in the neurotoxic. 12 DR. BLANC: That's not true either, in my read of 13 this. There's just not overlapping. 14 MS. PELTIER: Maybe that's one of the issues that 15 either in the context of looking at the molinate document 16 specifically, Dr. Blanc, or perhaps when we have the 17 workshop and talk about the way -- in some of these cases we 18 have a situation where the risk characterization document 19 has fully gone through our process where truly are going to 20 be taking one that we've already completed and just adding 21 addendums to it, in which case it would not be very 22 practical to go back -- 23 DR. BLANC: I understand that. That's why I'm 24 asking this as sort of a generic question. 25 MS. PELTIER: But proactively, and not be a PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 77 1 scientist, I can't comment to the extent to which this kind 2 of overlap goes through many of the documents. 3 DR. PATTERSON: I think it's something that would 4 be worked out in a workshop. 5 MS. PELTIER: But certainly for prospective, as 6 we're working through the rest of ours, that's probably a 7 helpful comment for us as we're preparing our regular 950, 8 our CDs, as well. 9 DR. BLANC: For example, in the molinate document 10 this is already been improved through the other process? 11 MS. PELTIER: Through the risk characterization 12 document in of itself has, but I would point out -- 13 DR. BLANC: Not the addendum? 14 MS. PELTIER: The addendum is not. 15 DR. BLANC: But the other part of it, the body of 16 the document has been? 17 MS. PELTIER: Has gone through the full process, 18 that's correct. 19 DR. BLANC: Can you again clarify what the full 20 process is, who is it that's reviewing it? Is there a 21 corollary to this panel that is for the reproductive -- 22 MS. PELTIER: It's not a totally separate body, 23 but it does -- documents do go through peer review. 24 First, we go through an internal peer review as 25 we're going through selection of NOELs. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 78 1 And then in addition to that when we have a draft 2 hazard ID document and the risk characterization document, 3 those are sent both to US EPA for their scientists to review 4 and to OEHHA for their review. 5 But not through a separate advisory panel such as 6 this. 7 Now, as a result of legislation that passed last 8 year there is an additional requirement for external peer 9 review on some documents and as an example the methyl 10 bromide document will be going through a full external peer 11 review, in addition to OEHHA, in addition to US EPA, and 12 we're anticipating that in the future as we're going through 13 this risk characterization process that there be additional 14 external peer review in addition to your review. 15 DR. BLANC: So let's take the example of those 16 documents that have already gone through the review process 17 and have been accepted for the reproductive -- there will be 18 some number that will be coming to us and then there will be 19 other ones where we're working in parallel. 20 MS. PELTIER: That's correct. They'll be some 21 where the risk characterization documents has fully gone 22 through the process. They'll be others in which we will 23 still be using our format, but we are in the process of 24 creating that document. 25 DR. BLANC: Let's take this from your overhead PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 79 1 that you had presented to us earlier. There's molinate, 2 which we're discussing now. Then there's the three 3 materials for which you propose the workshop. And then 4 there are other examples of full report in the A category 5 that include endosulfan, chlorothalonil, azinphos, and 6 naled. 7 Are those documents that have also already been 8 approved or they as far along as the molinate document? 9 MS. PELTIER: Not all of them. Perhaps it would 10 be helpful to walk through what the status of each of those 11 individuals documents is at this point. 12 Setting aside first the DEF document and the 13 methyl parathion document, which are in a different 14 category. The methyl bromide document has -- is in the -- 15 DR. PATTERSON: It's been sent to US EPA to be 16 looked at, so we're in the early stages there. There are no 17 finalization whatsoever. 18 MS. PELTIER: So that one is not a completed 19 document at this point. 20 The benomyl document has recently been submitted 21 to OEHHA, as I understand it, for peer review. 22 Molinate is completed. 23 MITC we anticipate, I believe that's going to be 24 sent later this summer, perhaps within the next month, to 25 OEHHA for peer review. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 80 1 The naled document will be going later than that. 2 We're anticipating at this point that that will sent out for 3 peer review in August of 1998. 4 Azinphosmethyl has already completed the risk 5 characterization document process. That's one for which we 6 don't currently have ambient air monitoring, I believe. I'm 7 not sure on azinphosmethyl. I do know the risk 8 characterization document is complete. 9 Chlorothalonil, that's a material that we are 10 anticipating submitting to OEHHA in November of 1998. 11 Endosulfan, the risk characterization document 12 isn't completed, but we're anticipating it's completion in 13 December of this year. 14 And thiabendazole, the final one that we're 15 anticipating may be a fact sheet, but we don't know for 16 sure, that also one anticipating having our RCD completed in 17 December of this year. 18 So we have sort of a mix between ones where the 19 RCD is already complete. 20 And then once again there also may be some where 21 the material has already been designated as a toxic air 22 contaminant, where an RCD is complete, but there isn't 23 monitoring data available yet. 24 DR. GLANTZ: For the cases where the RCD is 25 completed, I don't want to make you do kind of reinvent the PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 81 1 wheel, but I would like to see when that comes forward the 2 comments that you received on that as part of the process, 3 and the response to the comments. 4 You don't have, if you're satisfied with the 5 document, you presumably what you view as intelligent 6 answers to the comments, but I want to see those. 7 DR. BLANC: In fact, that would be an appendix 8 that's missing from this document, would be all of the 9 comments you received, is that what you're saying? 10 DR. GLANTZ: Yeah. 11 MS. PELTIER: We would certainly anticipate when 12 we transmit a real final document to you that we would 13 include those comments as an addendum or as a separate 14 section in the report. 15 DR. SEIBER: Does the department have a formal 16 external peer review process or panel or anything comparable 17 to this, that has a DPR unit? 18 MS. PELTIER: Not specifically set up beyond what 19 we have with OEHHA and US EPA. 20 I might have say that we have been actively 21 participating in overarching program that is being developed 22 under the auspices of the California Environmental 23 Protection Agency and I know Dr. Bill Vance is here and may 24 comment on that. 25 We currently have a proposal in the budget to PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 82 1 provide us the funds necessary to have a regular program of 2 external peer review, and I don't know if it would be 3 appropriate at this time to call on Dr. Vance. 4 CHAIRMAN FROINES: Certainly would. 5 Better not have a hornets' nest here, Vance. 6 We don't want to have our authority challenged 7 here. 8 DR. VANCE: You won't. 9 CHAIRMAN FROINES: Thank you. 10 DR. FUCALORO: It will do you no good. 11 DR. GLANTZ: Rick Becker tried. 12 DR. VANCE: I'm here. 13 DR. GLANTZ: You're here. 14 DR. VANCE: I survived. 15 DR. GLANTZ: You're not Rick Becker. 16 DR. VANCE: I'm Dr. Bill Vance and I'm a special 17 assistant to Secretary Rooney of the California 18 Environmental Protection Agency. 19 CHAIRMAN FROINES: Just one second. 20 The chair takes the prerogative here. 21 Dr. Glantz, be quiet, please. 22 DR. GLANTZ: Yes, sir. Yes, sir. 23 CHAIRMAN FROINES: We've got to keep Dr. Glantz in 24 his good form. 25 DR. GLANTZ: During the break I was accused of PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 83 1 being diplomatic. 2 CHAIRMAN FROINES: We don't want that to last too 3 long. 4 Go ahead, Bill. 5 DR. VANCE: Very early in, actually this dates 6 back to 1997 when Senator Sher passed or was able to get 7 passed Senate Bill 1320, that requires external scientific 8 peer review of all the scientific underpinnings of any rules 9 that are developed or promulgated by California EPA, boards, 10 departments and offices. 11 Rules are very liberally defined as anything like 12 a standard, like a public health goal that would go into a 13 maximum contaminant level for drinking water number, single 14 numbers, as well as some of the documents that stand in back 15 of the chemicals that are developed for your committee. 16 Okay. Some of those will come out of DPR. 17 In January the secretary for Environmental 18 Protection did ask each of the boards and departments by way 19 of a formal memo to follow the Unified California 20 Environmental Protection Agency Policy and Guiding 21 Principles for External Scientific Peer Review. So we have 22 approximately a 30-page document that outlines a process, 23 procedures, and guidelines for obtaining external scientific 24 peer review. 25 The way that this is set up it will be done PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 84 1 through the Office of the President of the University of 2 California, and we will have contract monies available, 3 hopefully. These are yet to be approved by the Legislature 4 but they're in what's called a Budget Change Proposal and 5 that decision is pending. 6 It is a substantial amount of money, and it will 7 cover all of the boards and departments within Cal EPA that 8 promulgate rules. We think it's a workable system and it 9 will provide the external peer review that is needed very 10 often before a document goes out for public comments, as you 11 know. 12 CHAIRMAN FROINES: Bill, so this means that it's 13 in a sense done on an ad hoc basis, that if you had 14 something about smoking and you wanted to get Stan to review 15 it, you would have a contract with him to do the peer 16 review? 17 This is a formal body that is essentially 18 permanent, and this seems to me to sound like a more ad hoc 19 approach where -- 20 DR. VANCE: Actually the Senate Bill 1320 does 21 point out that your body here is the external scientific 22 peer review process for toxic air contaminants, so 23 something, for example, coming from OEHHA on attack would 24 not go out for that peer review through the Office of the 25 President of UC. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 85 1 DR. GLANTZ: That's the thing I was curious about. 2 I mean, it seems -- well, I think getting, I think getting 3 peer review is a good thing. 4 I'm a little concerned for the stuff we're talking 5 about here it might be redundant, because this body is the 6 peer review body. 7 So for the reports that are coming forward to us, 8 that are those -- are there -- is there going to be another 9 layer of peer review before they get to us or is that the 10 function that we're going to be served? 11 DR. VANCE: I think, Dr. Glantz, the expectation 12 would be that that peer review done by the office -- by the 13 University of California or one of their contractors, they 14 can actually go to MIT or SRI or Cal Tech, if they choose to 15 do that, would be done before it comes to your body. 16 Now, what we found helpful is something like a 17 public health goal which, while in itself is not a rule, 18 that we wanted to have those peer reviewed before it went 19 out for public comment. We wanted some level of comfort 20 that the science that we're presenting to the public and the 21 image of our agency is of a very high quality. 22 CHAIRMAN FROINES: I didn't want to -- when you 23 sit on a lot of these committees this gets to be -- I don't 24 want to defer the time, but let's take MTBE, which the 25 public health goal has just been produced. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 86 1 Is that now going out for public -- for peer 2 review or for public comment? 3 DR. VANCE: Dr. Froines, that was done before it 4 went out for public comment. We had two reviewers from the 5 University of California look at that before it went out for 6 public comment in that workshop. 7 DR. SEIBER: I personally think this is a good 8 idea, and I think it would help us if an expert in delayed 9 neurotoxicity, going back to the DEF thing, had looked at 10 that part of the document before we get it, I don't think 11 that takes away from our ability to do what we need to do, 12 but that's what I was -- the reason I asked the question is 13 I could see as we looked through all these chemicals, 14 they're in different phases, but everything I heard was 15 internal peer review, and it seemed to me there ought to be 16 some external input. 17 I think peer review may be a bad term here. I 18 think we're talking about external consultants that help 19 with specific scientific issues. 20 And I think that's a good idea. The risk 21 assessment group advisory committee recommended that Cal EPA 22 utilize the University of California. I think they 23 specifically mentioned that, and there are many experts, 24 more liberally, and I think this is a process for doing 25 that. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 87 1 DR. VANCE: That's correct. 2 DR. SEIBER: I think that's good. 3 CHAIRMAN FROINES: Do you agree with what Jim just 4 said, that it's a consulting role rather than a peer review 5 role? 6 DR. VANCE: It has to be, because of the statute, 7 I must term it as external scientific peer review. In no 8 way is it meant to replace the decision that you make at the 9 end of the chain on the documents, where you are identified 10 as the scientific review body that can conduct that, can do 11 that function or perform that function. 12 It would be at the option of a board, department 13 or office to do additional peer review before it were to 14 come to you. 15 CHAIRMAN FROINES: Well, I think that this -- I 16 think it's good. I agree with Jim. But I think we have to 17 be a little careful about it too. 18 I would like the lead person -- let's assume we 19 were doing not a pesticide, so it's not in this context, 20 let's assume we were doing cadmium or mercury or something 21 like that, and Stan is the health effects person. 22 It seems to me that the lead person for the SRP 23 needs to be aware of who these consultants are and that 24 there should be some potential interaction between the 25 agency that consultants and the SRP so the SRP is aware on a PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 88 1 early basis what's actually happening. 2 I don't like the feeling of all of sudden a 3 document comes to us and in a sense the implication is, 4 well, we've had three peer reviewers who said it's okay, and 5 therefore it's okay. 6 We need to know the substance of that process, and 7 I think we need to be aware of its ongoing activity, level 8 of activity. 9 DR. VANCE: All I can comment is that because this 10 body is identified in the statute as performing that final 11 peer review process, it will be what you say. It is again 12 the option of a board or department if they want to go out 13 and either get through this process, this formalized 14 process, or even an informal process. 15 As you know, in my former role, I did ask from the 16 National Center for Environmental Enforcement at US EPA and 17 other bodies, World Health Organization, to also look at 18 specific chapters of the document, just that so we know when 19 we came here we were presenting the best work that we could. 