DR. STAN BARONE, JR.:  That's much clearer to us and more conscribed.  Again, in the assessment, we're making the distinction between ONUs and descriptively and the actual user but, in effect, the exposures are virtually on top of one another because neither -- we're not considering PPE at all in that particular condition of use.  And again, because of the activities, we are recognizing that spot cleaning and the dry cleaning are aggregated in some cases.  So that is part of the calculations so further support or --
                  UNIDENTIFIED MALE:  (Inaudible).
                  DR. STAN BARONE, JR.:  Pardon?
                  DR. KENNETH PORTIER:  Who is that?
                  UNIDENTIFIED MALE:  (Inaudible).
                  DR. KENNETH PORTIER:  Is that Dr. Anderson?
                  UNIDENTIFIED MALE:  (inaudible).
                  DR. HENRY ANDERSON:  No, that wasn't me.
                  DR. KENNETH PORTIER:  I think we're getting some bleed through here, but anyway, okay, good.  I think we need to add that kind of clarification, and Dr. Cobb will work Dr. Cory-Slechta to get that wording right and clear.
                  From what I've heard this morning, I think the one key thing you're going to have to work on is the dermal stuff, and I know Dr. Kissel always provides us good background on this stuff, so that'll be in the report.  Ms. Rudel.
                  MS. RUTHANN RUDEL:  Thanks.  I wanted to echo what the previous reviewer said about feeling like this is a good, carefully done document that has a lot of really difficult, complicated, and helpful sort of focused analyses to answer some very specific questions.
                  I think in Question 8, I might talk about that issue of the scope and how narrow you are and trying to address a recommendation for this one in particular.  I think that the Question 7.1 is -- I'm interested that you're specifically asking about objectivity of the underlying data.  I think I would just echo something that I said for PV29 which is that the one area where I really felt like I didn't understand the data gaps, or they weren't completely described is on how much is produced and where it goes and where it ends up.  So that sort of big picture about this, without knowing that, is really hard to evaluate the reasonableness of all the rest of the assumptions.  But for each of these specific scenarios that you've picked out, I feel comfortable with the way you've described things.
                  I have a couple of comments.  I think, about how easy or hard it is for people to understand what's happening when you talk about MOEs and excursions above or below them and above and below benchmarks and that's more, I think, for Question 8.
                  DR. KENNETH PORTIER:  Mr. Kaufman.
                  MR. ALAN KAUFMAN:  Hi.  I was going to cover this when we got to 8, but, since we're already on the topic, I'll go ahead and mention it now.  I would agree with Dr. Blando and some of the other speakers that I think it's an objective report.  I don't see anything to quibble with in a major way, I guess I would say.  I know there may be some adjustments that need to be made.
                  I think where there may be some improvements that could be made is in clarifying some of EPA's assumptions and thinking and I will say -- I think, somebody mentioned it yesterday -- the presentation, particularly the PowerPoint presentation, was very, very helpful in sort of understanding a lot of that.  And what I would recommend is maybe incorporating some of that, particularly some of the figures into the executive summary because I read through the risk evaluation, but it became must clearer as we went through the presentation.  Someone just picking up the risk evaluation is not going to have the benefit of that.  And so I think incorporating some of that into the assessment itself, I think, would be very helpful.
                  DR. KENNETH PORTIER:  Thank you.  Any additional comments before we go onto 7.4?  So let's move to 7.4.
                  DR. KATHERINE ANITOLE:  Question 7.4 Please comment on whether the information presented supports the findings outlined in the draft risk characterization section.  If not, please suggest alternative approaches or information that could be used to develop a risk finding in the context of the requirements of EPA's Final Rule, Procedures for Chemical Risk Evaluation under the Amended Toxic Substances Control Act (82 FR 33726).
                  DR. KENNETH PORTIER:  Dr. Cobb.
                  DR. GEORGE COBB:  Thank you.  So, again, I'm reading this response.  In essence, the environmental data that are presented from environmental aspects of the assessment are inadequate for a robust risk characterization and do not support the conclusion of no unreasonable risk to the environment.  The risk characterization for occupational exposures to 1-BP is supported by data in the assessment.  However, the risk characterization for consumers excludes several indoor air sources of 1-BP such as wallboards and other things.  Thus, the assessment underestimates risk to the consumer.
                  We also feel that the lack of the general population exposures excludes a vast extent of the U.S. population and should be considered, and we realize that's been deemed outside the scope.
                  Evidence of widespread exposure to the chemical that maybe 1-BP based on biomonitoring data is noted, and, although this biomonitoring data is not definitive proof of widespread 1-BP exposure, it does add to the uncertainty estimates for workers both directly and indirectly exposed and consumers.  This does raise concerns about broader exposures that may need to be assessed or recorded in the uncertainty analysis.
                  Two assumptions in the human health exposure require some further consideration: one is the assumption that seems to overstate things relative to dry cleaning operations where it's more likely that all employees are actually occupationally exposed which is somewhat different than what the Agency has done.  This could certainly affect the number of people exposed or the extent to which they're exposed.  And this is actually Dr. Cory-Slechta's remarks, the part I just read.
                  And then finally, the discussants identified some challenges in evaluating Table 5.1.  I think Dr. Davies, perhaps Dr. Willett, are going to speak to that.  And there are uncertainties related to the exposures via inhalation that Dr. Willett is also going to address in comments that I've captured here in this writeup.
                  DR. KENNETH PORTIER:  Before we move on, on your first statement about the environmental risk, are you going to kind of refer to what needs to be done to correct that.  I mean, we've had that discussion, but I think we need to, at least in this section, refer back to what the remedies might be for that.  And you mentioned something about including more data of lower quality, but do you have other recommendations that --
                  DR. GEORGE COBB:  So the first recommendation is with the paucity of data to go back to that reference that I provided just a few minutes ago about the assessment factor or it was actually the acute-to-chronic ratio and the species distribution that has been done to demonstrate what you have to do to do that acute-to-chronic ratio for a single species and then figuring out what to do about the inter-species adjustment factor is important and that will specifically will be called out.  There are also probably other ways to get to a worst-case scenario for where it leaks into the water, and there are varying things that you could do, but we'll make some recommendations there.
                  But those are the two big pieces.  Actually, you've got one data point for exposure that's marginal at best, and you've got two data points for effect and that simply has so much uncertainty that to just put it in a normal package just is definitely not protected.
                  DR. KENNETH PORTIER:  Okay.  Let's move on.  Dr. Cory-Slechta, do you want to add to these comments?
                  DR. DEBORAH CORY-SLECHTA:  No, I don't have anything to add.
                  DR. KENNETH PORTIER:  Dr. Davies.
                  DR. HOLLY DAVIES:  Yes, I was going to talk about Table 5.1 which is where it's all kind of rolled up, and I actually do have a table that I made in trying to understand this.  I keep going back and forth as to whether this is kind of -- I think of Question 7 as being more substantial information and Question 8 as being kind of presentation overall and go back and forth.
                  So I spent several hours trying to figure out Table 5.1.  At the end it all worked, and it seems like it was all substantiated and the unreasonable risk all seemed reasonable, so that was good at the end, but it all came together.  But it did take me a while to get there in trying to follow everything.  And I made this table, and Dr. Willett thought it was helpful, so I asked Don to show it.  I thought the rest of the committee might find it also helpful because I wanted to through how EPA had come to the either unreasonable risk determination or not unreasonable risk determination because that seems to be kind of the crux after all of this.  And, of course, the actual determination is appropriately an Agency determination, so the risk is what we're looking at with all the numbers.  So you don't need to look at my notes on the side.  You can make it bigger, Don.  They don't need to see all of it.  They don't need to see the M column.
                  So we looked at risk.  So I was kind of color-coding it, and I thought it would be kind of easy to pull out extra columns off to the side of when did they see cancer risk and when did they see non-cancer risk and who did they look at and obviously there might be mistakes in this because I did this quickly.  And it was interesting to see.  And then the green on the very left, it was the Agency determination of unreasonable risk or no unreasonable risk with green being no unreasonable risk and red being risk.
                  And so kind of going through it, you can just see the different categories and how they did it.  And what goes to Question 8 that we can talk about more in the next one is how it is hard to kind of follow and link through all the tables.  But I do think the Agency did a good job with going through, and it's confusing and complicated.  But going back, sometimes you have monitored end modeling with the APE, without APE; with controls, without controls which is why it ended up not being a simple table.  They know this.  I'm sure they've tried this where you end up looking at five tables that go into this or, of course, there's multiple endpoints for the non-cancer.  And, I think, they picked the lowest MOE for the highest one is what it looked like.  So, after following them, I was like, okay, they didn't say what they did, but I think that's what they did.  So it all ended up making sense which is good and what they looked at and what they didn't look at.
                  I sent you the wrong version because I found that was a mistake of mine that cancer that's red, that shouldn't be red because I thought that was red at first but it's not.  I was looking at the wrong table because it's confusing.  So they were right, and I was confused, which is great that they were right.
                  If you go down, you'll see some didn't look at ONUs and some of them were mixed where they made the determination.  If you keep going down, you'll see -- keep going, keep going -- and then they didn't look at PPEs, of course, as we saw, and Dr. Willett will talk more about PPEs.  They didn't look at those for some of them, and then you -- keep going  -- find consumers and bystanders for all the consumer products and then disposal at the end, which I assume is in that order.  For some reason, that makes sense to them, but it links back to Table 1.4, which is nice.
                  I just wanted to bring it up here, after going through it all, it did all link up and kind of hang together, and it seemed to be supported by the data in the previous chapters -- and if that table helps anybody else.
                  DR. KENNETH PORTIER:  Any questions of Dr. Davies on her table?  How is this table kind of different from the table in the last chapter?
                  DR. HOLLY DAVIES:  They have everything in words where it says go back to this table, go back to that table.  They just have many more words.
