For the number of dry cleaners in the state of New Jersey, when we did that study, we used the Dun & Bradstreet.  I think it used to be called the "I" Database, but now I think it's called Selectory (phonetic) database.  But it was basically a business database that told us, based on searching for NAICS codes, told us how many facilities there were in the state that had -- you have to have DUNS number -- but how many facilities they had in the state and how many employees they had.  So that's how we were able to come up with our estimates at that time for how many dry cleaners we expected.  In the state of New Jersey, we used a Dun & Bradstreet database.
                  So I don't know if you utilized those databases if they would be helpful.  But those are two other sources of information that I thought, if you hadn't used them, they might be helpful in doing some of the worker estimates and so on.
                  So, if we go to the other members of the charge question folks, Dr. Anderson, did you have anything you wanted to add for Question 2.2?
                  DR. HENRY ANDERSON:  The only thing, there was -- I think, it's part of the OSHA database now, but there's no OSHA Consultation Program which specifically is targeted to small businesses.  And so that might also be a source of information.
                  DR. JAMES BLANDO:  Okay.  Thank you.  How about Dr. Barton?
                  DR. CHARLES BARTON:  No further comment.
                  DR. JAMES BLANDO:  Dr. Bennett?
                  DR. STEVEN BENNETT:  No further comment.
                  DR. JAMES BLANDO:  Dr. Kissel?
                  DR. JOHN KISSEL:  I think I already said this, but I'll just reemphasize that the empirical data in the Frasch et al. experiment with respect to fluxes is not being utilized by EPA in this analysis and giving difference to the fraction absorbed rather than looking at the fluxes is a failure to utilize all the information that's actually in that study.
                  DR. JAMES BLANDO:  Okay.  I think that's it unless anybody else on the panel wants to comment.
                  DR. KENNETH PORTIER:  Any additional comments?  Yes, Dr. Davies.
                  DR. HOLLY DAVIES:  I wanted to add a few things.  Dr. Anderson had mentioned people living near daycares.  I wanted to add daycare -- living near dry cleaners.  Sorry.  And I wanted to add daycares onto living near dry cleaners.  Also, with the number of workers for the aerosol cleaners, in particular, it seems the aerosol degreasers -- because there's not big pieces of equipment to switch out, it seems like those workers, in particular, could be more workers because it's harder to estimate those.  They could switch products pretty easily.
                  And then I'm not sure where to put this comment, and so this seems like a good place to put it.  We're talking about estimating uses.  I like mass balance, and how much 1-BP is there?  And so I don't know where else to put this in the comments.  One of the public commenters, I think in the written comments, had said that the estimates that EPA's using through the public disclosures they do is overestimating it.  It's hard to know that.  Hopefully, they'd be able to give more information.  EPA can only estimate the information that it gets.
                  I was looking at it from a different perspective.  There was a point where EPA said there's only five pounds, I think, going into the water, and I thought, well, that's hard to believe.  You know, TRI -- TRI is what TRI is.  It's not all of the releases in the country, but it would be nice to really see kind of where it's really going.  If we're looking at the releases, is there really one five pounds going into the water?  If 24 million pounds are being imported or manufactured, it's hard to believe that little's going out, but a better kind of mass balance, better estimate, and maybe not that much is being imported or manufactured.
                  Maybe the commenter's right and only five pounds are going in.  And the list of uses on page 100 that are kind of niched, they aren't really estimated.  Some of those sounded like they could also be fairly large uses, but it would be nice to have better estimates on there.  And I think some of the other public commenters also commented on it.  In fact, Richard Denison's media had something about the toxics release inventory and how much was coming in from different places.  That could be added in.
                  Okay.  Yeah, I think Dr. Anderson had said a little bit about that too in his last comment that I wrote down.
                  DR. KENNETH PORTIER:  So you're kind of thinking like an accountant, right.  You had X amount millions; how do we separate them out?  What's leftover that's lost to follow on, right?
                  DR. HOLLY DAVIES:  Well, especially if we're looking at aggregate exposures to the whole population that we should be looking at where everyone is exposed, it would be nice to see where all of it is as we're looking at this.
                  DR. KENNETH PORTIER:  Dr. Blystone.
                  DR. SHERI BLYSTONE:  Sheri Blystone.  Just to kind of comment on that, I think there's uncertainties in all of that sort of data.  I have my own personal opinions of whether TRI data is even relevant for doing the types of things that they're doing because there's a lot of uncertainty in that and certainly overestimation.
                  The CDR data swelled.  There's potential for double-counting or triple counting as that public commenter mentioned.  So some of the uncertainties around that, that maybe there's an opportunity to expand on that.  But there's definitely challenges for all of that data.
                  DR. KENNETH PORTIER:  Dr. Cobb and then Dr. -- well, no, I'm sorry.  Ms. Rudel was next.
                  MS. RUTHANN RUDEL:  Thank you.  So I'm thinking about what the document says to sort of what it conveys to a risk manager also to the public who might be interested in this and how the uncertainty in the assessment overall is conveyed, and we talked about this with PV29 as well.  As I was sort of reading it, on the one hand there's one place where they use, I guess, an informal communication or a letter from Eviro Tech to say that there's maybe 27 dry cleaners that are using 1-bromopropane, but then other sources of information would suggest that maybe, are there 20 thousand?  Or like how many dry cleaners are using this now?  And on the one hand, it looked like sales data show production in sales are increasing over time, and then in other kinds of streams of information would suggest it's being replaced because of the hazard.
                  So I don't read this and feel like I have any real sense of what is happening with this chemical.  Where it's going?  How many facilities are using it?  Where it's ending up?  And so I'm echoing Dr. Davies' comment about -- and EPA does, I guess, according to the commenters, have the authority to get manufacturers to give sales data.  I think in addition to doing a better job of estimating sort of worker exposures and environmental releases that, well, then environmental releases will be important for characterizing exposure to the general population, which I know EPA has sort of excluded from this, but we'll come to, I guess, later in the discussion.  So I'm just recommending to avoid a misleading sort of representation of the precision in these assessments, also, given some of the uncertainties and also the uncertainties in the models that we were talking about.
                  And then I had, in terms of the modeling, there's a statement that there's consistency between monitoring and modeling, but I think it would be helpful to see that more clearly presented what that was so that people can evaluate how much uncertainty or confidence that they have in that.
                  I propose that the estimates of worker exposure are done assuming no PPE and no ventilation and assuming PPE and ventilation, that all of those results would be very clearly presented as separately so that some idea of the range of exposures and risks would be presented, and that the inhalation and dermal would be combined.  And there are different ways to represent uncertainty in the exposure estimates, but you could add another -- you could do more -- try to represent more of a worst-case and try to just be -- I don't know.  Like the slides that were shown this morning about the worker exposures and they don't say on them, this is assuming with PPE or this is without PPE.  But that should be sort of a big feature of any representation of this data of what the worker exposure is.  Like I would expect that to be on the figure.
                  DR. KENNETH PORTIER:  Dr. Cobb.
                  DR. GEORGE COBB:  So to a comment that was made earlier about double or triple counting on the TRI, based on the fact -- my estimation -- the report says that 15.4 million pounds of 1-BP were produced in 2012, yet we only have facility that's reporting discharge.  So, unless we get double or triple counted up to 15.4 million pounds, I'm personally not concerned about that.  As a matter of fact, I would say in the absence of data suggesting how much is released, perhaps the Agency should consider that all of the 15.4 million pounds is either released into air or water on an annual basis because it is used to spray or --
                  DR. KENNETH PORTIER:  -- it's not converted.
                  DR. GEORGE COBB:  -- so it's got to be disposed of somewhere.  So if it's not inventoried as being properly disposed, maybe that's the route that should be taken to be conservative.
                  DR. HOLLY DAVIES:  We were just saying some is exported.
                  DR. DAVID EASTMOND:  I believe quite a bit is exported.
                  DR. HOLLY DAVIES:  Hence the mass balance.
                  DR. DAVID EASTMOND:  I think that's one of the ones that we had public comments that were made.
                  DR. KENNETH PORTIER:  That was Dr. Davies and Dr. Eastmond.
                  DR. DAVID EASTMOND:  And exports would certainly fall into that category.
                  DR. SHERI BLYSTONE:  This is Dr. Blystone.  The double and triple counting wasn't around TRI data, it was around CDR data.
                  DR. KENNETH PORTIER:  I think we've kind of handled this question.  At this point, I'm going to turn to EPA -- and I need a break.  So I'm going to turn to EPA and say, do you have any clarifying questions or comments?  The panel will clearly write all this up.  Dr. Blando's got it already ready to go.
                  DR. STAN BARONE, JR.:  So I think we've heard some really constructive and robust discussion.  I do have some clarifying comments, and they cut across a number of the speakers' comments.  So I wanted to be sure that we're on the same page.
                  Number one, there was several discussants mentioned an OSHA PEL.  There is no OSHA PEL for 1-BP.  There is a hazard alert which refers to the ACIGH value.  That is not a regulatory limit.  That is a suggestion.  So that's not a PEL.
                  So let's just be clear about that.  Yes, we consider -- and the committee has also discussed about temporal issues with a PEL.  We'll be talking about that in the future.  We've received public comments about risks above and below the PEL -- not a PEL.  There's no PEL.
                  So again, we can look at the ACIGH value, and what is current practices and what's happening, and where does the monitoring data fall and those kinds of things.  That actually can be derived from what we have in the assessment.
                  There was mention of our exchange or information exchange with OSHA, NIOSH, and others and, in fact, we have a very active engagement in the federal family.  On their monitoring data, we actually incorporated monitoring data from OSHA, NIOSH, DOD, HSIA, and HSIA being an industry association that provided us monitoring data for some conditions of use.  And, again, that's incorporated into our assessment as well as publication data so monitoring data.  Again, as the presentation outlined, representativeness of those samples is always a question, and that's why we also look at modeling and what we said was looking at the modeling and looking at the monitoring data for at least six conditions of use where they overlap, there's pretty good agreement in those cases.
                  There was a discussion about workers and workers in the broadest sense and PPE.  And I still think we have some confusion about what we're presenting as far as risk estimates.  We are presenting risk estimates along a continuum, and it's in our supplemental files actually.  You have all of that in the supplemental file and the risk calculator with and without PPE and with different types of PPE.  And, again, the modeling efforts really, really help us facilitate this process by looking at the different combinations where monitoring, we can't always do that.  So we do have that there, and we actually show in the summary tables with and without PPE, and we show the range of PPE that may reduce the risk estimates.
                  But we also show -- and I think this gets to Dr. Anderson's point -- that not all workers are expected to use PPE and that the occupational nonusers -- again, the person or persons who are working within that far-field zone -- will not necessarily be expected to be wearing PPE, and we're presenting those risk estimates -- no PPE for those workers.  And you will also note that oftentimes the risk driver is the ONUs which has also received some comments.
                  I think that's pretty much all the clarifying points.  I wanted to make sure that -- there was a lot of good discussion -- I wanted to make sure we didn't lose some threads or overgeneralize what's in and what's out.  I think we, again, are trying harder to hyperlink our document.  In hyperlink, we've figured out a couple of tricks -- the hyperlink to the supplemental files too so to help you and the public be able to find the information because it's a lot of information to present.  And we're trying to get the summary information in the assessment file, but, yet, provide transparency to where the calculations are done and where the more detailed information exists in the appendixes and in the larger supplements.  And the exposure supplements and the risk supplemental files are debts.  We acknowledge that, but again, we're trying to show all the data we got including the monitoring data that we have received which has been sanitized, and we also recognize that it is difficult oftentimes for the public to understand what's in those inspection databases.
                  DR. KENNETH PORTIER:  Okay.  We're due a break.  I have 3:25.
                  DR. HENRY ANDERSON:  Just a quick question.
                  DR. KENNETH PORTIER:  Dr. Anderson.
                  DR. HENRY ANDERSON:  In all the data, is there a table somewhere that summarizes kind of by count how many monitoring samples you get from air, the various sources?
                  DR. STAN BARONE, JR.:  Dr. Anderson, you are asking for a number of samples per site or what are you actually asking?
                  DR. HENRY ANDERSON:  Just a total number.  I mean, are the number of samples or the data that you have to work with in the tens of thousands?  I think they'd be helpful.
