1 MEETING
2 OF THE
3 SCIENTIFIC REVIEW PANEL ON TOXIC AIR CONTAMINANTS
4 CALIFORNIA AIR RESOURCES BOARD
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6
7
8
9
10 SOUTH SAN FRANCISCO CONFERENCE CENTER
11 255 SOUTH AIRPORT BOULEVARD
12 SOUTH SAN FRANCISCO, CALIFORNIA
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14
15
16
17
THURSDAY, MAY 25, 2000
18
9:00 A.M.
19
20
21
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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
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20
21
22
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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
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