                  DR. KENNETH PORTIER:  Or is it just a quicker scan?
                  DR. HOLLY DAVIES:  I was thinking of it as more of the communication tool.  How could you do it?  The table, which is an end, that table has to be there.  It's the words, right, under this part of TSCA, we found unreasonable risk to the -- it has to be there.  And it links to all the -- I shortened a lot of these things which they can't do, but it has to be there.  But, in addition to that, I was like, was there an easier way of saying, well, we found this because what we saw was -- and it's just so many tortured words like, it was above the or below the MOE, but then with PPE it was -- it was just so tortured.  It's complicated and there's just too -- and I just was finding it's like, well, what's an easier way to present it, and like, the no with PPE or this one was no, which seemed easier.  And we looked at all of these and they all are agreeing in this way.  Okay, great, we found no unreasonable risk, or we found risk in all of these endpoints for all of these people, so we found risk, so kind of showing how that all kind of rolled up was more clear to me.
                  DR. KENNETH PORTIER:  So for those ad hocs on the committee that haven't sat through the previous three meetings, the permanent panel members continue to struggle to get the high-end view at the end of this whole process to where -- and what Dr. Davies is saying is that last chapter and it's got that very formal table, few of the panelists see that as a good communication device.  It's a requirement, I think, in EPA's regulatory environment, TSCA environment, but for the rest of us, as a communication tool, it doesn't cut it for us.  So this is the more general view, and this is kind of what I had in my head at the end of the reading the whole process, so I kind of could not see that.
                  DR. HOLLY DAVIES:  But I didn't have it in my head because I couldn't get into my head because it was so -- I needed to write it out and could you add other columns, and the words in the executive summary were really hard.  I started there, and it was like, these are okay and some of it is the MOEs versus the cancer.  Which ones you want to be below and which ones you want to be above?  And it's just there's so many double negatives.  There's just so many double negatives.
                  And it's the audience, so this where we go into Question 8.  It's the audience and some things are written for the audience with the double negatives and the legalese, and some things are written for a different audience where we can get rid all of that.
                  But, as I said, we've gone over this, and, I think, EPA tried to make clear and they really did make it clear who they assessed for what and they repeated it several times, and I can see that in this.  And sometimes they didn't have data or sometimes they said, we don't think we should assess them who they looked at cancer.  So sometimes that's not clear to us, and Dr. Barone has said that several times.  It's in the guidance that we're not always as intimately familiar with.  It's always good to refer to that which might not be something we always agree with, but it's definitely something EPA will follow.  And there's a reason that EPA will do it, and so it's good to see all of that what was assessed when.
                  DR. KENNETH PORTIER:  So, Dr. Davies, actually A, B, and C are really the conceptual model that EPA puts back at the beginning.  And the only thing kind of missing is this are those conditions that are considered out of scope that we continue to talk about even though they're out of scope, things like internal air for consumer products and external air for population exposures.  So that would be the only thing I might add to this is a couple of situations where we would just have a line that says, determined to be out of scope, so that a user who's looking or a reader who's looking for that condition of use needs to be identified right up front.  You're not going to find that in this document because it's scoped out.  That's the only thing I would --
                  DR. HOLLY DAVIES:  But I'd stop looking.
                  DR. KENNETH PORTIER:  Huh?
                  DR. HOLLY DAVIES:  Some people know to stop looking.
                  DR. KENNETH PORTIER:  Ms. Rudel.
                  MS. RUTHANN RUDEL:  Yeah, I think that's an especially important suggestion in order to -- because of the whole state preemption issue.  So if you are explicit about what is not in your scope, then it might make it possible for states to take action on things that you didn't cover if they end up being an issue.
                  DR. KENNETH PORTIER:  Dr. Doucette, do you want to do this or you're moving to another topic?
                  DR. WILLIAM DOUCETTE:  No, I'm still back on --
                  MS. TAMUE GIBSON:  Use the microphone.
                  DR. WILLIAM DOUCETTE:  Ooh, sorry.  Bill Doucette.  I'm still back on George's comments in terms of the unreasonable environmental risk.  So it comes around again to that, at least in my mind, we're continually fighting against this; what is the minimum data set that would allow us to be confident in making that decision?  I view that and, since I was on 4.1 and 4.2 and a lot of this is repetitive or just regurgitating some of that in a little bit different way, I felt there's always not going to be enough data.  What is that minimum data set that allows me to make that decision with some level of confidence that I can sleep at the night or whatever?  I'm not particularly worried about an environmental impact unless it's a spill situation of 1-BP based on what I've seen.  There is probably a scenario where I took the total year's or a single plan or a pubic -- a production facility that lost it all at once and it certainly would be an impact to the environment within that area, but I'm not sure it's a -- to make a statement that I can't say that it's unreasonable risk to the overall environment.  I'm struggling with what data I would need to be able to do that, and I'm not sure we can answer that.  Or how would you answer that?  I guess that's my question.
                  DR. KENNETH PORTIER:  Dr. Cobb.
                  DR. GEORGE COBB:  So, if you had release data from the industries, then that would give you the robust data set that you would need to assess what the releases are, where they are, what the strength loads are, what that looks like, so that would be one for aqueous.  I know that we're not talking about air necessarily here.  You tend to get the same information from air.
                  So that could solve the aquatic component largely, but then that's the exposure side.  Then you've got the effect side.  And to evaluate the universal species out there, I guess EPA has to FIFRA, a process that has a certain amount of fish and a certain number of invertebrates.  I'm not suggesting we necessarily need to go there, but if you had several species of fish that represented the universal species where you've identified the proper -- the releases might be highest -- maybe two or three in that particular area, then you could say, I'm pretty confident that we're not going to be adversely affecting environmental resources.
                  I shy away from even mentioning this, but you'd run into endangered species.  I think that's a whole other can of worms, which I don't think we want to get into here, but, if you layer all that on top, you do kind of have a mess.  But, to protect the environment, I think you need more than a couple of fish studies to do that.  And it might be three or four fish studies and a couple of aquatic insect studies, and that would probably do it for fish, but there are people on this panel that do that sort of thing much more than I do.
                  DR. WILLIAM DOUCETTE:  Just a follow-up and I think I had this discussion with Dan because I was dealing with the -- basically, we had one piece of solid information on the fish, and could I extrapolate from that one key piece of information all the way across multiple species and all sorts of things?  And that's a constant struggle.  And I'd like to hear somebody else, in terms of a toxicologist, in terms of that extrapolation because that's the key piece of data for the environment.
                  DR. KENNETH PORTIER:  Dr. Schlenk.
                  DR. DANIEL SCHLENK:  I think I mentioned this the other day.  The first version of this had absolutely nothing.  So, in my mind, this actually is an improvement, and I was going to say that when we get to 8 actually.  I actually appreciate the fact that there's an effort that's being placed to sort of address that, which wasn't in the 2016 document.  So it's kind of is your glass half empty or half full kind of thing.  The Agency's put in a really tough place because there's no data.  It's not like FIFRA.  FIFRA mandates you have multiple species that are done, and even that, there's uncertainty associated with that.  You still have uncertainty with that as well.
                  So, in my mind, given the data that the Agency has, I think they're doing the best they can with this, and you've got to go.  You can always say that we need more data which is great; we need more data.  My only sort of comment would be, it's always hard to prove a negative, and so, therefore, it just seems to me, at least in the uncertainty section, you have to be a little bit more descriptive about the uncertainties that are there.  Obviously, it boils down to lack of data.  But, again, to talk about other uncertainty factors that you can add to throw in, here's another possibility of this.
                  But, using the standard practice of the day, the Agency did what they're supposed to do.  I mean, the stuff that I am familiar with in my expertise, they did what they're supposed to do.  They took those uncertainty factors and they took those AFs and made a number and got a number off of that.  It was less than one, so they went with it.  Could you have thrown in an uncertainty factor because you only got an N of 2?  Sure.  But I don't know.  Does that really provide an extra amount of safety?  I don't know.  I mean, again, it's kind of what the standard practice is.  And then, do we think outside the box and go to something in addition to that?  Again, I don't know the answer to that question.  If you're following standard practice, they did what they're supposed to do.  If you back up and sort of looked the forest for the trees, then, yeah, maybe you can throw in an uncertainty factor.  You can throw in these other things.  You've got to be careful when you do that because are we going to do that for every compound down the line?  Again, as far as I'm concerned, I think they did what they could with what they had.  Is there more that's there?  Do we need more data?  Yeah, we need more data.  But, as far as what they had, they did what they were supposed to do.
                  DR. DANIEL SCHLENK:  Just to follow up to George's point, so if I had release data, I could estimate concentrations.  I could estimate all those sorts of things, but, without actual measured exposure data, I'm still just estimating.  So could we propose -- are you thinking about a worst-case scenario in a model like a level three fugacity model to estimate the concentrations in the environment and see if they correspond with all the appropriate adjustment factors toxicity to organisms?  I still don't see how the release data's going help me unless I have a model that looks at the overall fate within that particular release scenario in environment unless I have measured concentrations, so I have monitoring data.
                  DR. GEORGE COBB:  So I would agree that the monitoring data would be better.  But, I mean, the model would be perhaps the best way to proceed in the absence of monitoring data.  I think where this whole program needs to go is to monitoring data in advance of these assessments so that you can inform the assessment.  But, again, that's a different discussion.  Yeah, I think a fugacity model or some type of -- whether it's a WHAM model or something in a stream bed that's more specific for the stream could be used.
                  DR. KENNETH PORTIER:  Dr. Blystone.