                  DR. STAN BARONE, JR.:  We can get --
                  DR. HENRY ANDERSON:  I just don't have a sense of how much data you have.  Mention it.
                  DR. STAN BARONE, JR.:  Yeah, we can pull that out for you.  But it's not tens of thousands at all.  It's probably up to close to a thousand.  Again, I'm just guessing.  This is one of the cases where we have the most monitoring data points of any of our assessments.
                  DR. HENRY ANDERSON:  That's what I thought.
                  DR. STAN BARONE, JR.:  And we're still probably talking less than a thousand.  Again, when you look at monitoring studies, you're usually -- Dr. Blando knows.  If you had a hundred samples, you'd be singing a happy song.  I'm being a little colloquial and down in the country, but it is not unusual to have small samples when you're talking about monitoring studies.
                  DR. KENNETH PORTIER:  Let's take a break.
                  DR. HENRY ANDERSON:  Absolutely.  Oh, I just think it's hard, I know, from the public to get a sense of how data rich is the database you have to work with.
                  DR. KENNETH PORTIER:  Thank you, Dr. Anderson.  I'm dying for a cup of coffee here, so we're going to take a break.
                  DR. HENRY ANDERSON:  Oh, go take a break.
                  DR. KENNETH PORTIER:  3:45 we'll reconvene, and we can continue with your comments then, Dr. Anderson.
                  DR. HENRY ANDERSON:  That's okay.  I'm done.
                  MS. TAMUE GIBSON:  Committee members, we do have tea and coffee in our administrative breakout room from this morning.

                                    (BREAK)

                               CHARGE QUESTION 3

                  MS. TAMUE L. GIBSON:  All right.  We are ready to begin, and I'll turn it over to our Chair, Dr. Portier.
                  DR. KENNETH PORTIER:  I've asked EPA to read Charge Question 3 on consumer exposure assessment to kind of summarize, if they could, the four paragraphs of lead-in information.  If the panel can read that.
                  DR. KATHERINE ANITOLE:  Okay, Dr. Portier.  I'm a little caught off-guard.  I haven't summarized these four paragraphs.  I'm just going to read the first sentence of each one and then I'll get into the questions themselves.
                  Question 3:  Consumer Exposure Assessment.  Section 2.3.2 of the Draft Risk Evaluation.  EPA evaluated acute inhalation exposure to consumers for nine product use scenarios.
                  EPA evaluated exposure to consumers in residential settings following acute exposures and considered both users of a product and bystanders within the residence where the product was used.
                  Three models were used to evaluate acute inhalation exposure depending on the condition of use evaluated.
                  Product-specific consumer monitoring information was not identified during the systematic review process; therefore, model inputs related to consumer use patterns (duration of use, mass of product used, room of use, and similar inputs) are based on survey data found in literature.
                  Question 3.1:  Please comment on the approaches, models, exposure or use information (for example, information on duration, number of user events, amount used) and estimates for the nine consumer uses evaluated in this draft risk evaluation.
                  Question 3.2:  Please provide any specific suggestions or recommendations for alternative approaches, models, exposure or use information (for example, information on duration, number of user events, amount used) that could be considered by EPA in developing and/or refining the exposure assumptions and estimates for the nine consumer uses evaluated for this draft risk evaluation.
                  And Question 3.3:  Dermal exposure was evaluated using a permeability method within CEM based on the availability of a permeability coefficient found within the literature and a study by NIOSH 2017.  The permeability method within CEM does not consider evaporation when estimating exposure, which is the primary basis for EPA evaluating dermal exposure, only for consumer uses where there is a continuous supply of product against the skin, during use, or a barrier prohibiting evaporation.  Please comment on the chosen approach and provide any suggestions or recommendations for alternative approaches, dermal methods, models or other information which may guide EPA in developing and refining the dermal exposure estimates.
                  DR. KENNETH PORTIER:  Thank you.  And we've asked Dr. Bennett to lead this discussion.
                  DR. STEVEN BENNETT:  Thank you.  I think I will introduce a few concepts, then let the others take over.  I didn't have an opportunity to gather all the questions from the other panelists.
                  I think one thing I'll make a comment, and this will probably surprise others.  I think was a pretty good overall piece.  And I think one of the things, as I was going through a couple areas, I addressed -- a couple concerns I raised where I was thinking about as going through this, as I raised those issues, when I went to the end, to the discussion of the uncertainty, et cetera, they had addressed those questions.  So I want to compliment the Agency on that part.  So when there's deficiencies, if you appropriately address it, the panel usually -- it helps us out a lot.
                  A couple areas similar to what I raised earlier with respect to the consumer and the industrial/commercial uses, probably a good chance to reevaluate the uses.  I think in many cases, the uses that have been identified in some case were based off the earlier risk evaluation, and that's in 2017.
                  I did some spot checking on a few of the products that were listed in there, and I was not able to find them on the manufacturer's website now.  Some were broken links, some were searching.  But I'm not sure if that's fully accurate.  I would suggest the Agency may want to double-check those to make sure that those are still in the marketplace.  Others were definitely there, as well.  But I do want to make sure that is fully reflected.
                  Another issue that I articulated last time with utilization of the Westat Study Survey.  I still have concerns with that, dealing with that is 30-year-old data.  But I also recognize that is one of the best -- by far the best survey that is out there.  Certainly great for suggestion just broadly, figure out how to get that updated to some of today's use and practices.  I think that's both an encouragement to the Agency, but also to the recognized impacted industries, et cetera, like ourselves.  So it's certainly an area that should be looked into.
                  One area that I thought -- the incorporation of the inhalation within the consumer space, I was a little puzzled by why the vapor portion of the inhalation was incorporated into the consumer.  I would sort of think that's more applicable to a general population exposure, rather than trying to trace it down back to an individual, the consumer space.
                  So I think it might be useful, a better explanation as to why that was incorporated under the consumer space.  Granted, the general population is excluded from the risk evaluation or is put elsewhere.  But I think that there should be a better explanation of that piece, of why that approach was taken.
                  One area within one of the identifications.  I think it was the electronic degreaser and the specialized electronics utilization for cleaning program, VCR versus today.  I'm not sure that's fully reflective with respect to consumer electronics today.  You certainly can clean many consumer electronics now with water or other solvents rather than a typical chlorinated or halogenated degreaser.  So I think that might not be fully descriptive of that particular use.  I think that's a piece.
                  And I wanted to raise a couple other questions of looking at the population exposed and susceptible subpopulations.  I'm not sure if that was adequately addressed within the consumer piece.  So I think that's an area that may want to be looked at and make sure that's fully put in there as well.  And that's all I have for right now.  I'll open up to the next panelist.
                  DR. KENNETH PORTIER:  Dr. Barton.
                  DR. CHARLES BARTON:  Thank you.  If the modeling assumptions are made that provide inputs to the exposures and a justification for choosing these would assist in the reader understanding as well as transparency, I'd encourage this.  And this also goes to Charge Question 2 as well.
                  Another issue, a question that I had, was regarding the permeability that was used in the consumer exposure model.  I think it would be good if it was expressed why this was chosen, considering that vaporizing isn't taken into consideration in that, whereas the fraction that is absorbed was looked at in the worker exposure.  So why the differences in models that were used, at least mention it and why it was chosen.  Because right now I have to assume the reasons why.  And that's all that I have.  Thank you.
                  DR. KENNETH PORTIER:  Dr. Davies.
                  DR. HOLLY DAVIES:  Thank you.  I'm not a big model person, but the models and inputs seemed reasonable.  And I think we talked earlier about the size of the houses and such, and of course houses are all different.
                  I can't remember the phrase you used in there about them being the normal inputs or the reasonable inputs, or whatever it was, it was a good phrase.  Those are the inputs we all use.  Those are the assumptions that are commonly used, or something like that.  It was a good assumption, that is what we use for housing size and we have to use those assumptions of American house size.
                  I had missed that children could be bystanders.  I'd actually put down originally that children should be bystanders.  And Katherine in her presentation this morning said that they could be.  So I looked and I saw on Page 112 just a small line about bystanders could be any age, so I was really glad that you pointed that out this morning and that I saw that.  Because in all the other explanations, I hadn't seen that.
                  I looked for data and couldn't find it in the places that I normally look for data on chemicals in products.  I looked in the Danish EPA that has data and I looked for state data and I couldn't find anything else.  So again -- and the Westat study is old but does seem like it's a good study.  And I couldn't find any other data.
                  Not surprisingly, I looked up the criteria for the data quality evaluation for this kind of study, and there is no criteria for age.  So it was not ranked for being too old.  Some of the other types of studies have criteria for age.
                  And I also liked her explanation as to why it could still be relevant, but also reasons why to take it with a grain of salt.  So I think that was my comments.
                  DR. KENNETH PORTIER:  Dr. Kissel.
                  DR. JOHN KISSEL:  Okay.  For 3.1, my primary comment is that I couldn't really figure out what the approach was for the dermal -- I asked this qualifying question earlier, but I couldn't follow the calculation.  So that's my primary comment, that whatever is being done isn't transparent.
                  Are we doing these together or are we going one at a time on this?
                  DR. KENNETH PORTIER:  Do all three together.
                  DR. JOHN KISSEL:  So with respect to -- and this question keeps coming up -- permeability approach versus fraction absorbed, you know, ultimately you're trying to make sense of the data and you should be running both approaches and getting to the same place.
                  With respect to what other models might be used, for 1,4-Dioxane you were using the Kasting and Miller/ Frasch version, and there's no reason why you couldn't be doing that here also.  I didn't like the way you interpreted it last time, but the modeling -- this is a volatile compound and you've got competition between uptake and volatilization, and that model was intended to deal with that situation.  And ultimately you should be able to take those models and predict Frasch's low fraction absorbed, if the world actually makes sense, if we actually understand what we're doing.
                  So I'm a little put off by the either/or approach to modeling that I'm hearing from both EPA and the other panelists.  Because I think ultimately the goal is to get the physics right and then all those models will collapse together and be the same thing.
                  With respect to -- and I think I kind of said this already, but the permeability coefficient from NIOSH is okay as far as it goes, except that it's contradicted by the Frasch data.  And once again that's getting back to this big picture.  If you only pick one approach and it's contradicted by another approach, one of them is off the mark and the interest ought to be in making sense of this issue.  And we have more coming down the pike.  NMP and methylene chloride and TCE are similar kinds of compounds that these same issues are going to come up, and at some point I hope EPA evolves to making a coherent whole of all of those compounds.  So you can use the same approach for every one of them and produce a result that seems to make sense.
                  DR. HOLLY DAVIES:  Can I have one thing I forgot to say?
                  DR. KENNETH PORTIER:  Yes.  Identify yourself.
                  DR. HOLLY DAVIES:  This is Holly Davies, and I said this to John Kissel earlier, and I should say it for everybody.  Because I don't know the dermal models -- and I had asked John this, because it doesn't make sense to me why they couldn't use the same dermal exposure assessment for the consumer as they use for occupational.  But there's a sentence in there about we couldn't use the same ones, so we're going to use different ones.  And that was just a question that I had, because they're all people.
                  DR. KENNETH PORTIER:  Dr. Bennett.
                  DR. STEVEN BENNETT:  I think I'll add one recommendation.  There was an earlier question, a comment asking about the occlusion -- the occluded uses, recommend that an expanded discussion of that or incorporation of uncertainty associated with use of the gloves or other clothing et cetera that may occlude the solvents, or it may permeate the membrane and then be stuck to the user's skin.  That's certainly a discussion that probably should be looked at, both within the consumer space and possibly the occupational.
                  DR. KENNETH PORTIER:  Dr. Anderson, Dr. Cory-Slechta, Dr. Pessah.  Do any of you have comments to add?
                  DR. DEBORAH CORY-SLECHTA:  I don't.
                  DR. KENNETH PORTIER:  I'm glad to hear you've joined us, Dr. Slechta.
                  DR. DEBORAH CORY-SLECHTA:  I've been sitting here for a long time.
                  DR. HENRY ANDERSON:  My only comment, and it's probably a bit off the mark, but that has to do again with Holly's talking about mass balance.  I really don't know how much product is in these, but for having used spray cleaners and spot cleaners and degreasers on my motorcycle and things like that, pretty much it's gone when you're done.