20 DR. GLANTZ: I think that's fine. 21 But the point I was trying to make, I mean, 22 obviously you guys should do what you need to do to make 23 sure what you're bringing forward is good, but it seems to 24 me that we don't want to go overboard in a way, because we, 25 this committee, is functioning as the final reviewer, and so PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 89 1 to the extent that it makes sense to involve through the 2 university other people as reviewers or consultants, 3 whatever you want to call them, in the development of the 4 document, I think that's fine, but I'd hate to see that be 5 created an extra step that would end up slowing things down, 6 since the documents are ultimately going to be coming to us. 7 DR. VANCE: I need to repeat. 8 DR. GLANTZ: That should actually give you a 9 little bit more flexibility, actually. 10 DR. VANCE: I'll just repeat. It's the option of 11 the board or department to do that. There's no requirement 12 in statute for any document that is brought for our approval 13 to go through that University of California process. No 14 requirement. You will serve that. In fact, it saves some 15 money, if you will. 16 CHAIRMAN FROINES: I don't want to lose this whole 17 panel. All these guys get paid $100 a day and they know 18 they can become consultants to you now and do peer review 19 and make a lot more money. They'll all quit. Keep some 20 financial aspects out of this. 21 Thanks, Bill. 22 DR. FUCALORO: I'll give you my card at the end of 23 this meeting. 24 DR. SEIBER: Can we ask another question? 25 This is a little more technical and I think it's a PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 90 1 question probably for John Ross and John Sanders. 2 In the spirit of aggregating exposure and risk, 3 when I read through the molinate document, I don't have it 4 right in front of me now, it appeared that you did air and 5 food intake and you did water, and that was good. I thought 6 it was really good. You had all of those in the same 7 document. 8 But I wasn't sure that you actually put them 9 together at the end and said, okay, here's the overall risk 10 from all routes of exposure. 11 And could you comment on that and is that 12 something that needs to be in these documents? 13 DR. PATTERSON: Maybe I should answer that one. 14 Currently, we are now adding all routes of 15 exposure and coming up with ones. The molinate document I'm 16 not sure if we did, but that is our approach now. 17 CHAIRMAN FROINES: In that regard, I'm interested 18 in this notion of as we look at a document to really attempt 19 to define what are the routes of human exposure, I'm a 20 health person, and I have problems with monitoring, because 21 I think monitoring can provide useful information, but 22 sometimes it doesn't. So I'm interested in multimedia 23 questions and pathways to the human. 24 And more that this panel has a sense of when a 25 pesticide is applied, what are the routes to human PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 91 1 populations and what media are involved in that process is 2 useful to understand what the exposures are all about in 3 terms of potential risk. 4 So the more of that, I think, the better. The 5 more that we look at this as human exposure as opposed to 6 monitoring, the better off we'll be, and the more confident, 7 I think we'll be in terms of understanding who might be 8 affected or exposed to a pesticide. 9 I don't think Jim would disagree? 10 DR. SEIBER: No, I agree with that. 11 DR. ROSS: Dr. Froines, in response to that, I 12 think molinate is a particularly good example, because in 13 the case of worker exposure, we have biomonitoring and 14 concurrent air monitoring for these individuals, and we can 15 demonstrate that not more than 30 percent of the total 16 exposure comes through the inhalation route. 17 CHAIRMAN FROINES: Not more than? 18 DR. ROSS: Not more than. 19 DR. SEIBER: That's not true for ambient; is that 20 correct? The air tends to be the dominant route of 21 exposure? 22 DR. ROSS: That's right. 23 DR. SEIBER: That's why I think it's really 24 useful. 25 If we had a case, let's invent chemical X that a PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 92 1 tenth of a percent is through the air, and 99.9 is from 2 water or food, some point this body might say, well, true, 3 it's not a toxic air contaminant, but it looks like it's 4 pretty darn serious and maybe through some other route that 5 chemical ought to receive a detailed evaluation. 6 MS. PELTIER: Well, I would just point out once 7 again that falls into the other areas of regulatory 8 responsibility of the Department of Pesticide Regulation and 9 in the sense beyond the realm of the role of this body in 10 helping us make a determination if it's a toxic air 11 contaminant. 12 CHAIRMAN FROINES: Okay. 13 MS. PELTIER: If there aren't any other additional 14 questions about the molinate document, we could just briefly 15 walk through also the benomyl. 16 DR. BLANC: No, no. I have a lot of comments 17 about the molinate document that I'd like to make that have 18 to do with the content. 19 And let's see if we can bridge the gap to see how 20 my content questions are somehow either related or not 21 related to the structural setup of the document, since that 22 was part of your goal. 23 I want to preface this by saying let's 24 hypothetically say that this document were coming to the 25 committee for approval. I know that's not what is intended PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 93 1 today. But were this document to be coming to the committee 2 for approval, I would categorically oppose the acceptance 3 and I would say you have to come back in 30 days responding. 4 So since that's what we'd like to try to avoid 5 those kinds of situation, I'd like to see if there's some 6 structural reasons why certain deficiencies that I see in 7 this document occurred and whether or not we can 8 troubleshoot that. 9 Would that be useful? 10 MS. PELTIER: I think it would be useful. 11 DR. BLANC: To me the thing that most troubled me 12 about this document was that data related to neurotoxicity 13 in the dog, which appeared to be the most sensitive species, 14 were rejected in terms of their use, the pathological data, 15 in terms of their use for trying to address what would be 16 the lowest dose at which toxicity was manifest, and instead 17 data related to fairly crude symptomatic behavioral problems 18 in the dog were used. 19 And I'd like to know whether or not that reflected 20 some structural approach to pesticide data that made it be 21 rejected for interpretation. 22 And I would specifically refer you to Table 17 on 23 page 31 of the document, where the dogs at the lowest level 24 of exposure, one milligram per kilogram per day, had both 25 sciatic nerve and tibial nerve demylinization, and PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 94 1 apparently these were very small groups of dogs, four dogs 2 in each exposure category, because for some of these 3 findings there was a not noted a statistical dose response, 4 if I understood correctly, what the criticism of the study 5 was, therefore it was rejected as being useful for a low 6 effect level and yet the reason that there was no dose 7 response was because enough substance, even at one milligram 8 caused virtually all the animals to respond, so you couldn't 9 find a dose response. 10 So I guess I'm asking is there a structural 11 reason? This never -- is this a structural reason with 12 either the requirements of how you write these documents, 13 because if it is, then it's going to be a recurring problem 14 as we get other documents. 15 MS. PELTIER: Let me refer that question to 16 Dr. Patterson, with sort of the caveat that Dr. Patterson 17 wasn't the scientist who was directly involved in making 18 this determination, though this material, this product did 19 move through his branch. 20 DR. BLANC: It's page 31. 21 DR. PATTERSON: I don't know if I can answer the 22 specifics on it, but from what I'm hearing that you're 23 saying is that you would like to have more of a detail 24 discussion on these kind of cases where we decide that we're 25 not going to use this data. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 95 1 DR. BLANC: Well, I mean it drives a lot of the 2 rest of the document, because if you -- what you've done is 3 you've therefore chosen one milligram as in fact a no effect 4 level, when in fact I can make the argument that .1 5 milligram might not even be the no effect level, it might be 6 the low effect level and that would drive all of your ratios 7 later in the document. 8 MS. PELTIER: I guess I would respond that I think 9 that would fall into the category of kind of discussion that 10 we would be having with you or with other point people as 11 we're going through review of these documents, that kind of 12 detailed scientific information. 13 I don't know that Dr. Patterson is in a position 14 to comment on why the particular NOEL was chosen. 15 DR. BLANC: What I wonder is whether it's related 16 to the requirements for pesticide regulation where there are 17 certain criteria you have for accepting or rejecting a study 18 which in fact you may not be able to use for pesticide 19 regulation, but which will be very pertinent to us for 20 health effects and risk modeling. 21 DR. PATTERSON: No. We do have FIFRA guidelines 22 for acceptabilities of studies, but it doesn't have to be an 23 acceptable study by FIFRA guidelines to be used in our risk 24 characterization document. 25 DR. BLANC: It's not because of that? PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 96 1 DR. PATTERSON: No. 2 DR. BLANC: Maybe some of the other panel have 3 some comments on this particular point. 4 DR. SEIBER: I don't know whether we have enough 5 information to comment, but it seems like these kind of 6 questions, exactly as Jean-Mari indicated, could be asked 7 during the give and take between the lead person and the 8 staff with DPR. 9 DR. BLANC: Another question I would have in terms 10 of maybe this has a structural implication or not, or maybe 11 it's just a content peer review question, there are places 12 in the document where within one paragraph there are 13 seemingly contradictory comments or things that contradict 14 other parts in the document. 15 If you look at page 50 where it talks about 16 inhalation route. Now, clearly for this panel, if something 17 is quite persistent in water and then is volatile, and we're 18 discussing inhalation routes of exposure which could include 19 indoor inhalation in the shower, for example, this paragraph 20 here which is a very minor paragraph in the document, 21 becomes a very major issue for us and might require 22 additional appendix material to support an argument. 23 That is confusing to me, because the paragraph 24 starts out by saying molinate is very volatile and 25 evaporation is expected to be a major route of dissipation PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 97 1 from water. The last line says, therefore the potential 2 exposure to molinate via inhalation from household uses of 3 the water supply is expected to be negligible, and that's 4 based on a calculation of a Henry's Law Constant, which is 5 presented in terms of its relationship to the similar 6 constant for tetrachloroethene. 7 So I found that argument kind of circular and 8 confusing, especially since what matters in water, based on 9 other information in the document, is not the volatility of 10 the molinate, but the volatility of the sulfoxide breakdown 11 product, which is in the tap water, according to the 12 document elsewhere. 13 DR. FUCALORO: Can I ask a further question on 14 that. The Henry's Law Constant is given without a 15 temperature, and it really is temperature dependent, and I 16 think that has to be reported also. 17 DR. BLANC: It's given with a temperature in Table 18 24, but on page 51 it's not given with a temperature at the 19 very beginning of the document. 20 DR. FUCALORO: Right. 21 DR. BLANC: And it's a different number at the 22 very beginning of the document. 23 DR. FUCALORO: Which implies they are using two 24 different temperatures; right? 25 DR. BLANC: Right. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 98 1 MS. PELTIER: I might suggest that to kind of 2 recap what we're trying to attempt to do with this document 3 was not to go over in detail the scientific underpinnings on 4 whether or not this represents a valid document, but rather 5 whether this process of taking an existing RCD and adding an 6 addendum to it is sufficient. 7 And I might suggest that all of those are good 8 questions and good things for us to explore through, and 9 maybe we'll have an opportunity to do it before we formally 10 submit this to you so you won't have those questions. It's 11 been helpful to have that as a preview. But that -- 12 DR. BLANC: Well, if this is level of peer review 13 that such a document has gone through, prior to coming to 14 us, it's not going to cut mustard. 15 So perhaps I was relieved to hear you say that 16 most of the documents we're going to be seeing have not 17 already been approved, and we'll have time to be earlier in 18 the loop, but if this were to be representative, again, I'm 19 opposed in theory, I don't want you to restructure your 20 document drafting structurally, because I don't really care 21 about the structure that much, except insofar as my comment 22 about the confusion with this chronic toxicity and 23 neurotoxicity, but leaving that aside. But this is really a 24 quality issue, if the quality control is this poor, we're 25 going to have a problem down the road. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 99 1 MS. PELTIER: I think your point is well taken. 2 DR. GLANTZ: At one level, I think we all 3 appreciate that it's really not fair to have you guys come 4 in and defend this document at this level, but I also think 5 it's useful to let the panel members who have, you know, 6 have things to say to give you the kind of criticisms that 7 you would anticipate, realizing that you're not going to be 8 able to answer them right now, because I think it will be 9 instructive, since you haven't had the experience of some of 10 the ARB people who are now used to us. 11 So I think that if other people have things -- I 12 did not read this in great detail, so I don't have a lot to 13 say, but I think it would be worth spending a little time 14 and letting people who have gone through and ventilate these 15 criticisms, just so you can hear the kind of things that you 16 need to worry about, understanding that I don't think it's 17 fair to ask them to answer them right on the spot. 18 So I'd say keep going for a little while, at 19 least. 20 DR. KENNEDY: If it's permitted, page 31 there are 21 the discussions about hemolytic anemia in the dog, and 22 it's -- I have some concerns about the parameters that are 23 used to define hemolysis. I think you're mixing acute, 24 chronic, direct and indirect parameters of formed elements 25 in blood and for me to better evaluate that and its PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 100 1 significance, I think some presentation of the methodology 2 would be essential. 3 I don't think you can be comfortable with the 4 conclusion that you draw based on the information that you 5 have given here. 6 DR. BLANC: On another technical question, does 7 the use of term seasonal have particular meaning in terms of 8 pesticide regulation that I wouldn't -- that I would as a -- 9 that I would somehow misinterpret? Is that a technical 10 implication? 