                  DR. HENRY ANDERSON:  I could comment a bit on the fish, I think.  The challenge there -- I mean you can do a generic for their stored fish samples that EPA has on Lake Michigan, but that would largely show probably negative.  But the issue would be is there a discharge into a river or stream somewhere and some settlement in sediment and then you'd want to sample the fish that are actually resident of that area rather than fish in multiple areas.  That's kind of what's done with the Superfund program when you have a waste site where you may have some discharge into a stream.  You then pass the fish around that pond or wherever it is, but that's quite an undertaking.  The only thing would be, if there is a known discharge into a given stream, you could then query the state where that is and see whether their fisheries program has done any sampling in that area and may have stored specimens that could be analyzed.
                  So that would be kind of a gray literature kind of thing that there's a lot of.  For instance, there's a lot of monitoring done in Wisconsin that isn't really published, isn't necessarily sent to EPA either, so that's a concern.  That would be a group of people upfront you could query to see, do you have samples in this given region?  And do you have stored tissue that then could be analyzed?  So that could be relatively quick if there is stored specimens to do that.  That's basically what EPA has done with a lot of the emerging chemicals, is they go back to the tissue bank and see.
                  Now, with Lake Michigan, there just happens to be a single long-term species of lake trout that may not be very sensitive to this particular compound.  Again, as water runs down the stream, there's been quite a bit of monitoring of discharge into the river.  And many of these chemicals, when you have running water, you have higher rates of evaporation from the surface of the river.  So all of the compounds evaporate pretty quickly.  As I said, it's a bigger task other than to have a system to query if somebody has done that that hasn't gotten into your data collection or data identification process.
                  DR. KENNETH PORTIER:  Thank you, Dr. Anderson.  Dr. Blystone.
                  DR. SHERI BLYSTONE:  Yeah, I just wanted to make a couple of comments on the hazard side of things: number one, to remind everyone we're talking about industrial chemicals, not pesticides designed to have an effect.  I think the data that we have for this molecule, I think of it from the DHS hazard classification side, clearly puts it at moderately toxic -- clearly category three, possibly category two.  So the categories go less than one concentration limits that cause effects to populations, one to ten, ten to a hundred, or greater than that, right.  Ten to a hundred seems accurate.  It's about category three, moderately toxic.  I don't know that any additional data's going to give you anything different than that.  Typically, you test the aquatic species because they're more sensitive in most cases.  And then if we're talking about the conditions of use, we're going along that lane.  From my perspective, going out and trying to do several more species isn't necessarily going to get us any further along on the assessment.
                  DR. KENNETH PORTIER:  Any additional comments?  On the eco side, the only kind of strong recommendation I heard was the additional that more recent reference Dr. Cobb presented to a different adjustment factor that might be used.  I didn't see a consensus for going out and getting more environmental data at this point given the bulk of chemicals that we're going to be looking at.  That's the other thing I guess we have to think of as cost benefit on some of this stuff.  Dr. Barone, any closing comments?
                  DR. STAN BARONE, JR.:  Just a couple of clarifications, the reference that was referred to, we definitely would like to get that reference about the assessment factors and the discussion around the assessment factors.
                  We've mentioned this before; for TSCA, we do not have a minimum data set.  This us unlike what our sister program for food-use pesticides with CFR part 158 where a minimum data set and a rather extensive database is actually required for food-use pesticides.
                  So, again, this is part and parcel to grandfathering in the TSCA inventory.  We have what we have.  We do have authorities to collect data.  But, again, this is part of the first ten, and the first ten we were told to do risk evaluations essentially from the day that the bill was signed, which did not allow for robust data collection.
                  So that's the situation we're in.  We'll do the very level best we can to collect and acquire data, and, as you've seen, read-across and make inferences and apply the appropriate assessment factors.
                  Mention of spills is sort of an important context but not a condition of use under TSCA and not something we're assessing specifically, not that the information couldn't inform emergency management and risk communication, but that's not a condition of use.  So, just to be clear, that's out of scope.
                  Again, I'm hearing you guys struggle.  We have the same struggles internally, so one of the things that we're looking to you is prioritization of the recommendations.  What are the must-dos versus the nice to-dos?  So again, we have essentially less than six months to finalize this risk evaluation to meet our statutory deadline in the buffer in this estuary deadline.  So the more you can help us with identification of data or surrogate approaches, yes, we can go on to do aggregate and add things up.  We've got a lot of criticism for trying to take that approach previously.  If you think that's a strong recommendation, well, please let us know.
                  Just putting this out for context because some of these same themes are going to be coming at us again and again.  We're dealing with a data-poor environment, in general, and we do need to make decisions in the absence of information.  That's what risk assessment is.  And we're doing hopefully our best in being clearer, and that's what this section's about -- being clear about what those uncertainties are -- and we're making those assumptions.  If you think we can bolster or make more clear what those assumptions are, please let us know in your recommendations.
                  DR. KENNETH PORTIER:  Dr. Barone, I have a question.  Something that Dr. Anderson said and your comments on spills, I know moving forward, not with these legacy chemicals but, EPA usually goes out for a general request for information from the public, and I was sitting there thinking, well, you usually ask for gray literature, but what we've been talking about is gray data.  In fish collections where they may have done the analysis, it's sitting in somebody's -- I can see all the uncertainties that come up with that.  I understand, but sometimes some data's better than no data.  Bad data may be better than no data.  Spill information, while not required, might be available that would help inform.  So I'm just wondering if that kind of request for gray data goes out in those or can go out in those future requests for information.
                  DR. STAN BARONE, JR.:  The request for data with both a scoping exercise and the problem formulation was relatively broad.  I think a lot of stakeholders and a lot of the public were not as clued into that opportunity to provide information that they may have, but many did.  What has happened with the naming of the 20 high-priority chemicals for the next round, we've already started receiving data in the public docket.  We will probably also receive CBI data and there's ongoing discussions about that for some of those 20 chemicals.
                  In addition, the next public comments, which started a week ago Friday, we're getting additional comments and submissions based on the dossiers and the conditions of use that are presented in those dossiers.  So we hope to make this a more interactive process where we get information in a voluntary way and also have more lead time to obtain data that we don't necessarily get voluntarily.  The input from this committee and what we have experienced with the first ten risk evaluations will help us sort of focus in on critical data needs for the future.  It's informing us.  We're also looking at how to prioritize those efforts, so that's an important issue as we look at our pipeline and downstream because it does take time to generate information.
                  But it also is important to recognize that some of this data is existing data.  And how do we get that existing data without impacting CBI and proprietary issues?  These are all legal consequences.  It's not just the technical issues that I deal with day to day, but there are issues that we have to, of course, consult with our Office of General Counsel.
                  So it's complicated.  I get it.  I appreciate the comments and discussion about the conclusions, the risk estimates that go into the risk determination.  It was a very important exercise again that Dr. Davies did.  It's very similar to the worksheet that we have.  We have additional things that you didn't identify in that worksheet.  I appreciate you made that effort, and I think it helps display the transparency.
                  From the last comments from the last meeting, I also want to say, we've been working on trying to make that presentation.  We didn't get into this risk evaluation, but we do plan to present that summary table with the risk inclusions, the risk drivers, for every condition of use so that you see how many different decision points there are within the condition.  And we're putting numbers in there, not yes/no, because we think the numbers actually tell the story because there's uncertainties associated with each of the numbers.  And we're talking about high-end versus central tendency estimates, and you've already discussed with us all the different factors that are included.
                  So, hopefully, you'll see that in the very near future in the next round.  We're sorry we couldn't get that into this assessment for you, but again, with timing, there's a lot of issues with the timing.  We're trying to get these through our internal review process and get them out to the public for public comment.  And, hopefully, your comments are still affecting things that we're trying to make sure that we track back to.
                  DR. KENNETH PORTIER:  I think Dr. Willett and I just realized that I didn't make it down to the end of my list, so we needed your comments.  Sorry.
                  DR. CATHERINE WILLETT:  Yeah, that's just what I was going to mention.  So we didn't quite finish 7.4.  But my comments are not substantive, but I did want to chime in a little bit and support the idea that this risk determination description is of the considerations and the conclusions are, in my mind, a vast improvement over the previous two that I read through and are well supported but very, very difficult to walk through as Holly mentioned.  It just took hours and hours and hours to really check and go through.  I don't how everybody's going to check and go through everything, but that was sort of our job.
                  And it's, as you mentioned, extremely complex, so I'm really excited to hear about this table that you're putting together with the numbers and everything.
                  And my comment was really, again, just to try to get at this issue of including assumption of PPE use in the risk determination and trying to tease that out and maybe figuring out how to separate those two issues: the risk management and the risk determination.  It's a reiteration of what we had in the previous discussions or the discussions of previous chemicals.  But I have a long paragraph that talks about that, which I will not read because it's very detailed as there are so many different conditions.  I just wanted to get that particular thing on the record and also, basically, just support the direction that you guys are going.  I think each one is improving and that's it.
                  DR. KENNETH PORTIER:  Thank you.  Let's go ahead and take a 15-minute break.  I have 11:42.  I mean, 10:42.  We'll come back at 11:00, and I'll start of Question 8.

                                    (BREAK)

                  DR. KENNETH PORTIER:  Dr. Cobb tells me he has answered some of the questions that we had earlier before and if those were going to go into the notes.  So we're good with Question 7 so let's move on to the general content and organizations Questions 8.  And I've asked Dr. Anitole to just read both parts in and we'll move forward.

                               CHARGE QUESTION 8

                  DR. KATHERINE ANITOLE:  Question 8.1:  Please comment on the overall content, organization and presentation of the draft risk evaluation of 1-BP.  Question 8.2:  Please provide suggestions for improving the clarity of the information presented in the documents.
                  DR. KENNETH PORTIER:  Thank you.  We asked EPA to move this question from Question 1 to Question 8 so that we could, in a sense, look at this as what additional comments on content, organization and presentation, and what additional suggestions that we haven't discussed up to this point in the previous seven questions, because there's a lot of suggestions there.  So, we've asked Dr. Twiss to lead this discussion.
