DR. KENNETH PORTIER:  I have a follow-up question real quickly.  You mentioned at this meeting and in the previous that certain references that are not translated into English get excluded.  For example, on the eco tox you said the studies were in French and Japanese with no U.S.A. sponsor.  Therefore, EPA decided not to make a further attempt to obtain the full study reports.  So what's the policy on that?  Is that just kind of a blanket, or is that a case by case, situation by situation?
                  DR. STAN BARONE, JR.:  So again, I wouldn't say necessarily policy.  But with regard to our systematic review framework, that is called out specifically in the systematic review framework that we do focus on English reported studies first.  We have received and did evaluate the English robust summaries of those studies.  We did not have the full study reports in English and were not able to identify who the owner of the data was, the source of the data, to get further information for a translation.  And that's, again, quite a challenge with the ECHA database.  We are working with our partners across the pond on some of those issues.  But it is a challenge at times.
                  DR. KENNETH PORTIER:  Dr. Cobb, last questions.
                  DR. GEORGE COBB:  So I actually have several.  I may just pose -- can I give them in writing to the EPA and have them answer them later?  Or do we want to go through them all right here?
                  DR. KENNETH PORTIER:  If you really need to take the break, after the public comments, we'll open for a few more clarifying questions at that point.  If that works, we can do that.
                  DR. GEORGE COBB:  So my first question is about the algae toxicity, and it was about an order of two and a half lower than the fish toxicity.  And there was a rationale given for not including that, but that would only hold if you're only trying to protect fish, I think, or maybe fish and invertebrates.  So can you clarify why that was excluded a little more?
                  DR. STAN BARONE, JR.:  We'll follow up after the break.
                  DR. GEORGE COBB:  And then I have kind of a general question about the way that the data were evaluated for inclusion or exclusion.  I've got to find the right one here.  Hold on.  So when you were doing the search terms, as I was reading through, there's places where it identifies chemical uses and then exposure types of terms.  And did the strategy require both the chemical and the use terms in the strategy to be true before then allowing the exposure and engineering and fate terms to then kick in?  Or conversely, was it chemical identifier or use terms before the rest kicked in?
                  DR. STAN BARONE, JR.:  So I think you're talking about systematic review and the screening procedure for systematic review.  There are two bins that are important for our systematic review for exposure engineering and also fate, but exposure engineering.  The great sources of literature are much more important and more helpful to us.  We also look at the published literature.  So again, the chemical identifier, cast number, are the chemical specific information, but what we need for exposure assessment and engineering assessment is the use information, the activity information, the other.  So it's and, not or.
                  And we do -- and we've talked about this previously with systematic review with the published literature.  When you don't have that PICO, you don't have those and statements, you end up capturing -- pulling down a lot more literature that's cast number or chemical specific or synonym related.  And that ends up being a whole lot of extra work to go through in the screening process.  So we're refining our approaches as we speak on these very issues, again, learning from AI techniques and others.  So hopefully we'll have more to talk about on that subject later.  Thank you.
                  DR. KENNETH PORTIER:  Okay.  I have about -- what do I have here?  11:30.  Let's reconvene at 11:45.  We have about 45 minutes of public comments, so we're going to push the lunch break back to 12:30 or so.  So we'll take the public comments before we take the break.  Let's reconvene in roughly 15 minutes, 11:45.  Thank you.

                                             (BREAK)