                  And the question is where does it go and is it an environmental problem.  And that's partially on what's the volume of the material that's actually being distributed in small containers and used indoors.  And I suspect when it's kind of left over there's a bunch of gunk with it that's poured out on the ground in the backyard and ends up in -- or worse yet down the sewer and then it's out in the lake as a sheen.  So I'm not sure what other exposures remain if the work is done indoors.
                  DR. KENNETH PORTIER:  Dr. Kissel.
                  DR. JOHN KISSEL:  I just wanted to add that Holly's comment and Steve's comment were basically the same thing.  If you read 3.3, it's basically what EPA has done is assumed that these are -- that the consumers are having occluded exposures, that they have their finger stuck against a coin or something and it can't evaporate so it goes into the skin, however that long lasts.  You're doing permeability into the skin for however long that lasts and you don't worry about evaporation.  So, again, they're subsets of the same model.
                  DR. KENNETH PORTIER:  Dr. Doucette.
                  DR. WILLIAM DOUCETTE:  I didn't read this section as carefully as the ones I was responsible for, but I did have a question that either the panel members or maybe the folks from EPA can answer.  I didn't see it in the first couple of paragraphs, but I got involved in a study we were looking at vapor intrusion of chlorinated solvents and we were finding homes that had elevated concentrations that shouldn't have happened based on where they thought the plume was.
                  So we went in and did room-to-room measurements and looked for consumer products that actually were omitting these chlorinated solvents.  And what we found is we were looking primarily at chlorinated solvents, not the brominated.  But basically the spray cans that are used for degreasers or spot cleaners.
                  And what we found was that we measured the rate that would come out during use and then we also looked at what happened during storage.  And they were a continuous source.  And the spray cans that were nearly 100 percent of PCE, for example, were an unlimited source for as long as the can actually contained that substance.  And we found that in rooms, that actually exceeded the cleanup standards that the Air Force had for indoor air, just coming from that spray can.
                  So my question was do you consider -- just once you've stored that product, and it's been used, it continues to release constantly.  And is that something that you looked at?  Hopefully I made that clear.
                  DR. KENNETH PORTIER:  Dr. Barone.
                  DR. STANLEY BARONE, JR.:  We are looking at degreasers, spray degreasers.  I'm not sure I'm aware of that particular data.
                  DR. WILLIAM DOUCETTE:  You're using only during the use.
                  DR. STANLEY BARONE, JR.  Right.  I'm not aware that we have that kind of data.
                  DR. WILLIAM DOUCETTE:  And there are some flux data -- not for this particular compound, but I could send you a couple that where actually -- that measured the flux.
                  DR. STANLEY BARONE, JR.  That would be very helpful.  Again, it changes some of our calculations if we actually had that kind of source data.
                  DR. WILLIAM DOUCETTE:  Constant source.  Thank you.
                  DR. KENNETH PORTIER:  Dr. Kissel.
                  DR. JOHN KISSEL:  I would just like to say that the TEAM study demonstrated that in the early 1980s; that the solvent concentration inside homes in Bayonne, New Jersey was enormously higher than the outdoor air in a refinery town because of consumer products.
                  DR. KENNETH PORTIER:  Any additional comments?  Dr. Bennett, I would say when I read this section and I went back into my ceramics hobby area, and I found a bottle of mold release with            1-Bromopropane in it.  It's been there for at least 15 years that I know of, because I inherited it from my father-in-law.  And now I'm not going to use it.  I don't know what to do with that.
                  DR. SHERI BLYSTONE:  It's releasing anyway.
                  DR. WILLIAM DOUCETTE:  You've been exposed for the last 15 years.
                  DR. KENNETH PORTIER:  It's still got juice, I think.  I'm not about to test it.
                  DR. HENRY ANDERSON:  Take it to a paint collector.
                  DR. KENNETH PORTIER:  Ms. Rudel, you wanted to comment.
                  MS. RUTHANN RUDEL:  Just really quick.  There's one sentence about insulation, where it says we used a certain brand of Polyiso board, I guess as the basis for the model.  And I had been looking to try to get through the supplemental and see if there's more information.  But I was curious, like, why you used that, what information you had about the off-gassing of 1-Bromopropane from that particular product and whether -- that seemed like a board that's already -- it's already a hard piece of insulation when you install it, but is 1-Bromopropane used in the spray foam stuff that's installed on site that's blown in or whatever?
                  DR. KENNETH PORTIER:  Now we can turn to EPA.  Any comments or clarifications?
                  DR. STANLEY BARONE, JR.  One of the things you'll see in our assessments, and the puns intended, is we recycle our models.  Where we have developed a model for spray foam insulation for a semi valve tool, a flame retardant.  We'll basically build upon that model with additional modules or additional information.
                  A lot of the times, the model starts out for a particular chemical purpose, but gets expanded for other chemicals -- related chemicals, and then other chemical classes.
                  So, again, it's about validation and review of the domain, and the P-chem properties, of course, are driving a lot of the issues of is this covalently bound, is this emissive, or not.  So there's a lot of issues there, but I'll just say that we're trying to use these models to the maximum extent possible.  Questions?
                  MS. RUTHANN RUDEL:  I was just curious about my specific question though.  Is 1-Bromopropane used in spray foam insulation that's installed -- that's blown into people's houses?  It's like installed on site rather than put in as a board.
                  MR KEVIN VUILLEUMIER:  This is Kevin Vuilleumier again.  For the product that we looked at, it's actually a board.  It's a predesigned board.  We don't have information, based on our product review actually, to determine whether or not that showed that was in the spray -- I think you're talking about the spray foams that are just a bottle that sprays out and then expands.
                  That wasn't in the consumer uses that I know of, that we tracked down for products.  But we aren't certain -- I don't know an answer if we do or do not have it in some of those products, but we didn't any in the consumer uses that we did identify, that I know of so far.
                  So it's in the hardboard, which is what we analyzed.  And then for spray foam, we can certainly look back in the products and see if there are new products or products that we missed, that is a spray foam as you're referring to, that expands, and see if that contains 1-BP.  But for right now, the conditions of use that we looked at, no products were identified as a spray foam that contained that.
                  DR. KENNETH PORTIER:  So a crack and crevice foam would be a consumer item.  But what about an occupational?  Because the other one she's talking about is like a two-part spray foam, where the guy's in the full spacesuit and he's in your attic spraying this stuff all over the place.
                  DR. STANLEY BARONE, JR.  We actually have a model for that, for isocyanates, again for the expansive foam.  So, again, to Kevin's point, we haven't yet identified that in those spray foam products.  It's just in hardboard products right now.  Again, it would be an additional effort if we found that, but we have models to actually do that.
                  DR. KENNETH PORTIER:  Dr. Cobb.
                  DR. GEORGE COBB, III:  I think some of the confusion is probably arising from I think page 121 where you talk about a model for emissions from spray polyurethane foam, and whether that's -- I think that's where the question comes.  And I actually had that question, too, so --
                  DR. STANLEY BARONE, JR.  I think that actually gets back to the issue that I was trying to raise.  We're using models that were developed for one particular purpose, and using them for additional functional uses, related but different.
                  I have a couple other clarifying comments, if I may, Chair.  To Dr. Kissel's question earlier about which module within the model we were using -- and I believe this was the MCM model.  It's Peter 2B, not Peter 1B.  There was a typo for that module, and that's why you weren't following the proper breadcrumbs.  We had a typo.
                  For, I think, Dr. Johnson's question about the high and low intensity issue, the medium intensity is correct, but the high and low intensity values got switched.  And it's correct, I think, in the supplemental file.  The numbers are correct in the supplemental file, but in the text of the document they got flipped.
                  Also the earlier question Dr. Voorhees asked, and then there was follow-up about the housing stock.  Housing stock and the size of houses has changed over time.  We have updated information from the Exposure Factors Handbook.  That Exposure Factors Handbook, again, comes up with -- from the National Building Housing Survey, the average size of rooms, how many rooms in a house, whether they have basements or don't have basements.
                  So there is, for our model inputs, it does come from a national survey.  And again, as you may or may not be aware, when you do a national survey you have to adhere to rules and guidance about national surveys and information collection rule.  And it's not a trivial exercise to recapitulate a national survey, particularly if you have lots and lots of respondents, potential respondents.  That requires public comment rulemaking and OMB review.
                  DR. KENNETH PORTIER:  Ms. Rudel.
                  MS. RUTHANN RUDEL:  Ruthann Rudel.  So I guess I have two really specific suggestions for the report, on the subject of home insulation.  And if you've done this in the supplemental or I've missed it, then I'm sorry.  But I guess I still don't know whether 1-Bromopropane is in insulation or not.  And I heard you say we didn't identify that it was, except for these boards.
                  I think it would be -- it's useful, again, for risk managers or the public to know what you don't know, I suppose, which is we don't know that it isn't, I guess is what you're saying.  And to just be clear, like here's all these different kinds of spray foam insulation that people might encounter.
                  One of them is a company that comes in the back of their truck and they blow stuff into your attic and they're wearing hazmat suits.  And we don't know, I guess, if there's 1-Bromopropane in your house after they do that or not.
                  And then there's a can of stuff that you can buy and do your crack and crevice treatment.  And we don't know if 1-Bromopropane is in that.  And then there's insulation boards.
                  Then my second suggestion is to do an exposure scenario where the boards are put in a space that someone is living in, like if they have a basement apartment or whatever it is, rather than that it's in a crawlspace or attic where nobody is living.
                  DR. STANLEY BARONE, JR.  This actually gets to Dr. Bennett's question or comment earlier also.  We will be, post peer review, updating our analysis.  We'll be looking at new TRI data as the next cycle comes in.  We'll be making sure that we've captured, to the best of our ability, the updates of the product uses, and market uses, and that gets included.  And especially in context of where we have unreasonable risk findings.  So there will be additional review.
                  To your point, it really gets at we've identified to date what's in the products, what's in the market.  The market changes, and I'll use the example in the commercial sector with dry cleaning.  When we started the assessment, the number of dry cleaners were a certain number.
                  We found out from the producer/manufacturers of 1-Bromopropane that it was licensed to dry cleaners of a specific type of machine.  And so the original estimates of dry cleaners from Dr. Blando and others was way smaller than the total number of dry cleaners in this country.  It turned out to be less than 20 dry cleaners in the entire country were using 1-BP.
                  So, again, today we may have no great stuff spray foam with 1-BP.  It may not occur in the current product formulation.  That does not mean tomorrow it couldn't replace another solvent.  So this was brought up at our previous peer review, is there are always changes in formulations in the market; and, depending upon selection of what's the best propellant, what's the best for whatever purposes, things change.
                  So we are trying to anticipate.  We're looking at the uses.  We're looking across our assessments at these conditions of use and doing the best predictions that we possibly can when we formulate the conditions of use, which we took comment on previously -- and again, a year ago to now, things could change.  But we're still trying to anticipate all that in our assessments.
                  So we appreciate your comments.  And if you have any data, we really would appreciate data that would help inform or help expand that particular analysis for that condition of use.
                  DR. KENNETH PORTIER:  Dr. Gilbert.
                  DR. KATHLEEN GILBERT:  I was interested in the exact same question, as far as 1-BP in spray insulation.  And I just Googled it and I found several that you can buy commercially that have 1-BP in it.
                  Then I also looked at the insulation, the boring insulation, which is made by -- Dow is one of the biggest proponents of that.  And they very proudly say on their website that THERMAX, which is their version of Polyiso, is used in like 70 percent of commercial and residential housing now, for wall and attic insulation.  So it sounds more extensive.
                  You can find companies that will sell you insulated packaging for shipping that are lined with Polyiso.  So, to me, the insulation issue seems to be sort of underrepresented in this document.
                  DR. KENNETH PORTIER:  Good point to note.
                  Mr. Kaufman.
                  MR. ALAN KAUFMAN:  Thank you.  I was just going to make a comment on the blow-in insulation, that the ones that I'm familiar with are not polyurethanes.  It used to be cellulose, blow-in cellulose, and that's fallen out of favor because obviously it's flammable.  Most of them are glass fibers now.  And the reason for the hazmat suits is because it's a mechanical irritant.  You don't want to be breathing it or get it on your skin.  But I wouldn't expect it to contain 1-BP at all.
                  DR. SHERI BLYSTONE:  Excuse me, this is Sheri Blystone.  Just to comment on that, polyurethanes are absolutely used in spray foam insulation.  The blowing agent I don't know is       1-BP.  I think what we've heard there is no evidence that that is the blowing agent.  I worked for a company that did that.  I don't recall us using      1-Bromopropane.  So I think it's fairly -- but it is absolutely a use, spray foam.