                  DR. MICHAEL TWISS:  Thank you.  Want I'm going to do is directly respond to Question 1 very briefly.  And then Question 2 has more of the criticisms, both positive and negative.  First of all, the oral presentation made by Dr. Anitole was really very clearly made and well-organized.  Many people on the panel here said it would be an excellent template for the Executive Summary.
                  The content of the draft risk evaluation falls a template for chemical risk evaluation in each section that's complete as possible, notwithstanding the scientific arguments for more information, which are stated in the document and which we discussed earlier in Question 7.  In several instances, reviewers have shared examples of improvement in data presentation compared to previous risk evaluations, and so they consider it to be a better risk evaluation than the previous one done in 2016.
                  There was widespread concern among both panel members and public respondents with the shortened comment period.  Consideration of public comments during peer review preparation and its critical function and continues, truly, in challenging under the timeframes used in this risk evaluation.
                  Now for Question 2, and I did a bit of crowd sourcing here by requesting folks on the panel to provide information, and I'll state their names if they're not associate discussants.  And so, there is a request for improving the clarity of information presented in the documents, and the presentation techniques.  For example, the use of hyperlinks is useful, but a direct link to a document rather than to a database where it can be sought if proper references known is not really that helpful.  And so, hyperlinks are nice.  If there's a reference, you hit the reference hyperlink and you've got it right there, rather than going to a database where you don't have to go mine for it.
                  Catherine Willett stated with reference to question 5.2.  Although description and the weight-of-evidence, considerations for noncancer endpoints seem logical, the actual rate of evidence process is unclear; for example, what the weighting system is and how each datapoint was assessed and the result of that assessment.  And the table in Appendix I-2 was not that informative.  And perhaps, the second table showing the weight-of-evidence analysis for each endpoint with endpoints chosen would be helpful.
                  Steven Bennet mentioned something, but he'll be speaking afterwards.  Holly Davies stated a number of issues, some of which were mentioned earlier, so I'll just talk about them in more of an overview rather than getting into a lot of the details.  And it states that the document goes through smaller pieces for environment, occupational, consumer uses in this repeating loop, which makes it hard to follow in each major section.  And the presentation by the EPA on Tuesday was easy to follow when one topic was presented from start to finish, and that's referenced to Dr. Anitole's extended summary.  And so, the document would be more readable if it followed the same format as that presentation.
                  The Executive Summary was too long, confusing in spots, had too many acronyms.  It didn't seem to have a consistent audience in mind, and I'll be speaking about that at the end of my comments here.  All right.  There's a number of comments that are made, and I won't repeat them here, but they'll be included in the written comments.  They're both requests for added clarity and comments on various tables, which were well executed.
                  There are some requests for better clarity in expressions.  And so, in some cases and throughout certain tables, scientific notation is not used consistently, and it really doesn't need to be used at all.  And so, when you do those kinds of things, you have to be careful that you're not making errors, and so the reading it is difficult.
                  There was also a comment on use of colored titled information in tables.  And besides issues of inclusivity since a significant proportion of people are color blind -- so to our most computer printers.  And so if you're printing this off and handing it off to someone to read, they might not be able to get the same information that was intended.  And so, having color to bring out a point is really nice, but there can be an error in doing that.  So a different approach as an alternative should be sought.  There are some cross-referencing errors, and again, this will be in the written comments.  And some consolidation is required, particularly the WOE discussion is mostly rehash of hazard discussion that could be combined into one section.
                  Risk communication issues, again, we have reference to Question 7.  Table 5.1 was hard to read, and Dr. Davies did present a modification of the table, which I think would be a nice thing to incorporate.  There are a number of typographical errors.  I'm listing some, but it's not complete.  Definitely, a careful draft reading is required.  And finally, for my comments here, I'm going to state that this document is written purposely for us, a peer review audience.  So I went into the public comments and mined in and looked at some -- just your basic folks who are writing in on comments of those people who weren't representing an NGO or company, and there are clearly some individuals that are clearly uninformed about the properties of the chemical.  Some people may consider all chemicals to be bad and some of these public commenters may be in that group.
                  Nevertheless, the EPA does need to provide an educational service by composing some summaries in lay language.  And I suggest that summaries in lay language, for example, at grade six level -- and even at a primary language level, like a grade 2, should be included.
                  There's a strong correlation between literacy and health, and the situations that are different from medical health concerns and the need to communicate with its constituents.  And so this production of a lay summary would foster better communication with the public and help gain its trust that this institution has relied on for evaluating safeties of chemicals in our society.  And that's all I have to say.
                  DR. KENNETH PORTIER:  Thank you.  I wanted to make sure you had this missed link on page 153 and 181 that's referenced to Appendix H, which should be Appendix I.  It occurred twice.  If it had occurred once, I'd have disregarded it, but it occurred twice.
                  DR. MICHAEL TWISS:  Yes.  That cross-referencing error is noted here.
                  DR. KENNETH PORTIER:  Good.  Dr. Bennet?
                  DR. STEVEN BENNET:  And I think he captured it quite well.  I made the comment about the discussions of the uncertainty, and we've had a lot of conversations throughout the past three days about making sure that the uncertainties are well described.  I particularly like the consumer exposure piece.  That was the area I covered, but I did like that discussion within there.  So I think there may be some lessons that can be repeated in there to make sure those things are addressed.
                  I think one area is to make sure that the information is comprehensible when you take discussions within sections and then you summarize it in a table.  One example in Section <IP_ADDRESS>, there in the body of their text, one of the processors manufacturers noted Envirotech.  But when you go to the table that summarize that particular section, they were not noted.  That may be because they're captured with in the CBI portion of it, but I'm not sure.  I'm not really sure that information is in fact correct and accurate, so it represents both sides of it.  But certainly, learning by doing is definitely occurring as the evaluations go through, so I appreciate their efforts on that part.
                  DR. KENNETH PORTIER:  Dr. Blystone, I think you're next.
                  DR. SHERI BLYSTONE:  I agree with everything he said.  There's a few typos and stuff I'll send along, but I've nothing else to add.
                  DR. KENNETH PORTIER:  Then we swing back to Mr. Kaufman.
                  MR. ALAN KAUFMAN:  Okay.  Yes, I think a lot of this has already been cover.  I think as a general comment, yes, there are areas of uncertainty.  I think there are always going to be areas of uncertainty.  I think Dr. Blystone said it well, particularly about the environmental piece, but I think it applies generally.  I don't know that we're going to resolve that, and I don't know that additional work would necessarily change the conclusion, so I think it's a solid piece of work.
                  So I think where I do have issues is in presentation.  And I would echo some of Dr. Twiss' comments that when you think about a lay audience, they're probably not going to read any further than the Executive Summary.  And so I think making sure that that's very clear, and the language is at a level appropriate for that audience would be very helpful.  And lots of color and graphs always is helpful.  But generally, it's a very solid piece of work and I wanted to commend the EPA staff for the work that's been done here.  When you sit through one of these meetings, you get three days' worth of people criticizing what you've done.  But I think the issue is more one of presentation and explaining decisions well so that there's an understanding of how you got to where you ended up, and I think that will also help allay further criticisms of the evaluation.  Thank you.
                  DR. KENNETH PORTIER:  Ms. Rudel?
                  MS. RUTHANN RUDEL:  Thanks.  I have fundamentally three suggestions, and I'm going to just talk a little bit about why I think they're important.  But they relate to general population exposures, availability of data about when chemical is used, emissions, discharges and also the use of MOE on presentation, and a couple of presentation data questions that could make the report more accessible to people who aren't specialists.
                  But I want to reiterate that I thought the report was clear, and that EPA has done a nice job of estimating risks associated with these named conditions of use using information they have been able to gather on worker and consumer exposure.  And the toxicity database is fairly complete, and it does show the chemical is neurotoxic, reprotoxic immunotoxic carcinogenic with reasonable evidence for a mutagenic mode of action based on the electrophilic activity.
                  So, it's important that EPA moves forward sort of quickly to reduce risks that have been identified in the risk evaluation.  Worker and fence line community and neighborhood exposures to this chemical had been recognized as a problem for over a decade.  Earlier, people were talking about OSHA and not doing anything, but OSHA's enaction on the problem isn't a reflection of their lack of concern, I think, but rather of social and political realities that have made these risks hard for them to address.
                  And similarly, this chemical was proposed a decade ago to list as a hazardous air-pollutant with still no action.  And it seems optimistic to think that that's going to all of a sudden change.  And it's odd to have this report assume that that's going to happen and be effective.  And so this TSCA is what's in front of us now, and it does provide EPA with an opportunity and responsibility to reduce worker and general population risks, and I hope that that will happen.
                  So I've heard you say obviously you're not going general population risks, but I don't really think that's consistent with the law maybe because of the poor quality of data about chemical use and emissions.  So the document doesn't really support the decision not to consider general population exposures, which could occur through groundwater contamination and subsequent drinking water or vapor intrusion or indoor concentrations from consumer products, as well as air and neighborhood emissions.  But if you do maintain the narrow focus that you have currently, to be very explicit about what's in scope and what's out of scope to facilitate space, to take action without running into preemption barriers.
                  So for this and all the priority chemicals where you don't have good information about how the chemical, where it's produced and used and disposed and so on, I recommend doing some kind of data request that's going to give you that information because that's a really big source of uncertainty that underlies the whole assessment.
                  A presentation thing to help make it more interpretable and to help people think about general population exposures, I personally liked Table 5-1.  I found it helpful in understanding what you had done and so on.  And what I was looking for that I thought would be helpful would be, what would be the target indoor air concentration associated with a cancer risk of one in a million, associated with an MOE of a hundred or a thousand, whatever you set it for for a few of the key noncancer effects.