11 DR. ROSS: We use seasonal in the terms of season 12 of use. 13 DR. BLANC: Well, a phrase, consequently the 14 principle long-term exposure to molinate is seasonal, which 15 is on page 40. Does that have a technical meaning? 16 DR. ROSS: Yes. It means that most of the 17 exposure occurs during the five weeks of the year when it's 18 applied. 19 DR. BLANC: But it has a half-life of 3,230 days. 20 So four months after the end of its seasonal application, 21 there's half as much still around, so how is the principle 22 long-term exposure seasonal? 23 DR. ROSS: It's half-life in soil or half-life in 24 what? 25 DR. BLANC: It was somewhat of a debate in your PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 101 1 document. It ranged between 30 and 130 days, depending on 2 how it was measured and what it was in. 3 DR. ROSS: I think that depends on whether it's 4 aerobic or anaerobic. There's a variety of conditions that 5 these studies are run under. 6 DR. BLANC: The best case scenario, if the 7 half-life was not trivial, let's say. 8 DR. ROSS: Okay. If you look at the levels in 9 air, the resulting levels from these half-lives were quite 10 low. 11 Also, if you look at the levels in drinking water 12 as a result of the holding requirements, they are also quite 13 low. 14 So the half-life has been recognized in terms of 15 the permit conditions for holding water in the rice checks. 16 Half-life has been recognized in terms of what is in the air 17 in the period of time over which the monitoring was 18 conducted in air. And you will have the maximum 19 concentration during use in air. 20 DR. BLANC: I don't disagree with that. 21 DR. ROSS: Okay. 22 DR. BLANC: But to say that the exposure is 23 seasonal, the highest exposure may be seasonal, but clearly 24 there's ongoing exposure at a lower level that follows long 25 after the season of use; is that correct? PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 102 1 DR. ROSS: That's correct. In the case of chronic 2 exposure, that's taken into account, I believe. 3 DR. SEIBER: It seems to me the air exposure is 4 definitely seasonal. In fact we've done a study where we 5 looked at air concentrations and as soon as they start using 6 it, it goes up and it's when they stop, it goes down, almost 7 back to background. So that was pretty clear. 8 Now, in the case of water, drinking water, what's 9 coming down the Sacramento River it may not track quite as 10 well, although there is a tracking there also. 11 And so it seems, I'm not sure where that half-life 12 that you were looking at came from, Paul, but as far as the 13 half-life that's important for volatilization from water, 14 it's more like 40 hours. It's not several months. That's 15 for the parent compound coming out of the water. 16 DR. BLANC: The half-life wasn't clear. That 17 might be a start, because I did take the half-life from what 18 was written in the document itself. 19 DR. SEIBER: I was going to suggest, John, that we 20 ought to talk, as we go through here, about future lead 21 persons, and how those people might interact, because it 22 seems to me that, for example, these kind of questions are 23 really good and can be handled with the lead person, staff 24 person contact. 25 CHAIRMAN FROINES: Yeah, I think that's right. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 103 1 I'm very glad to see that Tony and Paul just volunteered to 2 be the leads on molinate, so we can move forward on that, 3 because clearly the two of them showed, demonstrated the 4 greatest knowledge base with respect to these chemicals. 5 DR. SANDERS: Could I elaborate on Dr. Blanc's 6 observation of the range of half-lives? 7 I think that that's due to the fact that there's a 8 lot of -- often there's a lot of that kind of information on 9 these chemicals, these pesticides, under whole range of 10 conditions and whether it's aerobic or anaerobic or it's in 11 the soil or it's in the water. So we don't try to 12 necessarily go into some big detailed explanation of that. 13 We just try to give a range that there are these half-life 14 and be aware of whether it's really persistent or it's less 15 persistent and kind of get the reader an opportunity to 16 evaluate that persistence. 17 CHAIRMAN FROINES: See, I think that my sense of 18 these is that it reflects part of the problem of regulatory 19 documents, that there are patterns that get established, 20 that provide information is not always useful. 21 My question is if we define the multimedia 22 pathways around which human exposure can occur, starts off 23 in the air, ends up in a whole range of different places, 24 and then we say humans may be exposed by a very significant 25 number of different, via different media, and then we try PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 104 1 and develop the half-lives within the context of that 2 strategy, then when somebody reads the document it makes 3 sense to them. 4 Otherwise, we always have lots of facts in these 5 regulatory documents that are not part of a process that 6 leads the reader to understand what the devil it's supposed 7 to mean. It's abstract numbers that go into documents to 8 fill them up and they're very heavy, but they don't tell you 9 the story. 10 The story is a pesticide is released, is applied, 11 it then can go a number of places, it can end up in water, 12 it can end up in soil, it can be re-entrained with dust. It 13 can be dermally absorbed in workers and so on and so forth. 14 We need to define the multimedia framework around which 15 exposure occurs. Then we understand the half-life within 16 that kind of context and it makes sense to people. 17 Otherwise you have information that's disconnected 18 from the process of defining exposure. I think we can do 19 better if we do it that way, and get away from information 20 kind of in here that fills out the document, but doesn't 21 answer any question. 22 And so I think that these questions are important, 23 and I would argue that we have an obligation to try and 24 define what is -- what are the relevant exposures and what 25 characterizes the nature of those exposures. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 105 1 And I think sometimes we don't do that and I'm 2 talking in a general way, not in a specific way about this 3 document. 4 But I think the notion of multimedia exposure 5 routes and then looking at half-lives makes perfect sense if 6 you say that it's in groundwater and its stuff has so much 7 of a half-life in that particular source, then you have 8 essentially defined one potential time frame around which 9 exposure could occur. 10 DR. SEIBER: This is a good one. Molinate is very 11 clear. It's got one use. It's used in water to control 12 weeds in water. So if it gets from the water into the air, 13 which it happens to do because it has a high Henry's 14 Constant, that's the whole driver, at least certainly so for 15 the toxic air contaminant part. 16 And so, you know, I think what you're saying is we 17 should create this understanding of how the chemical is used 18 and how it behaves and how receptors are likely to be 19 exposed and then gather the information that fits around 20 that channel of events. 21 Maybe that's what's not clear. I don't have the 22 document in front of me, but that's kind of was my 23 impression too. There's a lot of facts in there, but you 24 like to see at the end of each paragraph or each section 25 what we chose this one out of these 50 studies because it PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 106 1 really relates to this way in which people are exposed. 2 DR. FUCALORO: May I ask a question? 3 You said that the route of inhalation from 4 molinate evaporating from water was a very important route 5 because the volatility of the molinate was high. 6 Yet in the document itself on page 50 it has a 7 paragraph that's very peculiar and I'm just wondering if you 8 can explain. Maybe just clarification. This is a matter 9 of, I think, writing style. 10 It says molinate is very volatile and evaporation 11 is expected to be the major route of dissipation from water, 12 which is I think what you said, Jim. 13 At the bottom of the paragraph it says a 14 comparison of the calculated Henry's Law Constant, Table 24, 15 what Paul was alluding to before, shows that the volatility 16 of molinate is about seven-thousandths of a percent to 17 15-thousandths of a percent of that for tetrachloroethene 18 and tricholorethene. Therefore, the potential exposure to 19 molinate via inhalation from household uses of water supply 20 is expected to be negligible. 21 Now am I catching a contradiction there or -- 22 DR. BLANC: I asked the same question. 23 DR. FUCALORO: Yeah. Yeah. And it's hard to 24 know. 25 DR. BLANC: And also since all of the stuff in the PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 107 1 drinking water isn't molinate, but is molinate sulfoxide, 2 and since I don't know what the physical properties are in 3 comparison to molinate -- 4 DR. FUCALORO: And I would just say also, just for 5 purposes of if you're going to do a calculation like you 6 show in Table 24, there's got to be more clarity, it seems 7 to me. I can do those calculations and there's a term in 8 there, 16.04. 9 Now, I'm pretty sure I know I can get to that term 10 if I had to, but I'd have to think about it, because you 11 have Henry's Law Constant there in units that are very 12 atypical, micrograms per liter, divided by micrograms per 13 liter, which is reasonable because usually Henry's Law is 14 partial pressure versus some form of concentration, one of 15 the concentrations could be micrograms per liter and partial 16 pressure at a given temperature can be converted into a 17 concentration like micrograms per liter. 18 So I'm sure that's all in there, but it's really 19 somewhat atypical, but I'm sure it comes from some place, 20 maybe another calculation, and maybe you have to be a little 21 clearer on how that's done. Just a suggestion. 22 DR. ROSS: By way of clarification, I think the 23 reason for having other chemicals listed in there with their 24 Henry's Law Constant was to compare something that people 25 may be more familiar with in terms of volatilities. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 108 1 And as far as pesticides go, this is probably one 2 with a higher Henry's Constant than most, and so you would 3 expect to see air concentrations resulting from any material 4 in water. 5 I think what is missing in this discussion is that 6 there's not much in water. It's a few parts per billion. 7 Dr. Blanc has indicated, a lot of that is sulfoxide, and 8 sulfoxide has much lower volatility than the parent 9 compound. 10 And so perhaps we could add more detail to 11 indicate why we believe that this isn't a significant 12 mechanism of exposure. 13 DR. BLANC: Maybe one of the things that the ARB 14 could do for you in terms of sampling would be sampling what 15 ambient indoor levels are in bathrooms and using Sacramento 16 River water when you are running the shower at a nice warm 17 temperature for 30 minutes, is that something that ARB can 18 legally do? Or do you have to be only outdoor? 19 DR. FUCALORO: There is air indoors also. 20 DR. BLANC: I mean maybe -- 21 DR. GLANTZ: ARB takes indoor measurements too. 22 DR. BLANC: Maybe the Department of Pesticide 23 Regulation could actually ask the ARB to do some sampling 24 for molinate sulfoxide indoors with use of a shower 25 simulating what people are exposed to from Sacramento River PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 109 1 water. 2 DR. ROSS: I think we can probably do a Henry's 3 Law calculation much easier to first of all see if there is 4 the potential even. 5 But what I mean about a better explanation as to 6 why we don't think that indoor air is going to be a 7 significant contributor or that water from -- is going to 8 contribute to the indoor air concentration. 9 DR. BLANC: Well, it's technically probably pretty 10 easy to do what I'm asking, I think as a review panel member 11 I'd more impressed with the actual data than with the 12 calculation alone. 13 DR. ROSS: A lot of things are easy to do and 14 there's also limited time and money to do them. 15 DR. BLANC: Well, I've made my views known. I 16 won't harangue the issue. 17 CHAIRMAN FROINES: Other comments? 18 DR. BYUS: I just have one brief comment. 19 I realize this document was prepared a number of 20 years ago. How are you planning -- I think most of the 21 references stop around '94 in this document. Are you -- is 22 there anything else that's been out significantly in the 23 last several years, are you planning on updating some of 24 these older documents before you send them to us? What's 25 your -- how are you going to do that? PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 110 1 DR. PATTERSON: With this RCD here we would go 2 back, take a look and see what's been produced since that 3 time and this if there's something significant that needs to 4 add to it or relook at it. Otherwise we'd probably just go 5 with it. 6 DR. BYUS: At least put some statements in there 7 that you did look at the reference. Okay. 8 CHAIRMAN FROINES: Okay. If there's no more 9 comments, I want to make a few. 10 I believe that if this document came before us 11 today it would be rejected. So that we ought to at least 12 start out knowing that this document probably wouldn't fly. 13 I think it wouldn't fly for a number of reasons. 14 I think, one, it's extremely difficult to read. 15 You can't find anything in here. I was looking for the 16 cancer data and I couldn't find it and I still can't find 17 it, although I found some, but I didn't find all. And so in 18 terms of the -- there is a comment in here that says based 19 on the weight of the evidence -- I had it underlined and now 20 I've lost it. 21 Although molinate caused kidney tumors in male 22 rats, the weight of evidence suggested that the oncogenic 23 potential of the molinate was equivocal. 24 Well, okay. Let's take that as a given. 25 The fact is it then has to be argued someplace and PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 111 1 then one has to go through and find the data that justifies 2 the argument. And I can't find it any place in the 3 document. 4 And so if one is going to make a statement of that 5 magnitude for a compound, which has some -- which clearly 6 has evidence of carcinogenicity, then it better be laid out 7 in a place where it's readable, at least by me. 8 And so looking at this one I think the 9 organization of this document needs to be improved so it's 10 more readable. 11 There's some with respect to a mutagenicity study 12 with mouse lymphoma cells demonstrated mutagenicity with 13 activation and a published study indicated that molinate 14 caused micronucleus formation in mice. However, all other 15 genotoxicity studies were negative. Molinate was oncogenic 16 in male rats, causing kidney tumors at the highest dose, so 17 on and so forth. 18 And I want to know where is all that? It's not 19 any place that's easy to find, at least not by me. 20 I think that we are way past the way we used to do 21 documents in the '80s, and I think that one thing that's 22 important is that one takes evidence, one has to take 23 evidence of -- historically people had a section on 24 genotoxicity. And then they have a section on 25 carcinogenicity, and they have a section on developmental PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 112 1 toxicity. 2 But if you look at IARC documents now you find 3 that what IARC does is to say what is the mechanism, what 4 are the mechanistic implications of this data, and then you 5 try and look at the relevance of the biological data with 6 respect to mechanism. 