1                             MEETING

 2                              OF THE

 3        SCIENTIFIC REVIEW PANEL ON TOXIC AIR CONTAMINANTS

 4                 CALIFORNIA AIR RESOURCES BOARD

 5

 6

 7

 8

 9

10              SOUTH SAN FRANCISCO CONFERENCE CENTER

11                   255 SOUTH AIRPORT BOULEVARD

12                 SOUTH SAN FRANCISCO, CALIFORNIA

13

14

15

16

17
                       THURSDAY, MAY 25, 2000
18
                              9:00 A.M.
19

20

21

22

23

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


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 1                           APPEARANCES

 2   MEMBERS PRESENT:

 3   Dr. John Froines, Chairman
     Dr. Roger Atkinson
 4   Dr. Paul D. Blanc
     Dr. Craig Byus
 5   Dr. Anthony Fucaloro
     Dr. Peter S. Kennedy
 6

 7   REPRESENTING THE CALIFORNIA AIR RESOURCES BOARD:

 8   Mr. Jim Behrman
     Mr. Bill Lockett	
     Mr. Peter Mathews
 9

10   REPRESENTING THE OFFICE OF ENVIRONMENTAL HEALTH HAZARD
     ASSESSMENT:
11
     Dr. George Alexeeff, Deputy Director for Scientific Affairs
     Dr. Andrew Salmon
12

13   REPRESENTING THE DEPARTMENT OF PESTICIDE REGULATION:

14   Mr. Paul Gosselin, Assistant Director
     Dr. Nu-may Ruby Reed
15   Dr. Andrew Rubin

16

17   OTHERS:

18   Dr. Elinor Fanning, UCLA

19

20

21

22

23

24

25


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 1                              INDEX

 2                                                           PAGE
     AGENDA ITEMS:
 3
     1    Consideration of findings based on the report:       3
 4        "The Evaluation of Methyl Isothiocyanate (MITC)
          as a Toxic Air Contaminant"
 5
     2    Update on DPR's report schedule                     67
 6
     3    Discussion of topic for "Pesticides in the Air"     73
 7        workshop

 8   Adjournment                                              96

 9   Certificate of Reporter                                  97

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25


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 1                      P R O C E E D I N G S

 2             CHAIRMAN FROINES:  I guess I should officially

 3   call the meeting to order, so we can be official.

 4             George, I just wanted to say one thing.

 5             At the last meeting in Riverside, Peter Venturini

 6   gave a presentation on ARB priorities in air toxics.  And I

 7   noticed later that we had not asked OEHHA to participate in

 8   that presentation, so that OEHHA wasn't able to give a

 9   presentation on their sense of the priorities in air toxics

10   at this point.

11             So what I'd like to do would be to invite you for

12   the next meeting to make a presentation on your agency's

13   point of view on where we should be going with respect to

14   air toxics in the future.

15             And I don't know, is that a reasonable question

16   for you?

17             DR. ALEXEEFF:  George Alexeeff, OEHHA.

18             I guess it depends when the next meeting is, but

19   certainly be happy to do that in an upcoming meeting, the

20   next one or one right after that, and give you sort of a

21   overview as to all the different areas we're working on over

22   the next year or so.  We'd be happy to do that.

23             CHAIRMAN FROINES:  I think that one of the things

24   that we would like to do follows on Roger's and my comments

25   at the last meeting where we were actually raising the


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 1   question of what are the scientific issues that underlie our

 2   selecting chemicals for consideration.

 3             And certainly atmospheric chemistry is an

 4   important one in Southern California.

 5             So that it's issue not just saying about what we

 6   think we're doing next year, but more what do we think is

 7   underlying the problem and how do we think we should be

 8   approaching those questions.

 9             And I think you'll get a lively discussion.  We'll

10   have one, because I think there's a number of people here on

11   this panel who have views on this topic.

12             And we'll invite ARB also to participate as well,

13   but I think it would be useful to give you an opportunity to

14   hear from you.

15             DR. ALEXEEFF:  All right.  That's fair enough.

16             I think there's probably three areas that we'll be

17   talking about where this prioritization is occurring for us.

18   And we'll be happy -- one is the actual basic TAC program.

19   The other one is the hot spots issues that are coming up and

20   the third one is this new area working on the children's

21   health, which is going to come to the panel.

22             So we'll be happy to tell you how we're

23   prioritizing the different ones and how to integrate them

24   and determine from our perspective what are the important

25   issues.


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 1             CHAIRMAN FROINES:  I'll just say one thing.  We

 2   are in the process, for example, we've had three meetings

 3   this week on what analytical chemistry do we want to do on

 4   organics for PM and so the issue is absolutely current in

 5   terms of what kind of analytical chemistry one is doing.

 6             So I think it should be pretty interesting.

 7   Thanks.

 8             Did you didn't want to comment?

 9             DR. ATKINSON:  No, no.  That's fine.

10             CHAIRMAN FROINES:  So moving to the agenda,

11   consideration of the findings based on the report of the

12   evaluation of methyl isothiocyanate as a toxic air

13   contaminant.

14             Before we get to the actual findings that we sent

15   out last week, we'd like to have Paul Gosselin discuss the

16   Metam-Sodium Task Force submissions and changes that have

17   occurred, the changes that have occurred in the findings and

18   document, and other related issues.

19             So Paul.

20             MR. GOSSELIN:  Thank you.  Paul Gosselin, DPR.

21             All of you, I think, by now have got a copy of a

22   memorandum from the Metam-Sodium Task Force dated May 17th.

23             I got that over a fax on that date.

24             And I just wanted to lay out a couple of the

25   issues that they have raised and then a couple of their


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 1   concerns and how our response to it and how it affects or

 2   relates to the proceedings today.

 3             The one thing we wanted to do was to have through

 4   DPR as a conduit have this information get transmitted to

 5   the panel immediately, which we did through Jim Behrman, and

 6   to the panel, which that was done fairly quickly.

 7             There was an issue raised about the announcement

 8   of the meeting on whether it met the legal requirements, and

 9   I'll defer to ARB on that, but ARB can speak to that, that

10   the noticing of this meeting was legally carried out.

11             And then coupled with that, they wanted this

12   meeting cancelled and reconvened at a later date to ensure

13   that their comments were taken into full consideration.

14             They also raised an issue about concern about the

15   processes we went through and we're doing final revisions to

16   our document and the whole recommendation of listing as TACs

17   through the SRP process.

18             Overriding all of this was some of their concerns

19   about how we've either addressed or characterized

20   supplemental data they've sent into the record.

21             The two requests that they made, one, the

22   reconvening of the meeting, ties specifically back to the

23   notice, which as I said was done legally, so for a number of

24   reasons I don't think there's any need to reconvene or

25   reschedule the discussion on the findings for a number of


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 1   reasons.

 2             And then, secondly, on the revision of the

 3   document, which was approved a few meetings ago, the

 4   revisions that we're making are not substantive.  They're

 5   specifically reflecting what the record was during those

 6   meetings and staff have gone back very specifically, based

 7   upon the transcripts and the discussions, to make some

 8   fairly important but modest changes to the document.

 9             And I think one of the toning things out of the

10   Metam-Sodium letter was I think specifically tied to the

11   process of the proceedings here and what this document

12   really entails.

13             To go back, the document that we have is, in my

14   mind, I think the process is a compilation of all the

15   relevant scientific knowledge that we have associated with a

16   particular compound.

17             Our assertion is that through this process,

18   working with the panel, OEHHA and ARB and the public

19   comments is that we've done that.  We've gone to great

20   lengths to ensure that this document includes and

21   incorporates all the scientific information of this

22   compound, MITC.

23             And coming to this document here, the important

24   factor is to have the review and ensure that we've done that

25   job, and to provide us with findings and recommendations so


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 1   we then can go into the next steps which for us largely fall

 2   to risk management.

 3             There are two elements of that risk management

 4   step.

 5             One is our process of listing a compound or

 6   considering whether to list a compound as a TAC, which after

 7   this -- after the completion of the approval of the document

 8   is something that we would take up within ten days.

 9             Secondly to that, and coupled with that, is

10   decisions on whether we need to put more restrictions and to

11   manage unacceptable risk associated with this.

12             We're bound under both those actions, under fairly

13   formal rulemaking process, is that would then allow the

14   public, including the Metam-Sodium Task Force, to engage in

15   a public process to comment on our actions as we move

16   forward in the risk management phase and our responsibility

17   to respond to any comments we get through the public through

18   the risk management process.

19             One of the things that struck me in reading

20   through is the concern about whether DPR or the panel was

21   actually taking into account all the comments and issues and

22   science that was presented to us, and this is something that

23   we hold very seriously and something that we wanted to

24   ensure that this document does include and incorporate all

25   the most relevant science and all the information available.


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 1             And I think through the process set up in 1807 it

 2   does allow for that, the peer review by ARB and OEHHA, the

 3   years of work our staff that has taken actually preparing

 4   the document, and the public process, the public comment

 5   process that's set up.

 6             And actually I have my notes, but we actually had

 7   under this document and all the other 1807 documents a

 8   public comment period and a public workshop period which was

 9   held last summer on this document, and I think the main

10   intent on that is to formally go out as the agency

11   responsible for putting this document together to solicit

12   all relevant information from the public, including

13   registrants, to ensure that this document is full and

14   complete.

15             That process was completed last September when the

16   formal comment period officially ended.

17             As a matter of courtesy and our intent to go

18   beyond what the legal requirements are, many of the issues

19   and documents that the Task Force laid out here we did

20   incorporate into the document well after the end of the

21   formal public comment period and, specifically, because I

22   think we all share the same intent, that we want this

23   document to really reflect all the current science that's

24   out there, and I think we've done that.

25             Sort of an aside, one of the things we have done


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 1   as a matter of practice when we do risk assessments is to

 2   put registrants and data generators on notice throughout the

 3   entire process.  And our initiation of risk assessment on

 4   metam-sodium was officially noticed to the registrants back

 5   in 1996, and there was subsequent notices to the registrants

 6   as we've gone through this process specifically soliciting

 7   our desire to get any additional data from them.

 8             So I think the process that we don't want to steer

 9   away from that, that we do want to make sure that our

10   documents incorporate all relevant data.

11             And I think reading through the Metam-Sodium Task

12   Force document that we got on the 17th, their comments

13   strongly reflect that we actually did that.  A lot of their

14   comments actually reflect that the comments were included,

15   the data was included and summarized in the document, and

16   went into some length to actually critique how our staff and

17   other staff and the panel actually reviewed and assessed

18   that data.

19             I think two aspects on how we have done reflect

20   that data that the Task Force went through, and I don't

21   think -- we can, if you will, open up and go through point

22   by point some of their issues, but largely they do fall into

23   two main areas.

24             One is on the scientific side on how we've

25   discussed here at these forums and how our staff reflect


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 1   some of the scientific issues in the document, the panel --

 2   the Task Force sort of disagrees with some of how those

 3   issues were characterized.

 4             I think as we all found with a lot of these

 5   scientific issues, there can be a lot of disagreements and

 6   debate on that.

 7             And I went back and looked at some of those --

 8   well, actually all of those issues, and at least DPR's

 9   position is that we have taken all this data into account

10   and adequately have this record reflect the range of

11   opinions and our response to those issues.

12             So in the end the fact that the Task Force may

13   hold a slightly different view on what endpoints should be

14   chosen and strengths or weaknesses of the document, I think

15   starts to get into spillover into, I think, concerns that

16   they have on the risk management phase.

17             But clearly the documents do lay out the range of

18   data and I think a very lengthy and full discussion of all

19   the considerations related to all the data.

20             And the second issue that the concern out of the

21   discussion of the document do, I think, spill over largely

22   into, as I was saying, the risk management concerns.  A lot

23   of these issues that they were raised were not so much laid

24   out in terms of how the document may have been, but how in

25   the end the department may actually take this document, this


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 1   repository of data and science review, and utilize it.

 2             And I'll lay out that that's probably not -- not

 3   that that's a concern they shouldn't have, but for the forum

 4   today and the issues before the panel today, it really isn't

 5   relevant.  There's going to be, as I said, other forums as

 6   we go forward to determine whether to list or not, which

 7   will go through a formal rulemaking process which may

 8   involve hearings we conduct and a comment period and our

 9   response to that, and risk management, which will also

10   follow a public process.  Those are the forums to actually

11   engage the department in how we actually take this data and

12   actually are utilizing it in risk management.

13             The two important areas that for us on actually

14   having the findings approved today and bringing closure to

15   the document for us is, one, is to allow us to make the

16   decision to move forward on deciding whether to move forward

17   to list MITC as a toxic air contaminant.

18             One of the issues that was raised in the Task

19   Force was objections to the panel's discussion of whether

20   the document has information that meets the criteria or not.

21   And our reading of the regs of the requirements of the

22   panel, they brought out that that may not be appropriate,

23   but one of the things that we found very helpful in the

24   panel's findings is the comments and recommendations that

25   come out of that.  So there's -- from the department's


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 1   perspective, we don't have a problem with that, largely

 2   because any of the issues that are laid out in the findings

 3   come directly from the report.  And we do have some pretty

 4   narrow, stringent requirements on what would it take for us

 5   to list.

 6             The second issue for us on completing this process

 7   of wrapping up the document is I need to go forward with

 8   some risk management steps, off-site movement.  One of the

 9   things that we're required to do is to have an external peer

10   review conducted on our science before we move forward.  And

11   this panel was actually cited in the law in the guidelines

12   to actually carry that out, so this is actually fulfilling a

13   major step for us in completing the scientific foundation

14   for us to move forward on risk management that is needed and

15   we do need to move forward on that.

16             But getting back to, I think, the central role is

17   whether the document that is before you and the findings

18   that are reflected on the document have -- does that

19   document reflect all the scientific data, are all the

20   relevant issues discussed.

21             From our perspective we believe that and I think

22   we've gone to extra lengths to ensure that we have

23   incorporated all the scientific issues.

24             And that to the point that I don't think any of


25   the issues that the Task Force raised in the document on the


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 1   17th are going to be lost by the department, and we've

 2   actually offered up and considered to actually attaching

 3   those to section D.