                  So to come up with what would be a risk-based screening level air concentration for a 24/7 residential child/family exposure scenario, and then also to come up with an eight-hour time weighted average worker exposure that's associated with those target risk, 10 to minus 4, in the MOEs for workers just to be able to have some air concentrations as benchmarks.  I think it will help people understand what's the magnitude of range that we're talking about within this acceptable risk range for a short term or worker.  And also, if new data come if somebody does air testing in a home, if somebody does air testing at a fence line or in a workplace or personal air, to have those concentrations for comparison is always really helpful.  So I know they're in there somewhere, but that they were being more brought to the floor.  And I know that that doesn't consider dermal, so it's just for inhalation, but I still think it would be useful.
                  And then my last comment was about the margin of exposure presentation.  And in my experience -- well, that that margin of exposure are the two -- essentially the RFC -- not to the point of departure.  You've got the point of departure, then you've got these uncertainty factors of a hundred.  But the margin of exposure, as I'm seeing it, you're doing it to the point of departure.  Unless I missed it, that's what it looked like to me.
                  DR. STAN BARONE, JR.:  So the document does -- in several places -- actually it's both in the hazard section, but also in the risk determination.  It describes what the margin of exposure is.  It's the point of departure for the hazard divided by the exposure estimate.  That's separate.  That's the MOE for the risk estimate, which is separate from the benchmarked MOE, which is made up of the concomitant uncertainty factors.  That's not to be confused with an RFC or an RFD because the RFC is actually a different equation.  You're taking a point of departure and you're dividing the uncertainty factors into that point of departure.  Exposure is not considered in the RFC or RFD, so it's not a risk estimate, whereas the MOE is a risk estimate.  So there's a big distinction between the two.  There is a commonality, and the commonality is the PODs are an enumerator in both estimates.  But one's a hazard estimate; the other one's a risk estimate.
                  MS. RUTHANN RUDEL:  Yeah.  Well I think that it could be misleading for some people.  When you go into the point of departure, some of those effects are serious.  And I'm not sure that it's easy for risk managers to understand that you're talking about all of your uncertainty.  And if there's co-exposures and anything else, it's got to be within that margin of exposure.  The two uncertainty factors are -- I don't know.  When you say there's unreasonable risk, it's because the exposure is the point of departure divided by a hundred divided by the exposure.  No; it's just the point of departure compared to the exposure.
                  So it's kind of tight.  It doesn't have a lot of room for error, I guess.  And the uncertainties are big and that's not a very forgiving calculation, in my opinion.  Your target was to have the exposure be a hundred-fold lower than the point of departure, basically.
                  DR. STAN BARONE, JR.:  Not always.
                  MS. RUTHANN RUDEL:  No?
                  DR. STAN BARONE, JR.:  Not always.  The benchmark is not always a hundred.  Sometimes the benchmark is 10, sometimes the benchmark is 30.  We have benchmarks up to a thousand.
                  MS. RUTHANN RUDEL:  Wasn't in a hundred in most of them in this?
                  DR. STAN BARONE, JR.:  In many, the benchmark was a hundred, but there's also several where it's 30.  So the benchmark relates to the endpoint and relates to the study type.  It's not always the same.  Again, the uncertainty for that margin of exposure -- and that's one of the reasons -- and this is different.  We present multiple PODs for the effect domain and we present what we think is the most sensitive and robust for that domain.  And then when we look across the risk characterization -- you see this in the risk characterization section -- we actually show there's a whole range of effects.
                  MS. RUTHANN RUDEL:  Yeah, I saw that.
                  DR. STAN BARONE, JR.:  And what we're trying to do in the risk characterization is actually inform you, inform the risk managers between the most sensitive and the next effect domain what's the magnitude of difference.  Are we within the order of magnitude?  Do we have five different adverse outcomes with the same order of magnitude?  In fact, that's the case we have with 1-BP, so I think we've made that clear.  If you have some suggestions to make that more clear, please help us.
                  MS. RUTHANN RUDEL:  All right.
                  DR. KENNETH PORTIER:  Thank you. Dr. Schlenk?
                  DR. DANIEL SCHLENK:  Yes.  I was fortunate enough to be on the 2016 document, and I got to say this one is way better.  So it's encouraging to see, when you make comments, that they're actually incorporated into the next iteration, so I thought that was fabulous.  I thought the document was fabulous.  I'm with Jim on that.  I just thought you guys did a fabulous job in terms of the presentation overall, so kudos for that.
                  The only recommendation I would make -- and we talked about this before -- is, again, the uncertainty aspects.  I think that needs to be expanded, particularly when you're saying there's not an effect.  I think that's critical to expand on that.  And honestly, the only topic that I brought up in 2016 that was not put into this document was using adverse outcome pathway paradigm, particularly in the weight-of-evidence approach.
                  I know you guys did mode of action in there, and the last figure is nice, but I just think the AOP approach provides a way to look at uncertainty and the data gaps that are present, and it allows you to describe those a lot better in the uncertainty analysis.  Some people actually proposed using it in the problem formulation step as well to actually identify the gaps that you have there as well.  But since we're not part of that, obviously you can't make comments on that.  But at least in the characterization section, having that in there is a real plus.
                  And we're very fortunate today to actually have the guru of AOP sitting right next to me here.  I know he has some really nice examples of slides that can be utilized here.  And particularly, for this compound, the narcosis AOP which is pretty solid in terms of its science and in terms of what predictions can be made from that, I would totally put that in your eco evaluations, particularly for other compounds that are going to go through that which, according to the list I've seen, they're going to be very comparable in terms of their mode of action.  So what Ed is going to present here can be very useful for future documents that are coming down the pipe.
                  DR. KENNETH PORTIER:  Dr. Perkins, do you have something to present?
                  DR. EDWARD PERKINS:  Yes.
                  DR. KENNETH PORTIER:  Great.
                  DR. EDWARD PERKINS:  And the computer's turn down.  Well there goes my problem.
                  DR. KENNETH PORTIER:  While they're bringing it up, let me add in my comments while he's bringing that up.  And I just emailed these to Dr. Twiss, so he's got them.  My comments are around organization, and they are similar comments to what I've made previously.  In the introduction, Section 1.1 really should answer the question of why this chemical is on the TSCA priority list.  It's really not answered, but that really should be right there at the beginning before we talk about chemical properties.
                  The second thing is a comment we made yesterday about potential exposants susceptible to populations.  They're raised out in 2.4, but then they're kind of hiding in Section 3, and hidden even deeper in Section 4.  And I recommend you have a 2.4, a 3.3, a 4.4 and a 5.2 that actually highlight and discuss specifically past -- you're already doing it; it's just moving it up in the outline in some of those subsequent chapters.
                  And finally, in the scoping Section 1.4, I looked at that and I go, why do they present the conceptual model and then talk about the conditions of use included?  I think you really should present the conceptual model, Section 1.4.1.  Then Section 1.4.2 says, "conditions of use included in this risk evaluation, risk justification," which you already have.  And then Section 1.4.3 should be "conditions of use excluded in this risk evaluation," and justification for that.  And that kind of answers a lot of questions that the panel have had about why did you do this and not do that.
                  And sometimes you're not telling us what's in the model and what's excluded.  I think it's in there somewhere.  It's in that Section 1.4.1.  You just need to kind of pull it out and highlight it separately.  So those are just some practical organizational suggestions that will improve the layout.  And with that, I'll turn it over to Dr. Perkins for his comments.
                  DR. EDWARD PERKINS:  So, you mentioned wanting to see how you might be able to use AOPs or put them in, so I pulled out a few from some papers and from the AOP-Wiki and some that we're developing.  So these AOPs kind of demonstrate how you might start organizing general effects that you see proceeding from.  And the first case here, MIE is the molecular initiating event.  And we didn't know what it was at this point, so we had a question mark, so you don't have to know everything about it.  You can just put question marks there and it'll be data gap.  But it lets you arrange things along the order of the mechanism of action up to your adverse outcome point of interest.
                  So in that case, it's very similar to the cancer endpoints that you're talking about here.  And then narcosis is pretty explicitly one of the mechanisms of action.  That's only in eco.  And even in human exposures, you see some kind of narcotic-like effects as seen with the confusion, loss of equilibrium and other things.  So there's a great log KOW of compounds very predictive of that outcome, so you can use essentially a quantitative AOP based on that.  It also lets you take the data and align it with these essentially different categories with in it, and then you can do weighted evidence as Dan mentioned.  What kind of evidence do you have for which biological event will let you proceed down the line.
                  So I'm also thinking it's a good mechanism to look at how you might organize information and translate it into context of how it's acting.  So, next slide.  So in the AOP-Wiki, which is a database that has a number of AOPs in it, there's a few there for liver tumors and hepatocellular carcinoma and liver cancer, some of which are mutagenic mode of action, some of which are sustained AHR activation, one of which is set to E-1 activation where it cycles, a rat gets stuck in a cycle and keeps producing oxidative stress.  So all of these might be part of the multiple modes of action that you've been talking about here.
                  It allows you to sort of build a hypothesis and then see where your data fits in with that, whether it's quantitative data or not.  And then the dose response data can inform rates of going from one key event to the next.  And so you can start using that to build the key event, build the quantitative models.  I liked it mostly because it helps me understand things in a more intuitive way.  It takes all the descriptive tables and information you have and put it more in a flow-chart manner, help to understand things better.  So I'm kind of presenting it in an interesting way to organize different things.  Next slide.
                  And of course you can get more complicated.  You can put as much detail as you want in.  Next slide.  Or you can have the whole mess right there and have networks.  But part of the point is, is you can keep it as simple as you want to keep the communication down, or you can expand it out to include all of the different measurements you have, whether it's the chemistry, whether it's electrophiles, protein misfolding, cellular evasion, different things like that.  You can start putting them together in more of a logical context that might act as a way to organize your thoughts on how things are functioning, so I thought I'd put that out there.
                  DR. KENNETH PORTIER:  Are you using a concept mapping tool to do this?
                  DR. EDWARD PERKINS:  Cytoscape; so it's a freeware thing.  And we have a tool called AOP Explorer where these networks are available free, and you can draw your own.