7 And that you try and see does the positive mouse 8 lymphoma assay in an in vivo system, coupled with 9 micronucleus chromosomal changes, does that have 10 significance? And then you say, well, other animal data is 11 positive. And you say, yes. Well, then if we have animal 12 data and genetic toxicity data, that begins to be a 13 biological basis for carcinogenicity. 14 So you look at the issue holistically using all 15 the different data from toxicokinetics to genotoxicity to 16 carcinogenicity and so on and so forth, and then have a 17 discussion that talks about the biological and mechanistic 18 significance of the data in terms of cancer. 19 So then you get a picture of what this is 20 happening here. 21 And without that, without that what you have is 22 the genotoxicity is kept in its separate box, the 23 carcinogenicity is kept in a separate box, and all these 24 things are isolated from each other, and that's not the way 25 we do this anymore. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 113 1 And I think that it's important to not do that. 2 I think it's important to have a larger 3 discussion, for example, on the relevance of the two 4 microglobulin male rat tumor issue, because clearly this 5 compound does not fit that hypothesis, and so one can't 6 assume that this is a species specific carcinogen with 7 respect to male rats. 8 And so it seems to me that my biggest problem with 9 the document right now was, one, that there is this lack of 10 everything is kind of separated in the boxes, and there's a 11 lack of biological mechanistic considerations. That's one. 12 So I want to know what EPA and IARC and NTP are 13 saying about molinate. I want to know if IARC considers it 14 sufficient in animals and do they consider it however. I 15 want to know IARC is the most prestigious body in the world 16 in identifying carcinogens and we want to know what they 17 think about this compound. 18 Going to the other extreme, there is oncogenicity 19 study in mice, and I can't find the data showing what the 20 results were, but it's an 18-month study. It's not a 21 lifetime chronic bioassay, and somebody should comment on 22 that. 23 I'm starting a two-year chronic bioassay and C-57 24 black mice with 600 animals. We're going to run them for 25 two years. And so an 18-month study is year and a half, and PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 114 1 so if you don't find any cancers in 18 months, doesn't mean 2 that you won't find any in the full lifetime bioassay. 3 Somebody comment on that. An 18-month study may not be 4 appropriate. 5 DR. PATTERSON: Dr. Froines, in the mouse the 6 18-month is proscribed by FIFRA, under federal. 7 CHAIRMAN FROINES: Well, it doesn't mean that 8 somebody -- 9 DR. PATTERSON: It's one that we use the FIFRA 10 guidelines and it's one of those things where -- 11 CHAIRMAN FROINES: Put in you're following FIFRA 12 guidelines for your evaluation, but that's terrible science. 13 Nobody would agree at this point in history that you should 14 run an 18-month mouse study, not if you're doing good 15 toxicology. I wouldn't do it. 16 DR. ROSS: I think that's dependent on the 17 lifetime, life expectancy of that particular strain of 18 mouse. 19 CHAIRMAN FROINES: What's the mouse we're talking 20 about? I'd have to go back and look at the mouse. But 18 21 months is a pretty short time, depending on which mouse 22 you're using. 23 We're using C-57 black, and we're going to run it 24 for two years. They'll live that long. 25 MS. PELTIER: That area could well be one, though, PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 115 1 in which there are difficulties, because the studies that 2 are submitted to us, while we look at other data that are 3 available in the open literature, we're also dependent on 4 the studies that are submitted to us by the pesticide 5 registrants at the point when they're trying to have us 6 evaluate whether or not to register the material, and those 7 studies are submitted, both to US EPA and to us in 8 conformance with FIFRA guidelines. 9 CHAIRMAN FROINES: I agree. And one of the real 10 problems in this whole thing, Jean-Mari, is precisely that 11 issue, that the basis of what you do in many respects 12 derives from the registration requirements. 13 MS. PELTIER: And it derives from the enabling 14 statutes through FIFRA under which we operate and with whom 15 we coordinate with US EPA. 16 DR. BLANC: That underscores how useful it may be 17 to include an appendix to these kinds of documents that in 18 other words wouldn't require you to rewrite the documents, 19 but for us we'll need an appendix which has a summary of the 20 IARC and other relevant bodies which may not follow the 21 narrow confines of FIFRA guidelines, so that if there are 22 other data available -- 23 DR. GLANTZ: The other thing -- sorry. The other 24 thing is this is the way the studies are done because of 25 this guidelines and you're stuck with it, I don't think that PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 116 1 precludes you from doing what John is suggesting, and that 2 is recognizing that that's a severe limitation in terms of 3 interpreting a negative finding. 4 So I mean you are kind of a little bit stuck, but 5 from a scientific point of view that doesn't mean you can't 6 look beyond those limitations. 7 CHAIRMAN FROINES: One can comment. 8 DR. GLANTZ: At the very least. 9 CHAIRMAN FROINES: If one is using a FIFRA 10 18-month study, you can comment on the fact that it didn't 11 go the full lifetime of the animal. 12 Over here there are some things that are very 13 difficult. There's a mutagenicity evaluation, mouse 14 lymphoma multiple endpoint tests, cytogenetic assay. Series 15 of mouse lymphoma cells were looked at. And activation with 16 rat liver S9 extract resulted in some statistically 17 significant elevations in both chromosome aberration and SEE 18 frequencies, but this were not dose related and not 19 repeatable. No adverse effect. 20 Well, there are a couple problems. 21 One, based on what we have here, we can't evaluate 22 it. It's basically a conclusion for which the panel could 23 not evaluate the science. So we can't do our job if we 24 can't evaluate the science and this turns out to be a 25 Stauffer chemical report, and the question again is -- Peter PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 117 1 smiles, because we've been through this before -- is in 2 terms of the panel evaluating the quality of science in that 3 study, how are we going to have access to it? We can't rely 4 on the conclusions which are insufficient for us to 5 evaluate. 6 MS. PELTIER: Within the confines of the 7 restrictions that are placed on us for retention of 8 confidentiality of data, we would intend to work with you in 9 sharing that information. So we'd have to have -- we would 10 have to work with it within the confines of making sure that 11 we have a confidential agreement. 12 But I think that's one of areas where we have some 13 real vulnerability, frankly, with our ability to share data, 14 and I think it's one of the areas we've discussed quite a 15 bit with you. 16 CHAIRMAN FROINES: Then there's a cytogenetic 17 study that's published in the peer reviewed literature. 18 It's in mutation research. And it's a micronucleus test in 19 mouse bone marrow. 20 And the conclusion of that study is the mean 21 incidence of micronucleated polychromatic erythrocytes was 22 statistically significantly increased in both males and 23 females compared to controls. That's a published study. 24 The conclusion here is possible adverse effect 25 unacceptable. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 118 1 MS. PELTIER: And I can't comment as to why that 2 particular study was rejected. 3 CHAIRMAN FROINES: No individual data missing 4 information on study content. It's a peer review document, 5 though. 6 So we can review that document, right? We have 7 the ability to review that document and make a determination 8 as to whether or not it's adequate or not. 9 DR. PATTERSON: I think where it says unacceptable 10 is specifically referenced to whether it meets the FIFRA 11 guidelines. 12 DR. SANDERS: We can go ahead and use it, but it's 13 unacceptable according to FIFRA guidelines that meet those 14 study requirements, but it's not precluding us from using 15 it. 16 CHAIRMAN FROINES: But we're in a catch 22 right 17 now, because if all these are -- if how you look at them are 18 defined around FIFRA guidelines -- 19 DR. PATTERSON: It's a separate process under 20 SB 950, where we are required to determine whether or not 21 the studies are adequate, basically meet the FIFRA 22 guidelines. 23 The risk assessment process is a different process 24 where we're just citing it doesn't meet FIFRA guidelines, 25 but it may be acceptable to use for risk assessment PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 119 1 purposes. 2 DR. ROSS: Actually I think the objection that 3 we're raising for this particular study is that we don't 4 have the raw data with which to evaluate. That's exactly 5 the same objection that you have about the FIFRA studies for 6 which we do have the raw data, and that's one of the big 7 distinctions between what is submitted by a registrant, 8 where that data is kept in perpetuity and can be examined 9 at any time, versus a peer reviewed published literature 10 study where that data is destroyed shortly after it's 11 published. 12 CHAIRMAN FROINES: Without going into detail, 13 what's the conclusion then about the molinate genotoxicity? 14 How does the information then get used for both qualitative 15 and quantitative determination of carcinogenicity? 16 DR. PATTERSON: How is it used in the risk 17 assessment? 18 CHAIRMAN FROINES: Right. If you go back and look 19 at what's happened with IARC in the early 90's, and you see 20 how compounds are being changed, having a designation in the 21 past, and then those designations are changed, and so 22 ethylene oxide moves from 2A to a 1 compound, for example 23 and styrene oxide changes, and so on and so forth. 24 And that's based on the use of, quote, 25 biologically relevant mechanistic information to determine PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 120 1 the category of carcinogenicity within the IARC context. 2 And here is a good example where you do have some 3 micronucleus tests that are positive, you do have mouse 4 lymphoma tests that are positive, and then question then 5 becomes how does that affect your view of the 6 carcinogenicity of molinate? And where is that written in 7 here? 8 Because that's an issue because -- because you say 9 quite clearly molinate caused kidney tumors in male rats, 10 the weight of evidence suggested that the oncogenic 11 potential of molinate was equivocal. 12 I have nobody in the panel has any idea how that 13 conclusion was reached. And it may be a perfectly 14 reasonable conclusion, but I don't know where it came from 15 because it's not in here. 16 So it seems to me a risk assessment process has to 17 be transparent. We need to know what was the basis of the 18 conclusions that were drawn. You may disagree or agree, but 19 we can't judge them without knowing the basis. 20 So in these documents it seems to me that we 21 really do need to be sure that what's said can be understood 22 by the panel in a way that they can evaluate the adequacy of 23 the science, which is what our job is. 24 That fair? 25 I don't mean this as criticism. I just mean that PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 121 1 the more transparent what gets presented is the better it 2 will be in terms of this. 3 There is an enormous amount of work in here and I 4 think some of it could be dealt with just by some 5 organization issues. 6 DR. BLANC: Can I ask a question about the 7 Appendix A, that summary of toxicological information, which 8 is what you were reading from in part, I think. 9 This is a typical appendix which accompanies all 10 of your reports as part of this other regulatory process; is 11 that -- 12 MS. PELTIER: That's correct. 13 DR. PATTERSON: Yes. 14 DR. BLANC: And there's a printout of your own 15 database? 16 DR. PATTERSON: Yes. 17 DR. BLANC: This is some kind of ongoing -- 18 DR. PATTERSON: Yes. This is from the SB 950 data 19 from review of studies that have been submitted. 20 DR. BLANC: So this in itself reflects an 21 evaluation of the primary raw data? 22 DR. PATTERSON: Yes. 23 DR. BLANC: And this data -- is this database 24 confidential in terms of what's here or does the fact that 25 it's already made it to this database reflect screening PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 122 1 that's already happened? 2 DR. PATTERSON: What you have here is not 3 confidential. I think what you're talking about are the 4 actual studies themselves that are on file may contain 5 confidential business information. 6 DR. BLANC: And because it seems that part of the 7 text in the body of the document, for example, certain 8 sections appears to follow fairly word-for-word sections 9 from this file as if it was perhaps uploaded into parts of 10 the document. Is that part of the methodology of how the 11 overall risk characterization document gets written? 12 DR. PATTERSON: We have been trying to incorporate 13 as much of those initial reviews into the document to avoid 14 rewriting and mainly time table purposes. 15 DR. BLANC: That may reflect part of the 16 linguistic problem that John -- I mean a source of part of 17 that, I don't know, because the language and style and 18 structure of how you maintain this database for the purposes 19 of its utility may not serve you as well. 20 DR. PATTERSON: I agree with that in a sense that 21 some of these older chemicals that have been around have had 22 multiple reviewers and each person is going to have 23 different writing styles. That may be. 24 DR. BLANC: It may be more telegraphic in your 25 database than it should be for this kind of document too. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 123 1 I was just looking again at going to this appendix 2 and looking at the critical dog study that seemed to have 3 been discounted as -- or how the NOEL was derived, and it 4 seemed as if that was an outgrowth of how the dog study had 5 been handled in this database. 6 So I think that was probably not a good idea and 7 it got carried over to the document itself, from what I can 8 tell. 9 MS. PELTIER: I can't comment specifically on 10 that, Dr. Blanc, obviously, but I'm trying to interpret what 11 I'm hearing from your panel about our ability to follow down 12 this path that we had proposed. I recognize, certainly 13 based on the comments that have been made, that there are 14 some legitimate questions, obviously, that you would want to 15 be able to walk through with the scientific reviewers who 16 are involved in participation and creation of this document. 17 And we will continue to have -- we have now, and 18 will continue probably to have some difficulties with the 19 kind of data that you'd like to see versus FIFRA guidelines. 20 But I guess my question to you as a panel is are 21 we going to be able to pursue what we've proposed pursuing 22 for this year, recognizing that as you review some of these 23 older risk characterization documents they're going to be 24 more questions than hopefully there will be for those who 25 we're developing prospectively. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 124 1 But my question is are we basically going down the 2 right path? Can we use this as a starting point for having 3 a way of getting materials through to you, or is this still 4 going to be too difficult to process? 