 4             But once this document is done, our paper trail

 5   and dialogue with the regulated community or interest groups

 6   on issues related to this is not going to cease.  It's

 7   actually going to renew in vigor on some specific issues on

 8   where we need to go as a regulatory agency.

 9             With that there's -- we do have the opportunity if

10   you want to go through some of the specific scientific

11   issues.  I've had staff go through this.  I've gone through

12   this.  OEHHA and ARB staff have gone through this to look at

13   the issues.

14             And we could get into a specific discussion of

15   some of those issues, but, frankly, I think what it's going

16   to go back to is in the document these issues are discussed,

17   which I think is basically the point.  And our assertion

18   again is that our document is complete.  We are striving to

19   make sure it has all the relevant information.

20             CHAIRMAN FROINES:  Comments?  Questions?

21             I think we have a problem here.  I don't entirely

22   agree with that summation, frankly.  And it has to do, I

23   think, with the differences between our history with ARB and

24   OEHHA and our history with DPR, and we're still trying to

25   work through that history and develop some common approaches


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 1   to these documents.

 2             The history with ARB has always been that where

 3   there are important submissions from interested parties,

 4   that OEHHA and ARB then take those submissions and make a

 5   formal response to them and present that response to the

 6   panel so that the panel has the benefit of the formal review

 7   and response of comments from the interested parties.

 8             I think that's important procedurally, because

 9   this is a panel that meets quite frequently, but still is an

10   advisory panel with a limited amount of time, so that most

11   of the panel members don't study every document as though it

12   was their Ph.D theses.  Everybody brings a certain level of

13   knowledge and tries to augment that, but at the same time

14   people have limited time.

15             So it's very helpful for the panel that the

16   agencies identify the specific areas of comment and then

17   address them so that we have the benefit of those responses.

18             In this case, basically what you've said is that

19   we've incorporated into the document, and I'm familiar with

20   the Metam-Sodium Task Force, and I don't think that's

21   entirely true.  I think that there are some issues that are

22   unresolved in some respects.  And that I think it's true

23   that you have -- that we have had those comments for a

24   considerable period of time and that these are in a sense

25   resubmissions of older comments and you've taken them into


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 1   account, so I think in some respects you've attempted to

 2   deal with that.  But I don't think the panel necessarily has

 3   a sense of the substance of your response to those comments,

 4   and that's where I think we need to work on it.

 5             I think that for example there are differences of

 6   opinion between you and the Metam-Sodium Task Force on the

 7   subchronic NOEL for example.  They think it should be ten,

 8   you think it should be one.

 9             Well, we don't know, in a sense, the substance of

10   that debate.

11             And so my concern, I think metam-sodium is used at

12   a very high level in California.  It's a very important

13   compound.

14             The Metam-Sodium Task Force has gone to great

15   lengths to submit comments.  We want to take them seriously.

16             And so I want to make sure that we don't -- that

17   the panel then approves its findings based on a full

18   knowledge of what has been submitted.  So that's my concern.

19             I don't know if you've prepared a formal

20   presentation.  That's normally what happens in matters of

21   this kind.

22             I don't know how we should -- I don't know what

23   you've done and I don't know what George has to present from

24   OEHHA.  I guess we'll hear from him in a second.

25             That's my only concern.  My only concern is how


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 1   is -- that we don't appear -- we make sure that we have

 2   helped the panel by giving an appropriate response to the

 3   comments.

 4             MR. GOSSELIN:  I can -- we were prepared to have

 5   key staff from the various agencies come up and we can go

 6   through issues.

 7             CHAIRMAN FROINES:  Well, are they prepared -- do

 8   they have a presentation that they've prepared to address

 9   specific issues and say here's what our response is?

10             MR. GOSSELIN:  I think the responses would be

11   verbal, but with references to the document.

12             DR. BLANC:  Well, I think -- Paul Blanc here.

13             I think that if they can do that systematically,

14   we can enter it into the transcript of this presentation.

15             At the end of the presentations we can comment on

16   whether or not we feel that's sufficient.

17             But I think John's message would be that in the

18   future it would be more helpful to have prepared written

19   responses.

20             MR. GOSSELIN:  I think again, too, we haven't --

21             DR. BLANC:  Still a work in progress?

22             MR. GOSSELIN:  This is a new venture for us to get

23   something this late.

24             DR. BLANC:  John, why don't we proceed then?

25             DR. FUCALORO:  As I understand it, we will get a


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 1   presentation from members of the DPR to discuss --

 2             CHAIRMAN FROINES:  The Metam-Sodium Task Force

 3   submissions.

 4             DR. FUCALORO:  Do we believe -- do you believe

 5   that that's going to be sufficient for us to act on the

 6   findings today?

 7             CHAIRMAN FROINES:  Yes.  I hope so.  I mean, I

 8   think we'll have to not prejudge it.

 9             But I think that these comments have been

10   incorporated substantially in the past, so it's not -- this

11   isn't something that's brand new.  That's important to note.

12   I think that if that weren't the case, then I would be more

13   worried, but at the same time I think that I don't want to

14   prejudge whether or not it's sufficient.

15             DR. FUCALORO:  My concern is that as the matter as

16   a level of preparation if they're prepared to hit the points

17   that we need to have hit, then I agree with you, I think it

18   can go in a very efficient way.

19             But if people are going to start wandering through

20   the document with no order and rhyme or reason, I think

21   we're in for a very disappointing time.

22             So I just want to know if they believe they are

23   prepared to hit the points in an efficient way that we can

24   make an intelligent and informed decision.


25             CHAIRMAN FROINES:  And I'm assuming the answer to


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 1   that is yes?

 2             MR. GOSSELIN:  Yes.

 3             CHAIRMAN FROINES:  George, do you want to make

 4   comments now or after Andy makes a presentation?

 5             DR. ALEXEEFF:  Well, we don't have much to say,

 6   per se.  So I can just make them now.

 7             And that is that first of all we haven't prepared

 8   a formal presentation in responding to the comments, because

 9   DPR is the lead in this case.

10             However, we did look at the comments submitted and

11   we also looked at the previous document that DPR prepared,

12   this is dated March 2000, response to comments.  Their Part

13   D, it's similar to our Part C comment responses.  And

14   essentially the same issues, as far as we can tell, were all

15   raised in the previous submission, issues of eye irritation,

16   chronic NOEL, and DPR has written responses to those same

17   comments here.

18             That was our perspective that these issues

19   continue to be issues that were previously raised and they

20   have responded to them in writing.

21             Other than that, we didn't have any specific --

22   and of course that's just referring to the technical

23   comments raised in the documents.

24             CHAIRMAN FROINES:  I think that's important,

25   because in a sense we're not asking to -- going back to what


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 1   Tony said -- we're not asking to re-review the entire

 2   process.  We're basically saying, given what we received,

 3   what, two weeks ago, is what we've received two weeks ago

 4   substantially different than what has been commented on in

 5   the past, and are there areas that would specifically be

 6   helpful to review, just to reaffirm your point of view.

 7             I'm not asking for a four-hour presentation at

 8   all.  I'm assuming it's a very short presentation.

 9             MR. GOSSELIN:  Yeah.  I think as I go through

10   that, some of that, some of the issues are fairly

11   straightforward on how we've handled things in the document

12   and disagreements, but there are issues that they raise that

13   as we work through this document that you mentioned the

14   subchronic value as being an important issue that we've

15   struggled with, the lead and the panel have talked a lot

16   about, and actually I went back and I looked and our

17   document does speak to that, which I think is probably the

18   most important point that it honestly and openly has a good

19   discussion of the strengths and weaknesses of the endpoint

20   selections and rationale for that.

21             But I think the important thing in the end is that

22   the document, you know, has that broad discussion.

23             CHAIRMAN FROINES:  I think it's important to say

24   that this panel does a lot of work, but they're not going to

25   go back to review your basic document every time something


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 1   comes in.  They're just not going to do it.  I mean, it

 2   would be nice if we spent most of our time doing it, but

 3   we're not.

 4             So you have to take us by the hand and lead us and

 5   say here's an issue that's been raised, it's been raised

 6   before, you probably didn't remember it was raised before,

 7   but here we'll talk about it again for a minute or two, for

 8   however long it takes.

 9             So keep in mind that the important thing about

10   this exchange is that the panel feels comfortable with the


11   information it has before it, I think.  And without

12   expecting the panel to the encyclopedia of knowledge about

13   everything in your document.

14             MR. GOSSELIN:  Then I'll begin on page four.

15             CHAIRMAN FROINES:  Page four of what?

16             MR. GOSSELIN:  Of their letter.

17             I think the best way is to kind of walk through

18   their key bullets in their cover letter and give a response

19   to that.

20             CHAIRMAN FROINES:  Okay.

21             MR. GOSSELIN:  Okay.  I think the substantive

22   issues on the document being under the heading that we both

23   mischaracterized as exposure issues.

24             The first bullet, talking about their recent

25   state-of-the art exposures, that data was incorporated into


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 1   the document that came in after the end of the comment

 2   period in late '99.

 3             The Task Force and the department, the Task Force

 4   had been working closely with the department, understanding

 5   our need to get better exposure data on -- there was a

 6   cooperative effort that we afforded to them and to a lot of

 7   other industries, but one of the issues that they raise is

 8   that -- is how we've summarized this, and the other study

 9   that was conducted as being limited.

10             I think we still support that premise that they're

11   two studies with some strengths over some of the previous

12   data that has been collected over the past years, but did

13   have some inherent weaknesses to it on the study design, not

14   having samples all the way around the field and making some

15   judgments as where the predominant wind pattern would be.

16             So that data is in our report, and actually our

17   staff responses to it are in section D.

18             On page five, and I don't know if anybody wants to

19   speak to that --

20             DR. BLANC:  Where are we know?  Page five?

21             DR. FUCALORO:  The bullet at the top?

22             MR. GOSSELIN:  Yes.

23             The exposure reduction that they don't feel that

24   we went into sufficient detail on the technical information

25   bulletin labeling.  The concern that issues are buried in


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 1   the text and that we continue to have a full range of

 2   exposure data in this.

 3             I think this, the fact of the matter is we do go

 4   into some discussion that they agree with, that we did go in

 5   and actually discuss sort of the newer limitations on how

 6   people can actually use metam-sodium.

 7             And I will also say that there's some discussions

 8   going on too with the labeling on some clarity issues,

 9   because of some unclear label language that's going to

10   provide a little bit more certainty on compliance.  So I

11   think the fact of the matter that some of the label

12   requirements are going to be tightened up over the years is

13   just a matter of course.  Our report does reflect this and

14   it's actually crafted in a way we did -- and I know I

15   personally took some effort to make sure that restrictions

16   that were put in '94 and then recently were put into the

17   context versus some of the older data.  I think that was

18   very important and that is reflected in our document.

19             Their only comment on this is they don't think we

20   have gone to the extent to explain that and if we disagree,

21   I think we explained that some of that older data doesn't

22   reflect current practices.

23             The bullet below that speaks to the same issue.

24             And again some of the improved methods.  There are

25   two studies currently out there now, but as were found in


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 1   the past, that two data sets may not necessarily reflect the

 2   range of use patterns around the state.  And we're also

 3   seeing metam-sodium potentially being used in a lot more

 4   regions around the state for different crops.

 5             So I think having some concern about having the

 6   full range of data on exposure is a valid issue we have, and

 7   actually this -- I will speak to this later, and it's why

 8   ARB is going to go back out this year and monitor for

 9   metam-sodium and MITC and breakdown products to kind of keep

10   track of ambient exposures.

11             The bullet below, this discusses some of the

12   deficiencies in the study design on risk samples as were

13   located around the fields.  There were some judgment calls.

14   And it's always difficult to go back after the fact and

15   critique how someone made some assumptions on study design

16   to maximize sampling and based upon assumptions, but our

17   staff did go back and made a couple comments on the strength

18   of the study, but also pointed out a lot of the flaws in the

19   design on study design where standard practice that we've

20   used and ARB used is to include as many samples all the way

21   around the field to maximize, capture the materials as wind

22   directions shift, so you have other climatic conditions that

23   may affect off-site movement.

24             And this the staff did respond to this in section

25   D, and we still support staff's response to those issues.


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 1             On page six the bullet concern about exposure from

 2   misuse.  It is true that we typically don't base risk

 3   assessments or assessments in general on at least the way we

 4   operate on people misusing as a whole and enforcement and

 5   sort of compliance, however incidents related to misuse and,

 6   I think, the hazard related to particular materials is

 7   important and at least for us should not be lost in how we

 8   actually manage the compound in the real world.

 9             And we have had two recent incidents, one in Santa

10   Barbara involving a school, and another down in Tulare

11   County involving a residential area, that we're

12   investigating, found to be caused from some noncompliance

13   issues related to the labeling.  This gets back to at least

14   for us in the bigger picture is to taking a look at what

15   restrictions we have in and actually how we're carrying out

16   enforcement program, but I think what's reflected in the

17   document is sort of a hazard associated with the use of the

18   material, where what sort of margin do you really have out

19   in the real world if mistakes are made and what would

20   potentially impact communities, children and others.

21             And I think having that in the document and having

22   that reflected is also important for us to really keep an

23   eye on exactly how this material may effect people.

24             The last bullet on this gets into categorizing

25   eight days of exposure instead of 23 days assumed by DPR.


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 1   This gets back to typically for subchronic exposures we've

 2   had a policy of doing some default assumptions for

 3   exposures.  In this case we've gone back, my understanding,

 4   has gone back and actually looked at frequency of use and

 5   calculation of uses in different areas, and I think the Task

 6   Force went back and did slightly different statistical

 7   analysis.

 8             One of the things that we're also keeping in mind

 9   on tracking this, because this is frankly an important issue

10   that we are not going to lose sight of is that the

11   subchronic exposure, exposure to metam-sodium over an entire

12   season is going to shift and has been shifting over the

13   years, depending on use within a different county and a

14   different locale.  And this is something that we need some

15   better -- well, we do have the tracking means to do it, but

16   I think actually getting to the point of putting the tools

17   in place to track subchronic and chronic exposures is one of

18   our goals of starting to package together particularly for

19   fumigants, but currently this reflects the data we have and

20   the methodology that we've been following to calculate some

21   chronic exposures.

