1                             MEETING

 2                              OF THE









11                             SALON B

12                   255 SOUTH AIRPORT BOULEVARD






                       WEDNESDAY, JUNE 3, 1998
                              9:00 A.M.




24   Janet H. Nicol
     Certified Shorthand Reporter
25   License Number 9764



 1                          APPEARANCES


 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


 9  Mr. Lynton Baker, Staff Air Pollution Specialist
    Mr. Peter Mathews, Office of the Ombudsman
10  Ms. Genevieve Shiroma, Chief, AQMD


13  Dr. George Alexeeff, Deputy Director for Scientific Affairs
    Dr. Melanie Marty, Senior Toxicologist


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

    Dr. William Vance, Special Assistant to the Secretary







 1                             INDEX

 2                                                        PAGE
    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
    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
    Adjournment                                           172
    Certificate of Reporter                               173











 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



 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.



 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.



 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



 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



 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



 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



 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



 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.



 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,



 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



 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.



 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



 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



 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



 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



 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.



 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



 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.



 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



 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



 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.



 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



 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.



 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



 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.



 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



 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



 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



 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



 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.



 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



 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



 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 --



 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



 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



 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.



 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



 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



 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



 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



 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



 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.



 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



 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.



 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



 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.



 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



 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



 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



 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.



 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



 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.



 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.



 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.



 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



 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



 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



 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



 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



 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



 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



 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.



 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.



 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?



 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



 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.



 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



 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



 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?



 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



 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



 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.



 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,



 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



 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



 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.



 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



 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.



 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



 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



 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



 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



 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.



 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.



 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.



 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



 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



 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



 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



 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



 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



 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



 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.



 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?



 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



 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.



 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.



 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



 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



 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?



 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.



 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



 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.



 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



 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



 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.



 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



 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?



 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



 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



 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.



 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



 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,



 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



 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



 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.



 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



 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



 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



 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



 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.



 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.



 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



 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.



 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.



 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



 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



 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



 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



 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



 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,



 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.



 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



 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.



 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



 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



 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



 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.



 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.



 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



 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



 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.



 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



 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



 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



 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



 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



 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



 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



 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



 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



 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



 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,



 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.



 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



 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 --



 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



 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



 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



 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



 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



 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.



 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



 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



 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



 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



 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



 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.



 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



 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.

19             DR. WITSCHI:  I reviewed the document the last

20   time and found it to be a very very good good and useful

21   document, both for practical reports and for teaching

22   purposes.  And I would like to see those, what's going to be

23   added, but I think these are good.  The TAC summaries are

24   there already.  They have just becomes more useful.  And so

25   I really, as I suggested the last time, I thought that we



 1   recommend to the panel accept this document.

 2             CHAIRMAN FROINES:  So we'll hear that as a motion

 3   from you as a lead person then.

 4             DR. GLANTZ:  Second.

 5             DR. KENNEDY:  Second.

 6             CHAIRMAN FROINES:  All in favor.

 7             (Ayes.)

 8             DR. ALEXEEFF:  Thank you.

 9             CHAIRMAN FROINES:  That's a good example of

10   democracy in action.

11             DR. WITSCHI:  No, hungry stomachs.

12             CHAIRMAN FROINES:  You'd have gotten anything

13   through, George.

14             We have a motion to adjourn?

15             DR. BLANC:  I'll move to adjourn.

16             DR. GLANTZ:  Second.

17             CHAIRMAN FROINES:  Second.  Fine.

18             Thank you, everyone.

19             (Thereupon the meeting was adjourned

20             at 1:50 p.m.)










 3             I, JANET H. NICOL, a Certified Shorthand Reporter

 4   of the State of California, do hereby certify that I am a

 5   disinterested person herein; that I reported the foregoing

 6   meeting in shorthand writing; that I thereafter caused my

 7   shorthand writing to be transcribed into typewriting.

 8             I further certify that I am not of counsel or

 9   attorney for any of the parties to said meeting, or in any

10   way interested in the outcome of said meeting.

11             IN WITNESS WHEREOF, I have hereunto set my hand

12   this 7th day of June 1998.




                                     Janet H. Nicol
17                                   Certified Shorthand Reporter
                                     License Number 9764