5 CHAIRMAN FROINES: No. I don't know what the 6 panel thinks, and we should ask them. 7 But I think that we have -- we may have scientific 8 differences, you know. I haven't read the dog stuff that 9 Paul is talking about. And nobody else has focused so much 10 on the carcinogenicity. So there's a lot of science that we 11 haven't talked about. 12 Most of my problem comes from I think the 13 formatting in the way the documents are laid out that makes 14 them difficult to read. And I think information is missing 15 that shouldn't be missing. 16 For example, on just on carcinogenicity, I want to 17 know, I want to see all the data on the animal studies laid 18 out. 19 DR. BLANC: I don't think you mean by that that it 20 would be impossible for one document to serve the purposes 21 of both our review and the review under your other 22 regulatory requirements. 23 I think that the fundamental question that you 24 have and as a follow-up to the meeting we had in Sacramento 25 is can one document serve both purposes or does a completely PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 125 1 new document have to be written? 2 And I still believe that one document can serve 3 both purposes. 4 And the key thing is going to be for us to get 5 enough input early enough to have the things that we need in 6 the document from, I would say, based on the experience with 7 this document. 8 It is true that we are going to be putting a 9 somewhat higher hurdle on your agency than the review 10 process is currently giving you for the document for the 11 reproductive process, but certainly if you satisfy us, it 12 seems like you'll be satisfying them. 13 So I think that one document should be able to 14 serve both purposes, but we're going to have to be able to 15 have enough of a feedback loop that we can have questions 16 addressed. 17 A system where we see it very late in the process 18 is likely to be more problem ridden, but one -- the more 19 chance there is for give and take early on should work. 20 And that's, I think, going to be all the more so 21 true with the fact sheet, not with the content of the fact 22 sheet, but to convince us that something requires only a 23 fact sheet is going to require enough data to prove the 24 negative case, which is always difficult in a scientific 25 point of view. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 126 1 MS. PELTIER: Perhaps we can use as a baseline, 2 though, that if a material is no longer registered for use 3 in the state, that those are ones that we clearly can get 4 through the process with a fact sheet, and maybe use that as 5 a first cut and then beyond that we can maybe have 6 discussions with you early on when we're making a decision 7 that we think product X is going to go fact sheet. 8 DR. BLANC: We get a sense of what pathway we're 9 going down and what data we would need to be able to go down 10 that pathway. 11 DR. GLANTZ: And getting back to the original 12 question you asked about are these criticisms indicating 13 that this process you're outlining isn't going to work. 14 I don't think there are. I think this is -- this 15 discussion reminds me of some of the early discussions we 16 had with OEHHA and ARB under the other part of the AB 1807 17 process, which is what led us to the lead person idea, to 18 avoid having to deal with this at the back end. 19 And I think that you can use the existing material 20 you have as a jumping off point, but I think to get it past 21 the panel is evidenced by this discussion. You're probably 22 going to have to do some work on it. 23 But I think it would be a mistake for you to take 24 what you have here and just throw it in the garbage and 25 start over from scratch. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 127 1 I mean, you have a lot of stuff you need. It's 2 just a matter of filling in the gaps and justifying the 3 conclusions that you're making better than maybe you have in 4 some of these instances or changing the conclusions. 5 But I think it will be workable. I think that 6 when you're working from the older documents, you're going 7 to have to do more tinkering with them, probably, than the 8 things you're going -- that you're doing prospectively. 9 DR. BLANC: I means, sometimes when they were 10 things that were controversial, let's say, in the diesel 11 document, about assumptions, then there were appendices 12 which played out what the modeling would look like under a 13 different set of assumptions. 14 There are ways through appendix material of 15 addressing certain concerns. 16 MS. PELTIER: I think that is exactly what my next 17 question was going to be. 18 If we can handle this via appendices to the 19 document, I think that would be preferable than trying to 20 dig back into them and reformat them, especially those that 21 have already been completed, have gone through the 950 risk 22 assessment process. 23 DR. GLANTZ: Yeah. I mean we're not here as 24 literary agents, and but I think you need to put it forward 25 in a format that people that -- we can understand and feel PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 128 1 comfortable about. 2 If you end up exactly how you structure that, I 3 think you should do it in the way that works best and 4 minimizes the work for everybody. 5 CHAIRMAN FROINES: I think that these are not -- 6 we're not literary agents and these aren't literary 7 documents. They're scientific documents. 8 My view is that they must have within them, they 9 cannot be conclusory. 10 They must demonstrate the science that can be 11 evaluated to determine the appropriateness or correctness of 12 the conclusions that are drawn. 13 So they cannot be long, executive summaries. They 14 must be documents in which the reader can determine what was 15 the basis for the conclusions that were drawn, and then 16 evaluate whether those conclusions are correct within the 17 context of the data set before them. 18 And my concern here is they're conclusions that 19 for which we don't have the information to do the 20 evaluation. And we don't have a sense of the process, so to 21 speak. And so it's going to need more of that, I think. 22 I think that's a writing task. I don't think it's 23 a big -- I don't think it's a major issue. 24 But the science panel has to evaluate the quality 25 of the science, therefore it has to be before them. That's PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 129 1 the key issue. 2 MS. PELTIER: I guess one concern that I have, and 3 I don't want to drag this out, but one concern I have is 4 that our commitment in getting 12 pesticides to you is 5 really based on the idea that we will be able to take 6 existing RCDs, submit them to you, have the give and take 7 that will allow us to provide additional information to you 8 as necessary, to submit additional comments via appendices, 9 but if we go back to the process of retinkering before we 10 submit to you molinate, if we agree to rewrite 11 azinphosmethyl, although we've already completed it, if we 12 do something other than just an appendix, we will not be 13 able to get through the 12 documents through to you. 14 And I think we're both saying the same thing, that 15 we recognize that these that are already complete are going 16 to be a little more rocky, potentially. But hopefully in 17 establishing a dialogue and walking through that, we'll have 18 a better idea as we move through prospectively as well. 19 DR. GLANTZ: Well, it may be that the way you're 20 going to operationalize it will be to write an appendix to 21 the molinate document that deals with all the issues that 22 are being raised, rather than going through and rewriting 23 the molinate document. 24 But I think that the substance, I mean I think 25 what John is saying is that the substance of these things is PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 130 1 going to have to be addressed. And how you guys actually go 2 about addressing it, you should do it in the way which is 3 more efficient, but the questions are going to have to be 4 answered. 5 I think the point that both the John and Paul were 6 making was that there are statements in here that are just 7 not supported by what's in the document. That's the 8 fundamental problem. 9 And we have to have before us in one form or 10 another, the evidence to support the statements. 11 CHAIRMAN FROINES: I'm not that negative. I'm 12 not -- 13 DR. GLANTZ: I'm -- 14 CHAIRMAN FROINES: I'm only -- 15 DR. GLANTZ: I'm sounding more negative -- 16 CHAIRMAN FROINES: What I'm saying is there are 17 places in here where there are conclusions which I can't 18 find the documentation yet. Maybe with the complete reading 19 I'll find it and it will be fine. 20 But if you can't find it, that means that there 21 may be some formatting problems for how it's laid out. 22 The reader should be able to have it, be able to 23 go through it like that, and I feel like I have to go 24 looking for things. 25 And so I don't think that's a major issue. I PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 131 1 don't think it's a question of being as extreme as you're 2 making it sound. 3 DR. GLANTZ: Actually, I'm sounding more extreme 4 than I think it is, actually. 5 I mean, I think the issues that have been raised 6 here, for example, I don't know much about the substance of 7 that compound, but I haven't heard anything said here that 8 are things that I don't think you could deal with in a 9 fairly finite amount of time. There are important 10 substantive issues, but they're not insurmountable. 11 CHAIRMAN FROINES: I also think that with a lead 12 person you start out in the beginning to address things 13 where Paul says I don't like the way this is written, and 14 that this is a process that starts day one and then we get a 15 complimentary, or whatever we call it, informational copy, 16 and then there could be feedback and so by the time it 17 actually comes to us, I think all these things can be 18 eliminated. I think the process is good and all we're 19 saying is that this document would probably look different 20 if it had gone through that kind of process. That's all. 21 The reason you brought this forward was to say 22 this is sort of what we're looking at and now we have a 23 process in which it will be improved and I think that 24 that's -- 25 DR. GLANTZ: And you were saying how -- we're PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 132 1 showing it to you to get some feedback. 2 DR. KENNEDY: Do you have fundamental objections 3 to what we're requesting, is really the issue? Because if 4 you cannot -- we're talking in the final analysis this is 5 all format. This is all the fact that we demand a document 6 which essentially backs everything with documented 7 information. It is not simply a litany of factual data. 8 And it's going to be a royal pain in the neck to change what 9 you've got in this document to do it this way. There's no 10 question about that. 11 But if you are in agreement with the process 12 with -- I mean, if there's at least a meeting of the minds 13 that this is acceptable, it's doable, you've got our 14 commitment to assist you with that. 15 If you're not comfortable with our basic requests, 16 then we have a real problem and it is an enormous job. And 17 I guess that's the next question. 18 MS. PELTIER: It's difficult for me to respond to, 19 because in responding to that I don't know the extent to 20 which you'd be looking for us to include in the document 21 actual data that might otherwise be considered confidential 22 business information. 23 But if I can take the assumption that that's not 24 what you're looking for -- 25 DR. KENNEDY: We're looking for science, PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 133 1 scientific confirmation. I don't know, I'm so naive I don't 2 know business from business. We don't want to take 3 somebody's secrets away. Somebody published work about 4 hemolytic anemia in this dog, I'd sort of like to know his 5 methodology, because it doesn't make a lot of sense. If 6 you're going to bring up the subject, you want to leave it 7 out, that's okay too, I guess. But if you're going to make 8 some sort of statement from which I am to draw a conclusion, 9 I need to understand how, what the information means. 10 That's all we're saying. 11 MS. PELTIER: If I can just respond to it, what I 12 think what your question is, Dr. Kennedy, is basically do we 13 have a problem with this process of give and take where you 14 tell us that you see that there's a deficiency and we 15 respond to it. Either we respond to it through a workshop, 16 whether we respond to it in formal setting like this, or 17 whether we respond to it first informally through the two 18 point people, and then have revisions to the document, I 19 think I would suggest in the form of an appendix, rather 20 than sending it back for a de novo right from my staff. 21 That we don't have any problem with that process 22 and that's what we're hoping to walk through. 23 As I say, as we go through prospectively, then 24 hopefully we will get more used to the way you're used to 25 seeing us characterize the date. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 134 1 DR. KENNEDY: The first one will be bloody murder. 2 The first prospective study will be very difficult. After 3 you've done a couple, it will be very simple, because, 4 believe it or not, our way really flows pretty well. 5 CHAIRMAN FROINES: I think the process, it will be 6 successful, because I think the process is a good one. 7 Let's go on and talk about benomyl. 8 DR. GLANTZ: Can we get the temperature turned up 9 in here? It's freezing. 10 MS. PELTIER: I thought you were just freezing me 11 out. 12 DR. GLANTZ: It's not you. 13 MS. PELTIER: Or else I was awfully nervous. 14 CHAIRMAN FROINES: Let's talk about benomyl 15 because -- then we'll be finished. 16 Everybody stand it for another half hour? 17 Jean-Mari, you okay for another half hour? 18 MS. PELTIER: Sure. 19 I'm just conferring with staff to walk over how 20 we're going to walk through the benomyl issue. 21 If I may, what I'd like to do is call on Dr. Ross 22 to walk through, because I think a key point in this 23 particular document is how we would plan to go through the 24 issue of insignificant exposure in cases where there has 25 been ambient air monitoring, and there is some kind of a PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 135 1 find. 2 So if I can call on Dr. Ross. 3 I think we had agreement earlier today that in 4 those cases where we have a material that was previously a 5 candidate toxic air contaminant, but for which that material 6 is no longer registered for use in California, we can agree 7 that those are products that we can get out of the process 8 by doing fact sheet on. We'll just get into the areas where 9 there still are uses. 10 CHAIRMAN FROINES: I just wanted to ask the court 11 reporter, would you like a five-minute break? 12 This is a five-minute break. 13 (Thereupon a short recess was taken.) 14 CHAIRMAN FROINES: Can we go ahead. 15 We've got a quorum. 16 Jean-Mari. 17 MS. PELTIER: I'd like Dr. Ross to talk about this 18 issue of insignificant exposure and walk us through the 19 toxic air contaminant fate with an example of benomyl. 20 DR. ROSS: As I think Jean-Mari alluded to 21 earlier, in most cases the use of this fact sheet will be 22 for chemicals that are no longer registered. And in some 23 rare instances we anticipate potential use of a fact sheet 24 like this for chemicals that have either low detects or 25 non-detects in recently conducted studies. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 136 1 Benomyl is probably not a particularly good 2 example. We put that out here as purely an example of how 3 one of these might be constructed. We are conducting a full 4 risk assessment on benomyl and I think you can anticipate 5 seeing an air contaminant component of that risk assessment. 6 But in the event that we do construct one of these 7 fact sheets for a currently registered pesticide, we would 8 go through, provide an introduction, something about the 9 properties and persistence, setting up the same situation or 10 background that we have for the environmental fate portion 11 of the AB 1807 document. Talk about the use pattern and how 12 that relates to where the monitoring was conducted. 13 And I agree with you that we can probably do a 14 better job at providing specific examples of where 15 applications were done in relation to the monitoring. 16 In this particular instance, the study was 17 conducted before there was hundred percent use reporting, 18 and this was not a restricted material. We don't have that 19 luxury. 20 So, again, this is not a particularly good example 21 of how one of these fact sheets might be presented. 22 We would go on to present the air monitoring data 23 that's available and that's been done on the third and 24 fourth pages of this fact sheet. 25 And in this particular instance, we've concluded PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 137 1 that there's insignificant exposure. That term was coined 2 in Senate Bill 950, the Birth Defect Prevention Act of 1984, 3 and section 13127. 4 And I guess we can say that it's somewhat 5 analogous to the safe harbor level in Prop 65. It's a level 6 that we have defined empirically. And it's based on looking 7 at the toxicity database that we have for a wide variety of 8 chemicals, and we chose a value of 0.3 micrograms per 9 kilogram as a level of insignificance for acute exposures, 10 and a level of .004 micrograms per kilogram as a level of 11 insignificance for chronic or oncogenicity endpoints. 12 The reason that we chose these two endpoints was 13 primarily these two exposure dosages primarily was that 14 there are very few pesticides that have no observable effect 15 levels that are 100 times the 0.3 microgram per kilogram 16 level, and there are no pesticides that we're currently 17 aware of that are registered with an oncogenic potency that 18 exceeds .44 per milligram per kilogram per day, which is a 19 millionfold below the .004 microgram per kilogram level that 20 we call insignificant exposure. 21 Our experience with use of insignificant exposure 22 determinations for the Birth Defect Prevention Act are that 23 56 high-priority pesticides for which we have conducted only 24 worker exposure, there is one that had an absorbed daily 25 dosage less than 0.3 micrograms per kilogram and there were PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 138 1 none that had a lifetime daily dosage of less than 0.004 2 micrograms per kilogram, so that on the basis of our 3 definition of insignificance for workers, there are no 4 chemicals that we would define currently as insignificant. 5 However, for particular products or in the case of 6 only looking at air levels, a chemical could meet this 7 criteria of insignificant exposure. 8 The case of benomyl where we calculated the acute 9 exposure for the child based on the monitoring data provided 10 to us by ARB, it came up less than the level that we defined 11 as significant. 12 And for the chronic exposure it also came out less 13 than the value that we have called insignificant. 14 So for the purposes of air, ambient air exposure, 15 we are calling these insignificant exposures. 16 CHAIRMAN FROINES: Comments from the panel? 17 DR. BLANC: There are going to be two kinds of 18 fact sheets then, actually, and this would be the more 19 atypical one. 20 One question I would have, leaving benomyl aside, 21 let's take one where were it to be in use, air exposure 22 would be an issue, but it's not in use, it's no longer 23 allowed, how did you anticipate the -- and let's say the 24 fact sheet was still four pages long, what would be the 25 relative weighting of information on toxicity or other PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 139 1 issues and there wouldn't be a whole section on monitoring 2 airborne levels, because there wouldn't be any airborne 3 stuff to measure, right? 4 DR. ROSS: There might be in the case of 5 monocrotophos, which is no longer registered, we do have air 6 monitoring data. 7 DR. BLANC: When it was used? 8 DR. ROSS: And we do have a complete risk 9 characterization document. 10 So those could be referenced in these fact sheets. 11 And we might conclude, on the basis of the air 12 monitoring data, that in fact there was significant 13 exposure. But I don't think you would see that in the fact 14 sheet. We would develop an addendum. 15 DR. BLANC: What would be in the fact sheet then, 16 for example? 17 DR. ROSS: For monocrotophos? 18 DR. BLANC: Yeah. 19 DR. ROSS: We would reference the existing 20 documentation and concluded by saying that it's no longer 21 registered and that basically be the end of it. I mean, we 22 would -- 23 DR. BLANC: There would still be a section on the 24 physical properties of the material? 25 DR. ROSS: Right. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 140 1 DR. BLANC: Would there be a section on toxicity 2 though? 3 DR. ROSS: Yes. 4 DR. BLANC: So the section on toxicity, for 5 something which was a bad player but -- and that's maybe why 6 it's no longer approved for use, might be bigger than the 7 toxicity section here? The toxicity section information 8 here, is where? 9 DR. GLANTZ: I couldn't find any. 10 DR. ROSS: I think in this particular case, I 11 don't think the toxicity is referenced, because we're going 12 for an insignificant exposure. 13 DR. GLANTZ: But I think you can't put forward -- 14 I mean, if a fact sheet like this came forward to me that 15 didn't talk about toxicity, I wouldn't approve it. 16 I mean, it's the old question if the tree falls in 17 the forest and nobody is there, but I mean if something is 18 toxic, I mean, if one of the reasons that something is no 19 longer registered it's usually because it's toxic, very 20 toxic, and I think to put forward a fact sheet on a compound 21 and not talk about the toxicity in a toxic air contaminants 22 program is silly. 23 So I mean I think you have to talk about the 24 toxicity. I mean, I read this and I thought, well, where is 25 this toxic air contaminant? And there's no toxic. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 141 1 MS. PELTIER: I think you raise a good point, 2 Dr. Glantz, that we can still reach the conclusion that a 3 material has an insignificant exposure and shouldn't be 4 listed as a toxic air contaminant, but I think you're right. 5 I think it is appropriate to add a section to this that 6 talks about the toxicity of the product. 7 DR. GLANTZ: Well, good, because that will save a 8 lot of fighting. 9 The other thing, though, is I think, and this has 10 been the debate with DPR plus all of your various 11 predecessor agencies is if something -- if there is isn't 12 significant exposure, that doesn't mean it isn't toxic. 13 That just means it's toxic and there aren't significant 14 exposures. 15 MS. PELTIER: I guess there's a question of 16 whether or not you would designate it as a toxic air 17 contaminant if there isn't an exposure in ambient air. 18 DR. GLANTZ: If there isn't, I'm looking at the 19 law here, and it says which may pose a present or potential 20 hazard. 21 Now, something could be toxic, a toxic air 22 contaminant, if it could pose a potential hazard, which 23 would be -- which it isn't posing an actual hazard, because 24 it isn't there, you know. 25 DR. ROSS: I think you can probably say that all PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 142 1 pesticides, because they are pesticides, are toxic to 2 something, and therefore are potential toxic air 3 contaminants. And if we want to go down that line, then we 4 don't need to review -- 5 DR. GLANTZ: Wait. It's not a question of whether 6 it's toxic to something. It's whether it's toxic to humans. 7 DR. ROSS: I think you can probably say that 8 they're all toxic to humans. 9 DR. BYUS: The question is the dose. I think in 10 the fact sheet -- 11 DR. ROSS: That's exactly right. 12 DR. BYUS: What you need is just a paragraph 13 discussing the dose, and if you define the chronic or acute 14 effects in dose and say and then it's -- you cannot measure 15 it in ambient air, and the limit of detectable, or it's very 16 low and we measure it and this is the level and it's five 17 orders of magnitude below what these other dose is, then you 18 can conclude that it doesn't have any toxicity in the 19 environment. 20 I mean, that's the way I think of it. We're not 21 saying, sure, almost anything could be toxic, given in 22 enough quantity. 23 So it's dosage, it defines it, and it actually 24 makes the case much stronger and clearer for you, because if 25 you don't have any toxicity information in these fact PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 143 1 sheets, especially since it's the title of it, it's like 2 you're trying to avoid it. 3 But if you just couch it in these numbers, to me 4 it makes your case more stronger. 5 DR. FUCALORO: The term insignificant exposure has 6 to be measured against a toxic concentration. That's what I 7 think you're saying. And you know plutonium has -- you 8 don't need to be exposed to much plutonium, and it may seem 9 insignificant at first blush, but you really need a term, 10 you really need a quantification of what the level is. 11 And even if you don't find anything, you have a 12 limit of measurability that you can put and say -- 13 DR. GLANTZ: See, the other thing, and this is 14 getting -- I'm looking at this where the toxic air 15 contaminants doesn't -- something isn't toxic if it's used 16 minimally or detected at levels that result in insignificant 17 exposures. 18 I don't agree with that, because let's say we've 19 taken some compound that comes out of the back end of the 20 car and listed it as a toxic air contaminant, and then the 21 ARB went out and undertook an aggressive control campaign 22 and got rid of it, okay, it's still toxic air contaminant. 23 It's just that the control measures have been undertaken to 24 reduce the public health burden due to the exposure of the 25 toxic air contaminants, because it isn't there anymore. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 144 1 That didn't make it not toxic. That's just meant 2 that there wasn't public health problem. 3 And I think that difference is something that is 4 in the discussions with the pesticide people from the 5 beginning that something that's been confused. 6 So I mean I think if you can conclude, and I'm 7 looking at the law again, where you can conclude there's a 8 demonstrated threshold for a fact, then I think you can use 9 the kind of logic that you're using here. But in the 10 absence of evidence for a threshold, I think what you should 11 say is this a toxic air contaminant. However, it's not 12 registered for use in California or the levels of exposure 13 that have been measured are low, are low enough that it is 14 not a public health consequence. 15 That doesn't mean it's not toxic. 16 DR. FUCALORO: Well, yeah. But I don't think -- 17 doesn't toxic air contaminant have a specific legal 18 definition. And, understood, but it has to go through a 19 certain process here. And this will not have gone through 20 that process because people have concluded that they put it 21 low on the priority list, let's say that, and only -- we can 22 only do so many of these a year and this would be a very low 23 low on the priority list. It's certainly toxic, but it's 24 not designated legally a toxic air contaminant unless it 25 goes through a specific process like we went through with PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 145 1 diesel exhaust. 2 Am I correct on that? 3 DR. GLANTZ: My understanding is this is actually 4 what they're saying is this is sort of a highly expedited 5 process for things which are not, say, not registered in 6 California so there's no -- it's at least no current use. 7 MS. PELTIER: I think that's right. If we take a 8 look at it. Let me respond to a couple of points that have 9 been made, if I may. 10 Dr. Byus, your point, and I believe it was yours, 11 Dr. Fucaloro, about the need to include information in these 12 documents about toxicity is absolutely right on and 13 Dr. Glantz you raised that same point. 14 DR. BYUS: Toxicity as related to dose. 15 MS. PELTIER: As related to dose and as related to 16 exposure in ambient air. 17 DR. BYUS: Exactly. 18 MS. PELTIER: Let me go once again, if I may, back 19 to our regulations in the area and it specifies that the 20 pesticide should be identified as a toxic air contaminant if 21 its concentration is in ambient air are greater than the 22 following levels. And then goes on in section 6890 to go 23 through those actual levels that would allow it to be 24 defined as a toxic air contaminant. 25 But I think that position of the department as PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 146 1 reflected in the regulations and as reflected in the intent 2 of the Legislature in passing this, we went back through at 3 the time when we were promulgating regulations and 4 considered the possibility that we could, because all of 5 these materials are inherently toxic at some does, could 6 declare all them as toxic air contaminants and the 7 Legislature wanted to make it clear that, and we did it 8 through regulations, that not only do they have to 9 demonstrate that they are toxic, but also that there is a 10 exposure in air. 11 So I think what we're proposing to do with the 12 fact sheets is we found ourselves in the situation where 13 we've been criticized because there are materials that have 14 been listed as a candidate, as a toxic air contaminant, that 15 we've never acted on, and some of those fall in the category 16 that we've never acted on and we've never moved them on 17 ahead to you, either because there was no exposures in 18 ambient air, or because the material was no longer 19 registered in the state. 20 What we're proposing with this process is to say 21 we have -- we'd like to have a way to get materials out of 22 the process so that we can say, you know, not only have we 23 had all of these that we've done have risk characterizations 24 on, but we have these that are no longer appropriate to 25 include on a list of toxic air contaminants, because it's no PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 147 1 longer to appropriate to consider them such. 2 And so, you know, I would in conclusion say that 3 we would -- I agree with what you have said that, there be a 4 question of the toxicity component, the dust component, 5 included in these documents as well. 6 DR. BLANC: I think that in the conclusion 7 section, which you're going to have in these, you have one 8 here, section 5 which I guess would now become section 6 9 because there are toxicity section, to make it clear that 10 this fact sheet represents a recognition that the material 11 is toxic and would have potentially been eligible for a more 12 detailed assessment were it to be in use and there to be air 13 release. 14 But given the current regulations and its current 15 nonregistered status, it does not meet those criteria and 16 therefore this fact sheet is in lieu of that. 17 And perhaps even the caveat that were that to 18 change that would be revisited, although I don't know of a 19 situation where a pesticide has once it's not -- you know, 20 off the list, gets back on the list, but I suppose that 21 would be an issue. 