22             Page seven referencing the air board's monitoring

23   under 1807 for MITC and breakdown products, comments, and,

24   yes, we will be sharing the protocol and working with the

25   Task Force on that protocol, as they suggested that we do as


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 1   a normal course of business.

 2             In the end, to summarize on their points on the

 3   exposure, as I said, these issues largely fall into data

 4   that we have in the report and were commented by our staff

 5   in subsection D to address this.

 6             This is a point to maybe talk about this section

 7   before moving on to the toxicity issues?

 8             DR. BLANC:  Is there any comment made in this

 9   memorandum regarding the first section you've just addressed

10   that you would consider either addressing something that was

11   not already addressed in your initial report or follow-up

12   reports or issues of interpretation, semantic interpretation

13   of terms or what is essentially a semantic interpretation?

14             Do you think there's anything new of a substantive

15   nature in any of the bullets you've addressed so far?

16             MR. GOSSELIN:  No.  Other than the fact that how

17   to determine the number of days in a subchronic season may

18   fluctuate and change, is going to be to a dynamic issue.

19   And so I think this just doesn't reflect MITC.  And we've

20   talked -- and I think we've learned a lot over the years

21   over the concerns the panel had on how we've actually

22   brought exposure data here and viewed it as somewhat of a

23   static issue that is dynamic and we do need, once the part

24   of our continuous process tracking that, because the number

25   of days people are exposed is going to varying from county


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 1   to county and region to region and year to year as uses

 2   change.

 3             I think that point in and of itself is not

 4   specifically for the documents, but is a future issue.

 5             DR. BLANC:  So other than the generic question of

 6   eight days versus 23 days as a likely estimate of exposure

 7   for the groups of subchronic risk assessment, it would be

 8   your response that you do not see anything substantive here

 9   that has not already been addressed or does not refer to

10   semantic interpretation of terms?

11             MR. GOSSELIN:  That's true.

12             Page seven, DPR and the SRP have inappropriately

13   applied the toxicology data in assessing risks.

14             This first issue gets into regulating from an

15   endpoint dealing with, as we've talked about, eye blink or

16   eye irritation, and the assertion that eye irritation should

17   not be used as a regulatory endpoint.

18             And they talk about some of the episode incidents,

19   Cantara spill, that should not be a part of the document.

20             Both of those issues I will lay out as interest

21   that we have in having them in the document, and I think the

22   first point on eye irritation as a regulatory endpoint kind

23   of goes counter to, I think, the way we've been managing

24   pesticide risks probably from its inception is before there

25   were toxicologists and formal risk assessments involved, if


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 1   people got odors or complaints, they called at the time the

 2   appropriate regulatory agency, and some response was made to

 3   manage that sort of whether it was a health case or societal

 4   thing, and some action was taken and it's a series of

 5   restrictions we have on the books that go back 40 years,

 6   particularly death at the time, dealing with odor complaints

 7   where regulatory action was taken to deal with those issues.

 8             And I think the fact that we've had some even

 9   recent incidents that were not very fortunate that resulted

10   from people having a lot of irritation effects, and to view

11   that as not being of regulatory concern goes counter to the

12   way we've been operating, a lot of agencies have been

13   operating, as a regulatory agency.

14             So these are relevant endpoints for us to

15   consider, as well as the other toxicological effects to

16   ensure that we are not going to have systematic effects of

17   people getting exposed to this, but also the things that are

18   going to prompt a lot of other problems with people.

19             DR. FUCALORO:  I have no quarrel with using this

20   particular endpoint for purposes of regulation but is it --

21   speak to the notion that it is a proper endpoint for

22   designating something as toxic air contaminant, which is a

23   different type of regulatory structure, isn't it?

24             MR. GOSSELIN:  Yes.

25             DR. FUCALORO:  Because in the law, and I don't


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 1   have the law in front of me, it talks about risk health

 2   issue.  I mean eye irritation in and of it doesn't

 3   necessarily mean a health issue.  It may, it may not also.

 4   So that's what I think I'd appreciate hearing.

 5             MR. GOSSELIN:  Yeah.  And I think the issues with

 6   this compound and its -- or metam-sodium and its breakdown

 7   products, going into this, we knew this was going to be some

 8   of the obvious things on eye irritation and effects were

 9   going to be pretty obvious and then our need to regulate it

10   and then how this actually fits into a toxic air contaminant

11   and what that calls for raises a lot of issues.

12             DR. BLANC:  Perhaps this would be a good point to

13   have your toxicologically oriented staff respond.

14             But several specific questions would be do you

15   have any reason to believe, you or your staff, that the

16   mucous membranes of the eyes would respond in a manner that

17   would be substantively different than the mucous membranes

18   of the upper respiratory or lower respiratory tract given

19   exposure.

20             DR. RUBIN:  Andy Rubin.  Andrew Rubin.

21             I don't think we have any specific data to

22   differentiate, with respect to MITC itself, to differentiate

23   the mucous membranes from either the eyes or the upper

24   respiratory tract.

25             DR. BLANC:  Would that then indicate that an


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 1   endpoint of mucous membrane response could be taken

 2   generically, absent data, human exposure data specifically,

 3   that would have assessed lower respiratory or upper

 4   respiratory tract inflammatory responses, for example, since

 5   we do not have those data, since those data do not exist?

 6             DR. RUBIN:  Since those data do not exist, I felt

 7   that we were constrained to make a health conservative

 8   assumption that irritation in the eyes is -- that it's fair

 9   to consider irritation in the eyes as reflecting what would

10   happen if MITC came in contact with it, with the respiratory

11   tract.

12             Is that what you're asking?

13             DR. BLANC:  Well, yes.  From a scientific point of

14   view then you believe that's an appropriate surrogate

15   endpoint?

16             DR. RUBIN:  Yes, I do.

17             DR. BLANC:  And, Dr. Alexeeff, would you agree

18   with that assessment?

19             DR. ALEXEEFF:  Yeah.

20             But actually I think you have to kind of look at

21   the whole picture of all the data that's available.

22             In our findings we outline the difference between

23   if one used this study or used the animal study and if you

24   used -- one of the differences is the animal study, although

25   it has its own limitations, was looking at breakdown


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 1   products of metam-sodium, which is more akin to what's

 2   happening in the environment and it was a whole body

 3   exposure.

 4             At the same time you have to add additional

 5   uncertainty factors for the animal study.

 6             Now, if you compare that to the human study, which

 7   was focused simply on other eye irritation with no other

 8   exposures, the limitation is what's the other combination of

 9   effects if respiratory tract was included in the exposure

10   and that sort of thing.

11             So what about the other breakdown products within

12   the metam-sodium.

13             So I think that there is uncertainty, but if one

14   did not use this -- there's two things.  One is if one did

15   not use this study, what would one use?

16             DR. FUCALORO:  This study --

17             DR. ALEXEEFF:  The human study on eye blink.

18             DR. FUCALORO:  Got you.

19             DR. ALEXEEFF:  If one did not use that study,

20   pretty much the alternative is to use the animal study,

21   which suggests greater risk.  So the human study is actually

22   suggesting a little bit less risk than we thought, because

23   there's less uncertainty in the extrapolation.

24             So that's kind of one issue.

25             The other thing is that this is simply, you know,


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 1   we know that at higher concentrations, MITC causes greater

 2   effects.  There are other studies showing increased

 3   respiratory irritation and things like that.  So it's not as

 4   if this is the only effect that MITC causes.  It is simply

 5   we decided to say that is the NOEL of the effects, is

 6   increase in concentrations --

 7             DR. BLANC:  Do either of you see any reason to

 8   exclude consideration data from a large human exposure

 9   incident in the consideration, either from a scientific

10   toxicological point of view?

11             DR. RUBIN:  I think that we would be very

12   ill-advised not to look at the data that come from the

13   field.

14             DR. BLANC:  That would actually, inferentially

15   that would include not only the Cantara spill, but would

16   also extend to the MIC population exposure in Bhopal, India?

17             DR. RUBIN:  Certainly, yeah.

18             I'd make one other comment on top of what George

19   just said, and that is that even considering eye irritation

20   by itself, without any consideration that there may be more

21   serious irritative effects in the lung, we have to remember

22   that MITC is under FIFRA is a category 1 eye irritant.  That

23   is, when it's dropped directly in the eye it is considered

24   to cause irreversible damage.

25             Now, in the human eye irritation experiment, of


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 1   course that wasn't done.  The subjects were exposed to a gas

 2   coming through a port into the eye.

 3             But from my standpoint if people are in the field

 4   are experiencing some eye irritation, it's well to remember

 5   that we don't really know what the dose response curve is,

 6   but under FIFRA guidelines, this stuff is -- we have to take

 7   this stuff very seriously just considering the eye alone.

 8             MR. GOSSELIN:  Actually, these questions were

 9   questions that the staff were putting the document together

10   the questions that were asked internally about eye

11   irritation, we know about that and that what other endpoints

12   if it wasn't an eye irritant, what would we be concerned of

13   trying to get at this dose response issue, and that's where

14   a lot of these other data become very relevant, incident

15   data, some of the other data.

16             And that's where we found that, you know, a lot

17   other effects may be starting to trigger very short along

18   that exposure line, which, you know, if we were just dealing

19   with eye irritation in and of itself, this would probably be

20   viewed differently, but there's a lot of other suggestions

21   that once you start getting into this effect, you know,

22   other things may be very short down the road.  And sort of

23   in a back of the envelope that's sort of the thing we were

24   most interested in to try to evaluate.

25             DR. FUCALORO:  I'm hearing two things, and not


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 1   contradictory, but two things.  One is the plausibility

 2   argument that if in fact it's irritating the eye, it's

 3   scientifically plausible that it's irritating other mucous

 4   membrane perhaps in the air tract.

 5             And the second point I'm hearing is that eye

 6   irritation is perhaps causing damage to the eye in high

 7   concentrations, although you're not exactly sure.  You have

 8   NOEL for exactly that.  You don't have a NOEL for that.

 9             DR. RUBIN:  Right.

10             DR. FUCALORO:  So these are two things I'm

11   hearing; is that correct?

12             DR. BLANC:  In addition, you're hearing that the

13   eye study is one of -- it's consistent with other

14   experimental and accidental human exposure data.  Therefore,

15   it should be viewed in context.

16             And following up on that, I would assume that,

17   based on what you've said, that the bullet on page eight,

18   which appears to be a continuation of a point from the

19   previous bullet, but in this case is more nuanced, rather

20   than suggesting the Cantara data should not be considered at

21   all, this purports -- this puts forward the view that too

22   much importance has been placed on the Cantara episode in

23   both your report and our summary findings from our draft

24   summary findings from your report, and consistent with your

25   earlier comments I can assume that from a scientific point


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 1   of view you would reject that interpretation?

 2             DR. RUBIN:  Yeah.  In my evaluation I felt that I

 3   could not reject all the epidemiology that --

 4             DR. BLANC:  Did you feel that you weighted it too

 5   heavily?

 6             DR. RUBIN:  No.

 7             DR. BLANC:  And, finally, it seems the remainder

 8   of the bullets, unless I'm misreading this, all focus on a

 9   single study, the Rosskamp, so-called Rosskamp study, which

10   all the rest of the bullets basically insist that that study

11   not be used for any regulatory purposes.

12             Have you previously -- I take it this point has

13   previously been made by the Task Force?

14             DR. RUBIN:  Yes.

15             DR. BLANC:  And previously rejected, this point of

16   view?

17             DR. RUBIN:  The point has been made by the Task

18   Force.

19             DR. BLANC:  Has it been considered by DPR?

20             DR. RUBIN:  Yes.

21             DR. BLANC:  Has it been rejected by DPR?

22             DR. RUBIN:  Yes.  We continue to use the --

23             DR. BLANC:  Therefore you've rejected the point

24   that it should be not used for regulatory purposes, you have

25   used it for regulatory purposes?


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 1             DR. RUBIN:  Yes.

 2             DR. BLANC:  Is there anything new in any of these

 3   remaining bullets regarding the Rosskamp study and why it

 4   not be used, according to their point of view?

 5             MR. GOSSELIN:  No.  Actually I think on page 443

 6   in the document, I think some of the issues that went into

 7   consideration on using it actually was discussed at length

 8   on --

 9             DR. BLANC:  Let me summarize then.

10             In the terms of this entire document, which is the

11   Metam-Sodium Task Force letter of May 17th, other than

12   semantic interpretations of terms, a question of whether

13   eight days should be used instead of a longer period for

14   subacute exposure period, the comments as discussed on the

15   mucous membranes of the eye as a surrogate endpoint, and the

16   previously rejected point about Rosskamp and implicitly the

17   rejected point about utilizing information and its relative

18   weighting from the Cantara incident, there's nothing of

19   substance here that would change your --

20             DR. RUBIN:  That's correct.

21             DR. BLANC:  -- recommendation?

22             DR. RUBIN:  I would change one word in your

23   characterization.  That is the word reject.  We actually, I

24   actually read the MSTF's comments on Rosskamp very

25   carefully, and do not -- and feel many of their points are


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 1   actually valid and entered some of the uncertainties that

 2   they brought up with respect to Rosskamp into the hard copy

 3   of the --

 4             DR. BLANC:  But if their core contention is that

 5   it can't be used for regulatory purposes, you've obviously

 6   rejected that?

 7             DR. RUBIN:  Right, that's correct.

 8             MR. GOSSELIN:  I think Andy has a good point that

 9   none of these were rejected, and actually we went to great

10   lengths to understand them and ensure that the document

11   fully discusses some of these issues, that many of them are

12   very valid scientific issues that staff have spent

13   considerable amount of time taking a look at the range of

14   data, the strength of the data and to package something that

15   would provide a good basis to characterize the risk

16   associated with metam-sodium and MITC.

17             DR. BLANC:  Well, I would I think we can proceed

18   with our activities, but I would suggest that it would be

19   useful for you to prepare a written summary, a brief

20   memorandum, that would include in it these issues, since it

21   seems to me you could put it to rest rather easily.