                  DR. KENNETH PORTIER:  Dr. Bennett, you got all this?
                  DR. STEVEN BENNETT:  I hope so.
                  DR. KENNETH PORTIER:  Good.  Any additional comments from the panel, from panelists on the phone?  I'm ready to move on to Question 4.  Not hearing any, I will bring up Question 4 and let's move forward.

                               CHARGE QUESTION 4

                  DR. KATHERINE ANITOLE:  Question 4, Environmental Hazard and Risk Characterization.  Section 3.1 and 4.1 of the Draft Risk Characterization.  Reasonably available information indicates that 1-BP exhibits a moderate environmental hazard to aquatic species.  A screening level analysis of potential risk to aquatic species indicates that expected environmental concentrations are below hazard thresholds for aquatic species.  In addition, a qualitative consideration of physical chemical properties and the conditions of use in this draft risk evaluation indicate that risks to sediment-dwelling invertebrate species and terrestrial species are not expected.
                  Question 4.1:  Only a few environmental test data endpoints, including ECHA, are available in the public domain for 1-BP.  Most are from the ECHA website.  EPA attempted to obtain the full ECHA studies with no success.  Since the studies were in French and Japanese, and no U.S. sponsor, EPA decided not to make further attempts to find the studies.
                  Given that the ECHA environmental test data results are in the public domain, EPA decided to use the environmental data.  Please comment on the reasonableness of this approach for the environmental hazard assessment of 1-BP.
                  Question 4.2:  EPA determined that there are no environmental risks based on a screening level assessment of risks using environmental hazard data, TRI exposure data, fate information and physical chemical properties.  Please comment on the approach used in the screening level assessment.  Are there other data that EPA could have considered?  If so, please provide specific data and references.
                  DR. KENNETH PORTIER:  Okay.  Dr. Doucette, before we jump into this question, I just wanted to let the panel know we're not going to move on to Question 5 if this question -- which I think is going to get some pretty good discussion -- goes short.  Sometimes the panel is ready and gung-ho, but I don't think we're ready to jump into the human head.  We want to be fresh on that.
                  So we're going to take the environmental hazard and risk characterization and we're going to work it very well, and then that's going to be the product for today.
                  Dr. Doucette.
                  DR. WILLIAM DOUCETTE:  This is Bill Doucette.  So what I've tried to do is just kind of summarize things in bullets, to kind of facilitate the discussion and I'll provide more detailed comments in the report.
                  First of all, I'd just like to thank the folks from EPA.  I thought this was a much more refined document than the PV29 that I was first involved in, and I really appreciate that.  I also appreciated the uncertainties and limitations slides each time, because I think that helps me put things in perspective also, and it was fairly well documented.
                  I'm still having a little bit of difficulty understanding why spills to subsurface aren't considered a potential release to the environment when stormwater releases to surface waters were considered.  And in talking to my colleague, who's been involved in a lot of dry cleaning facilities -- granted, there's not as many as there are for the chlorinated solvents -- he was aware of leaks and again this issue of vapor intrusion into homes near the mom and pop dry cleaning facilities, and the whole idea of soil vapor movement and things like that.  I'm still struggling with why we don't consider that as a potential source, even though I understand that regulatory we're going to deal with it as a toxic air release.
                  Not to make a mountain out of a molehill, but I was involved in a TCE contaminated site where we actually looked at the risk of TCE vapors to burrowing animals as an ecological risk point.
                  So, again, I'm struggling with that, but I'm not going to belabor that anymore, other than I still think there is that potential environmental route of exposure that might be considered.
                  Also the idea of looking at more data rich solvents like TCE, PCE, benzene, that are very similar in chemical properties, maybe not in terms of persistence; but to help put things in perspective I think would be nice.  And as a matter of fact, I kind of wish we would have looked at several of those solvents together if we're going to do another packet of compounds.
                  I mentioned the consumer products as a continual source of material into the indoor environment, not necessarily related to the environment that we're supposed to be talking about.  But if that's a source, it's eventually going to get out.
                  These are general comments.  Avoid -- I think -- who brought this up as far as the low, medium and high solubility sorts of things?  I think it was over there.  And it was much better than last time, because there was also inconsistencies between the physical, chemical properties.  And it's always difficult to describe something as high, medium or low unless you actually put that value behind it, and maybe not even say high, medium or low.  Just say this is the solubility, and then you get rid of all those sorts of potential inconsistencies.  Just a thought.
                  When you talk about something being highly volatile, I go over this with my student in my environmental health or fate courses, it depends on the phase.  Vapor pressure is a great descriptor if it's spilled on an inert surface or in a beaker.  If it's not so good if it's spilled onto soil or activated carbon and all those sorts of examples.  So it's not so much that I worry about the overall assessment, is that at least the terminology should be a little bit more precise all the way through the documents.  It just makes things -- you're less open to criticism if you do that.
                  So, again, volatility depends on the phase, and it also depends on the environmental conditions.  And all the parameters that are given in terms of physical chemical properties, or almost all of them except the persistent properties, are equilibrium distribution, and they say nothing about rate.  So there are times where we refer to volatility when we're really talking about decision between two phases.  And I think it's just important to be correct.
                  There were also several assumptions talking about zero concentrations in a phase.  There's never zero concentrations in a phase.  It may be small.  But even if we look at the last go-around with this that you did in 2016, the Fugacity Level III model was presented, and there are measurable percentages in soil and sediment depending on the release scenario.
                  So, to say that there is zero in a particular phase, maybe from a practical sense that might be true; but really it depends on the inputs relative to the outputs.
                  So, again, it's more of a terminology sort of thing than anything else.  And partition coefficients is still equilibrium.  And you can't use an equilibrium partition coefficient to describe whether or not something is going to be there in no concentration, because it's always got to be there if you're assuming equilibrium.
                  The other thing that -- again, related -- and these are very generic, and I'll have some specific ones, and I'll try not to take up too much time.  But there was a statement made that we're not going to consider soil an issue to terrestrial organisms because it has a low Koc.  And I think that's a reasonable assumption to make, but you need to keep in mind that even a Koc of 40, which is relatively low in the grand scheme of things, means there's 40 times more of the compound in the organic matter associated with that soil than there is in the water.  And so, again, it comes back to properly using the terminology of equilibrium partition coefficients with respect to what I'm trying to say.
                  There was also a statement in there about dry soil sorption.  If the soil is dry, the assumption was -- since this is -- if I remember correctly, the way it was quoted, the idea was it's reasonably soluble in water, and if the soil is dry, it's not going to sorb to the soil because there's no water there.
                  Well, that's exactly the opposite for most volatile solvents, is that there's actually more sorption to dry soil than there is wet soil.  So there's just some things like that, and I'll provide references, that I think just the accuracy could be a little bit better.
                  As far as the things specifically to 4.1, the environmental test data endpoints we were supposed to look at, there was really only one study that was highly evaluated, and that was the fish study -- which was interesting because I actually worked at that lab for Larry Brook and Dan Kolub (phonetic).  I guess it was probably five years before they actually did this study.  So I'm familiar with that group and they do wonderful work.  But I also remembered -- so I decided to go back and look at that.
                  So this was the key study.  Everything else was really extrapolated from that.  There were ECHA studies that talked about toxicity to daphnia and other organisms and algae, and I talked to Dan a little bit over this.  But this was the key study.  And the reason that I could justify using the ECHA data was because it all seemed to intercorrelate well with this result.
                  So then I wanted to go back and look at that fish study.  And I'm not a fish toxicologist, I'm a chemist.  But it was interesting.  The first thing I did, of course, as a chemist is you look at the analytical data and how they did that, and would I consider that a key study or a study of high quality when I looked at that.  And the only information they provided within that document, that long document with multiple chemicals in there, is either they used gas chromatography by direct injection or liquid extraction, or they used HPLC.
                  For 1-Bromopropane they should be using head space -- you know, there's a lot of techniques.  So that makes me doubt a little bit the quality -- even though I was involved in some of the earlier analysis, it makes me doubt the quality of the exposure concentrations for that particular fish study.
                  Now, granted, chances are that these concentrations that they measured then were probably actually higher to the organism than what they reported.  So that may be an okay thing in terms of being conservative or not.  But the criteria that was used to qualify that as a high-quality study, as an analytical chemist, I wouldn't view it that way.
                  So it's just something to -- again, that you've got to work with the data that you have.  But that stuck out to me.  And I don't know, hopefully some of the other panel members will talk about the quality of the study.  But everything was based really -- that was the grounding piece of information that allowed me to use the ECHA data.  I don't know how everybody's going to feel about that.  Hopefully we'll get some feedback.
                  I do agree that there's relatively low persistence in the environment based on -- although it's not readily biodegradable, there is evidence of biodegradation aerobically.  It is one of those compounds that should undergo hydrolysis and photolysis once it reaches the atmosphere.
                  There was a table that was given in the summary looking at what was -- in terms of physical chemical properties, what was considered high quality data and what was considered low quality data.  And I found it interesting that all the EPI Suite estimates were considered high quality, and there was one -- I think it was on the hydrolysis, which I think was 26 days, that referenced a classic publication, where most of the QSARs were developed for hydrolysis that was given low quality, and I wasn't sure exactly why.
                  I favor estimated values over what I think was an experimental value.  And there are reasons for that.  It would have been nice to have a little bit more information on that.  Then also within the EPI Suite estimation routines, there are multiple methods usually within all those properties.  And it would have been easier for me if that would have been specified, whether I used an octanol water partition coefficient to estimate Koc or I used the molecular connectivity indice to estimate that, just so I know.  And that gives me also a better feel for where I think the air associated with that is going to be.  And those were considered key and high properties for that.  So it's very important to be transparent in how that was done, at least in my opinion.
                  The other thing that came up from several members, including our chairman, was the assessment factors.  Again, hopefully somebody else will address this that's a toxicologist, but the assessment or uncertainty factors, whether one, five, ten.  I found a couple papers that for pharmaceuticals, obviously not related, that used 100.  So I think for the most part it was fairly well documented, but I missed it in a couple places.  It would be nice if I got hit over the head with that a little bit better.
                  The TRI data, we'll have some discussions whether that's conservative or realistic.  It's just something to think of.
                  And then let me see.  I've got to scroll down to the next one.  So that was kind of addressing 4.1.  Again, the fish data and the other data, hopefully other panel members will discuss.
                  In terms of 4.2, there really isn't any measured environmental data to speak of.  Several of the key properties that were used to estimate fate were obtained from book chapters, and not the original reference.  Merck index was used for most properties, not what I would consider key references.
                  I'd come into this after the PV29 thinking ah, there's going to be tons of environmental data for this particular compound.  And there doesn't seem to be.  Most of the key properties were actually estimated.  It's that minimum data set question to feel good about it.  But anyways, that's just something I noticed.
                  There were a couple of cases, for example, the biodegradation data, and the hydrolysis data, and even the photolysis data, where data was pulled from a reference.  Since I used EPI Suite for some of the key properties, it would have been nice to actually have both the experimental data and the EPI Suite data side by side to see how well they corresponded.  Because there are -- particularly for hydrolysis and biodegradation, that would have been nice to put together.  It would have helped me feel a little bit better about the experimental data, too.
                  Again, I brought this up, but the idea of analog comparison.  Again, I don't know that -- well, I know that TCE and PCE and benzene are not the same as 1-Bromopropane, but they are very similar in physical chemical properties, and they're a lot more data rich.  And it might help just to kind of put things in perspective for the -- certainly that's what I do when I look at the data for 1-Bromopropane, is I want to compare that relative to compounds that I know have more data and I have more experience with.
                  So, with that, I'd like to open it up to my other discussants.
                  DR. KENNETH PORTIER:  Dr. Blystone.
                  DR. SHERI BLYSTONE:  I sort of volunteered for this question, thinking naively that I'd be able to get some value out of ECHA database that nobody else could find.  But that's not true.  But I will take this opportunity to -- so that was really my interest in this.
                  I think this runs squarely into the problem that we had, even with PV29, that there are studies out there, there's commercial values associated with those studies; and until we resolve that question, you're not going to get the full studies, if there's no commercial incentive to provide those to the Agency.  There was certainly no legal requirement to provide them.