22 DR. GLANTZ: I guess the point is I guess I mean 23 what you're saying is you want to expedite things that are 24 in many cases so toxic that you can't use them, and so to 25 come out and say, well, it's not toxic, it's not a toxic air PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 148 1 contaminant because it's so toxic that we can't use it -- I 2 mean, I think Paul is giving you a way of dealing with this 3 that will make everyone happy. 4 But I mean because I don't want to get in a 5 position where somebody said, well, this wasn't -- the SRP 6 didn't say it was a toxic air contaminant, so it's not toxic 7 or it's not a problem. 8 DR. ROSS: I think it's jumping to conclusions to 9 say that these things are no longer used because they're so 10 toxic that they can't be used. 11 Monocrotophos is no longer used because Dupont 12 decided that it was not economically feasible to continue 13 marketing it in the state. 14 It comes down to an economic decision in many 15 cases, and not a matter of toxicity and risk assessment. 16 DR. GLANTZ: Right. Except that we're a 17 scientific body ruling on statements about toxicity, not 18 economics. 19 CHAIRMAN FROINES: Let me get this away from this 20 discussion and compounds that aren't being used, to 21 compounds that are being used. 22 The law says here for pesticides which do not 23 have -- threaten the regulations, rather, which do not have 24 thresholds for adverse health effects, this level shall be 25 equivalent to the air concentration which would result in PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 149 1 tenfold lower risk than that which has been determined by 2 the director to be negligible risk. 3 So we need to know, the panel needs to know what 4 is the director's negligible risk for benomyl? How was it 5 arrived at? What does the tenfold value below that mean? 6 What does that mean in terms of the number of persons who 7 would be at risk? 8 So that we need -- we need you to go through for 9 us this determination. For example, you have an ARB 10 monitoring station in Bakersfield that found 13 parts per 11 trillion. That's a measurable concentration in the air from 12 benomyl. I don't care whether it came from the air 13 monitoring. That's something that they found. It's there. 14 And I want to know what is the relationship 15 between that 13 parts per trillion and this negligible risk 16 level. 17 I don't know what those -- somebody has to go 18 through and do the numbers. 19 But when you find 13 parts per million, it does -- 20 it does say that there's something in the air and then it 21 raises the question can there it -- can it be in the air in 22 other places as well? And we've better try and figure out 23 what that might be. 24 So one can do a study in a field and find nothing 25 and then you go into Bakersfield and you find 13 parts per PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 150 1 trillion. 2 Well, somebody has got to resolve those 3 ambiguities before we just say, okay, it's not out there and 4 it's not a problem. 5 Second issue I think -- so we need you to take us 6 through this process, so we understand, because all you've 7 given us here is the conclusions without the substance. 8 The second point is Paul's point, which I think is 9 really important, we need to know what the negligible risk 10 level for n-butyl isocyanate is, which is volatile, and we 11 need to know whether or not there's any n-butyl isocyanate 12 in the air, and whether that constitutes a negligible risk, 13 before we say benomyl is negligible in context. 14 DR. BLANC: I mean, basically what I think you're 15 saying is, and maybe this is what you already said before, 16 was that you don't anticipate that they're going to be -- 17 maybe this is a poor choice for prototype, because you don't 18 anticipate that this is going to be the rationale for most 19 of the fact sheets, that fact sheets that we see the 20 rational for them is going to be nonusage, non-detection. 21 So this is an exception rather than the rule. 22 And I think John's point is that the review 23 process is going to require a great deal of convincing of 24 the negative. To prove the negative is very difficult. 25 So if you want to make the argument that something PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 151 1 is not a problem because there isn't any in the air, then 2 the sampling that's going to be required to convince this 3 body that in fact there isn't any in the air is going to 4 have to be probably fairly elaborate to convince us that we 5 haven't -- because this is actually a situation in which 6 you're not innocent until proven guilty. You're guilty 7 until proven innocent, in this kind of situation. Where we 8 know something is in use and we're trying to argue that even 9 though it's in use we can't seem to find any in the air. 10 That a safe summary of what you -- 11 CHAIRMAN FROINES: That's fine. I want to finish 12 what I was starting. 13 DR. BLANC: All right. 14 CHAIRMAN FROINES: Let me make a comment. 15 Because I think that Lyn Baker's comments this 16 morning were particularly interesting. 17 This document has something in here that says use 18 formulations and application method of benomyl. But that -- 19 section 3. There's not a single word in here about 20 application methods. Not a word. 21 DR. ROSS: That's easily remedied. 22 CHAIRMAN FROINES: But the point is for the most 23 part when you go over here, you find that there are two or 24 three ways of application of benomyl. 25 And aerial application isn't used very much, as PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 152 1 the document suggests, or at least that it's implied. 2 And so if I were doing this and wanted to find out 3 if this was insignificant, I would try and find out when 4 they are some aerial applications going to go on and I'd go 5 do some monitoring, seeing what kind of ambient levels I 6 find when you have air application of the pesticide. 7 And I'd feel much better about that, because I 8 take that as a worst case solution situation. 9 So that I'm still concerned a little bit about the 10 fact that we were saying that none exists, period, pretty 11 much unequivocally. 12 And so that application issue is still I think 13 before us, although I don't want to push a compound which is 14 exposure is negligible, so we're really not disagreeing as 15 it may not be negligible. What we're really saying is that 16 burden of proof is still before us. 17 DR. ROSS: The vast majority of this chemical is 18 used by ground, not by air. And so for an acute exposure, 19 it might be appropriate to go look for an aerial 20 application, but certainly not for chronic, and that's 21 probably what's -- not what's going to drive benomyl. 22 Benomyl will probably be driven by chronic as opposed to 23 acute. 24 On your question about breakdown products, I think 25 this is something that we need to consider. The Department PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 153 1 of Pesticide Regulation doesn't regulate breakdown products. 2 We have toxicity data for the parent compound and in a few 3 cases for some specific breakdown products, but for the most 4 part we don't have toxicity data to evaluate the toxic 5 potential of all of the breakdown products of any given 6 pesticide. 7 DR. BLANC: Well, in this case I think we're 8 really talking about something which is -- there's a good 9 corollary in MITC, as the principle hydrolysis breakdown 10 product of metam-sodium. 11 DR. ROSS: The primary difference there is MITC is 12 at one time was registered as a pesticide. 13 DR. BLANC: Well, I know you were lucky in that 14 way. 15 DR. ROSS: We were fortunate to have a complete 16 tox database. 17 DR. BLANC: But I'm saying this is no less 18 important for this one. 19 DR. ROSS: We speculate that in the case of DEF 20 the primary toxic of concern is really the n-butyl 21 mercaptan. That's what causes most of the complaints. 22 That's what you can smell at part per trillion levels. But 23 that's not something that we regulate. And it's not 24 something for which we have a complete toxicity database. 25 DR. BLANC: But it is something we have to address PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 154 1 in this panel; isn't it? 2 CHAIRMAN FROINES: Well, I don't -- John, I don't 3 entirely agree with you. 4 DR. BYUS: You must regulate it. 5 CHAIRMAN FROINES: Wait a second. If n-butyl 6 isocyanate is a breakdown product of benomyl, then we're 7 talking about benomyl. 8 DR. ROSS: No. 9 CHAIRMAN FROINES: Yes. 10 DR. ROSS: I beg to differ. If we're talking 11 about n-butyl mercaptan from DEF, how do you distinguish 12 that from what comes out of a skunk or what comes out of a 13 crop that's being grown down the road? I mean, we don't 14 regulate those things. 15 CHAIRMAN FROINES: If you want to limit exposure, 16 if persons are being adversely affected from exposure to 17 n-butyl isocyanate, that may require you to establish 18 certain controls over benomyl to prevent that from 19 occurring. 20 DR. ROSS: That requires, first of all, that we 21 have knowledge of the toxicity of this breakdown product. 22 If we had not got the toxicology data, we can't do it, even 23 if we wanted to. 24 CHAIRMAN FROINES: But all I can say right now is 25 that I know quite a bit about isocyanates, and so does Paul, PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 155 1 and we know that those are particularly toxic compounds, and 2 this is a volatile compound. So you have volatility and 3 toxicity. 4 And so we may not have -- we have what's necessary 5 as a starting point. We don't have sufficient information 6 yet. And I think we all agree on that. We don't know -- 7 this is not toluene diisocyanate. This is not those kinds 8 of -- hexomethylene diisocyanate. But it is an isocyanate. 9 And so it seems incumbent upon us, if one finds a breakdown 10 product or even a metabolite of significance, you know, lots 11 of the chemicals that we, as you well know, that turn out to 12 be toxic, aren't toxic in themselves, they are metabolized 13 to bioactivate to toxic compounds. We still deal with the 14 parent compound. 15 So benomyl becomes the parent compound with 16 respect to the isocyanate. So it seems to me we have an 17 obligation to find out what's the story with isocyanate. 18 DR. BLANC: Is the question maybe we're all 19 talking about the same thing, but is what you're saying that 20 the database that you have will not be supplied to you as 21 part of the registration process for the breakdown product, 22 in this case, let's say butyl isocyanate, but that doesn't 23 mean that your agency would be prohibited from seeking the 24 data on the toxicity of that breakdown product, which is 25 available in the open literature. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 156 1 DR. ROSS: We have no regulatory mandate for that, 2 to my knowledge. 3 DR. BLANC: You will to us, so you'll -- we 4 certainly have regulatory jurisdiction for that. 5 CHAIRMAN FROINES: I don't understand. Help me 6 with this. When you say that, tell me, explain it, because 7 I don't really understand it. 8 DR. ROSS: The breakdown product is not a 9 registered pesticide. 10 DR. BYUS: You mean if someone had a pesticide 11 that broke down into some incredibly toxic compound and 12 killed people, you cannot regulate the pesticide, is that 13 what you're saying? I mean, that's what you're saying. 14 There's two things. Whether, A, you have the 15 data, or B, you don't, for all the breakdown products and I 16 can understand that. But clearly if the chemical breakdown 17 product of a pesticide is harming people, you have to be 18 able to regulate the pesticide, the parent compound. 19 DR. ROSS: I think if we had evidence that it was 20 harming people, then we would. We have no evidence. We've 21 got speculation here. 22 CHAIRMAN FROINES: Wait a second. Wait, John. 23 You got to keep a consistent story here. You're 24 saying you don't have regulatory authority. Okay. We'll 25 buy that. Then you say if it was harming people, we would PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 157 1 have regulatory authority. So what is it? 2 DR. ROSS: In the case of DEF we did something in 3 response to the odor complaints, despite not having toxicity 4 data on n-butyl mercaptan. 5 CHAIRMAN FROINES: Is what you're saying about 6 regulatory authority is dependent upon the registration 7 issue if it's -- if the -- help me. I just don't know. 8 DR. SANDERS: The laws are clear about regulating 9 the poisons and the I think the differences here that we 10 have no -- take the DEF the mercaptans. We're assuming that 11 that's causing the problem, but we don't have data 12 specifically to say that. But we do have complaints about 13 the use of DEF and so action was taken back in the '80s to 14 take care of that. 15 If there's a similar situation like that we can 16 deal with that, but we don't have the authority to run after 17 and get data on things that might be a problem and we don't 18 know about. I think that's the difference. 19 On the benomyl issue, yes, we can speculate that 20 the isocyanates are a problem, and they may very well be, 21 but we don't get the data from the registrants because the 22 isocyanate is not a registered pesticide. We do get it on 23 the parent, and that's what we regulate off of is the 24 parent. 25 CHAIRMAN FROINES: The literature -- PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 158 1 DR. BLANC: That was my question, that confused 2 me. I understood, I thought that was your implication of 3 your original comment is that you're not automatically going 4 to get data submitted to you, nor could you require it from 5 the manufacturer, but as part of preparing a document for 6 our review you can certainly review the open literature 7 insofar as it touched on the toxicity of that breakdown 8 product. 9 DR. SANDERS: We can. We can certainly do that. 10 DR. BLANC: You can ask the Air Resources Board to 11 monitor for the isocyanate compound, particularly if you had 12 reason to believe that that's what would be more volatile 13 than the other molar part of the breakdown product. 14 DR. SANDERS: Yes, we can do that. 15 DR. BLANC: That's all I -- that's how I 16 originally understood your comment to mean, that you 17 wouldn't automatically in a passive sense, get data from the 18 manufacturer, nor could you require data from the 19 manufacturer, but you certainly could independently review 20 data that were available in the open literature. 21 DR. SANDERS: Yes. But I think the next step you 22 have to walk through is what are the resources allocated, 23 because we've got 500 active ingredients that we're 24 eventually going to be evaluating, so if we're going to do 25 that we need to set up some kind of criteria by which we're PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 159 1 going to choose which ones we're going to go after, because 2 all these compounds have many breakdown products. 3 DR. BLANC: Well, I would say that in the case, it 4 sounds like you've backed off from trying to get benomyl 5 short-tracked as a non-ambient issue, but let's say you were 6 trying to get benomyl short-tracked as a non-ambient issue, 7 then you certainly have to show me data that indicated that 8 this principal breakdown product, which one would anticipate 9 would have adverse health effects is not detectable. 10 DR. SANDERS: I understand that. 11 DR. BLANC: It's a priority thing just like 12 anything else. We're not saying that for every single 13 breakdown product or every single thing that you look at, 14 you need to provide us data. It just depends on what seems 15 to be the most salient issue involved in a particular 16 product. 