22             MR. GOSSELIN:  Yes, we can do that.

23             CHAIRMAN FROINES:  George, anything to add?

24             DR. ALEXEEFF:  No, I don't have anything to add.

25   Thanks.


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 1             CHAIRMAN FROINES:  Can we move forward then?

 2             Okay.  Then the burden falls to us at this point.

 3             So we need to -- I'm going to go back to the

 4   Metam-Sodium Task Force document a little bit later, but

 5   I'll hold it for the moment.

 6             So I think we should proceed to discuss the

 7   revised findings.

 8             Elinor, would you do me a favor, and tell the

 9   panel the small changes?

10             There have been a new changes that have been made

11   since the panel received the document, and she can fill us

12   in on what those are.

13             DR. FANNING:  Okay.  Just a few small editorial

14   comments that have come in from various people who I can

15   identify as we go through.  I don't think any of these have

16   any substantive impact.

17             So but if we just walk through the document, the

18   first, Lyn Baker requested that the parts per billion be

19   re-represented parts per billion volume.

20             CHAIRMAN FROINES:  Let me interrupt you just for a

21   second.

22             Peter, is what you're passing out the version with

23   these changes having been made?

24             DR. FANNING:  Correct.  Peter has got the version

25   that was sent on Friday the 20th to the panel.


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 1             DR. FUCALORO:  They still list it as part per

 2   million, not parts per billion.

 3             DR. FANNING:  Right.  So I'm going to walk through

 4   some suggestions that have been made by others and you can

 5   tell me --

 6             CHAIRMAN FROINES:  This doesn't --

 7             DR. FUCALORO:  It's the same one --

 8             DR. FANNING:  Right.  So as we walk through you

 9   can say yes make that change or not.

10             DR. BLANC:  Where are you now?

11             DR. FANNING:  I think the first instance is in

12   finding number eight, so there was a suggestion to change

13   the parts per billion in air just to indicate parts per

14   billion volume, so ppbv.

15             DR. BLANC:  I suggest then the first time that

16   you -- who suggested this?

17             DR. FANNING:  That was from Lyn Baker at ARB.

18             DR. BLANC:  Okay.  That terminology may be -- it

19   may meet his needs and therefore you should go with it, but

20   I would put in a parenthetical statement which says what

21   you -- I mean, in parentheses, because if I read that I

22   wouldn't know what ppbv was or why you were using it.

23             DR. FUCALORO:  You know, microgram per meter cubed

24   probably is the best way to do it.

25             DR. FANNING:  It would be --


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 1             DR. ATKINSON:  Ppbv is perfectly fine, I would

 2   think is a --

 3             DR. BLANC:  Fine.  You're the unit man.

 4             DR. FANNING:  Unit man.

 5             CHAIRMAN FROINES:  If Craig and Paul don't know

 6   what ppbv is, then the parentheses the very first time --

 7             DR. ATKINSON:  Define it the first time.

 8             DR. BYUS:  Right.

 9             DR. FANNING:  Okay.  That's fine.

10             In finding No. 13, the dates of the study in which

11   MIC was measured and the study in which hydrogen sulfide

12   were measured were reversed in my -- in our previous

13   version.  So MIC was measured in the 1995 study, and H2S in

14   '93, so that's just a point for accuracy of citation.

15             In finding 41, the uncertainty factor of ten that

16   was applied in this case is actually for interindividual

17   differences in humans not for species-to-species

18   extrapolation.  So that was an incorrect citation in the

19   earlier finding.

20             DR. FUCALORO:  That is intraspecies?

21             DR. FANNING:  Yes, that's correct.

22             Finding 42, the last sentence should be removed.

23   DPR did not calculate separate RELs.  There were different

24   dosages calculated based on for adult and child seasonal

25   doses, but there's only the one REL.  So that last sentence


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 1   will be removed.

 2             And I believe the very last is just the date at

 3   the end needs to be updated.  It says approved April 13th,

 4   and we will of course modify that date to be either today or

 5   whenever the findings are finally approved.

 6             So those were just the list of small things I

 7   wanted you to be aware of.

 8             DR. ATKINSON:  Item No. 33 has an extra half

 9   sentence in it.

10             DR. FANNING:  Yes.  That's right.  I have that

11   highlighted as well.  There's redundant language there.

12             DR. ATKINSON:  Too many highly toxics.

13             DR. FANNING:  Yeah.  It's highly toxic and

14   irritant twice.

15             DR. FUCALORO:  It was surely irritating reading

16   that.

17             But also 40, the smaller one, is in the first

18   sentence, you have ambient airing monitor data also used to

19   generate minimum seasonal, you have a D that you need to

20   scratch.

21             DR. FANNING:  I'm sorry?

22             DR. FUCALORO:  Finding 40, first sentence, ambient

23   air monitoring data also used to generate minimum seasonal

24   MOE.

25             DR. FANNING:  Yes.  For tense.


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 1             There's the issue of the MIC NOEL.  And,

 2   Dr. Froines, do you want to take that up now or after or do

 3   you want to go through findings item by item?

 4             CHAIRMAN FROINES:  I think that before -- that's

 5   right.  I shouldn't say that, because I had forgotten.

 6   Let's take it up now, because then I want the panel to be

 7   able to go around and discuss their changes.  But they

 8   should have a complete deck before them and that will help.

 9             DR. FANNING:  Okay.  The issue that we're

10   discussing is that in the meeting of the panel in February

11   at UCSF there was some discussion of the MIC acute NOEL

12   determination.  The draft document in March, DPR determined

13   an acute NOEL based on animal developmental toxicity study.

14   At the UCSF meeting the panel had quite a bit of discussion

15   about the available human data for MIC with an eye

16   irritation endpoint.

17             At that point the panel recommended that DPR take

18   another look at the way that they determined that NOEL.

19             So in the meantime Andy Rubin has done that and

20   has some changes to report to you.

21             DR. RUBIN:  Right.  Well, as Elinor said, it was

22   brought up in February that perhaps I had overlooked some

23   human data, which were actually in the report, but I had not

24   placed enough weight on them.

25             At the last meeting of the SRP in Riverside this


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 1   was hotly under discussion in the extracurricular meeting

 2   between myself and Dr. Andy Salmon and Dr. John Budroe,

 3   which is why the change hadn't been made by that time.

 4             We located a study, John Budroe actually was able

 5   to get a study for me, done back in the '60s in the Mellon

 6   Institute where humans -- I don't think you would ever see

 7   this in a post-Bhopal world -- but humans were exposed to

 8   gaseous MIC and the eye irritation measured.

 9             I looked at that, at that study, and decided that

10   indeed this was probably a better study to use to determine

11   a NOEL, than either the mouse myelotoxicity study or the

12   mouse developmental toxicity study that I had relied on

13   previously.

14             The other change that I decided to make was that

15   in reading my own document I felt that putting a one-hour,

16   six-hour and 24-hour REL was not -- was, first of all,

17   confusing.  Second of all, it was not consistent with the

18   approach of OEHHA in setting RELs.  An acute REL is, correct

19   me if I'm wrong, is a one-hour REL.

20             So in order to make our NOEL determination and

21   ultimately REL determination consistent within the agency, I

22   decided to use -- to just set a one-hour REL and rely on the

23   human study, which set the lowest NOEL value that we could

24   find.

25             Turns out that particular human study did not set


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 1   a NOEL, the lowest concentration tested, which was .5 ppm,

 2   500 ppb, was a LOEL value, and I estimated a NOEL value for

 3   ten-minute exposure by using a default assumption of

 4   dividing the LOEL by ten and then estimated a one-hour

 5   exposure by invoking Haber's Law using an exponential

 6   compound specific value that appeared in and that was

 7   referenced in OEHHA's acute hot spots document for eye

 8   irritation.

 9             So that the REL value that we're now generating is

10   0.98 ppb or about one ppb, 14-fold lower, actually, than the

11   value that I had had for one hour up previously.

12             DR. BLANC:  That is reflected in which point?  I'm

13   sorry.

14             DR. FANNING:  So what we've proposed to do, I

15   think Andy and I discussed this Monday or so, was to replace

16   what you currently see as findings No. 44 and 45 with a

17   single finding reflecting the new determination NOEL.

18             The way that that the findings currently read

19   first described in finding 44 the determination of NOEL

20   based on the animal data that was reported in the draft

21   document.  Then in 45 indicating that the human data were

22   available.  And that was our previous language.  So we would

23   remove those two into a single finding that describes the

24   determination of the new human derived NOEL.

25             DR. BLANC:  But where is the written form of


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 1   everything you just described to us orally?

 2             DR. RUBIN:  You mean in the document itself?

 3             DR. BLANC:  It's not in document.  Is there a

 4   supplemental memorandum, written memorandum somewhere?

 5             CHAIRMAN FROINES:  There is a supplemental, but --

 6   well, I read it and thought it was a little wordy, and so I

 7   thought that it could be cut down, but why don't we

 8   circulate it and then everybody else -- if everybody likes

 9   it, we'll --

10             DR. BLANC:  No, no.  I mean a supplemental written

11   memorandum from you.

12             DR. RUBIN:  Right.  Well, what I've done, I'll do

13   what I'm -- what's appropriate.  What I have actually done

14   is amended the discussion in the report.

15             DR. BLANC:  Okay.  But --

16             DR. RUBIN:  And I have a copy of it here, where I

17   have the calculation written out and --

18             DR. BLANC:  I'm just trying to figure out what

19   we're responding to is just what you've said now or whether

20   there's any written materials that we're also responding to

21   given the fact that our findings need to reflect --

22             DR. FANNING:  We do have some proposed replacement

23   finding language and I could --

24             DR. BLANC:  That's exactly what I'm asking.  I'm

25   asking that --


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 1             CHAIRMAN FROINES:  Paul is asking the question

 2   about --

 3             DR. BLANC:  The scientific record upon which the

 4   finding is based.  And in part that could be your oral

 5   summary right now, but there absolutely has to be some kind

 6   of written thing which we are responding to.

 7             This is quite a different issue than our earlier

 8   discussion which basically clarified that there was nothing

 9   new in the Task Force memorandum of substance.  Now you're

10   talking about something which is substantively new, improved

11   and useful and it's helpful, but we obviously have to be

12   responding to it in a coherent manner.

13             DR. ATKINSON:  The report will be changed; is that

14   correct?

15             DR. RUBIN:  Yes, the report, it's already changed

16   on my computer.

17             MR. GOSSELIN:  Probably the question is how much

18   additional write-up or description had to go in, versus how

19   much of that information was already summarized in the

20   document?

21             DR. RUBIN:  The study was already summarized in

22   the document.  The calculation is different.

23             DR. BLANC:  Okay.

24             DR. RUBIN:  And it actually arose out of

25   discussion right here in this panel.


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 1             CHAIRMAN FROINES:  But Paul is raising a very

 2   important procedural issue.  We don't want to be approving

 3   findings today that we haven't reviewed a record on this

 4   issue.  But if we have looked at the study and we can take

 5   into consideration your remarks about the calculation of

 6   NOEL, which I think is relatively straightforward, then I

 7   think that's appropriate.  Otherwise we would have a

 8   procedural problem, I think.

 9             DR. FUCALORO:  I'd actually -- I'd like to ask

10   about the substantive issue in terms of the calculation.

11             As I understand it, the human study exposed in its

12   lowest concentration 500 parts per billion, ten minutes to

13   some, and that was a LOEL?

14             DR. RUBIN:  That's correct.

15             DR. FUCALORO:  Because there was an effect.

16             Then arbitrarily, and I guess this is standard

17   procedure, I've been up against this before, and I have to

18   keep repeating this, I still can't imagine we do this, but

19   you divide by ten and make that a NOEL.

20             DR. RUBIN:  That's correct.

21             DR. FUCALORO:  When in fact something 20 could

22   still have an effect.

23             And then this was a ten-minute exposure which you

24   expanded to an hour using Haber's Law with the appropriate

25   exponent; correct?


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 1             DR. RUBIN:  Correct.

 2             I might say that it is my opinion, having looked

 3   at several of these studies and comparisons, that if the

 4   response at 500 ppm, that that value of --

 5             DR. BLANC:  Ppb.

 6             DR. RUBIN:  Ppb.

 7             DR. BLANC:  Ppbv.

 8             DR. RUBIN:  If ppm, they wouldn't have survived

 9   the study, that the eye irritation response at that level

10   was rather -- was rather attenuated.

11             DR. BLANC:  Was there a factor of three for

12   intraspecies sensitivity in your calculation?  This is a

13   human exposure, so there's no --

14             DR. RUBIN:  There's a factor of ten.

15             DR. BLANC:  Well, that's to go from the LOEL to

16   the NOEL.

17             DR. RUBIN:  Yeah.

18             DR. BLANC:  Is there a factor of three --

19             DR. RUBIN:  No.  A factor of ten.  In other words,

20   in order to calculate the REL value --

21             DR. BLANC:  I know you have a factor of ten.  Do

22   you have a factor of three on top of that?

23             DR. RUBIN:  No.

24             MR. GOSSELIN:  Two factors of ten.

25             DR. BLANC:  Okay.


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 1             DR. FUCALORO:  It has to go to the REL.

 2             MR. GOSSELIN:  Yes.

 3             DR. FUCALORO:  Am I right?

 4             DR. RUBIN:  Correct.

 5             DR. BLANC:  And then something like multiplying --

 6   dividing by six because you're going from ten minutes to 60

 7   minutes?

 8             DR. RUBIN:  Essentially --

 9             DR. FANNING:  Correct.

10             DR. BLANC:  Okay.  Then you have your written text

11   of the modified point, which could you --

12             DR. FUCALORO:  Which you'll distribute; right?

13             DR. FANNING:  Which we can have Peter take a Xerox

14   and distribute.

15             DR. FUCALORO:  And this would replace 43?

16             DR. FANNING:  44 and 45.

17             DR. BLANC:  And then everything else would be

18   renumbered, obviously.

19             DR. FUCALORO:  I'm glad you mentioned that.  It's

20   always good to remind people.