                  Imagine if there was a way to get that data that didn't adversely impact the commercial value of those, that perhaps that would be an opportunity.  Other than that, I agree.  I don't have anything to add to what Bill said.
                  DR. KENNETH PORTIER:  Dr. Cobb.
                  DR. GEORGE COBB, III:  Thank you.  I agree with much of what's been said here.  I will maybe start the conversation about the adjustment factors.  To me it seems like an adjustment factor of ten for a chronic value that's based on one acute value and an acute to chronic ratio of ten.  Probably too low because you've got uncertainty -- excuse me, an adjustment factor of five for a known value for the acute.  So it doesn't seem to me that you can have just 2x more than that for converted value.  But I'm going to, again, leave that to the toxicologist to speak to more later.
                  Also the epi study that was used to develop the hazard quotient has 95 percent confidence in that report -- or at least in that summary.  It also has a NOEC, and neither of those are presented in this assessment.  Again, perhaps in the absence of any other data, you would err on the side of conservativism and go with one of those lower bounds.  The highest toxicity was predicted to be 17.7 milligrams per liter, and the lowest toxicity of 33.3.  That's the 95 percent confidence bound.  And then the NOEC predicted to be 1.77.  And those look like factors of ten.  But that's probably where the doses were set at.
                  Sorry I'm reading through these.  I'll echo something that Dr. Doucette said about the volatilization from soil or the contamination of soil.  I think that's possibly a place where we definitely need some clarification and addressing in the risk assessment.  I know you haven't had any time, but the .93 milligrams per liter for the algae is still not addressed, how that was determined not to be used in the assessment.
                  I maybe can talk to Bill about this a little bit more afterwards, but the degradation   half-life of 1-BP is estimated to be one to twelve days in the atmosphere, which maybe sets the lower bound of exposure as what's being released rather than that being the exposures.  So there's probably a way to model that to what the exposure would be if there was a continuous release.
                  Also as far as the HAP assessment for atmospheric exposure, data from that assessment should be considered here to assess what people are actually being exposed to, because we're being exposed to -- especially workers are being exposed to something at work and then they're also being exposed at home.  Or as they're driving around their neighborhoods, those kinds of things should be considered or we're not protecting those populations.
                  Finally, maybe I should ask this as a question.  It seems like if these compounds are used in insulations, and they are used in cleaning computer products, that schools and exposures in schools are important for children.  And I'll leave it at that.
                  DR. KENNETH PORTIER:  Dr. Schlenk.
                  DR. DANIEL SCHLENK:  Thanks.  So I'll just kind of go through 4.1 and 4.2 separately.  I think Bill did a great job sort of describing the fate issues.  I tend to agree, and almost verbatim said the same sort of things.
                  With 4.1, the ECHA documentation, it seemed to me the question was is it okay to use this data.  And I would say definitely.  Given the paucity of data that we have for any of the other compounds, I'd say use whatever you can get, within reason obviously.  But particularly in this approach, I think it's definitely warranted.  Particularly at least in a weight of evidence approach.
                  In fact, we talked a little bit about the exclusion of so many articles and references.  This is a great example of why maybe we shouldn't exclude so much, and that they can be used in a weight of evidence sort of capacity.  Because there's definitely some papers that I found when I did a CiteFinder search that were not included even though the number was there.  And I'll talk about that here in the effects side of things in just a bit.
                  I've always been puzzled by the exclusion aspects of literature.  I know there's criteria that you have to use.  But I think as an academic, I think all the literature has some value, even though it may not meet some standards.  But this is a great example of a language requirement that could be easily remedied.
                  In fact, I've been on like 30 of these things, and I know we've had Canadian scientists as ad hoc members.  If the French study was that important and data is so hard to come by, it would seem to be that would be a no-brainer to bring some of the French, you know, Canadian guys on board.  Even if it were for that one study, they could still evaluate the same things that Bill and I are actually doing.  Japan, obviously, is a bit of an issue, but I do know we've brought people from overseas, at least on FIFRA panels.

                  UNIDENTIFIED MALE:  There's also Google Translator.

                  DR. DANIEL SCHLENK:  Yeah, there's that too.  Google Translator works well.  Dear translator works well, too, I just found out.  So, anyway, that's my 4.1 comments.
                  4.2, I kind of split this into exposure and effects sort of components.  First of all, a conceptual model.  Again, this was the same thing that came up with some of the other compounds a month or two ago.  But if this compound is an insulation and it's at five percent, that seems like a pretty high concentration.  It would seem to me that landfill would be another significant environmental source, particularly for leachate.
                  If the compound has a log Kow of 2 and it does have that water solubility component, there's definitely potential movement into waterways from that.  Especially given the stormwater episode for the TRI, I would think that landfill would be another sort of source that was there.
                  Again, I know you don't have data for this, but it would be something to include in at least the uncertainty analysis at the end.
                  Based again upon Bill's comments, a log Kow of 2 still represents 100-fold more likelihood that this compound is going to be in inorganic media versus water.  So even though the VCF is predicted to be low, I think you still are going to see issues related to that, as well as size.  I mean, that's the other thing when I teaching ADME, is it's not just -- the felicity it's not just charge.  It's size and it's a small molecule.  So again, at least partitioning into organisms, you might be a little bit underestimated there.
                  I'm not convinced these compounds don't partition into sediment.  But again, we were told not to recommend research studies, but to identify research gaps, and this is definitely a research gap, that at least a registrant or a manufacturer should be able to remedy, perhaps, if that were possible.  I would sort of estimate, again, it's pretty well biodegraded.  But again, there's some uncertainty there with that.
                  So the good news is -- I would say, you could look at this also half full.  The good news, having been here three years ago, there was zero on environmental relevance, which was pretty boring for me.
                  But the good news is I really appreciated the water exposure that was provided by TRI, so that was obviously the good news.  I'd recognize it did represent a worst-case scenario with a range of values really dependent upon water volume, at least in the E-FAST model.  And I talked a little to Dave about this as well.  It seems that that seems to drive the concentrations that are actually predicted.
                  I guess my only concern with that, kind of boils down to what Bill mentioned earlier, is the nomenclature and the upper end number.  I'm more comfortable with a percentile number, that if you're going to say this is the 90th or 10th percentile, whichever way you're using it in that regard of exposure, this gives a little more credence to the number instead of saying that.  I like that you presented the range of values that was there.
                  So that's the good news.  The bad news, obviously, was that you have one facility and that value is based on stormwater, which probably -- I'm not sure that represents a real world sort of exposure scenario.  I'm guessing most of this would come as a point source, input from a facility.
                  So that's the bad news, is you've only got the one point.  And I recognize it's the only data you've got.  One issue, one thing I would recommend, it sort of goes to Bill's issue, is there's a ton of halopropane concentrations that are measured in MPDS data that's out there.  I don't know what it takes to go into that.  I just emailed my colleague at L.A. County San, that they measured nine different halopropane compounds.
                  So, using those values, you might be able to at least get at an estimate of what's there, at least as an exposure side of things.  Again, just something to throw out there as a possibility to enhance your data set.  And again, these compounds have very similar physical chemical properties, and it would be nice to -- I think you can make that comparison.
                  On the effects side of things, and this was mentioned before, I honestly think that the methods were appropriate given the data that you guys had.  Using the safety factors and AFs, that's a standard practice using the ten and ten, and the two and five.  I understand that is the case.
                  Again, it's a tremendous amount of uncertainty, and this will deal with Question 6 or 7, whatever it is, from the risk characterization side of things.  I just thought that needed to be a little bit more described, that this is really, really uncertain, that you're basing this on one value, and there's some huge data gaps there, particularly when you don't have any reproductive or developmental data here.  And again, these are huge data gaps that need to be filled by somebody.
                  The other thing that I found lacking -- and it kind of goes back to the CiteFinder search, there's some pretty solid papers out there on QSAR AOP-based methods that could have predicted at least more acute data that could have been utilized in the assessment.  Again, given the investment the Agency has made into adverse outcome pathways, I'm shocked that that hasn't been utilized as much, even -- not only for the eco side, but also for the human health side, talking about some of the mechanistic tox data.
                  I do recognize the MOA is in there, but the AOP stuff still is lacking.  And I'd mentioned that three years ago too, as well.  So I'm happy that you included the water stuff.  I'm still a little bit disappointed the AOP stuff is not in there.  I'll provide those references, as well, for the AOP narcotic agent acute data.
                  Again, yeah, given the mammalian toxicity data where we do see reproduction and developmental neurodevelopment being sort of targeted, it would seem to me as zebrafish assay would be a really, really good thing to run on this, at least for the eco side, as well as maybe the mammalian side just to confirm.  I recognize we're not supposed to recommend research, but those are things that would be good to have.
                  DR. KENNETH PORTIER:  Dr. Twiss.
                  DR. MICHAEL TWISS:  Thank you.  In response to Dr. Schlenk's comment about the French language, we have someone on the panel who speaks French. I did my doctorate in French.
                  And so I'm going to answer in response to these specific questions where I felt most comfortable speaking about.  And with respect to 4.1, it becomes a question of trust, trust in science.  We all agree that the EPA must use the best science available to support its conclusions.  And the application of a robust critical review of the available aquatic toxicity studies to select and use only those of high quality is an example of this approach.  And that gives the public confidence that the EPA is indeed using the best science available.
                  An example of that, they took 147 studies and just pulled it into one.  However, neglecting studies due to them being written in a foreign language and not having a U.S. sponsor, I believe is illogical.  And as was mentioned this morning by the woman from the University of California San Francisco, it's a non-empirical based scoring system.  So it just doesn't fit the way that US EPA wants to be selecting these studies.
                  So those documents in the ECHA database should be examined fully to see if they're usable, especially given the fact that so few acceptable studies are usable.  One out of 147.  And the fact that data from the ECHA set of studies provide results in support of the single study on aquatic toxicology that was deemed of high quality, yet remembering the comments made by Dr. Doucette, to justify the use of ECHA data derived from studies that were not examined in detail is not a powerful approach, and therefore seen as an unreasonable approach.
                  Similar statements made in the public this morning, and in the submitted written comments that were received, and I'm pointing outlined the Environmental Defense Fund, Earthjustice and Dr. Woodruff, as I mentioned from the University of California San Francisco, support that view.  Thus, the public confidence in this approach is rightly not very high.  So there has to be some effort to examine those data.  You just can't blow them off, especially since, this was mentioned earlier, there's such a paucity of data.
                  With respect to the second question, 4.2, the uses of 1-BP have destined to atmospheric waste disposal fallen or during use rather than entering surface or groundwater by any other means other than accidents or leakage and spills.
                  Although the solubility of water is moderate, two factors prevent it from accumulating to its maximum solubility in water, notably its high volatility and low partition coefficient to organic matter, both dissolved and particulate.  And also, I'm aware of the criticisms of considering just that by Dr. Doucette.
                  The estimate of surface water concentrations in those two rivers in Texas, where the Nueces River and some unnamed water body is conservative, and that did not assume any degradation in the water, assumed low stream flow discharge, and assumes a total annual discharge occurred in one day.  So the estimated concentration of surface water under these conditions would be very low, at least considered to be 70 parts per billion.
                  And I think that's kind of what it would be.  I don't think it should remain high because of it's going to want to leave and get into the atmosphere.
                  Looking at some other references, note that the USEPA Great Lakes National Program Office supports the Great Lakes Fish Monitoring Surveillance Program.  And they measure legacy organic contaminants and chemicals of emerging concerns in fish flesh in the Great Lakes.  And the Great Lakes is a region that's suffered from environmental discharges from the population of 35 million people living in the basin.  So anything that bioaccumulates should be detected in fish.
                  And the PI of that program, Dr. Tom Holsen, I spoke to on the 27th of September, and he says it's not something that they measure in fish flesh or monitor it.  And they would know because they scan for a screen of compounds.  So that's somewhat heartening.  That's all.
                  DR. KENNETH PORTIER:  I have a question for those of you who've already commented.  Earlier this morning there was sort of a discussion about the ECHA data that brought up the issue of the green algae.  And on page 138, the report says, "Secondly, one additional study with green algae was identified in the ECHA database which was not presented in the June 2018 problem formulation.  These updates do not affect the preliminary conclusions of the screening level analysis presented in the June 2018 problem formulation.  So the preliminary conclusions that additional analysis of environmental hazard remains unchanged."