                  DR. KENNETH PORTIER:  I used to do these and then people would just laugh.  And I looked at this and I'm thinking, okay, and then the EPA communication people can write this up at sixth grade level.  That's the problem with the communication recommendation.
                  DR. EDWARD PERKINS:  Right.  And so, then you'd back up over to the simpler ones.
                  DR. KENNETH PORTIER:  Right.  You got to the two or three previous.
                  DR. EDWARD PERKINS:  Right.  And then the nice thing about these for risk assessment, these are all causal linkages that if one activates, the next one happens.  So you don't put in things that you know don't happen, so it helps you winnow out all things.
                  DR. KENNETH PORTIER:  So where do you see something like this going in this document?  I mean, I'm just trying --
                  DR. EDWARD PERKINS:  Well, no, it can go multiple places.  So there's was a lot of uncertainty around the effects and how it was causing different toxicities in the human risk assessment component.  So it could act there as different hypotheses of how it might be acting, and then you can talk about which data aligns where.  And you can have dashes in between airways you think it's going; and then you can build a weight-of-evidence based on that.  So what's the likelihood of that hepatotoxicity goes to liver cancer based on this chemical and things like that.
                  So each of the AOPs, when you look at a specific chemical, it's a hypothesis for how that chemical might cause cancer or whatever endpoint you want.  And then each of the boxes essentially is where you have the evidence for that happening based on literature and experience.
                  DR. KENNETH PORTIER:  So this image here, which is liver cancer, you'd have it in the human health hazard liver cancer section.
                  DR. EDWARD PERKINS:  Yes, you could do that.
                  DR. KENNETH PORTIER:  Dr. Schlenk?
                  DR. DANIEL SCHLENK:  Yes.  I would put it actually in the characterization uncertainty section.  That's normally where you see it.
                  DR. EDWARD PERKINS:  That's pretty good too.
                  DR. DANIEL SCHLENK:  In the weight-of-evidence, I'd address the uncertainty that's there.  That's kind of where most people have proposed to put it, is in that section.
                  DR. KENNETH PORTIER:  Okay.  But when we make this recommendation, that they look at this and use this as part of the presentation or the modification of risk evaluations.  It's nice to be able to say, well we see this as a tool in discussing uncertainty and laying out the weight-of-evidence.  I understand that.
                  DR. DANIEL SCHLENK:  Also, the other thing, it helps when we're talking about mutagenic and non-mutagenic modes of action on that other question, because it actually lays out the gaps that are there and the uncertainties that are there.  But in a figurative way it allows you to make more certain statements, at least with regard to those mechanisms.  I mean, I see it as a way to get at that as well.
                  DR. EDWARD PERKINS:  Yeah.  Also, if you have a quantitative AOP such as the narcosis ones, you can take that actually and see does your chemical -- is it predicted to cause narcosis based on the statistics that we know or mechanisms that we know that we have.  So in the characterization stage, it could be used for that too.
                  DR. DANIEL SCHLENK:  I mentioned this the other day, and I'll put it in the comments for Question 4.  But this is how, when you don't have data, you can actually use this to predict at least acute tox data from that mode of action for solvent-like compounds that have long KOWs between, like two to five, two to six.  It's pretty solid in that range in terms of predicting, at least LC50 numbers proficiently.
                  DR. KENNETH PORTIER:  Dr. Cobb, you want to follow-up on this?  I see Dr. Davies is --
                  DR. HOLLY DAVIES:  If he has a follow-up, he can go.
                  DR. KENNETH PORTIER:  Yeah, if he wants follow-up, yeah.
                  DR. GEORGE COBB:  So, a couple of things.  First of all, I'm assuming that the low long KOWs are higher in narcosis, is that correct, low log KOW gives you a high narcosis --
                  DR. DANIEL SCHLENK:  No.  Usually they're directly proportionated.
                  DR. GEORGE COBB:  Directly proportioned, okay.
                  DR. EDWARD PERKINS:  Yeah, if you want to put it to that actual in the slide.
                  DR. GEORGE COBB:  It's okay.
                  DR. EDWARD PERKINS:  Yeah, because they're accumulating the membranes.
                  DR. GEORGE COBB:  So it's an accumulation in the membrane.
                  DR. EDWARD PERKINS:  Higher would mean more in the membranes.
                  DR. GEORGE COBB:  And then would you envision a presentation of this having highlights around the boxes that you have high confidence in, or just presenting it and writing text around it?  How would you envision that?
                  DR. EDWARD PERKINS:  You can do a lot of things.  You can do different colors and different sizes.
                  DR. DANIEL SCHLENK:  Different lines.
                  DR. EDWARD PERKINS:  Different lines, thicker lines, dotted lines.
                  DR. EDWARD PERKINS:  Dotted lines.
                  DR. DANIEL SCHLENK:  Dotted lines.
                  DR. EDWARD PERKINS:  Four-dimensional lines.
                  DR. DANIEL SCHLENK:  Polk-a-dot lines.
                  DR. KENNETH PORTIER:  I'm still envisioning this.  So how many of these pathways have you already identified?  I'm thinking in terms of, well, you know, a new chemical comes up, I'm going to take this box and put this in and this one in, and I'm going to talk about them.  It's a limited number, or is this created each time a chemical comes up?
                  DR. EDWARD PERKINS:  Well that's why they say they're supposed to be chemical-agnostic, so it's really about -- okay, what happens if I get something that accumulates in the membranes?  What cascading effects does it have?  What does it lead to?  So, any chemical that would accumulate and activate something.  So for the SIP 2-E1, if something interacts with that and it gets stuck in cycling and causes excess of oxidative stress, any chemical that would do that would cause the same pathway to be activated.
                  So right now, there's probably 100 or 200 with multiple species at the AOP-Wiki, some more in publications, but they're meant to be reused and recycled.  As you can see if you go to the next one, basically those are three different ones, but they have some of the same things.  They have cytotoxicity or they have regenerative proliferation, self-proliferation, cellular proliferation and hyperplasia.  So those are being really reused within different things.  So they got different ways to get there, but the actual mechanisms -- the descriptive things are still being reused.  But for your particular chemical in a regulatory context, you have to overlay your data that shows that your chemical actually does it.
                  DR. KENNETH PORTIER:  Any questions on Dr. Perkins?  Dr. Willett?
                  DR. CATHERINE WILLETT:  Well maybe I have some questions, but I wanted to just stress and point out that this is a terrific example.  And I'm so glad that you brought this up and that Ed was here because Ed has this really great visualization tool for the AOPs.  But even so, this is a really interesting application that would be great to include because it would demonstrate the utility of this information base in assessing the weight-of-evidence for a decision, even when you don't have a lot of information about the chemical.  So what people don't really understand is the utility of the biological information that's in this information base is relevant to any chemical in any context if you can map your chemical activity on that wonderful picture that Ed showed, which there are some end-routes there.
                  So the whole discussion that Dr. Eastmond had around the mode of action, he could substantiate that in this pictograph.  You could show it there and it's a lot easier to grasp or to just see, oh yeah, thick bars, thin bars, and here's the biology that's supports it, and you look at all these gaps.  So that's an amazing example of how to use this database.  And there are other aspects of it that would substantiate some of the other biological discussions that we've been having.  So, I'm actually very excited and I really support the inclusion of some discussion of this in the weight-of-evidence.
                  DR. KENNETH PORTIER:  I was going to ask Dr. Davies if she wanted or --
                  DR. HOLLY DAVIES:  I have a different topic, so if you just remember that I have a different topic that we can get to after the AOP discussion.  But I'm also excited that we're having the AOP discussion because I think it's great to include.
                  DR. KENNETH PORTIER:  Dr. Eastmond?
                  DR. DAVID EASTMOND:  While I like the concept of having figures, it helps me follow things.  The challenge with this chemical is, your predictions are really nice, but the in vivo evidence does not support the predictions, and that's the fundamental problem.  So you can go through and say, yeah, a direct-acting alkylating agent will bind to DNA and that will cause a mutation and this.  And you can support this in vitro, but when you go in vivo, which is the higher, more reliable studies, those all fall through.
                  And so, you can put forward all these predictions, but fundamentally you're going to have to say at some point, reality hits and now we have to make a decision based upon our predictions or what we see.  So I see that as being useful in one sense, but it doesn't answer the key question for me here.
                  DR. KENNETH PORTIER:  Down to comment point now.
                  DR. DEBORAH CORY-SLECHTA:  Can I make a comment?
                  DR. KENNETH PORTIER:  Dr. Cory-Slechta, do you want to step in here?
                  DR. DEBORAH CORY-SLECHTA:  Yes.  I want to highly concur with the comment that was just made.  I think we have to be very conscious about these.  There are so many limitations of how this data was derived and how it predicts or doesn't, what actually goes on physiologically that I'm concerned that we're over excited about something that isn't ready yet for what it's being proposed as.
                  DR. DANIEL SCHLENK:  To counter that, I look at this a little bit differently because I think it makes predictions that allows you to show that the in vivo data doesn't match that.  It's stating a hypothesis that it should go this way, but your in vivo data doesn't support that, and it gives you a mechanism to show that it's not supported.  And it provides you with an alternative hypothesis in terms of whatever mode of action that you're getting for that effect, if that make sense.
                  DR. DEBORAH CORY-SLECHTA:  You're going to explain all that in the documents?
                  DR. DANIEL SCHLENK:  No, you already are.  I mean, the documents are already there.  We just spent half the day yesterday talking about it.  So, to put it in a format that allows you to see that graphically makes things simpler to understand.
                  UNIDENTIFIED FEMALE:  I think Dan wants to respond to AOPs.
                  DR. KENNETH PORTIER:  Dr. Barone, do you want to comment or ask questions?