21             DR. FANNING:  I would just add on the selection of

22   this study there, that there were actually three studies

23   reported in the document.  And so the levels at which

24   effects are seen are quite consistent across studies.  One

25   found a LOEL of 2 ppm and another found effects at 1.75, and


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 1   the most sensitive at .5 ppm.  They were quite consistent.

 2             DR. BLANC:  Okay.  Moving right along, John.

 3             CHAIRMAN FROINES:  I just want to make one comment

 4   to Tony.

 5             You know, remember when Dale Hattis and Romberg

 6   came and made presentations about maybe a year ago?

 7             It is true that we are using risk assessment

 8   techniques that were derived in the '50s and they reflect

 9   that time lapse.  It's unfortunate we have not moved beyond

10   them, because they're pretty crude, to say the least.  And

11   the danger is that you begin to apply them automatically and

12   with rote and --

13             DR. BLANC:  Well, now that we've done that piece,

14   would you then like to simply go around the table and people

15   can put in their little other final changes?

16             CHAIRMAN FROINES:  Yes.  So why don't we start

17   with Roger.

18             DR. ATKINSON:  I don't have any, apart from the

19   one I mentioned.

20             CHAIRMAN FROINES:  Roger is the lead and so he's

21   been deeply involved in the process.

22             DR. FUCALORO:  And he's --

23             CHAIRMAN FROINES:  We've gotten lots of changes

24   from him already.

25             DR. FANNING:  I'll also add that I did meet with


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 1   Dr. Witschi by phone to take his comments and they're

 2   reflected in the draft you have.

 3             DR. BLANC:  Point 14, the last sentence, dermal

 4   and mucous membrane uptake has not been estimated for risk

 5   assessment.

 6             I assume you mean non-respiratory tract mucous

 7   membrane; is that right?

 8             DR. FANNING:  That's a good point, yeah.

 9             DR. BLANC:  So I would say dermal and

10   non-respiratory mucous membrane.

11             On points 15 and 16, to be completely technical I

12   would avoid the term residents in referring to Dunsmuir, and

13   in point 15, I would replace local residents with those

14   exposed.  And in point 16 relace residents with persons,

15   since some of the more highly exposed were the cleanup

16   people and the railroad workers who were not residents of

17   Dunsmuir.

18             And point 17, again I question -- I assume the 183

19   case reports were exclusive of the Dunsmuir incident; is

20   that correct?  It's my interpretation of that.  It's rather

21   DPR pesticide is --

22             MR. GOSSELIN:  Yes.

23             DR. BLANC:  I would suggest beginning that with

24   exclusive of the Dunsmuir incident, comma.

25             Point 23, the very last phrase, where you say in


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 1   agreement with limited evidence in humans.  Perhaps the term

 2   would be consistent, rather than in agreement.  Just if you

 3   want it to be.

 4             And then there's a point 24, there's a comma

 5   missing after decrease in serum protein.  At least, it's

 6   strongly likely to believe that --

 7             DR. FUCALORO:  I agree.

 8             DR. FANNING:  In that case there are commas

 9   missing before and in a number of places.

10             DR. BLANC:  People have different views about

11   three things or more, but that's certainly a long list.

12             DR. FUCALORO:  But Dr. Blanc is absolutely right,

13   that's the proper stylistically.

14             DR. FANNING:  Sure.  We want your grammar to look

15   good, guys.

16             DR. BLANC:  Point 28, again this is a question,

17   but the thrust of the point is that the maternal effects

18   make the interpretation of the data probably, but that's how

19   I read the point was that because there were maternal

20   effects at these dosages, it was difficult to interpret the

21   fetal effects.  Is that correct?

22             And I suggest a sentence at the end that says this

23   makes interpretation of the developmental toxicity data

24   probably, if that's your intent.  I mean, that's how I would

25   read it, but I would be a bit more explicit.  Was that the


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 1   intent?

 2             DR. FANNING:  Yeah, that's the intent, in general

 3   if clear adverse effects are seen in the dams then it's

 4   difficult --

 5             DR. BLANC:  Then I would put in a sentence at the

 6   end.

 7             DR. FANNING:  Developmental toxicant.

 8             Panel members agree?

 9             DR. BLANC:  In point 29, in the middle of the

10   paragraph you start to talk about function tests.  Those are

11   pulmonary function tests, right?  So what I would say is

12   pulmonary -- I would reword it to read pulmonary function

13   tests were indicative of lung volume, air flow and pulmonary

14   vascular impairments.

15             Because you really, the inference about, I don't

16   know where the pulmonary hypertension came from.  That would

17   perhaps be an inference from pulmonary function test.  It

18   was a different test, I don't remember by heart all the

19   data.

20             DR. FANNING:  I don't either.  And the language

21   there was recommended by Dr. Witschi, so I actually just put

22   it in without editing.

23             DR. BLANC:  So I would --

24             DR. FANNING:  Could you repeat for me, please --

25             DR. BLANC:  Pulmonary function tests were


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 1   indicative of lung volume, air flow and pulmonary vascular

 2   impairments.

 3             But you better double check that.  I think that's

 4   what you mean, but I'm not sure.

 5             DR. BYUS:  Can you assess pulmonary hypertension

 6   by a --

 7             DR. BLANC:  You can't.

 8             DR. BYUS:  You cannot.

 9             DR. BLANC:  But you could assess pulmonary

10   vascular disease.  Pulmonary vascular -- you'd have to have

11   different tests.  So I think this is just something you need

12   to clarify.

13             If you show me what that was based on, again, I

14   can tell you whether this was --

15             DR. FANNING:  We'll look.

16             DR. KENNEDY:  While you're on 29, I had one small

17   change.  Pulmonary edema is related clinical syndrome, and

18   you're talking about anatomic observations, but in the

19   middle of the that paragraph saying interstitial and

20   alveolar edema, so we know we're talking about the lungs.

21             DR. FANNING:  Okay.

22             DR. BLANC:  Point 30, just consistent with your

23   phraseology, I would put in the words to MIC, after the

24   first phrase, three controlled human exposure -- three

25   controlled exposures of human volunteers to MIC, as you put


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 1   in MIC specifically after every other point, so.

 2             Point 33, you're talking about the hydrogen

 3   sulfide in terms of its irritant effects.  And you talk

 4   about the decreased ability to smell it, but actually the

 5   reason it is lethal for cytotoxic is asphyxia, so I might --

 6   I know you're cutting out the duplicate phrase there, but

 7   the very last sentence I would amend the three -- append the

 8   three words through cytotoxic asphyxia.

 9             CHAIRMAN FROINES:  There's a problem there in the

10   draft that I have because there's a period.

11             DR. FANNING:  Isn't that --

12             DR. BLANC:  Airborne concentrations of 700 parts

13   per million and more cause immediate death from cytotoxic

14   asphyxia.

15             CHAIRMAN FROINES:  But in the draft I have you say

16   here, H2S poses the greatest exposure concern of these

17   compounds.  There's no period there, in the draft I have.

18             DR. FUCALORO:  It's not in mine either.

19             CHAIRMAN FROINES:  Then you go on to say H2S is

20   highly toxic irritant gas that causes respiratory symptoms

21   and eye irritation after acute --

22             DR. BLANC:  We've already fixed that.

23             DR. FANNING:  But you're correct, there's a

24   missing period after the word compounds.

25             CHAIRMAN FROINES:  The other, Paul, can I just


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 1   stay with this for one second.

 2             The sentence, H2S poses the greatest exposure

 3   concern with these compounds, that -- I was a little

 4   concerned about that because I assume you're basing that on

 5   the airborne concentrations that have been measured and so

 6   it's an issue of not so much toxicity but airborne exposure,

 7   airborne concentration.  Because I would argue that carbon

 8   disulfide is an extremely toxic compound and it would be a

 9   matter of concern as well.  So it's a little bit of a

10   question of whether you're making a toxicological or

11   exposure-based judgment.

12             DR. FANNING:  I'd agree with your comment

13   concerning the toxicology.  The derivation of the phrase

14   there is that based on DPR's Part A document, and Paul may

15   want to comment on this, the environmental conditions that

16   in which metam is generally used in California are unlikely

17   to produce significant quantities of carbon disulfide.

18             DR. BLANC:  Why don't you simplify the sentence

19   and make it as H2S poses the greatest concern based on

20   exposure levels.

21             CHAIRMAN FROINES:  I didn't understand that

22   sentence that you just said.  We'll come back to that when

23   it gets to be my turn.

24             DR. BLANC:  Point 37, the middle of the paragraph,

25   at the maximum 24-hour exposures reported in application


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 1   site studies, however neither the adult nor child MOEs

 2   reached the protective level.

 3             This is somewhat repetitive, but just to make it

 4   absolutely clear, I might add, comma, in both cases,

 5   following below 10.

 6             DR. FANNING:  Okay.

 7             DR. BLANC:  I know it's sort of beating a dead

 8   horse.

 9             And I have a similar point about item 39, if I

10   understood the implication here, which is that although

11   there's a range of estimates for these, in all of the cases

12   the estimates include a value less than ten in their range;

13   is that correct?

14             DR. FANNING:  Right.  Of course, remembering that

15   all these -- that these ranges are the ranges of the maximum

16   exposures that were seen, so those are the six.

17             DR. BLANC:  Right.

18             DR. FANNING:  Okay.

19             DR. BLANC:  I would put a phrase at the end, all

20   cases, comma, the range of estimated MOEs fell below ten.

21             DR. FANNING:  Below 100 in the case of No. 39.

22   The benchmark would be 100, because this is comparing to an

23   animal derived NOEL.

24             DR. BLANC:  So they all were completely below a

25   hundred.  I see.


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 1             Then I would say in all cases the range of

 2   estimated MOEs fell below 100, indicating that the MOEs did

 3   not achieve a protective level.

 4             Again, it's redundant but just --

 5             And then finally the currently numbered 55,

 6   although it's going to change to 54, I suppose, this is

 7   again a question.  I wonder -- a question for our chair -- I

 8   wonder if you want to insert a sentence there that also says

 9   the panel also reviewed the responses of DPR and DHS in

10   light of follow-up comments from the Metam-Sodium Task

11   Force.

12             CHAIRMAN FROINES:  Good.

13             DR. FANNING:  Do you want to say that, do you want

14   to specifically highlight that public comment, or do you

15   want to say that the panel has reviewed public comment and

16   DPR's response to them, which was submitted to you in Part

17   D?

18             CHAIRMAN FROINES:  No.  I think that -- well, my

19   view would be that the problem that we had with the

20   Metam-Sodium Task Force is these late comments, and so

21   there's another issue we'll have to take up after this

22   meeting, which is again the scheduling of comments as they

23   come to the panel, because it obviously makes everything

24   much more difficult when you get comments two weeks or a

25   week before you have a meeting to finalize the document.


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 1             So I think that in this case I would argue that we

 2   should speak to the specific issue rather than the general

 3   one, because the general issue is I think given.

 4             DR. BLANC:  That was my intent.

 5             CHAIRMAN FROINES:  Unless there's strong

 6   disagreement.

 7             DR. BLANC:  Those are my comments.

 8             DR. FANNING:  So the panel has also reviewed

 9   public comments submitted by the Metam-Sodium Task Force and

10   DPR's response to them?

11             DR. BLANC:  My wording was the panel has also

12   reviewed the responses of the DPR and DHS in light of

13   follow-up comments from the Metam-Sodium Task Force.  Our

14   job is to review their response to the Task Force.  The Task

15   Force is not communicating with us.

16             CHAIRMAN FROINES:  And he doesn't mean DHS.

17             DR. FANNING:  Substitute OEHHA for DHS.  That's

18   fine.

19             DR. BLANC:  Isn't OEHHA a part of DHS?  It's part

20   of --

21             CHAIRMAN FROINES:  Cal EPA.

22             DR. BLANC:  Sorry.  Sorry, guys.

23             I just want you to know that I gave a lecture

24   yesterday where I was introduced as being the head of

25   occupational therapy, by one of my colleagues.


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 1             CHAIRMAN FROINES:  Moving right along.

 2             DR. FUCALORO:  You wouldn't be angry if it wasn't

 3   such a compliment.

 4             DR. KENNEDY:  I have two little bitty grammatical

 5   things.

 6             38, the line two, we have an errant preposition,

 7   and I would suggest the sampled homes are not at risk from

 8   MITC being used, eye irritation, instead of risk of eye

 9   irritation.

10             And representativeness of the samples in the last

11   line of that same section is a pretty weak word.

12             DR. FANNING:  My spell checker would agree with

13   you.

14             DR. KENNEDY:  And whether it is reflective of the

15   samples for human exposure or something else.

16             CHAIRMAN FROINES:  Tony.

17             DR. FUCALORO:  Just a few things.

18             On item 2, you at some point spell out methyl

19   isothiocyanate instead of just MITC.  MIC is identified as

20   methyl isocyanate, and you need to do the same for MITC

21   which it's --

22             DR. FANNING:  Thank you.  I believe it used to be

23   in the title spelled out, and now it's not.  So, yes, it's

24   going --

25             DR. FUCALORO:  And then the other small thing is


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 1   maybe it's just a question, in No. 23 on the second line

 2   starts a sentence acute effects produced in rats following

 3   inhalation exposure included both hyper and hypoactivity.  I

 4   mean what --

 5             DR. BLANC:  Remember, that was a study where -- I

 6   thought about that too.  I thought, well, couldn't we just

 7   say changes in activity.  You know what, we should just

 8   leave it this way because in fact it seems goofy, but it

 9   wasn't a great study.

10             DR. FUCALORO:  It is goofy.

11             DR. BLANC:  Not that it wasn't a great study, but,

12   you know, anyway -- none of those endpoints.  Not to impugn

13   the study.

14             DR. FUCALORO:  I'm easily assuaged.  Bias, you

15   know.

16             I'm complete.

17             CHAIRMAN FROINES:  Craig.

18             DR. BYUS:  You got all of mine by now.  So I have

19   nothing additional.

20             DR. KENNEDY:  Another little tiny one in 23 since

21   we're looking at it.  In rabbits are you comfortable saying

22   simply MITC is a severe skin and eye irritant?  Lots of

23   passive stuff.