                  And I wanted you guys to comment on that, that incorporating the -- it sounded like the algae were much more responsive to this chemical than the fish were, but that was disregarded.  Any comments?  Dr. Cobb?  Or Dan?  Dr. Schlenk.
                  DR. DANIEL SCHLENK:  One comment you can have on this is that -- I mean it's not very common to include a chronic algal value that's there.  So they're actually including a chronic fish value that essentially kind of says the same type of thing.
                  So if you've got the chronic fish value that's not showing any effect, then oftentimes that can -- the conservatism that's present in that would sort of provide enough safety to sort of oversee the algal effects.  But that's how I kind of look at that.  I don't know if anybody else has something to add.
                  DR. MICHAEL TWISS:  I'd have a hard time with considering chronic exposure in algae, considering they kind of reproduce rapidly and they will evolve in a flask over a week.  And plus these ECHA data aren't -- we don't have the studies available to us to criticize whether or not they were done properly.  So I don't think we can discuss the number.
                  DR. DANIEL SCHLENK:  That's a good point, actually.  Because I think they were actually using it to confirm the Geiger study.  So that was kind of the primary use of that.  Wasn't necessarily to set it as its own standard, which is another reason I guess you wouldn't use the algal study.  We don't usually do chronic algal studies, so that's just not a --
                  DR. KENNETH PORTIER:  Okay.  Just wanted to kind of get that on record because I did hear that kind of as a criticism this morning; and I wanted to get the feel for it.
                  Is there anybody else on the panel who wants to comment?  Dr. Doucette, you wanted to keep going?  I think we've got a clarifying remark from EPA.  Do you want to jump in at this point?
                  MR. GARRETT JEWETT:  I just wanted to clarify quickly what you were saying.  Hearing those words back at me, I realize this may be not as clear as it could have been.  So regarding that algae study, we did incorporate the algae study into the assessment.
                  What I was trying, I guess failing, to say, was that since the problem formulation where this screening level analysis was initially proposed, since the publication of that, another algae study was identified in the ECHA database.  So that was just mentioning that if you're reading the problem formulation and you saw this screening level assessment, and then you jumped over to the risk evaluation and you saw, oh look, there's another algae study in there.  Where did that come from?  It was just clarifying that that's where that additional endpoint came from.
                  DR. KENNETH PORTIER:  I didn't read it like that at all; but thank you.
                  Dr. Doucette.
                  DR. WILLIAM DOUCETTE:  Just a little bit of follow-up, I guess, to several comments that were made and the whole idea of water concentrations, bioaccumulation and those sorts of things.  I totally agree that it's relatively low.  But again, that log Kow of 2 is a factor of 100.  And oftentimes you just look at Koc and Kow as being equivalent.
                  The other thing that's important to remember in all these things is it really depends on the rate of input relative to the rate of output.  And I've been on -- one, two, three different sites -- and again this is TCE not 1-Bromopropane, where we were actually worried about things in surface water, not because it persisted very long, is because the input was greater than the volatilization rate.
                  It was a relatively stagnant pond.  It had a lot of biological material that actually served to help restrict the volatilization, and the concentrations were close enough that we were actually asked to go and measure them because they were close enough to suspected toxicity values.
                  So I think that it's nice to look at some of these partitioning values and make general references to them, high or low or medium, but you have to be careful.  It's really a dynamic system and it's kinetics, which we don't get from that.  So there are cases where the input is greater than the output, at least for reasonable periods of time.
                  We also showed for a TCE cite that it bioaccumulated into earthworms with C14 labeled.  Even though -- again, TCE is not the same as this compound, but it's similar enough that I wouldn't be surprised under the right circumstances that we could see that.
                  So, again, it's just being careful -- in the terminology that is used to give blanket statements that there's nothing there, there's no risk or no chance of environmental concentration, it really depends on the situation and input versus output.  Sorry for getting on my bandwagon again.
                  DR. KENNETH PORTIER:  I think, Dr. Schlenk, you wanted to comment.
                  DR. DANIEL SCHLENK:  Yes, I couldn't agree more in terms of your comments, Bill.  I guess the question is here -- I mean these are things that I think need to go into the uncertainty analysis.  Because obviously the data that they have is so limited.  It's really, really tough to do that.
                  But the movement question is definitely something I think needs to be addressed, at least for those log Kow(2) compounds, because they're definitely absorbable and movable.  But again I think this is something that should go into the uncertainty aspects that are there, for future studies or whatever.
                  DR. KENNETH PORTIER:  Mr. Kaufman, is your flag up for a comment or just left up?  I thought it was a legacy.
                  MR. ALAN KAUFMAN:  Sorry.
                  DR. GEORGE COBB, III:  Since we're mentioning uncertainties, it's my preference or perspective that those uncertainties should be included in the adjustment factors or the uncertainty factors earlier, rather than just spoken to as uncertainties later.  And towards the comments about the algae, that was me that started that.  I agree with the agency, that even if you put them in, you would not get to a higher quotient over 1.  So we're totally in agreement there.
                  I guess my point was more towards future assessments.  If we're not trying to protect algae or if that chronic assessment's not going to be something germane to protecting algae, just state it up front and be done with it; rather than including it and then saying we're not going to assess it because of not protecting fish.
                  Then, finally, to wrap back to something Dan said about what other data could or should be used, I think some data should be gathered by the trade organizations or the industries to inform these exposure assessments.  And that's really the crux of the issue, is those data aren't available.
                  DR. KENNETH PORTIER:  I want to reiterate something that Dan said on the adjustment factors.  I know he and I talked about it and he says, well, these are standard and well understood, but they're not well documented in the report.  Because I looked at him.  I said, "Where did that number come from?  I couldn't find it."  And I kind of came to the same conclusion, well, that's just a number they used.  And I think that's what you said, this is the number we used.  It would be nice if that were a reference to where the heck that number came from.  Dan.
                  DR. DANIEL SCHLENK:  Just one other thing I forgot to mention with Bill's comments.  There is a term, in terms of the input that we use for pharmaceutical input, and it's called pseudo-persistence.  And that's exactly -- I mean obviously it depends on the loading.  And given the volume of these, I'm not sure what the loading is that allows pseudo-persistence, but that's a terminology issue that seems to be coming up more and more, particularly with compounds that aren't supposed to be absorbed and aren't supposed to be persistent, but they actually are because of the loading issue.  So I just wanted to get that on the record.
                  DR. KENNETH PORTIER:  Dr. Johnson.
                  DR. MARK JOHNSON:  I heard others say this and I just want to reiterate, I think it would be useful to do some in silico projections.  I think EPI Suite has got a model to do this, right, where you can compare your refined value, using the adjustment factors, to what the QSAR would predict.  If they corroborate, then that would be very nice if that were to happen.
                  Just a quick comment.  There's a paragraph -- actually it's a sentence on page 141 -- that talks about concentrations.  If we could normalize that for units, that would make it a whole lot easier for interpretation.
                  In other words, we always do milligram per kilogram per day for human health.  It would be good if we kind of did that and just used exponents just to be able to understand exactly what was done in these calculations.
                  DR. KENNETH PORTIER:  Any additional comments?  Committee members on the phone, any comments?  Are they still there?
                  Seeing no comments, I'll turn it over to EPA for any clarifying questions or comments.
                  DR. STANLEY BARONE, JR.  I have two process issues that I wanted to clarify on, and one clarifying question.  The first process is I heard Dr. Blystone talk about the data issues.  And then I think there's some -- maybe some misunderstandings about what the data is and who owns the data.  So I wanted to talk a little bit about that, because it's not just this case, but it's going to be other cases.
                  In FIFRA, we have 10(g), which is a particular element of FIFRA where data owners can get remuneration for the value of their data, others can use their data in a submission package.  We don't have that under TSCA. So that's one issue, background issue.
                  Then the other issue is the ECHA database.  The data, robust summaries, is what's provided to ECHA.  ECHA doesn't own that data.  The companies or consortia own the data.  And so if there's not a U.S. sponsor or a U.S. company in that consortia or owning that data, we don't have direct access to get that data.
                  So it's not like we just oh, go take a French translation of a study or a Japanese translation of a study and translate it.  It's not like it was published in French or Japanese and we can just translate it at will.
                  So there's a couple of process issues we're still trying to work through.  And even with our colleagues across the pond and in communication with their registrants, encouraging conversations to proffer this data, offer this data to us, to reduce uncertainties and provide more transparency.  There's some things we have not worked through, because of the way -- we have different statutory authorities.   And some comments -- oh, just sue or just use all your TSCA authorities.  Well, if it's not a U.S. company, it's not a U.S. entity.  There are some real challenges here.  So it's not as simple.
                  Then we're trying to do a risk assessment on a schedule, three-year schedule.  And again, this is a little more protracted because this is a do-over.  We started this back in 2014.  And then TSCA happened, and then we did it over.  So we've had more time on this particular one.  So I just wanted to lay that out as some background.
                  There was also comments made about, oh, well, we can just have a non-U.S. citizen or a foreign speaker as part of this panel.  Well, actually, we now have regulations that limit peer reviewers on our panels or have limitations to our FACA committee composition.  You have to be a U.S. citizen or a Green Card holder, and there are some very rare exceptions where we can have foreign participants in a federal advisory panel.
                  So it's not so simple.  And as was pointed out, it's great when we have foreign speakers, U.S. citizens, on the panel who can actually read and interpret and advise, but that's not -- you just can't go get the world experts like we used to do.  And the DFOs know about this and know the limitations that this has caused in the constitution and makeup of ad hocs and of standing panels.
                  And that's a relatively recent development.  Some of you who've served on federal advisory panels know that it hasn't always been that way.
                  So I just wanted to put some of this process stuff out there for you to understand.  It's not because we're not trying.  There are process issues and regulatory issues that we have to work with and work around.
                  Now I'm going to shift to the science, and I actually have a clarifying question.  And this goes back to discussion about mode of action and AOPs, and I heard Dr. Schlenk speak to the Agency's investment in AOPs.  We don't have a lot of quantitative AOPs, very few in fact.  But your guidance on which AOP you were actually referring to in your comments, and how you think that might be applied, would be very, very helpful, to bolster this.
                  And again, this kind of gets at Dr. Doucette's comments about reading across and looking at similar compounds and building the evidence with other compounds.  And again, that's why the Agency and other agencies are investing in AOPs.
                  So more constructive comments on that will help us, not just for this chemical but for other chemicals.  So I appreciate that discussion.  We do.
                  DR. KENNETH PORTIER:  And especially going to be good for tomorrow's discussion as well.
                  Dr. Blystone.
                  DR. SHERI BLYSTONE:  Just following up a little bit more on the ECHA database and the robust summaries.  I mean, that is publicly available information.  The robust summaries were designed to provide information without giving away the commercial value in the study itself.
                  So I think the question to the panel is, it is publicly available information that, in this case, EPA was unable to get the studies for.  Is the way that they used that appropriate, or should they just ignore that publicly available information?
                  And to me that's the heart of the question here.  It's like it is there, there is quite a bit of information in the robust summary to allow you to evaluate the type of data that it is.  It isn't enough to do a data quality evaluation.  You can't put it through systematic review.  But is it something that they should consider?  And if they did -- and as they did consider it, is that an appropriate use of it?
                  For me, I think it would be -- we're talking about why you throw literature out the window.  This is information.  It is relevant.  So, for me, it seemed like it was an appropriate use of that publicly available information to further inform this assessment.
                  DR. KENNETH PORTIER:  Any additional comments?  I think the panel is worn out.  This has been a long day, and tomorrow's possibly going to be even longer.  At this point I'm going to kind of call the end of the meeting, turning it over to the DFO if she has any additional comments, especially when we begin tomorrow morning.
                  MS. TAMUE L. GIBSON:  The only additional comment I have is we'll see you at 9 a.m. in Ballroom C.  So we'll see you then.  Thank you.

                  (MEETING ADJOURNED FOR THE DAY)
                        OPENING OF THE MEETING - DAY 2

                  MS. TAMUE GIBSON:  Good morning and welcome, everyone.  I would like to thank you all for participating in today's meeting for the risk evaluation for 1-bromopropane.  At this time, I will like to reconvene the meeting of the TSCA SACC.  As a reminder, I would like to indicate that the meeting materials are located on regulations.gov and the docket number and the website are noted on the meeting agenda.  I would like to now turn the meeting over to our chair, Dr. Portier.