                  DR. STAN BARONE, JR.:  Yes.  So in my previous life and several previous lives, I've worked on mechanism in the AOPs and developing AOPs.  And again, I think some of the practical questions that have come up here from the committee are key concerns for us.  And I mentioned earlier, quantitative, that AOPs are really where we need to go, and that's where the rubber meets the road.  Again, we have to have a defensible presentation.  What's the predictive validity between the A box, the B box, the C box, or the A to C box?  And I think your narcosis AOP is fitting that bill, because we've got to be able to defend the stakeholders, hey, we don't have this data, but we can use surrogates.  We can use this other biological information for X chemical.
                  Again, I think that's one of the important approaches.  We talked a little bit about this in BP29 with the lung overload in our approach to use surrogate information for lung overload.  We'll probably be presenting some of this in future assessments, but again, it's an important research tool.  It's an important hypothesis testing tool.  We're still, from a practitioner's approach, still behind on implementing this into our risk assessments.
                  Our risk assessments are based upon apical endpoints, apical data.  What we've struggled with 1-BP here this week was, here's the cancer incidents, here's the tumor incidents.  We have multiple hypotheses that get us to cancer.  We have multiple hypotheses to get us to neurotoxicity and developmental toxicity.  At the end of the day, as a risk assessor, I'm going to make a risk guesstimation (phonetic) or a call based upon that dose response for that apical endpoint.
                  We would like to have more confidence, more relevance, more robust explanation of the relevance, and I think the AOPs will help us in that regard, but I don't think it's a panacea yet.  There's about less than two dozen peer reviewed AOPs in the Wiki, quote/unquote, validated the last time I checked.  There's about 86 that really have robust documentation the last time I checked.  And it's been a little while but, again, Dr. Perkins, it's not the universe of all the hypotheses that are proposed in the literature.  And the Wiki is a wonderful platform.  And at least in my experience, it's sort of been an effort where other duties as assigned, there's not a fully funded effort of the Wiki supporting this.  So that's something that EPA has contributed significantly to, and several other agencies and academics, but it's not this greatly funded effort.  So, if you guys think this is important, let us know.
                  DR. KENNETH PORTIER:  Dr. Perkins?
                  DR. EDWARD PERKINS:  Yes.  No, I totally agree with your comments on that.  The Wiki is an ad hoc effort pretty much and driven by need.  However, I think that the idea in showing you these was showing you the potential to try to organize information and organize it in a way so that you can get some weight-of-evidence for what potential mechanisms might lead to your outcomes of concern.
                  If you have specific rulings on how you monitor exposure, whether it's mutagenic or non-mutagenic, then that can be very helpful.  That can be very helpful in determining what kind of exposures you're considering, like that.  Then also, if you start extending it to population level effects, then you can start incorporating things.  It's not meant to be a cure-all really.  And I think you're absolutely right; there's not very much out there.  There's certainly very little on risk assessment and how to use these.  So one of the challenges is how would you use this and how could you include this.  That's why offering it more as an organizer for information, except where you can develop enough data and connectivity or relationships where dose response information to make a quantitative model based on that.  But then still you've got another model, at least, that's going to measure your variables and what you're trying to account for in it.
                  I think there's a number of ways you can use it, and I don't think AOP-Wiki is going to have a lot of that in there.  So, there's still a lot of work to do.
                  DR. DANIEL SCHLENK:  Just to add, I do think the narcosis one is ready for primetime though.  I think you can definitely use that to estimate at least LC50 data off of that, especially when you don't have that.  And it gives you at least something to bounce your measured laboratory data, if there is any, against to see whether you're in the right ballpark or not.  So I think at least that one, and particularly with the compounds that we're going to be dealing with down the pike, those I think will fit into that.
                  In terms of the cancer-based stuff, I agree with that.  I think it's an organizing tool, at this point, in the weight-of-evidence section that I would see it as its benefit.  But I agree it's not a panacea.  We're not there yet, but it is a step forward in terms of how to think about these things.
                  DR. KENNETH PORTIER:  And I also worry about what happens as we move away from generating a million data into a lower file of data, and that's all you have.  You know?  Today you have some animal data.  Five years from now you may not have that animal data, or at least mammal data.  You may have a little fish data or some zebra fish and some in vitro information, and that's all you're going to have, and somehow you're going to have to extrapolate that to a human health outcome.  I see this as the only way to do that, at this point.  And there are a number of panels that have looked at that and made that point.  Dr. Pessah, do you want to jump in here?
                  DR. ISAAC PESSAH:  Yes.  So I think that the pathway approach, especially what it includes, all of the data that's available, whether it's molecular, cellular or in vivo, can be highly informative.  Clearly that's been essentially proven, or it's as close to proof as you can get in genomic analysis.  And when there are discordances between what the pathways tell you and what outcomes at the population organismic level, it tells you quite valuable information.
                  My concern -- and this is a question for Dr. Perkins -- is what happens if you do not include 80 to 90 percent of the available data into the AOP approach, which is really essentially what EPA has done.  I think we've beaten this horse quite a bit.  I don't remember the exact numbers, but of 800 or so available papers in the literature, 24 were used for the assessment.  And this has come up over and over again.  Using the AOP approach in the Wiki, how sensitive would it be to inclusion and exclusion criteria?  And should that be a point that's also made along with the points you wanted to make?
                  DR. EDWARD PERKINS:  I think that's a very good point.  I'm expecting that there will be some criteria to make sure people have actually looked at a sufficient number of papers and what their exclusionary criteria is for why they exclude certain datasets from building their AOPs.  If we want to have these to really support risk assessment in a regulatory context, we have to have some sort of understanding of how hard did they look for data, what kind of data did they search for and where did they search.  It'll be exactly like some of the same issues that were here on exclusionary things, but maybe only finding one paper.  Why did you find that? Did you just not look hard enough?
                  I think the AOPs all have to get examined under the same context as the data here.  So, it would affect it.  If you only searched for one thing and you exclude other useful information that was contradicting that could increase uncertainty, then you're going to have too much confidence in what you're doing where it's not really deserved.  Does that answer your question?
                  DR. ISAAC PESSAH:  Yes.  Thank you.
                  DR. KENNETH PORTIER:  Dr. Davies, I think we've discussed this.  Dr. Barone, you wanted some final?
                  DR. STAN BARONE, JR.:  Yeah.  I did want to come back to Dr. Pessah's point, and I think he actually hit on something that's an important clarification distinction.  In our systematic review, a lot of our searching efforts, we're looking by chemical name and by CAS number and by outcomes.  And again, a lot of these mechanistic studies are not necessarily informing us about the apical endpoints that we use in the risk-assessment.  So they become put over here into another category and essentially they're excluded.
                  So there's a lot of literature in that realm.  And by using AOPs and informing more systematically -- and again, this is a larger effort.  We tried to do this in the IRIS program, and we saw it was a huge effort and resource intensive.  But including this into the assessment, it's a bigger deal.  So again, having this effort integrated into our risk evaluation process is going to be incremental.  I think it's going to be focused.  I think it has to be targeted because we have limited resources and limited time to complete these evaluations.  They are not 10-year research projects; they are three-year evaluations.
                  So having this modular, getting this fit for purpose and ready to launch is going to be critically important.  But I do agree, incorporating more of the clinical information and other biological information in some context, AOPs is one of them, is going to be important for us as we move forward.
                  DR. DANIEL SCHLENK:  Yeah.  What I had thought of in terms of Dr. Pessah's comments are -- again, this can be used in the problem formulation step in targeting the data that you need, in terms of that exclusion process.  So again, it's a way to set hypotheses of data that maybe you do need in the evaluation document.  So again, just something to think about in terms of the problem formulation step, which I realize we're not a part of.  But it is, I think, a tool that can be used in that capacity.
                  DR. KENNETH PORTIER:  Dr. Cobb?
                  DR. GEORGE COBB:  So one thing about this when you mention the narcosis -- and I've been pounding on the positive of data in the fish model.  Maybe this can be used to ground truth that very specifically in this assessment.  Just go ahead and do that and see if it matches what you've got.
                  I'll also say to Dr. Willett's point, I think this is a good visualization tool, even the prancing reindeer that we saw at the end there, the last slide.  If you highlighted where you have data and what it looks like is happening, that can give our human brains a visualization of maybe what's happening.  So, that's my thoughts on that.
                  DR. KENNETH PORTIER:  Any additional comments on this?  Dr. Davies, another topic.
                  DR. HOLLY DAVIES:  I think they're smaller topics.  I had just wanted to go back to something that Dr. Twiss mentioned in his original list.  In the human health hazard, there was a nice summary of all the papers.  And then in the next section was the weight-of-evidence discussion where it went through, again, summarized all the papers.  And it just seem like those could be put together because it was the same paper summarized within a little bit of the weight-of-evidence discussion since they are both summaries of the same papers.
                  And we've talked a lot about the Executive Summary and that seems like a good place for the Federal Plain Language Guidelines, not the rest of the document which obviously is much more technical.  But the Executive Summary, since they are the Federal Plain Language Guidelines.  And something I've mentioned before; it would be really helpful to have next steps.  And obviously you don't know what's going to happen.  You can't give us detailed next steps, but something more generic where you've made a determination of no unreasonable risk, what does that mean?  That means that this chemical is now available.  It's on the inventory.  It's available for people to use in this way, or whatever it is.
                  I don't know what the legal ease is.  You know what the legal ease is.  You know what that means.  Where you have made a determination that there is unreasonable risk, there's going to be a process after that.  It'll just be helpful to have a short -- obviously we don't know what the agency is going to decide to do with that, other than there's going to be another step.  You're going to go into the next phase, and just the outline that would involve rulemaking, that involve these steps.  Again, you can't tell us what the outcome is.  But I think it's helpful to the public and to everyone else to say that there are next steps coming after that, to the extent that you can.
                  DR. KENNETH PORTIER:  Dr. Kissel?