24             DR. FANNING:  Sure.

25             DR. KENNEDY:  That's fairly obvious conclusion.


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 1             DR. BLANC:  John, it's up to you.

 2             CHAIRMAN FROINES:  I think we should take a short

 3   break to give the stenographer a chance to take a rest.

 4             DR. FANNING:  And maybe before that break we could

 5   have Peter pass out the changes to the MIC finding, the new

 6   No. 44, and the panel would have a chance to look at it for

 7   a moment during the break.

 8             CHAIRMAN FROINES:  Yeah.  I wanted to take a break

 9   now because my part may take a little bit of time, and so I

10   think it's better to take a break now.

11             (Thereupon a short recess was taken.)

12             CHAIRMAN FROINES:  Elinor, the first change that I

13   think is important to make is in the title.  Pesticide

14   Regulation's toxic air contaminant document for metam-sodium

15   and breakdown products.

16             DR. FANNING:  Yes.

17             CHAIRMAN FROINES:  That was our motion that was

18   carried when we resolved this.

19             And I wanted to speak to that for a second,

20   because in the Metam-Sodium Task Force document one of the

21   things that Paul didn't refer to, and that I've now lost, is

22   the Metam-Sodium Task Force raises the point on their page

23   four, it says, and I quote, some members of the SRP

24   improperly suggested that metam-sodium be listed as a TAC.

25   Such a recommendation is not authorized by law in this


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 1   proceeding and so on and so forth.  I won't read it all.

 2   You have it there to read.

 3             In fact, we got an opinion from legal

 4   representation at ARB, and basically, I'll just quote here

 5   from a couple things, Food and Agricultural Code section

 6   14023 lists the information needed to list something as a

 7   TAC.  Basically the panel can only recommend that a

 8   contaminant be listed as a TAC, for example metam-sodium, if

 9   there is sufficient information in the report to support

10   such a determination.

11             It was our judgment at the meeting where Paul made

12   the motion that we title the report this way was that there

13   was sufficient evidence in the report to designate

14   metam-sodium as a toxic air contaminant.  So that was the

15   conclusion of the panel, but since it's been raised by the

16   Metam-Sodium Task Force I wanted to reraise it in case

17   anybody felt that there was a difference of opinion at this

18   stage.

19             No?

20             So hearing none, we'll proceed with that title,

21   which was the original title that we proposed way back when.

22             That's my major issue, which I thought would take

23   us a long time, and it clearly didn't.

24             So I was preparing for the -- I have a question

25   for Andy or Paul.  On No. 4 you say the degradation -- we


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 1   say the degradation pathway most likely to occur in

 2   California produces MITC and H2S.  What does it mean, most

 3   likely to occur in California, as opposed to Idaho or

 4   Montana?  Or I don't understand the in California part.

 5             DR. FANNING:  I have the Part A document here and

 6   if I remember right, it is about -- it's the -- it pertains

 7   to environmental conditions, so relatively warm

 8   temperatures.

 9             But let us just take a moment and see if we can

10   find something a little less relative for you, which is, I

11   think, what you're getting at.

12             CHAIRMAN FROINES:  Whether we need that sentence

13   is a good question.  Maybe the question I raise, do we

14   really need to say -- does that illuminate the issue?  I

15   don't know.

16             DR. KENNEDY:  Say under specific --

17             DR. FANNING:  I did find something in the Part A

18   document that says -- I don't know if any of you have it in

19   front of you, but pages 38 and 39 there are two mechanisms

20   drawn, and the pathway leading to carbon disulfide is not

21   thermodynamically favored when pH is less than 9.5.

22   Consequently, second process expected to dominant.

23             So that's what's here.

24             MR. GOSSELIN:  And I think maybe what the way this

25   was written, just the words in California may have been


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 1   inappropriately inserted, because, you're right, I mean,

 2   California conditions can run anywhere from the Imperial

 3   Valley up to the coast and it runs the range.

 4             CHAIRMAN FROINES:  If use in Arizona versus

 5   Montana, you might find very different -- it seems like, I

 6   don't know what we gain by saying in California, unless you

 7   think there is some particular reason to.

 8             DR. KENNEDY:  All of the discussion, I'm sorry for

 9   interrupting, all of the discussion of decomposition and

10   degradation, reflect field conditions, and I think if

11   you're -- if that's what you want to say, then just say

12   that.

13             DR. BLANC:  Or a simple way of doing that might be

14   to substitute the two words, California produces, with two

15   words, practice favors.  So it would read likely to occur in

16   practice favors MITC and H2S.

17             DR. FANNING:  Or under field conditions, either of

18   those.

19             DR. ATKINSON:  Or after application to occur.

20             DR. BYUS:  After application.

21             DR. ATKINSON:  Produces MITC.

22             Because page 38 has that in an acidic medium it

23   will lead to carbon disulfide and methylomine, but that's

24   less than pH 5.

25             CHAIRMAN FROINES:  That's the interesting issue,


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 1   because also the question I have, which I don't know the

 2   answer to, is that in acidic medium, you won't have

 3   metam-sodium anymore, you have the sodium gets replaced by a

 4   hydrogen and so you then have a volatile compound, which

 5   would have a vapor pressure unless the breakdown at that

 6   point is so rapid that you don't get any volatilization,

 7   then it's more of a question of quantity rather than -- more

 8   of a quantitative rather than qualitative.

 9             DR. BLANC:  The reason I used the word favor,

10   rather than produces, is that there's some that might have

11   looked at the other pathway, so everything is produced, it's

12   just a question of the relative likelihood.  Isn't that

13   right?

14             DR. FUCALORO:  Sure.

15             CHAIRMAN FROINES:  The reference to Merricks,

16   Elinor, you might want to make sure that the final document

17   has those references in it, because nothing we've gotten has

18   the references.

19             DR. FANNING:  That's true.  The Metam-Sodium Task

20   Force, the Merricks et al exposure study, the Rosskamp study

21   is also cited in here, and so those specific references need

22   to be added to the final version.

23             CHAIRMAN FROINES:  You say measured air

24   concentrations were adjusted for field recovery percents by

25   DPR.  Is that clear to everybody?


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 1             DR. ATKINSON:  Yeah.

 2             DR. BLANC:  Yeah.

 3             CHAIRMAN FROINES:  Okay.  No. 23, last line, I

 4   would just take the word in agreement out.

 5             DR. FANNING:  I think Paul already suggested

 6   substituting consistent with limited evidence in humans.

 7             CHAIRMAN FROINES:  I don't even know if you need

 8   that but --

 9             DR. BLANC:  That's all right.

10             CHAIRMAN FROINES:  MITC may be a dermal sensitizer

11   in guinea pigs with limited evidence in humans.

12             It's a trivial point.

13             So I have nothing more.

14             And I just want to make sure that the panel is

15   happy with the No. 56, our recommendation is we recommend

16   that these -- pardon me.

17             The panel recommends that the director of DPR

18   initiate regulatory steps to list MITC as a toxic air

19   contaminant, and then below we recommend that these -- that

20   dazomet and metam-sodium be listed along with MITC as toxic

21   air contaminants.  MIC is automatically listed as a TAC due

22   to its status as a hazardous air pollutant.

23             So that is the final conclusion that will go

24   forward and I want to make sure everybody finds that

25   appropriate.


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 1             And hearing no argument, so that's it.

 2             We can now entertain a motion of acceptance.

 3             DR. BLANC:  I'd like to move that the findings as

 4   modified with the suggestions made by panel members at this

 5   hearing be accepted.

 6             DR. FUCALORO:  Second.

 7             DR. KENNEDY:  Second.

 8             CHAIRMAN FROINES:  Discussion?

 9             All in favor.

10             (Ayes.)

11             CHAIRMAN FROINES:  Opposed.

12             (No response.)

13             CHAIRMAN FROINES:  Tony, did you vote?

14             DR. FUCALORO:  I voted aye.

15             CHAIRMAN FROINES:  Okay.

16             Thank you, Andy.

17             DR. FANNING:  Thanks.

18             CHAIRMAN FROINES:  Paul, you're back on target.

19             MR. GOSSELIN:  Thank you.

20             CHAIRMAN FROINES:  Since the diesel lawsuit, I'm

21   trying to be very careful with words, so I take back saying

22   with you're on target.

23             You're up next.

24             MR. GOSSELIN:  Thank you.  The next agenda item we

25   wanted to give is an undate on the status of documents we


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 1   have in the queue.

 2             I think Peter has handed out -- Peter, did you

 3   hand out -- do you have the time table?

 4             DR. FUCALORO:  You mean yet another time table?

 5             MR. GOSSELIN:  Of the time table, right.

 6             What this currently reflects are the three

 7   documents we have under production and the status of them,

 8   the one that's furthest along is azinphos-methyl.

 9             We're expecting to have the draft report available

10   by July 3rd.

11             And you'll see a series of footnotes.  OEHHA has

12   provided comments to us, the peer review comments, and ARB.

13   OEHHA is working on the final findings.

14             And then after that, once we get down to the

15   presentation to the panel, these dates become very much

16   softer on the planning.

17             But roughly looking around August or so to have

18   the discussion on azinphos-methyl.

19             Molinate has completed the comment period.  Staff

20   is going through the public comments, and working with ARB

21   on OEHHA on that.

22             So roughly looking towards the end of August, and

23   that's somewhat contingent upon certain dates I'm getting

24   findings and comments from OEHHA.

25             And then chlorpyrifos is currently being scheduled


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 1   for a workshop and a public comment period towards the

 2   summer and we need SRP lead reviewers for that.

 3             These three compounds will take us towards the end

 4   of the year.

 5             One of the things we're tasked to do, and we're

 6   late doing it, is updating the '96 report on the

 7   prioritization document.  Staff should have that document

 8   updated with all the new relevant information by the end of

 9   June.  So we'd be prepared to talk about this after the next

10   meeting after June, whatever the schedule fits.

11             But we're going to need to also as we scope that

12   out consistent with the discussion from last November's

13   workshop on putting down in writing a more logical thought

14   process on not just how we prioritize for monitoring, but

15   once we get monitoring in, what sort of would prompt us to

16   actually initiate a document to bring before the panel.

17             And I think one of the things we were looking to

18   do is not only have that methodology written down in a clear

19   way, but also have some open discussion with you on exactly

20   as we go through an annual planning process what's the most

21   important compounds we have concerns with.

22             So we're in the phase right now of getting that

23   document updated and putting in an additional discussion on

24   how we're going to make judgment calls on initiating

25   documents, but we're also going to be looking to have the


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 1   panel's input on crafting that and subsequently I think on

 2   an annual basis deciding what we're actually going to move

 3   forward on.

 4             CHAIRMAN FROINES:  When do you want the panel's

 5   input to begin, did you say?

 6             MR. GOSSELIN:  I think we'll probably be prepared

 7   to have a draft in about three weeks for discussion.  What

 8   I'd like to do is have, similar of what I've seen worked

 9   with real well with ARB and OEHHA, is having one or two

10   panel members work with the agency before it comes here to

11   have it in a much better format.

12             CHAIRMAN FROINES:  So that's what you're referring

13   to in three weeks?

14             MR. GOSSELIN:  Have something to share with --

15             CHAIRMAN FROINES:  With the lead.

16             MR. GOSSELIN:  Whoever wants to jump in and work

17   with us.

18             CHAIRMAN FROINES:  So we need two leads on the

19   prioritization.  And so since we have only four people here,

20   why don't we not get into that right now.  Let's poll the

21   panel and see who we can get.

22             MR. GOSSELIN:  Andrew would also need a lead, two

23   leads for chlorpyrifos, for later in the summer.  But that

24   doesn't need to be done --

25             CHAIRMAN FROINES:  I shouldn't say that we won't


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 1   take volunteers to be the lead.  I thought I might have to

 2   do more arm twisting, so I decided to do it out of the

 3   bright lights of the media.  Okay.

 4             MR. GOSSELIN:  That's the current status of the

 5   three documents we have that will carry us to the end of

 6   this calendar year, and then hoping by July once we get to

 7   this document and actually the tables and the discussion

 8   here at some point in August or September a discussion on

 9   probably the next three we would actually flag to actually

10   start getting documents going.

11             CHAIRMAN FROINES:  So in August or September

12   discussion of a prioritization document?

13             MR. GOSSELIN:  Which ones we should actually start

14   getting documents going.

15             CHAIRMAN FROINES:  Well, there wouldn't be a

16   August meeting, so we haven't come up with dates yet for

17   even June or July, and so I think that September is the more

18   likely date.

19             Hearing all this silence.

20             DR. FUCALORO:  In any event, I'm lead on two of

21   those.  I couldn't help but notice, but I knew about it

22   anyway.

23             CHAIRMAN FROINES:  This is the reverse lobbying

24   strategy.

25             DR. FUCALORO:  I appreciate getting the documents


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 1   as soon as possible.  That's my interest, so I have

 2   sufficient time.

 3             MR. GOSSELIN:  You should have molinate, and you

 4   should have azinphos-methyl.

 5             DR. FUCALORO:  I actually do have both of those,

 6   but are you going to update them?

 7             MR. GOSSELIN:  Yeah.  I believe azinphos-methyl

 8   has --

 9             DR. FUCALORO:  I haven't received -- I received

10   those a while back.  And is there an updated version after

11   OEHHA?  I'm not exactly sure on the scheduling, but you're

12   going to revise them; right?

13             MR. GOSSELIN:  Yes.  Right now azinphos is pretty

14   close to having the revisions based upon the OEHHA comments.

15   I'd say in the next week or two.  OEHHA is working on their

16   findings in concert with the changes we're making, based on

17   their comments, so that's getting fairly close.

18             And molinate, a month ago just completed the

19   public comment period, and I don't know offhand how many

20   public comments we got, but then at this point work starting

21   with OEHHA on their comments and working that out.

22             DR. FUCALORO:  Just send it to me as soon as you

23   can.  That's all.  I have to have sufficient time.  I

24   suppose the same with you, John and Paul.  Paul is not here.

25             CHAIRMAN FROINES:  Well, also we had some problems


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 1   with molinate, so we are particularly curious about that.