                        FOLLOW UP FROM THE PREVIOUS DAY

                  DR. KENNETH PORTIER:  Thank you.  Good morning, everyone.  We're not going to introduce all the committee members because, I think, we know each other, and we did that yesterday.  There's less of a public here and all of that public was here yesterday, so they know our names.
                  I want to finish up with a few comments on Question 4 before we jump into Question 5.  I was talking to Dr. Kissel this morning, and he indicated that something in the discussion at the end of the day fired off some neurons.  John, it's not quite there, yet so I'm trying to stretch this out while his computer comes up.
                  DR. JOHN KISSEL:  I think I have it in my brain.  Well, I was going to present a slide which I don't have ready.  The discussion yesterday when Bill mentioned indoor air quality, it strikes me that for VOCs in the context of Lautenberg that there should be a general public consumer pathway for indoor air which is not -- that we've been arguing about HAPs and whether we'll ever get to that or not, but HAPs is a different issue and that's outdoor air.  The team study showed pretty clearly that indoor air -- for a typical person who doesn't live immediately adjacent to a production facility or a waste disposal facility, indoor air is a much larger source of VOC exposure than is outdoor air.  And it's because products are just generally in commerce and you take them into your house if you have aerosol cans, paints, all manner of things.  Wite-Out used to be -- the solvent in Wite-Out was TCE.
                  There were lots of ways that you could be exposed to VOCs from just buying things that were in commerce which I think is a large part of the inspiration for the Lautenberg Act.  Those data from Bayonne, New Jersey, which showed that so clearly, that's Frank Lautenberg's home state.  I think he was aware of that data.
                  I think this notion that there should be an overall accounting -- if you're going to sell chemicals in mass quantities in society, then you want to know, what are the consequences of that?  And one of the consequences is that everybody's going to have trace levels.  And we have heard that there is maybe a biomarker.  It has an asterisk on it because it's not specific, but there is reason to believe that everybody in society is getting some exposure to this compound.
                  We know that it's in some common products like insulation board.  And so, if it's in houses, then everybody's breathing some of it all the time, and those exposures may or may not be of toxicological significance.  But they are of significance in the context of the Lautenberg Act in understanding because basically the idea is that somebody should be accounting for chemicals in commerce and we should have some concept of to what extent we're being exposed to those things.
                  So, I think, for this VOC and for other VOCs, that should be part of the overall matrix.  The schematic of how people get exposed should include for things that might show up in common commercial products.  Indoor air should be in the mix because, I think, that's what the Lautenberg Act is all about or, I think, that's part of the inspiration for it.  And so, I think, we're missing something here, and the HAP argument is a little bit of a diversion away from where a typical American consumer might be actually exposed to this compound.
                  DR. KENNETH PORTIER:  Thank you, John, and you're going to provide this to the lead to add.  Is there anything else on Question 4?  Anybody wanted to -- okay, well, we're going to then proceed to Question 5.  Oh, I'm sorry.
                  MR. MARK HARTMAN:  Chair, so I heard the comments, and I think they're definitely an extension of what we discussed yesterday.  I'm not understanding if there's a recommendation there.  Is the recommendation to -- because we've already spoken to the issue of assessing consumer products and assessing insulation in the indoor environment, so I'm not sure what the recommendation is.  I'm paraphrasing.  I'm not trying to put words in your mouth, but is the recommendation about aggregate exposure assessment?
                  DR. JOHN KISSEL:  Well, I am an advocate for doing aggregate exposure assessment.  I think that maybe what I'm arguing for is an attempt to close the circle a bit about the -- so you've done modeling with CEM that says we expect these levels are showing up in housing.  The question is would those levels explain the urinary metabolite that's apparently widespread in the population.  Can you explain what those exposures might be?  So that biomarker might be coming from someplace else because it might be a different brominated compound, but this a 25 million pound a year chemical, and it would take a lot of other things to account for -- to be a similar kind of mass in general play in society.
                  And going a step beyond the -- this is just my general -- somebody mentioned -- I think Holly mentioned the merit of mass balances yesterday.  In exposure science, the object shouldn't just be to generate an estimate and say, okay, we don't have a problem.  It ought to be to generate an estimate, and then test the estimate against biomarker data and say, oh, not only do we not have a problem, we actually understand what's going on.  And, I think, this exercise falls short of that.  Just generating a number and saying that's what's out there needs to be proofed against whatever biomarker data you can find.
                  DR. KENNETH PORTIER:  This is Ken Portier.  Also what I was hearing was that what you've done is a condition of use, and you've looked at indoor air for one particular condition of use.  Then what I'm hearing from the toxicologist to say, but that may not explain the whole internal air issue.  Because of the other consumer uses, multiple consumer uses that utilize this chemical may provide less or as much exposure in the indoor air as that insulation condition of use.  Does that make sense, John?
                  DR. JOHN KISSEL:  Yeah, I think the foam board was one thing that we think is there, but there was still this issue of propellant in spray cans and how widespread is that.  Maybe it's not widespread, but there was an awful lot of, well, we don't really know.  You can make projections, and then you could take that to, well, okay, if people are breathing this much, then this is what should be coming out in their urine and is that a large number or small number compared to that biomarker that happens to be in most of the people in the United States?  And so, do we really understand what's going on?
                  I don't recall -- and I'm running behind today -- but I was going to look up 1-bromopropane as an indoor air pollutant, and I don't remember seeing it in some of the conventional compendiums.  But that could be not because it's not there but because it doesn't fall in the GC scan that people are routinely doing.  There's lots of reasons why things show up in the list of common indoor pollutants that aren't necessarily because they're actually the things we ought to be most concerned about.  So, I think, the exercise under the auspices of Lautenberg ought to be actually not just kind of check off a box and say, okay, we assessed this, and we didn't get high risk; it ought to be, do we really understand what is going with this compound?  Where it's going?  What is the life cycle assessment?  What is the life cycle of this compound?  And how much of it is out there?  How much of it is passing through human beings on its way into the atmosphere where it ultimately breaks down with sunlight?
                  DR. KENNETH PORTIER:  Yes, Dr. Blando.  Oh, I'm sorry.
                  DR. SHEELA SATHYANARAYANA:  I just wanted to say that I completely agree with John in reading these documents and listening to the discussion yesterday and just knowing the data that within NHANES and then with NCS, you have over 90 to 99 percent exposure and you know that that metabolite is in the metabolic pathway.  And then that's even further confirmed by the occupational studies where you see correlation with the exposures and urinary biomarker.  You could do better modeling of general exposure scenarios to better understand the risk.  And I felt like it was just written off in the discussion.
                  DR. KENNETH PORTIER:  That was Dr. Sathyanarayana, right?  Your name.
                  DR. SHEELA SATHYANARAYANA:  Oh, I'm sorry.  I didn't even recognize.
                  DR. KENNETH PORTIER:  Just remind the committee to say -- at least I tried this time.  I didn't say Dr. Sheela.
                  DR. SHEELA SATHYANARAYANA:  I haven't had a lot of coffee.  It's Sheela Sathyanarayana.
                  DR. JAMES BLANDO:  Sure, this is Jim Blando.  I would agree that, certainly, we want to understand all the exposures and, in particular, the consumer product exposures.  But I do want to just point out a concern that I had when I read the documents is the biomarker that folks are referring to, I don't believe, is specific to bromopropane.  So you can really have a lot of misclassification error of exposures and, I think, that's something that really just needs to be very well understood.  Perhaps I'm not understanding it, but my understanding is that biomarker's not specific.  So we would definitely need to understand what other compounds would be related to the presence of that biomarker.
                  Certainly, if you have workers that are working with bromopropane, you can easily make the attribution to that specific biomarker.  But, in the general population, if people are exposed to multiple chemicals, and this biomarker is not specific, you could very easily misclassify their exposures.  So I just think that's something that really has to be carefully thought out.
                  DR. SHEELA SATHYANARAYANA:  Can I just respond to that really quickly?  So I do think you can do that kind of modeling because you do know that it's a biomarker of other compounds, and you know those exposure levels.  And I feel like that level of modeling is not so advanced.  I mean, it's something that people do all the time.  So I do feel -- I understand that it's not a specific biomarker, but you still can do the advanced modeling with the other compounds.
                  DR. KENNETH PORTIER:  Dr. Gilbert, I think, and then Dr. Schlenk.
                  DR. KATHLEEN GILBERT:  I agree with what's being said.  So it may not be a specific marker, but in the document, which is going to read by many different sorts of folks, it says in there, all it says is, it may not be a specific marker.  And I followed it.
                  At one point, they don't have any references or explanations, and, at one point, they reference one of the supplemental documents.  So I looked in there, and it just said, basically, look, it's so widespread and we don't think 1-BP is that widespread, so this must be wrong.  It doesn't have any explanation.  It doesn't have any sort of rationale for that statement.  So, to me, if you're going to say that it's nonspecific when it's such a big issue as far as the public being exposed to it, then you'd need something to back that up as opposed to just saying it may not be specific.
                  DR. KENNETH PORTIER:  Dr. Schlenk.
                  DR. DANIEL SCHLENK:  We just looked up a paper.  In 1966, there is a metabolism paper of halopropanes -- iodopropane, 1-iodopropane, 1-chloropropane, nitropropane -- any one carbon propane is going to give you that metabolite.  I mean, it's just a basic metabolic biotransformation concept.  And it's not even going to be enzymatic; it's actually it's a substitution reaction for glutathione on those electronegative halo groups that are on that molecule.
                  And, again, we said this three years ago; all you've got to do is look at drinking water.  There are halopropanes in drinking water without a doubt.  There's one 2-halopropanes.  There's at least nine of them that are monitored from wastewater discharges.  So you know that they're formed by chlorinated byproducts.  I don't know.  It just seems to me that that's a fairly obvious one plus one equals two kind of situation where it's not specific.  I mean, chemistry is chemistry, I guess.
                  DR. KENNETH PORTIER:  Can you provide that reference to Dr. Blando?  Dr. Blando.
                  DR. JOHN KISSEL:  It should be possible.  One of the things that gets monitored pretty well is drinking water, and you ought to be able to do a mass balance on, how much of that stuff is drinking water, and how much of that biomarker could be accounted for that, and is there a missing piece or is there not?
                  In terms of -- otherwise, what is the annual production volume of those compounds?  This is a huge 25 million pounds a year are coming in.  This is a huge amount of material.  There aren't that many compounds out there that are produced in that kind of mass annual input into society.  And it might very well be that the drinking water would swamp, but, okay, work out the numbers and show me that.
                  DR. DANIEL SCHLENK:  Yeah, I mean, I can't do the mass balance, but, based on Bill's data the other day saying that you find chloropropanes in other things too, I'm just guessing drinking water's one possibility.  I've never done that, but I think it's a compound that is fairly prevalent.  And, again, that's just one.  And to try to identify every single halopropane that's present out there and try to do a mass balance, I think, is a little bit difficult to do.  I don't know.  It could be done, maybe.  I don't know.  But to try to identify a source of every halopropane and every -- and not even halopropane, even a cyanopropane is going to be on there.  Any nitrile propane is a prominent metabolite through that pathway.
                  DR. KENNETH PORTIER:  Dr. Blando.
                  DR. JAMES BLANDO:  This is Jim Blando.  I agree that I think it'd be great to do the modeling and really understand this issue.  I'm certainly not at all trying to discount that.  I'm not sure that 25 million pounds a year is a high-volume production -- an HPV, high-volume production or H -- whatever the acronym is, the High-Production Volume chemical.
                  But, from a public health intervention standpoint, the problem is, if you miss a tribute, a source of a pollutant, you may end up producing an intervention that doesn't get you to your goal.  If you have this nonspecific biomarker that's coming from chlorination disinfection byproducts, for example, and you spend a lot of money to control Wite-Out or to control consumer products, you may find that there's no change in the biomarker concentration at all because you're trying to control the wrong thing.  So I would agree with Dr. Gilbert that this seems to be an important issue, especially things that people have cited, so perhaps -- although I know we're not making research recommendations but perhaps -- that's something that would be worthwhile to really try to better understand, so we don't end up with an intervention strategy that's not going to work.
                  DR. KENNETH PORTIER:  To use Dr. Schlenk's terminology, we've identified another data gap that somebody should fill but not this particular group at EPA.  Dr. Doucette.