17 For this, even when you come back with a longer 18 document, if it appears that it's not particularly -- the 19 parent compound is not particularly volatile, that you have 20 reason to believe that this breakdown product is and this 21 breakdown product by analogy to other isocyanates is likely 22 to be a human health problem, then that would be what I 23 would use as my target or one of my target measurement 24 constituents. 25 DR. ROSS: Looking process wise, if indeed we come PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 160 1 to that conclusion and come to the conclusion that there 2 needs to be additional monitoring, obviously this material 3 is not going to make it through the process this year. 4 DR. BLANC: Well, I would say, based even on the 5 preliminary data that we have, we do need -- I certainly 6 need to see some data on the isocyanate, and I would put 7 that on your to-do list for the Air Resources Board for 8 sure. 9 CHAIRMAN FROINES: George, how about spending 24 10 hours, 48 hours and see what you can find on the Internet on 11 this particular compound? 12 DR. ALEXEEFF: Me? 13 CHAIRMAN FROINES: Your staff, now that you're in 14 this high-level position. 15 MS. PELTIER: We can call on your scientists to do 16 the same thing. 17 CHAIRMAN FROINES: I'm just saying he can do a tox 18 search in a day and see if there's anything there at all, 19 because he's here. That's I -- I'm not trying to, yeah, of 20 course have your scientists. George was in the back and I 21 took the easy path. It's not meant to be an insult. 22 DR. GLANTZ: The other thing you have to 23 understand is that we usually spend these meetings torturing 24 George. 25 MS. PELTIER: I'm anxious for you to get on to PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 161 1 that favorite part of your -- 2 DR. GLANTZ: We're having to pick on you instead 3 of George. 4 CHAIRMAN FROINES: Believe me, I'm very happy to 5 have DPR do the literature search on this compound. 6 And it would be nice to see what's out there on 7 this compound. I bet there's not much of anything. 8 Jean-Mari, this is particularly interesting. 9 We're doing this big study on MTBE for the State 10 Legislature, and one of the things we're finding is one of 11 the major breakdown products of MTBE turns out to be 12 isobutane. Isobutane is good small alkene compound that 13 forms epoxides and it's very likely to be a carcinogen. 14 So that there's a breakdown product which actually 15 may have very significant health effects since we are all 16 breathing MTBE and its breakdown products as we sit here. 17 And so these breakdown products can have major 18 significance and certainly the atmospheric chemistry of 19 nitro-PAHs in the South Coast Basin is another example. 20 It's not like we're in any way attempting to pick 21 on you, but I think that it's an issue that deserves some 22 attention. I think it will all just make this process move 23 more smoothly. 24 I think Peter is right, that as we go through and 25 have the hardest problems with the first ones that it will PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 162 1 be easier as we go. 2 MS. PELTIER: To summarize where we are on this 3 issue, the concept of the fact sheet is not -- you're not 4 opposed to that on its face, provided except for maybe you, 5 Dr. Glantz. 6 DR. GLANTZ: No, I'm not opposed to it on its 7 face. I think it's a wonderful idea. The less I have to 8 read, the better. 9 MS. PELTIER: That basically what we're talking 10 about is that there is a need and I think it's an omission 11 on our part. There is a need to have both the toxicity data 12 and information about dose response and put it in these 13 documents, along with the discussion of whether we are 14 taking this path because either there were zero detects and 15 they truly are zero detects, or if we're in a situation 16 where the material is not appropriate to consider because 17 it's because it's no longer used, no longer registered. 18 CHAIRMAN FROINES: I think if you have a compound 19 which you think the concentrations that you've measured, 20 your fourth category, are so low, as to be insignificant, 21 you probably should have what you consider a negligible 22 level to be, and then show how far below that you are, so 23 everybody sees exactly that they can actually see what the 24 facts are. 25 MS. PELTIER: That's a good point, Dr. Froines. I PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 163 1 had that in my notes, but I didn't comment on it. 2 CHAIRMAN FROINES: Thank you very much. 3 MS. PELTIER: It's been our pleasure. 4 CHAIRMAN FROINES: I think it's rough, but I think 5 that it's really going to work out. I think we're moving 6 along. Anything that we said is in spirit of moving things 7 forward. Everybody hopes we understand that. 8 MS. PELTIER: Dr. Froines, I don't know if you 9 wanted to cover Item 5 in the workload, or if that's an item 10 that we can really handle perhaps in a separate side bar 11 conversation. We had talked briefly about trying to move 12 ahead with the DEF document. 13 CHAIRMAN FROINES: Why don't you and I or you and 14 your staff do that and we'll get -- then I'll communicate 15 with the panel. 16 MS. PELTIER: Be glad to do that. 17 CHAIRMAN FROINES: I think that this many people, 18 especially this many opinions, it won't take five minutes. 19 MS. PELTIER: Thank you. We'll follow up. 20 CHAIRMAN FROINES: George, everybody is hungry 21 tired and -- 22 DR. ALEXEEFF: At me? 23 DR. FUCALORO: But still we have enough time for 24 you. 25 DR. GLANTZ: Yeah, George. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 164 1 CHAIRMAN FROINES: I have to say -- 2 DR. GLANTZ: We're cranky from the previous 3 discussion. Sit down, George. 4 CHAIRMAN FROINES: George, I have to say that it's 5 really nice that you still feel as loyal to this panel and 6 that you have come back, instead of putting Melanie in the 7 entire breach. 8 DR. ALEXEEFF: My name is George Alexeeff, deputy 9 director for Scientific Affairs of OEHHA. 10 And at some point my involvement with these 11 documents will be distanced and I'll be less likely to be up 12 in front here. So but at this point I'm so heavily invested 13 in these documents it makes sense for me just to kind of go 14 through them. 15 DR. GLANTZ: Plus you enjoy having us ask you 16 questions; right? 17 DR. ALEXEEFF: Yeah. Actually this is fun. 18 CHAIRMAN FROINES: George, before you move 19 forward, if Genevieve could join you for just one second, 20 I'm going to go off the agenda a little bit and maybe the 21 lawyers will complain, but I'm going to do it. 22 Genevieve, could you come up for just second? 23 One of the things that this morning's session 24 points out is that in some form or another we're going to 25 get a significant number of documents from DPR. I had the PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 165 1 feeling that when at the end of this I'm hoping they still 2 feel as positive about that as they did originally, and I 3 hope we haven't put a blanket of damper on it, because I 4 don't think that was intended. 5 But on the assumption that they are going to work 6 quite assiduously to bring us 12 compounds, one of the 7 things that we need to know is what are the plans from OEHHA 8 and ARB in terms of bringing things before the panel over 9 the next, say, year, because we need to sort of factor that 10 in to what may be happening with DPR. 11 So you don't have to say a word. I just, I think 12 what all we need is for you to develop a list of things that 13 are going to come before us and make that available to us so 14 we can look and see as we try and plan meetings how we're 15 going to approach that. 16 And I assume you do have some compounds that will 17 be coming forward. 18 MS. SHIROMA: We have a number of OEHHA documents. 19 No problem. We can do a schedule for you. 20 CHAIRMAN FROINES: Thank you. 21 DR. ALEXEEFF: Well, actually mention as part of 22 this short, very short presentation that we have, last 23 December we began discussing this document here, that's this 24 one here, on cancer -- available cancer potency factors. 25 And I'm just going to want to make a brief summary PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 166 1 as to what we said in December and then Melanie will 2 summarize the proposed changes in the document that we have 3 thus far. 4 Okay. As a summary, this document primarily comes 5 from what's called the hot spots program created from 6 AB 2588. It's a related program to the toxic air 7 contaminant program, but it is different. 8 In this program, we have to provide health 9 information about 450 chemicals to the Air Board and air 10 districts, so in this case we're trying to grapple with 11 providing information on many chemicals simultaneously, and 12 trying to let them know what is the best information that we 13 see out there for them to do any sort of management or 14 review. 15 And these 450 chemicals include all of the TACs, 16 hazardous air pollutants, Prop 65 chemicals and other 17 chemicals. 18 Now, the reason we're bringing it to the panel is 19 because the law that created the hot spots requirement 20 requires that the panel evaluate what's called the hot spots 21 guidelines and recommended any changes. 22 Now, this particular document here is not the hot 23 spot guidelines, but the health information in here will 24 become part of the hot spots guidelines and we thought it 25 would make sense, instead of having the document five times PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 167 1 this side to review, to review it in parts, where we look at 2 the different components of what will ultimately be these 3 guidelines. 4 And this is really the most straightforward of all 5 the components that we have, this cancer document summary. 6 And of those 450 chemicals, there's 200 that are 7 carcinogens, and this document considers 119 of them. And 8 we've compiled in this document the health information and 9 the potency information on those chemicals. We haven't 10 really developed any new numbers. We're simply compiling 11 the information from either the TAC program or the 12 Proposition 65 program or from US EPA, because again the 13 goal of this program is to provide information to the Air 14 Board and air districts trying to grapple with all these 15 different substance. 16 One thing that is new and noteworthy in this 17 document is that in Appendix A we discuss a change in how we 18 calculate dioxin equivalents, and that's something that's 19 different. We had a dioxin document in '85-86 and that 20 suggested one method for calculating the equivalencies. 21 Since then, more information has come in and allows a more 22 improved way of calculating it. So that's what's proposed 23 here. 24 It doesn't dramatically change the toxicity of 25 dioxins or anything like that, it's just a slightly PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 168 1 different weighting scheme. 2 So, again, just as a summary, this document 3 provides the districts and the Air Board with the cancer 4 potency factors for use in hot spots program and another in 5 other programs and it's done to in a way that presents 6 sufficient documentation of where these numbers came from. 7 The other alternative we could have had was simply 8 present just a table, and we felt just for a lot of the 9 questions we have, once they start using these numbers, are 10 where how did they come from, how did they come to be, it be 11 an animal or human number, and this provides that type of 12 information for us. 13 So Dr. Marty will now just sort of present, review 14 some of the comments that have been made by the panel up to 15 now and those changes. 16 DR. MARTY: In reviewing the December '97 SRP 17 transcript, to look and see what was actually said back 18 then, we noted that Dr. Witschi had a couple of comments as 19 well. And one of them reflects one of the public comments 20 we got. 21 So the first one was a public comment asking us to 22 add new epi data to the toluene diisocyanate summary, which 23 we're doing. 24 And then Dr. Witschi wanted us to include 25 summaries for the TAC chemicals. This document has just the PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 169 1 summaries for everything else but the TAC documents that 2 have gone to the panel, so we've prepared summaries and 3 we're going to add those in. And it just, all it does is 4 make the information in one place, easy to look up. 5 And then also we were requested to have a better 6 or expanded definition of cancer potency units. So there is 7 some confusion out there in terms of people looking at those 8 database versus looking at our numbers and not sure what the 9 numbers actually mean. So we're putting in an expanded 10 definition. 11 Dr. Witschi also asked for a discussion of surface 12 area scaling versus body weight scaling. And this is to go 13 generally from animals to humans in milligrams per kilogram 14 body weight, versus milligrams per space area. So we do 15 have an expanded discussion of that and we added to the text 16 of the document. It's something that we always do, the 17 surface air scaling, is something we've always done, so it's 18 a good place to put reasons why. 19 And then finally we've thought that we should 20 probably add in the diesel exhaust TAC cancer unit risk 21 range, which currently isn't in this document because, as 22 you know, the diesel exhaust just finished going through the 23 process, and including the SRP's best estimate, either as a 24 footnote or in the table. We haven't really figured that 25 part out. PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 170 1 Those are the five changes and we'll be working 2 with Dr. Witschi to finalize the document. 3 That's all. 4 DR. BLANC: This a document that will be on hard 5 copy, but also on the CD ROM? 6 DR. MARTY: It's actually on our Web site, so the 7 existing document -- 8 DR. BLANC: You can download? 9 DR. MARTY: So people can download it. 10 CHAIRMAN FROINES: All the documents are on the 11 Web site. 12 DR. MARTY: Yes. All the hot spots documents are 13 on the Web site. 14 DR. FUCALORO: I was told by George to mention 15 this, that there are as many as six possible errors in the 16 table on pages two through six that I discovered and I've 17 since given it to them to check out. So it maybe want to be 18 aware of that. 19 CHAIRMAN FROINES: Thanks, George. 20 Thanks, Melanie. 21 DR. ALEXEEFF: I think it probably be good to 22 have, although the panel is not required to adopt this 23 document, it's not a requirement, but I think it would good 24 for the panel to conclude that they have evaluated it and 25 that we'll just -- we can, after reviewing changes with PETERS SHORTHAND REPORTING CORPORATION (916) 362-2345 171 1 Dr. Witschi, we can finalize this. 2 The process is that following review by the panel 3 the department can then finalize this document and then this 4 information can ultimately be put into the guidelines that 5 will be adopted by the department. So just to -- 6 CHAIRMAN FROINES: We can -- 7 DR. ALEXEEFF: So we can bring this to a close in 8 terms of the panel discussion, is what my concern is, until 9 the guidelines actually have formally come up. 10 CHAIRMAN FROINES: We'll take it up next time when 11 Peter and you will resolve the final -- 12 DR. ALEXEEFF: I think those are just minor 13 changes. It's just summary paragraphs that we're adding. 14 CHAIRMAN FROINES: You want the panel to go on 15 record as approving your document? 16 DR. ALEXEEFF: Yes. I think endorsing the 17 document or concluding that the document has been reviewed 18 and can now be used and subsequently.