 2             DR. FUCALORO:  That's correct.

 3             MR. GOSSELIN:  Yeah.

 4             CHAIRMAN FROINES:  Okay.  Thanks, Paul.

 5             Finally, Elinor.

 6             You might stay there, Paul, just in case there's

 7   any comments you have to make.

 8             But everybody in the panel now has the document

 9   that Elinor just passed out or Peter just passed out.

10   Proposed agenda for the AB 1807 SRP pesticide workshop in

11   September 2000.

12             DR. FANNING:  Everybody has a copy?

13             CHAIRMAN FROINES:  You better lead people through

14   it, since they haven't had a chance to read it.

15             DR. FANNING:  Right.  This document is a follow-up

16   to our discussion in February at UCSF.

17             At that meeting, I brought a very sort of brief

18   proposal to the panel.  We talked about ideas for further

19   discussions that we could have on pesticides, and one of the

20   items that I proposed at the time was to follow up on the

21   panel's recommendation to DPR to consider organophosphate

22   pesticides, organophosphate TAC candidates, in groups.

23             This was a suggestion made at, I believe, our

24   October workshop by, I don't actually remember who, but the

25   panel recommended that it may be a way to facilitate


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 1   evaluation of these TAC candidates, because they have very

 2   similar mechanisms of toxicity.

 3             So we looked at a brief proposal in February and

 4   the panel asked me to go ahead and develop that proposal

 5   further.

 6             So since that time, I met with DPR staff and

 7   discussed with them and got a revised version containing

 8   DPR's suggestions, as well as some very useful suggestions

 9   for possible speakers.

10             I also met with OEHHA and talked with them and

11   have gotten some input on the issues that they feel would be

12   important for us to address.

13             So what you see today is a little bit of a hybrid

14   of the comments from the agency then.

15             This is still a working draft and the DPR staff

16   I'm working with on developing this workshop haven't had a

17   chance to review it.  So I don't consider this a final.

18   It's just still in proposal form.

19             To walk through it, the first item is what is

20   essentially be an update reminding us of which

21   organophosphate pesticides are TAC candidates at this time

22   and haven't yet been reviewed, some of them have been listed

23   and some are in process.  Paul just talked about

24   chlorpyrifos.

25             So we'd go through and get an update on risk


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 1   assessment activity on these TAC candidates, including

 2   whether available tolerance reassessment reports are

 3   finalized at US EPA, whether pesticide illness reports are

 4   available, whether ARB has completed monitoring on these

 5   chemicals, and based on this information DPR staff would

 6   present a suggested group 1 of organophosphate pesticides

 7   that could be evaluated.

 8             Then we would progress to a discussion of some of

 9   the key toxicological issues with organophosphate

10   pesticides, focusing, because it's such a big field, there

11   are many interesting issues we could get into if we were

12   going to do an academic forum on the topic, but what we want

13   to do is focus on the toxicological issues that are

14   pertinent for DPR's risk assessment activities.

15             So we've identified some of those here.

16             One of them first, pharmokinetic organophosphates,

17   and I know this is Dr. Froines has brought this up in the

18   past and there are some issues here that may affect

19   interindividual sensitivities to these pesticides, and in

20   turn that affects how we think about using safety factors in

21   the risk assessment process.

22             So DPR has suggested a couple of potential

23   speakers here.

24             One is Dr. Janice Chambers from Mississippi State,

25   who I believe has worked quite a bit on some of the enzymes


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 1   through which organophosphates act, mostly in animals, I

 2   think.

 3             Is that right, Ruby?

 4             Yeah, mostly in animal toxicology studies.

 5             Another speaker is Dr. Furlong from the University

 6   of Washington who has worked on the peroxynates polymorphism

 7   in human populations.

 8             So those two, I think, would bring some

 9   interesting research perspective to our discussions on

10   pharmacokinetics and metabolism and with a particular focus

11   on interindividual variability.

12             CHAIRMAN FROINES:  I think that's a key.

13             DR. FANNING:  You agree that's an important issue?

14             CHAIRMAN FROINES:  Interindividual variability,

15   absolutely.

16             DR. FANNING:  Okay.  Second, I have listed

17   cholinesterase inhibition studies in workers.  I think the

18   idea is to have someone come in and talk a little bit about

19   what are the human data that we have available in general

20   for OPs on cholinesterase inhibition and looking now for to

21   address questions like what are the correlations between

22   inhibition in various body compartments, i.e., plasma or red

23   blood cells, how do those inhibition levels correlate with

24   clinical signs and symptoms, how can we understand those

25   data a little bit better.  That becomes very important later


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 1   when we talk about using cholinesterase inhibition as an

 2   endpoint for risk evaluation.

 3             CHAIRMAN FROINES:  But the toxicokinetics of that

 4   processes are also key elements there too.  So the

 5   toxicokinetics folds into the different target sites.

 6             DR. FANNING:  Yes.  Particularly from a number of

 7   standpoints, one of which is distribution.  That's an

 8   important part of the pharmacokinetics, distribution through

 9   the body, some of these pesticides cross the blood brain

10   barrier, some don't.  We have a certain amount of difference

11   chemical to chemical in the biology.

12             So Barry Wilson from UC Davis has been suggested

13   as a good speaker for organophosphate issues by both OEHHA

14   and DPR.  I'm not sure, I checked with Ruby, whether this is

15   the appropriate place to put him, but this is still a little

16   under development.

17             Do you want to comment?

18             DR. REED:  This is Nu-may Ruby Reed, from DPR.

19             As Elinor said, this is the first time that I have

20   looked at it.  We did suggest or recommended Barry for the

21   cholinesterase issues.  Mostly we were thinking of him being

22   familiar with both the cholinesterase measurements in terms

23   of essence, but also his experience in participating in US

24   EPA cholinesterase inhibition policy for risk assessment.

25             I'm not sure that he would be able to address the


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 1   worker's side of the database, but I will be very open to

 2   any other suggestions in terms of who would be the best

 3   person for this.

 4             DR. FANNING:  One other suggestion for a speaker

 5   on that subject was Dr. Richard Ames at OEHHA.  So he may be

 6   a good candidate for some of those issues as well.

 7             And of course if panel members in the next few

 8   months come across people who have expertise in these areas,

 9   please forward those to either Ruby or myself and we will

10   take them into consideration.

11             What I'd like to look at today are more topical

12   subject matter, and we'll work to further develop the

13   speakers a little bit later.

14             Then continuing with toxicology subjects, looking

15   at the delayed and chronic neurotoxic effects that have been

16   observed and trying to get some perspective on how many

17   organophosphates have been observed to have these kinds of

18   effects, how well do they correlate with some of the

19   cholinesterase inhibition effects that have been seen and

20   trying to get some biological background on how to interpret

21   those findings in a risk assessment setting.

22             MR. GOSSELIN:  I would also throw in something

23   less than chronic that would mean lifetime or a year, but

24   something in between, because we typically sometimes are

25   dealing with seasonal exposures to workers.


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 1             DR. FANNING:  Right.

 2             And finally --

 3             CHAIRMAN FROINES:  I think actually I expect that,

 4   you know, we know, we think we know something about how

 5   cholinesterase inhibitors work, at least in the acute sense,

 6   but our mechanistic understanding of longer term

 7   irreversible changes, so it's not necessarily it's not

 8   chronic in the -- I think it's a mechanistic statement, not

 9   a exposure statement that she's making.

10             MR. GOSSELIN:  I only meant that something

11   intermittent, continuously over a duration and what actually

12   happens.

13             DR. FANNING:  I think that the area of the delayed

14   and either seasonal or longer term effects is really

15   important because this is where, as you say, we're less

16   certain of the biological mechanism and there may be more

17   difference between the chemicals.  And since part of the

18   focus of this batched assessment was to be able to develop

19   some standard risk assessment methods so that the OPs can be

20   quickly evaluated, it may be that that's quite easy for

21   acute exposures and somewhat more difficult for looking at

22   longer term exposures, so this was the thinking to get some

23   biological background expertise to help us with that.

24             DR. BYUS:  I think this is great.  You've got

25   everything in here.


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 1             Just from my perspective, either leave

 2   pharamocokinetics, but then tremendously, the key issue when

 3   I was evaluating methyl parathion is one of the key issues

 4   was the serum cholinesterase, how predictive is that of

 5   effects in the brain, is the serum level of cholinesterase

 6   inhibition predictive of the brain effect, inhibition of the

 7   brain enzyme.  There's a lot of discussion and disagreement

 8   about that as you go from one chemical to another.  Okay.

 9             And then that second question is is then can you

10   use that serum level to predict the neurotoxicity, either

11   chronic or delayed.

12             I mean that's really the key issue, because you

13   can measure the serum levels very easily.  This is the --

14   you can measure this in human populations and people that

15   are exposed and workers and whatever.  How predictive of

16   that is that value of toxicity, and that's the really the

17   key issue that I have my opinion, and you can argue it

18   around, and then how clear is that relationship from one

19   compound to the other.  Is that correct?  Are you --

20             DR. REED:  Correct, yes.

21             DR. BYUS:  That's really what we need to know.  If

22   it can be arrived at.

23             DR. FANNING:  It could be, I had sort of planned

24   to address that more in the context of human data looking at

25   the different blood measures and correlation with clinical


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 1   symptoms, but you're very right that it's also important to

 2   include enough animal data to look at the brain inhibition.

 3             And what also comes into this is how often do you

 4   have -- how often do you see peripheral type of effects

 5   versus central nervous system type of effects, so is the

 6   brain always the major target organ and there's some

 7   breakdown there as well in terms of where the key target is.

 8             DR. REED:  I think in that respect that the

 9   correlation between the serum cholinesterase and brain

10   cholinesterase is important, but relationship between serum

11   and peripheral tissue cholinesterase is important too.  Most

12   of the time that was not measured in some.  So lot of times

13   we're saying that the serum cholinesterase is a surrogate of

14   that, but it would be nice to have a holistic look at this

15   issue.

16             CHAIRMAN FROINES:  I'd even go one step further

17   and say that one of the areas that we don't ever really

18   spend much time on is autonomic effects, and we certainly

19   shouldn't leave that out, because people die from autonomic

20   effects.

21             DR. FANNING:  Okay.  So it seems what I'm getting

22   here is that we could modify a little bit the way that

23   number 2 is laid out and maybe we need to divide that into a

24   couple of items to address this effect and --

25             CHAIRMAN FROINES:  Yeah.  I first thought I was


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 1   going to say to Craig that you were going to address that

 2   issue in your risk assessment issue, but I assume that

 3   you're in a sense dividing it between the sort of underlying

 4   science on the one hand and then the application to risk

 5   assessment and policy on the other.

 6             DR. FANNING:  That is kind of the way my brain

 7   broke it down.  They are going to smear into each other to

 8   some extent, and so, yeah, I think it's exactly right under

 9   part 3, number 1, where we have different agency

10   perspectives on what endpoints do we select and what are the

11   uncertainties of that endpoint.  These are exactly the

12   issues that are going to come up.  So it may just take

13   further work on our agenda to figure out.

14             MR. GOSSELIN:  Except I think the way we were just

15   talking about scoping this out on the beginning and in the

16   end, but putting some of the discussion on the tox of the

17   OPs into context about -- because I think we would get

18   there, but focus it on what data is available, what does

19   that data kind of show and versus also adding in what types

20   of data of, you know, would be better to help characterize

21   this.

22             So you get both outcomes of the session about what

23   we have to work with.

24             And then in the end the assessment is with what we

25   have to work with, how do you make sound judgments.


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 1             CHAIRMAN FROINES:  I think this is great.

 2             DR. FANNING:  Okay.  Yeah.  I guess just a brief

 3   look at the part 3, the risk assessment issues, number 1 is

 4   the item that we're just discussing, sort of how you use

 5   cholinesterase inhibition in risk evaluation, which body

 6   compartments are relevant and for which types of clinical

 7   science are those inhibitions relevant.

 8             And we had thought to have a speaker from US EPA

 9   present -- they have a policy document developed on sort of

10   guidelines for use of inhibition data and risk assessment

11   and have DPR's perspective and then OEHHA's perspective.

12             CHAIRMAN FROINES:  There's one problem here,

13   Elinor, that I wanted to ask you about is in that notion

14   that part 1 sets up for part 3, or part 1 and 2 set up part

15   3, then there's nothing in part 1 or 2 on oncogenicity.  And

16   so you're into the risk assessment issue in number 2 of part

17   3, but you haven't got any preparative --

18             DR. FANNING:  It's actually supposed to be under

19   part 2, number 4, other toxicological considerations.

20   Actually oncogenicity is supposed to be in there.  I had it

21   as a separate item and then it -- it's partly going to

22   depend also on who we identify as good speakers to address

23   these subjects, so if we find someone who is really terrific

24   on the oncogenicity subject, then that will get a little

25   more highlight.


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 1             And it will also develop based on what you see in

 2   the risk assessment issues session, look at number 2,

 3   chronic risk endpoints.  DPR is going to go through

 4   evaluations of OPs to date and try to pull out what are the

 5   chronic endpoints that have been observed and considered

 6   important for risk assessments so far, where is sort of the

 7   weight of evidence on different endpoints, where do we

 8   see -- what are the major chronic endpoints that have been

 9   observed and may help focus which subjects we want to look

10   for an expert on in the first part.

11             CHAIRMAN FROINES:  We're going to find that very

12   depressing.

13             DR. FANNING:  Yeah.  We're going to find that

14   there's not much to do on that.  That's a difficult part.

15             And finally the children's risk issue, I think is

16   relevant for OPs.  So I haven't yet identified a particular

17   speaker, but I think we can do that.

18             CHAIRMAN FROINES:  I think you need to send --

19   make sure, Peter, that everybody has this, because we're

20   down to four people, five people, and send an e-mail asking

21   for suggestions from SRP members.

22             DR. FANNING:  Yeah.  What I'd like to do

23   procedurally is let the DPR staff, Ruby and Randy Segawa and

24   Jim Sanborn, who were working with me on this, and so I'd

25   like to get sort of a more current version after they've had


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 1   a chance to look at this.