                  DR. JOHN KISSEL:  I have a general comment.  There was effusive phrase for the overall document.  But as I noted under Question 7, I think the dermal exposure assessment is sub-fabulous, so I don't see how the document as a whole can be ready for primetime.  And I also have a specific comment which gets alluded to in many places here.  But there's language repetitively in here, for instance, on page 260.  This appears at least twice.  There is no unreasonable risk when PPE, APF equals 10 is used.  That's the stock phrase which gets cut and pasted all over.
                  I think that would be enormously improved if it said, there is no unreasonable risk when PPE is used in a manner that achieves an effective APF of 10, which then acknowledges that one can use PPE and not actually achieve the designed protection.  And it also doesn't imply that EPA is endorsing other people's occupational hygiene practices.
                  DR. KENNETH PORTIER:  Dr. Eastmond?
                  DR. DAVID EASTMOND:  Yes, just a brief thing.  This is following up.  I do think that attempts to trying either your figures or tables to try and clarify it would be helpful.  It's kind of unusual that there isn't an appendix summary of some of the in vitro gene tox data.  There's an error or two in that that I'd probably point out in my comments.  But there wasn't anything for the in vivo data, and that's where you can see the totality of what's there, and that influences the way you look at it.  So I would recommend putting a table in for the in vivo data as well.  And in other areas, looking at that, and possibly doing some sort of simple figure to illustrate how you think things are happening as far as the mechanistic or mode of action.
                  DR. KENNETH PORTIER:  Was somebody on the line?  Dr. Anderson, Dr. Cory-Slechta, Dr. Pessah, did you guys want to add comments?
                  DR. DEBORAH CORY-SLECHTA:  No comment.
                  DR. ISAAC PESSAH:  No comment from me.
                  DR. KENNETH PORTIER:  Any additional comments in the room on this section?  There was something Dr. Davies said that fired off a neuron, especially when I was looking at all the supplemental files and the assessment that goes into the review.  And at some point I thought, at the end of this big table, I'd almost want some kind of comment on the quality of this study for this thing.  But you've got comments on every item, but not an overall comment.  But I'm not sure that would add anything.  I have to think about that, next meeting.  That's the nice thing.  And those of us on the permanent panel have another opportunity to do this next month.  Any additional comments?  Dr. Davies, is your flag still up?  I just didn't know.  Dr. Eastmond, I guess you've made your comment.  Any additional comments?  I look to EPA.  Any additional insight?
                  DR. STAN BARONE, JR.:  No, I don't think so.  I really, really appreciate the robust dialogue of the committee and the input from the public.  And stakeholders, you've commented.  I think you all who were on the previous assessment recognize we've put some significant work into this.  There are still some data gaps.  There are some methodological issues in our prior assessment.  We didn't have eco; we didn't have dermal even considered.  We've gotten some good suggestions and I think that's a significant contribution.
                  We will be looking forward to getting your report and recommendations.  We very much would like actionable prioritized recommendations for what you think is most important.  We really have to move expeditiously to finalize this risk evaluation because this is a draft.  And so your comments will be incorporated, as well as the public comments, into a revised risk evaluation.  Risk determination is part of that.  And then a response to comments document which will synthesize our responses to both the recommendations and comments of the peer review panel as well as the public.  That's the final piece of the puzzle for the peer review and for the risk evaluation.
                  And then if there are still unreasonable risks -- as was said in my intro slides during the orientation, that triggers an order for risk management for those conditions of use.  And then the risk management piece, that process starts.  And the risk management for those conditions of use will of course include outreach efforts.  It will include different kinds of data collection, information collection and option development, impact assessment and so on.
                  I can't really say anything more about risk management at this point.  We can't really say anything more about what an unreasonable risk call means because it's very, very different.  It's fit for purpose and it's on a case-by-case basis depending upon the condition of use.  There are, of course, multiple option selections or option development that goes into that as activities, and it's really a broad range of considerations.
                  And again, economics and impacts, other than risk-based criteria, are evaluated during that phase.  That phase, according to TSCA, is supposed to be completed in two years.  So, we have three years to do the risk evaluation.  We have two years to do the actual impact analysis and option selection for risk management.  That's what we have with some degrees of freedom around that, but that's basically what we're required to do under TSCA.
                  DR. KENNETH PORTIER:  Dr. Davies?
                  DR. HOLLY DAVIES:  And one reason I was bringing it up is because the finding of no risk does seem like it's a final -- it seems like when EPA finds that there's no risk, it seems like we do know more.  That was part of the -- the states are preempted, and it's permitted to be used.  As you said, there's more uncertainty in how we go forward with risk management.  It does seem like certainty in the no-risk.
                  DR. STAN BARONE, JR.:  So to Dr. Davies' point, the process is, if there's no unreasonable risk found in the final risk evaluation, that's a reviewable decision.  That's the legal context, and preemption and other factors are also part of that reviewable piece of the decision.  That's about as far as I can go.  I'm not with our attorney's office, but I do know that much.  That is a final reviewable decision, so there are two bifurcates.  No unreasonable risk, reviewable decision.  Unreasonable risk starts the whole risk management process, and then it's not until the end of that that it becomes a reviewable decision.
                  DR. KENNETH PORTIER:  I had one last comment.  And in the risk evaluation doctrine, you have a section called Acknowledgements, and you just acknowledged a team.  And I'd like to see names.  Okay?  I'd like to see how big that team is and who's on the team.  So over time, we can begin to put faces to names.  I know that's not necessary, and you can actually put that as a separate supplemental document.  But no one in the panel have asked for that to understand, you know, is it two people working on this or 20 people?  We suspect it's 20 people, but it would be nice to see names.  And I realize, with a document like this one, which started in 2014 and now it's 2019 and you've got five years' worth of work in there, there's probably a lot of names.  Some did early work; some did late work.  You can pick a cutoff point and say since 2017, these are the people who've worked on this document.  But I think it would help us.  Otherwise, all we see is stand-alone.
                  UNIDENTIFIED SPEAKER:  It's hard.
                  DR. KENNETH PORTIER:  I know it's hard, so it's just a suggestion.
                  DR. STAN BARONE, JR.:  Please, please, please; there is a huge team behind me.
                  DR. KENNETH PORTIER:  They're great.
                  DR. STAN BARONE, JR.:  Figuratively speaking, the risk-assessment division, our chemical control division, our economists help us, and there's a lot of technical input.  It is not just one individual doing these risk evaluations, by all means.  It's an interdisciplinary team.  I totally believe in what you're saying.  Authorship, ownership is an important thing.  Acknowledgment for both career development and permission is another important aspect to this.  We've had a lot of internal discussions about putting names on these documents and there have been differences of opinions, both at the staff level and at the leadership level, and I think we're coalescing around a position.  We take your point under advisement.
                  DR. KENNETH PORTIER:  And with that, I think we're done.  Mr. Kaufman; didn't see your flag there.
                  MR. ALAN KAUFMAN:  Yeah.  Actually I just had one quick question for Dr. Barone.  You had mentioned that a finding of unreasonable risk would trigger the risk management process, but that's a formal process, as I understand it.  If there is a situation where you find no unreasonable risk, that doesn't preclude the agency from making recommendations because some of the underpinning of no unreasonable risk here, for instance, is the proper use of PPE.  In other words, I would assume that you would be able to make recommendations to OSHA to say we recommend that, in the case of this chemical, that appropriate PPE be used, let's say as an example.
                  DR. STAN BARONE, JR.:  I'm going to leave that one alone.
                  UNIDENTIFIED SPEAKER:  It's a sensitive subject, yes.
                  DR. STAN BARONE, JR.:  Well, no.  It's part of the reviewable nature of the decision.  I'll leave that alone.
                  DR. KENNETH PORTIER:  So I guess that brings up the question.  I know you confer with them at the beginning of the process.  The question might be, do you confer with them at the end of the process.  So you've got a final document.  Do you sit down with your federal partners and say, here's what we've concluded, what do you think?  I just wondered.  Or do you at least say, here's what we concluded; go make of it what you want?
                  DR. STAN BARONE, JR.:  Actually that's a good question.  And in fact, that is part of the process.  So after we revise the risk evaluation just before we release it to the public, we have a consultation within the federal family.  We have a consultation internally within the EPA offices, and then we have a consultation within the federal family with the other agencies, and it's fairly broad.  And they review the draft evaluation and the supporting documentation.
                  When we get to the penultimate final risk evaluation, the response to comments and the risk evaluation, we'll also take that to the same group, and we'll be talking with them about our conclusions and whether we address the peer review recommendations.  And they're the checkers.  Do we address the peer review recommendations?  Because we don't come back to you to say did we answer all of your peer review recommendations.  And believe me, for those of you that have been involved in Government service that are familiar with this process, it's an important check and balance.  People look.  So that is part of the process before we go final.  It affects the timeline.  We have to incorporate that into our timelines as well.
                  DR. KENNETH PORTIER:  With that, I think I'm going to close the formal part of the meeting and turn it over to Ms. Gibson, our DFO, for final comments and discussion of how we're going to wrap this up into our report.
                  MS. TAMUE GIBSON:  Thank you, Dr. Portier.  First I would like to thank members of the public as well as the committee.  Thank you so much for your participation and your robust discussions.  This was very successful, and I greatly appreciate your time and efforts here.  I would like to thank our Chair, Dr. Portier.  Thank you so much for keeping us on track and allowing us some time to come together and break for some who have long days, so thank you again for your service.  At this point, I will close the public portion of the meeting.
                  UNIDENTIFIED SPEAKER:  Are we going to meet to follow-up?
                  MS. TAMUE GIBSON:  Well, yes.  We can meet for several minutes just to follow-up to have some ending comments and directives, if you would, just for a couple of minutes.  And I know that some individuals are on some timeframes, so we will officially adjourn this meeting.  Thank you.
                              (MEETING ADJOURNED)