                  DR. WILLIAM DOUCETTE:  I think this was all my fault anyway with the example of the spray can, and I don't apologize.  It's just something that came up, and it worked its way around.
                  But that might be a relatively simple thing to do is look at the -- if I have a can identify -- and I don't know how widespread this is relative to some of the other splat solvent degreasers that are used in commercial products, but it might be as simple as looking at how widespread that is.  Put that in a house, assume that it all goes out, and I can provide some rate information, and I know what -- you get measurable concentrations in the air, and is that important relative to the insulation scenario or anything else?
                  I guess that's kind of where I was going with that yesterday, and I didn't maybe explain that as well as I should.  And that might be another way to avoid having to worry about the -- at least it would give you another common scenario of potential exposure in indoor air, independent of the markers and all the other issues that are related to that.
                  DR. KENNETH PORTIER:  Dr. Blystone.
                  DR. SHERI BLYSTONE:  Yeah, just a couple of clarifying comments.  I agree with Dr. Blando.  Twenty-five million pounds -- although, I think this is actually more in the 10 to 15 -- while it's over the one million pound for high production volume, amongst high production volume chemicals, it's not that high.  And on the drinking water side, it's, potentially, the disinfection process that is generating these compounds.  So that has nothing to do with production volume of anything; it's part of the waste treatment process.
                  DR. KENNETH PORTIER:  Dr. Cobb.  Flags down, flags up.
                  DR. GEORGE COBB:  So, to circle back, we're dancing around the issue of we don't have the data we need.  And the data gap can easily be filled by simply monitoring bromopropane indoors in several locations and be done with it.  And that's what the industries producing and using these compounds should do.
                  DR. HENRY ANDERSON:  This is Henry Anderson.  I view this as there needs to be a word of caution that you have this data.  We really don't have all the details about it, but it is of sufficient concern that there may be a consumer or a general population exposure that should be investigated further.  At best, these measurements, now, are kind of a qualitative rather than a quantitative indicator of exposure.  And I think it's enough to not just dismiss it, which I think is kind of done in the document, but rather identify it as a potential concern that needs to be evaluated.  So it's just kind of recognize the issue, not just dismiss it.
                  DR. KENNETH PORTIER:  And I think that's the recommendation that's coming out.  Thank you, Dr. Anderson.  Dr. Blando, did you capture that?
                  DR. JAMES BLANDO:  Yes.
                  DR. KENNETH PORTIER:  Okay.  Now, can we go on to Question 5?  I didn't mean for this to -- that was an interesting side discussion.
                  MR. MARK HARTMAN:  I just wanted to clarification on the recommendations, and I think this, Chair, I think this conversation was very helpful.  And I think there are actually some actionable things that we can do.  Thank you.
                  DR. KENNETH PORTIER:  Well, I think you captured the kind of disagreement as to the level of importance that comes into the committee.  I didn't expect that, but it's good that we've captured that.  Let's carry that into the human health.  I've asked Dr. Anitole to make kind of a shortened presentation, and we're going to take kind of one question at a time today because we have different leads on different questions.  So we're going to kind of take a measured approach to today's questions.

                               CHARGE QUESTION 5

                  DR. KATHERINE ANITOLE:   Thank you.  So Question 5.   Human Health Hazard and Dose-Response Assessments.  This question pertains to Section 3.2 of the Draft Risk Evaluation.  Summarizing this slide -- EPA considered the adverse human health effects for 1-BP across organ systems.  For hazard identification and dose response, EPA reviewed the evidence for 1-BP toxicity and selected liver and kidney toxicity, reproductive and developmental toxicity, neurotoxicity, and cancer.
                  EPA selected endpoints supported by the weight-of-the-scientific evidence for non-cancer and cancer following acute and chronic exposure scenarios for workers and acute exposure scenarios for consumers.  EPA determined that using developmental toxicity and neurotoxicity endpoints for dose-response calculations would be protective of the most sensitive life stages including the developing fetus for non-cancer points of departures and risk estimates.  EPA used these endpoints to calculate points of departure to assess non-cancer risks associated with chronic occupational inhalation exposures.
                  Question 5.1:  As part of the review, please comment on the choice of these endpoints as PODs for assessing risks in humans associated with acute and chronic inhalation exposures to 1-BP.  Specifically, are there other data that EPA could have considered for the hazard identification and dose response associated with acute inhalation exposures?  If so, please provide specific data and references.  Are there other data that EPA could have considered for the hazard identification and dose response associated with chronic occupational inhalation exposures?  If so, please provide specific data and references.
                  DR. KENNETH PORTIER:  Thank you.  Dr. Barton.
                  DR. CHARLES BARTON:  Good morning.  Thank you.  This draft is fairy mature.  It's already gone through several drafts, and it really is seen here because it's much more advanced than some of the other chemicals that we've looked at.
                  Well, the non-cancer endpoint selected for points of departure for both acute and chronic exposure scenarios were derived from three studies: WIL Research (2001), Ichihara (2000), and Honma (2003).  All three studies scored high in data evaluation, followed OECD guidance, and good laboratory practice; and this is appropriate.
                  With that said, typically data from the acute inhalation toxicity study are used to examine hazard and dose response from an acute inhalation exposure.  Such data were not submitted to the committee for review; however, three key and two supporting studies have been submitted to ECHA, however, not enough detail provided in the submissions to ascertain a point of departure.  The point of departure derived by EPA from short-term exposure to the F0 generation in the two-generation inhalation reprotox study was based upon a decrease in live litter size.  It was assumed that this decrease in size of live litters was due to effects on both the male and female rats.  This approach is not generally accepted or considered appropriate for deriving a point of departure for acute inhalation toxicity.  However, it may be acceptable in lieu of data from better studies if the assumption is true that the decrease in live litter size is actually due to exposure between ovulation and implantation in males and females in the F0.
                  Both post-implantation loss and decreased live litter size are being used for both acute and chronic exposures.  The argument was already made by EPA that the live litter size decrease was from a short-term exposure.  The rationale for how it is now being used to characterize chronic exposure needs to be explained.  It's understandable, but it needs to be explained, so everybody can understand in following.
                  Details for how the assumptions were derived and calculating dermal HED from an inhalation HEC needs to be provided, and the validity in these assumptions need to also be provided.  It was noted that regarding the BMD calculations supplemental information, pages 22 - 26, it seems to be a MAR calculation for post-implantation risk -- is highly uncertain due to removing the high dose which has a lower trend leaving three points to include the control.  All of which are highly variable where there's post-implantation loss and controls.  This suggested using reduction in litter size predominately.  However, it doesn't seem to matter much as results from both result in similar margin of exposures.  It's further unclear why the EPA used the standard uncertainty factor for animal-to-human extrapolations when they already apply to dose of metric adjustment factor in addition to other allometric adjustments to account for species differences due to kinetics.
                  Comparing the NOAELs and LOAELs from all of the reported animal studies support EPA's choice of endpoints.  Nearer toxicity endpoints were consistently the most sensitive followed by hepatic reproductive developmental renal.  There was a 105-week study that showed LOAEL of 62.5 parts per million for respiratory toxicity.
                  Human case reports, several indicate neurological effects at around a hundred parts per million, maybe not be able to use these for dose response, but, as EPA describes, certainly add weight of evidence support for neurological findings as a critical endpoint for human health risk assessment.
                  Regarding other publications, there was a publication in 2018 by Miao et al. regarding mechanism of action in humans.  It's in Human Experimental Toxicology, Volume 37, pages 3 to 12, where it talks about mostly proteomics.  And there's some editorial issues which, if you want to see them, I can point them out afterward.
                  Recent data should be considered for carcinogenicity.  Specifically, Stelljes (2019) which supports a nonmutagenic threshold mechanism of action for carcinogenicity.  And other data that EPA could have considered for hazard identification and dose response associated with chronic inhalation exposures were identified.  However, the data can be further supported with the limited epidemiological studies or case reports.  Thank you.
                  DR. KENNETH PORTIER:  Thank you, Dr. Barton.  Next, I think, is Dr. Willett.
                  DR. CATHERINE WILLETT:  I think Dr. Barton captured all of my comments.  Thank you.
                  DR. KENNETH PORTIER:  Dr. Johnson.
                  DR. MARK JOHNSON:  Initially, I had some issues with the post-implantation risk.  Just looking at the benchmark dose algorithm, it looks like the controls have some baseline reductions in post implantation.  It's hard to see because the y-axis isn't labeled.  Point zero two occurs at the controls in the metric, and I'm not sure exactly what .02 means.
                  But I also noticed that the high dose was removed, and I assume that's being done to fit the curve better, to meet the data, because it looks like the highest dose actually goes down.  I don't know if that's statically accurate, but it looks -- in other words, it looks like the dose response in the high dose kind of goes down.
                  And so I'm not a DART person, so I refer to my colleagues who are experts in developmental and reproductive toxicology, but I really question the use of looking at post-implantation risk.  I really don't know what it means for humans; rats have lots of pups, people don't.  However, reduction in litter size does look like a good endpoint, and it comes out to about the same number.  So it's not that big of an issue, but it's something that I would consider.
                  Regarding the question -- we're just in Question 5.1?  Is that correct?
                  DR. KENNETH PORTIER:  Yeah, we're still on 5.1.
                  DR. MARK JOHNSON:  Okay.  So I'll go beyond that.  I also have some issues with -- or questions -- regarding the use of the BMR one versus five versus ten.  It looks like a BMR of one was used for brain weight, but that's a continuous variable.  And I thought in the text somewhere it said it used plus or minus one standard deviation for continuous variables.
                  And that's another endpoint I'm not sure about.  What's reduction brain weight mean?  Is that an adverse effect?  It doesn't justify having a one percent BMR, which is really what you're saying.  If you're doing a BMDL, you're saying that your 95 percent confident that one percent or fewer will exhibit this effect exposed at this level in that organism.  So, I guess, I'm just a little confused about that.  And that's all I had.
                  DR. KENNETH PORTIER:  Mr. Kaufman.
                  MR. ALAN KAUFMAN:  Thank you.  I was going to say most of my comments have already been covered, but one issue was in looking at dermal exposure.  In one case, there's fractional used.  I think it was for occupational.  I can't remember which way it went.  And, in the other case, it's consumer; I think it was permeability, and so, I guess, the question is why the difference?  And I think it leaves you open to criticism kind of splitting the difference that way.  In other words, sort of pick a lane and defend it rather than trying to say we're going to go one way for one set of exposures and another way for another set of exposures.  It didn't seem to make a lot of sense, and I think it does open you up to criticism.  I think everything else has pretty much been covered.  Thanks.
                  DR. KENNETH PORTIER:  Thank you.  Dr. Pessah.  Dr. Pessah, if you're speaking, you're on mute.  We'll move on to Dr. Vorhees, and we'll come back to Dr. Pessah.
                  DR. DEBORAH CORY-SLECHTA:  Dr. Portier?
                  DR. KENNETH PORTIER:  Yes.
                  DR. DEBORAH CORY-SLECHTA:  This is Dr. Cory.
                  DR. KENNETH PORTIER:  Yeah.
                  DR. DEBORAH CORY-SLECHTA:  I can hear my -- I think you skipped over me.  I wanted to -- I'm hearing myself in the background, so it's a little difficult.  But I wanted to respond to the comment.  I'm on this question, but I also want to respond to this comment about brain weight.
                  A one percent decrement in brain weight -- any decrement in brain weight -- means that we are losing cells that we shouldn't be losing.  And we have a long history of understanding what a poor prognostic indicator it is to have reduced brain weight.  So I personally believe it's a good metric, a very serious kind of metric, and I don't have any problems with a one percent.  I certainly wouldn't want to find out that my child had a low brain weight ever.  Thank you.
                  DR. KENNETH PORTIER:  Is Dr. Pessah on?  Dr. Vorhees.
                  DR. CHARLES VORHEES:  Okay.  One thing I would like to comment on is under the reproductive section, the Agency uses this post-implantation loss, and the way it's calculated is the number of implantation sites minus live births.  Then under developmental reproduction, we use litter size as an independent outcome except those two both rely on litter size.  So they're basically using the same data in two different ways, and it seems to me that's one outcome, not two outcomes.  So I didn't see why it fell under reproductive and developmental; it's really developmental and it's litter size.