 2             CHAIRMAN FROINES:  Who is lead on this from OEHHA?

 3   John?

 4             DR. FANNING:  Pardon me?

 5             CHAIRMAN FROINES:  Who is the --

 6             DR. FANNING:  On this?  Lou Bojoa is the person

 7   who is going to work with us and present on the

 8   organophosphates.

 9             CHAIRMAN FROINES:  Who is the lead -- Andy, are

10   you the lead person on this for OEHHA?

11             DR. FANNING:  I met with George Alexeeff and

12   Michael --

13             DR. SALMON:  In terms of management it's George

14   and Michael.

15             DR. FANNING:  Right.

16             CHAIRMAN FROINES:  Andy, why don't you say who you

17   are for the --

18             DR. SALMON:  I'm Andy Salmon.

19             DR. FANNING:  Right.  So we'll refine this a

20   little bit and then send it to panel members and see if you

21   have specific input on topics, questions that you want

22   answered like Dr. Byus brought up, and also if you have

23   suggestions for speakers that would be very useful.

24             DR. BYUS:  My other little pet concern with OPs

25   was this whole idea of multiple exposures for multiple OPs.


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 1   In the field, how they're all sprayed on and all the

 2   different times, it is my feeling that from some of the food

 3   data one could extrapolate backwards from what sorts of food

 4   residue -- how many OPs are found on food, and then you can

 5   get some idea of how much had to have been sprayed on them,

 6   rather than taking it from the front end, go from what you

 7   actually see and work backwards and do they both agree.

 8   Maybe you're already doing this but --

 9             MR. GOSSELIN:  No.  But --

10             DR. BYUS:  One of the Task Force -- not the Task

11   Force.  The public concern groups, its name escapes me, this

12   was one of their major concerns that there's a huge number

13   of OPs out there that are used all over and if you just look

14   one at a time you may have a cumulative risk assessment

15   here, I think is really appropriate.  It's not always so

16   appropriate, but it seems to me much more appropriate here.

17             MR. GOSSELIN:  This whole area could be a whole

18   nother topic on modeling exercises, and there's been some

19   dietary risk models used for a number of years, but there's

20   started to get into other models because of FQPA and

21   bridging into what data we have on use to be able to

22   actually do some models on exposure, worker exposure and use

23   patterns, and there's at least two major models out there

24   that we've been looking at and EPA has been looking at that

25   have a whole bunch of different modules off of them to do


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 1   exactly that kind of analysis.

 2             So sort of the trends in modeling to get to the

 3   predictive sort of issue we're looking at might be a topic.

 4             DR. REED:  In terms of what's indicative of what

 5   we know about chemicals, not only from residues in food,

 6   that the profile that you see in residue in foods, but our

 7   department also has the full pesticide use report database,

 8   and that should give us some idea about that.

 9             I think we could include that in the item number 1

10   introduction presentation in there.

11             I do have a comment about that with the item

12   number 1 introduction, and that's just my sort of a feeling

13   right now, is that it might be a little bit premature for us

14   to make that presentation up-front about what possible OPs

15   could be batched together without going through the proper

16   kinetics and what can be batched and what cannot be batched.

17             I would propose maybe with this as a draft we move

18   that to the end of the presentation so that we have a more

19   sort of a flows better in terms of the logistics of how to

20   batch, present OP risk assessment.  If that's okay.

21             DR. FANNING:  That's fine.  That seems reasonable.

22   Yeah.

23             Now, on the cumulative risk, another thing to keep

24   in mind was that Randy Segawa did present to us, I think in

25   the Claremont meeting in November, a little -- a preliminary


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 1   analysis on pesticide use reports that showed us where sort

 2   of a temporal and spatial analysis of which organophosphate

 3   pesticides were used together, so they have done a bit of

 4   development on this point, and it could be that we could

 5   have some further development of that.

 6             I think, though, that we want to keep in mind a

 7   little bit that the goal, the primary goal of the workshop

 8   is to develop the methods and format for this document.

 9             And I'm not -- Paul may want to comment here, but

10   my understanding of the toxic air contaminant program is

11   that we are listing individual pesticides based on their

12   individual activities, and I'm not sure how much cumulative

13   risk would actually be incorporated into TAC listing

14   evaluation.  It seems more risk management type question

15   but --

16             MR. GOSSELIN:  Well, you're right.  I think the

17   goal up-front, the primary goal, should be we do have a

18   number of OPs that EPA has reviewed, we've reviewed, we have

19   data on it and it lends themselves that we can probably be a

20   little bit more efficient and how do we go about doing that,

21   given all these issues, and that should be probably the

22   primary goal.

23             These other issues, you know, the science is

24   moving swifter than it has ever before and people are

25   thinking a lot differently that -- I wouldn't want to lose


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 1   sight of things that -- and it will be a balance to make

 2   sure that we do get the practical steps out of this so we

 3   can actually maybe produce a document that includes a couple

 4   OPs under the current structure, but some of these other

 5   issues are here and now, and we have to start thinking about

 6   how we're evaluating pesticides in air from multiple sources

 7   and how to go about doing that in a logical fashion.  That's

 8   probably not going to happen in the immediate future in

 9   documents, but until we actually start thinking about the

10   different processes and ways of doing it, we're never going

11   to get there and we're at a means now to start talking about

12   it.

13             DR. BYUS:  If there's one to start with it's

14   organophosphates, because they're clearly, in my opinion,

15   because they do have some reasonably clear mechanism, they

16   do work by pretty much the same -- in the same enzymes, the

17   same mechanisms, by and large, I'm exaggerating sightly, but

18   you could consider them all together.

19             In that regard it is very -- multiple exposure in

20   this case is very much more clear than for many other

21   multiple exposure chemicals, because all of these work by a

22   similar mechanism.  So it's sort of a mechanism based upon

23   exposure, because there's no better -- that I can come up

24   with -- no better example of it than this group right here.

25             DR. FANNING:  Yeah.  I think it's clear that


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 1   it's --

 2             DR. BYUS:  As muddy as it is, this is the clearest

 3   one I can come up with, could come up with.

 4             DR. FANNING:  It's a very interesting issue and we

 5   want to develop some of the workshop material to address it

 6   and get an interesting discussion about how it could be

 7   done.

 8             My point was just that we not lose sight also of

 9   developing some practical guidelines for the issue closer at

10   hand, which is the TAC listings.

11             CHAIRMAN FROINES:  I think that the tenor of what

12   you're saying here is that the emphasis in this workshop is

13   really more biological than exposure related.  That's the

14   way this is laid out.

15             Taking Craig's point, there are enormous number of

16   exposure estimation issues that are probably out of the

17   scope of this particular meeting, it would seem to me,

18   because --

19             DR. FANNING:  Well, maybe not.  If there are

20   exposure assessment questions that are going to come up in

21   the listing documents, then we should identify those if

22   possible now and do our best to address them.

23             CHAIRMAN FROINES:  Well, you know, I'm of the

24   opinion that we need in a sense a follow-up session to the

25   workshop we had earlier, precisely for two reasons.  One,


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 1   that methyl bromide report it raises a number of issues from

 2   the National Academy of Sciences and that the panel has,

 3   everybody has that.

 4             And, secondly, when we were going through and

 5   working on the exposure issues in MITC, there were problems

 6   that arose in terms of understanding how best to describe

 7   that information, so that some of the issues with MITC and

 8   metam-sodium and methyl bromide illustrate that there are

 9   still exposure issues that are worth addressing.

10             So I would argue almost, Elinor, that we don't

11   want to overdo trying to do much in one workshop so that we

12   sort of lose the depth for the breadth.

13             DR. FANNING:  So you're suggesting then that we

14   develop this OP workshop to look primarily at the biological

15   issues, and then develop a second workshop that more broadly

16   considers exposure assessment questions that come up with

17   pesticide evaluations?

18             CHAIRMAN FROINES:  Workshop or a follow-up

19   meeting.

20             DR. FANNING:  A session where we have some

21   discussion about how best to use the kinds of data that

22   become available through the air monitoring pesticides.

23             CHAIRMAN FROINES:  I don't think that that

24   precludes a discussion of cumulative risk that Craig is

25   raising, but I think the exposure assessment is clearly


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 1   related, but also it's also one could carve it out as a

 2   separate issue as well.

 3             DR. FANNING:  In that case would you suggest --

 4             DR. BYUS:  I think it's going to depend on who you

 5   can get to talk for one thing.  I really -- how many

 6   organophosphates are registered in the state, roughly?

 7             MR. GOSSELIN:  I don't know.

 8             DR. BYUS:  It's a lot.  I remember I had a number

 9   once.

10             DR. REED:  I thought it's in the order of maybe 30

11   something, 40.

12             DR. BYUS:  30 to 40 seems like it.  40

13   organophosphates that are sprayed on plants all the time and

14   they all have a similar mechanism and if you only consider

15   one at a time, you're going to lose your -- and there's no

16   better example than organophosphates, as I said, for

17   multiple exposure that I can think of.

18             So really that has to be folded in here to this.

19             I do agree with you, though, the methyl bromide

20   report had very important issues that we've dealt with very

21   clearly outlined that we should deal with separately as

22   exposure.

23             DR. KENNEDY:  Somebody completely on the outside,

24   it would seem, that witness the comments that we had here,

25   as pervasive as the OPs are, they're going to be detractors


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 1   coming out of the woodwork, and understanding as much as we

 2   can about the biology of this system, this set of compounds

 3   as a system, will give us the strongest position to work

 4   from, so I think we need to plod through.  It if it takes

 5   two sessions or three sessions, so be it, but it will be a

 6   significant contribution.

 7             MR. GOSSELIN:  If I could add something, I think

 8   we can probably, the best thing would be to take this and

 9   actually dovetail it almost into a session right after to

10   deal with exposure because of the NAS comments on the methyl

11   bromide risk assessment, which we had a good discussion with

12   them last week.

13             We are, and I think we saw some of the same issues

14   on how we described exposure data and actually characterized

15   it in our documents.  We need to retool how we do that, and

16   that's not just going to be for the fumigants but also for

17   the OPs and as you couple the various modeling approaches

18   that people have been putting together out there, all of

19   that is going to, you know, be a good day or two session

20   alone, and I think that it's worth the discussion.

21             And plus that will give some time, I think, for


22   good planning, give us a chance to kind of better scope out

23   where we see the changes we need to bring our exposure

24   assessment documents to.

25             CHAIRMAN FROINES:  Parenthetically I'll say,


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 1   remember, that we have also been asked to do something about

 2   your methyl bromide document, so we have to review it too,

 3   although whether what that means right now is still unclear,

 4   so we don't even need to talk about it.

 5             DR. BYUS:  Interestingly methyl bromide, as I read

 6   this document, is an in vitro carcinogen and doesn't have

 7   any animal oncogenicity, just like methyl parathion.  So

 8   it's an interesting question.  So I mean we can deal with

 9   it, hopefully.

10             CHAIRMAN FROINES:  Well, as a person who believes

11   that methylation is a cancer mechanism, methylation is -- I

12   can take an animal and underfeed them in folic acid, choline

13   and methionine and that will produce cancer in a minute.

14   Not in a minute, but over a period of time.  So the

15   methylation patterns are really crucial.

16             And we just finished an 18-month study with 600

17   animals that were methyl deficient, and so the fact that

18   this is a strong methylating agent blew me away when the MTP

19   bioassay was negative.  I would have predicted just the

20   exact opposite.

21             But I think the theory is out still, because

22   mechanistically you can predict that it would be.

23             DR. BYUS:  Right.  I know.

24             DR. FANNING:  Coming back to scheduling, just sort

25   of to close up, it seems to me, I mean, I could imagine


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 1   trying to merge together the OP biology and risk assessment

 2   discussion with the exposure discussion, but I think we may

 3   end up with quite an exhausting meeting if we tried to do it

 4   at one.  I'm thinking we need two separate.

 5             So then the question becomes which would you like

 6   to see first?

 7             I mean we can continue to develop both.

 8             CHAIRMAN FROINES:  You say biology?

 9             DR. ATKINSON:  Yeah, that sounds fine.

10             DR. KENNEDY:  I don't understand anything else.

11   Better start there.

12             CHAIRMAN FROINES:  Well, that's one of those

13   things that bring you to closure.

14             So biology comes before exposure.

15             DR. FANNING:  All right.

16             CHAIRMAN FROINES:  And we got a buy-in from Roger,

17   so we know he can do it.

18             DR. FANNING:  All right.  So in that case, we'll

19   continue to develop this agenda in front of you, circulate

20   it to you and look for a target date of early fall, and then

21   try to follow very soon with a workshop agenda that touches

22   on some of the exposure issues.

23             So I would anticipate that we'll bring a proposal

24   for that exposure workshop to you at a later session.

25             CHAIRMAN FROINES:  Yeah.  I think the exposure one


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 1   is very important.

 2             DR. FANNING:  And very challenging.

 3             MR. GOSSELIN:  I would also throw in that we can

 4   also use this as a follow-up to the session last November on

 5   the changes we and ARB had taken, so I think we can pull a

 6   lot into this as we're continuing.

 7             CHAIRMAN FROINES:  Great.

 8             DR. FANNING:  Right.  That's an important point

 9   that the exposure follows very nicely on the discussion we

10   had in the fall on air monitoring strategies and whether the

11   air samples that we're getting are best representing human

12   exposure, and then we can -- this will follow nicely on

13   that.

14             CHAIRMAN FROINES:  Great.  I think we're done.

15             I was hoping we'd make it before 12:00, but

16   then -- but wait, we have to have a motion to adjourn.

17             DR. FUCALORO:  Motion to adjourn.

18             DR. KENNEDY:  Second.

19             DR. ATKINSON:  Second.

20             CHAIRMAN FROINES:  All in favor.

21             (Thereupon the meeting was adjourned

22             at 12:10 p.m.)

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 1                CERTIFICATE OF SHORTHAND REPORTER

 2

 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 3rd day of June 2000.

13

14

15

16
                                     Janet H. Nicol
17                                   Certified Shorthand Reporter
                                     License Number 9764
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