PUBLIC COMMENTS

                  DR. KENNETH PORTIER:  Let's reconvene.  Thank you.  This next section we're going to entertain comments from the public, and Ms. Gibson's going to moderate that section for us.  Each of the speakers have a designated about of time -- limited amount of time to talk to the panel.
                  MS. TAMUE GIBSON:  Thank you, Dr. Portier.  So we will begin our public comments session at this moment.  You are limited to five minutes.  There are a number of public commenters, so I'll ask you -- there's an order in your agenda.  So if you could move after the speaker has concluded their talk.  Please move into the seat directly in front of me where you have a placard that indicates public commenter.  So if I could have Ms. Lindsey -- I'm sorry.  Ms. Stephanie Schwarz, please, from -- a legal fellow from the Environmental Defense Fund.
                  MS. STEPHANIE SCHWARZ:  Hello.  My name is Stephanie Schwarz, and I am a legal fellow at Environmental Defense Fund.  I will make brief comments today with more detail in the written comments we've already provided to the SACC.  Recently, EPA has publicly stated that a number of the topics discussed are in the realm of policy and are therefore not relevant to the SACC's charge.  These include EPA's decision to exclude all exposures from releases to land, air, and water based on the assumption that other statutes adequately address the exposures; EPA's decision to assume that appropriate personal protective equipment is always used based on the authority of the Occupational Safety and Health Administration; and EPA's decision to use a benchmark cancer risk level of one times ten to the negative four to define unreasonable risk to workers.
                  EDF strongly disagrees that these issues are beyond the scope of the SACC.  In fact, they fall squarely within the SACC's charge.  All three decisions have major direct scientific consequences as they clear to underestimations of chemical's risk to the environment, the general population, workers, and vulnerable subpopulations.   Charge Question 7, among others, expressly directs the SACC to address the uncertainties and assumptions that EPA uses in the draft risk evaluation.  All three of EPA's decisions I just described represent assumptions that EPA has not verified or adequately explained and then introduce major uncertainty into its risk evaluation that EPA has not analyzed.  It is vital that the SACC consider and address in its report the scientific consequences of these assumptions and decisions on EPA's characterization of exposure, hazard and risk.
                  Let me address each of these issues a bit further.  First, the statutory based exclusions, EPA has asserted that exposures to the general population are adequately managed without any analysis whatsoever of the standards under the other statutes, including standards that are not strictly health-based, unlike TSCA's standard.  EPA devoted less than three pages to justify its decision to eliminate entire pathways and provided no data or analysis of the exposures and risks that remain and our contribution to total exposure and risk.  EPA has failed to provide any scientific rationale for this assumption, and the SACC has been charged with commenting precisely on the adequacy of the support EPA has provided for just such assumptions.
                  Second, EPA has also assumed that OSHA ensures that suitable PPE is always used in order to find no unreasonable risk to workers, even though EPA has state elsewhere in the draft risk evaluation that few literature sources indicate the use of respirators in 1-BP conditions of use.  And EPA does not know the actual frequency, type, and effectiveness of glove use in specific workplaces with 1-BP conditions of use.  Despite the lack of data regarding the use of PPE, EPA has made broad assertions about OSHA's authority.  In order for the SACC to fully evaluate these assumptions, the SACC should request that EPA provide any feedback EPA has received from OSHA and NIOSH on its assumption regarding PPE use and, more generally, any input they have provided EPA regarding the extent and sufficiency of OSHA's authorities.
                  Third, EPA's unprecedented use of one in 10,000 as the cancer risk benchmark for workers also clearly underestimates risk and flies in the face of EPA's longstanding policy that it should reduce risk to less than one times ten to the negative six for as many exposed people as reasonably possible.  In sum, TSCA specifically states that the purpose of the SACC is to provide advice on scientific and technical aspects related to the implementation of TSCA.  And EPA's sweeping assumptions regarding environmental exposures, PPE use, and adequacy of a less protective cancer risk benchmark have direct impacts on the scientific integrity of EPA's implementation of TSCA.  The SACC needs to address the scientific consequences of each of these decisions.  At the very least, it is the SACC's responsibility to state clearly in its report that the result in serious underestimations of risk.  Thank you for your time.
                  MS. TAMUE GIBSON:  Thank you.  I actually would like to make note that for you public commenters, if you could -- we will definitely email those comments to all of the committee members as well as placing them into the docket.  So for those who have not submitted their comments to me, please email them to me so that we can make those arrangements to have them submitted to the committee as well as into the public docket.  Okay.  Ms. McCormick.  She's program manager, Environmental Defense Fund.  Please turn your mic on, please.  Yes.
                  MS. LINDSAY MCCORMICK:  That would help.  Okay.  Good morning.  My name is Lindsay McCormick.  I'm also with Environmental Defense Fund.  In 2016, Congress strengthened EPA's authority and mandate under TSCA to protect workers by expressly identifying them as potentially exposed or susceptible subpopulation.  Yet, EPA's draft risk evaluation grossly understates the risk to workers and overstates OSHA's protections.  I will discuss four concerns, which are most germane to Charge Questions 2 and 6.
                  First, EPA ignores real world limitations of PPE and distorts OSHA requirements.  EPA heavily relies on the assumption that all workers will always use gloves and respirators, and they'll be universally effective in most scenarios.  For example, EPA assumes that workers are properly trained and fitted on the respirator use and that they wear respirators for the entire duration of the work activity where there's potential exposure to 1-BP.  These assumptions are wholly unwarranted.
                  First, any OSHA requirement for employers to provide respiratory protection from 1-BP exposure will apply only extremely rarely for many reasons, including the fact that OSHA PEL does not exist for 1-BP.  EPA distorts development OSHA requirements when it invokes OSHA respiratory protection standard at 29 CFR 1910.134, which only applies for chemicals with an OSHA PEL.  Dr. Finkel's (phonetic)comments to this fact discuss this issue further.
                  Second and more broadly, even where OSHA respiratory protection requirements do apply to a chemical, OSHA's database of inspections demonstrate significant noncompliance with those requirements.  In physical year 2018 alone, OSHA cited 2,892 violations of the respiratory protection standard identified in 1,281 separate inspections.  Violations of the respiratory standard were the fourth most common type of violation in OSHA inspections that year.  EPA overstates or distorts other OSHA requirements, as well.  For example, EPA implies that safety datasheet recommendations for PPE are mandatory, when, in fact, OSHA standard mandating SDS specifically states that there is, quote, no requirement for employers to implement their recommended controls.
                  Second, EPA conflates the risk evaluation and risk management processes by assuming use of PPE.  TSCA intentionally divides risk evaluation and risk management into two distinct processes whereby regulatory measures are considered after EPA finds an unreasonable risk.  However, by choosing to make risk determinations based on the assumptions of universal effective use of PPE for most scenarios, EPA conflates risk evaluation and risk management and leaves EPA either not to find unreasonable risk or to underestimate the magnitude of that risk in a number of scenarios thereby denying itself the authority to impose mandatory requirements sufficient to control workplace exposures.
                  So I want to just look at one example on the slide here.  On this table from EPA's draft on page 237, you can see that for cancer risk from dermal exposure EPA has actually found excessive cancer risk in every scenario, even using its one in 10,000 benchmark.  You can see that in the pink.  Yet when it comes to the risk determinations, EPA finds no unreasonable risk in several scenarios, including manufacturing import, which is displayed on the slide by stating that there is, quote, no unreasonable risk when PPE gloves of PF of five are used.  EPA's failure to make an unreasonable risk determination will mean it will lack any authority to require that such gloves are actually used.
                  Third, EPA understates risk by using the one in 10,000 benchmark.  So let's look at the same EPA table through another lens.  Again, the shading shows that the EPA found excessive risk using the one in 10,000 benchmark.  Recall my colleague Stephanie's earlier comment that EPA should be using a much more protective cancer risk benchmark.  So if EPA were to use even one in 1,000 -- in 100,000, the table shows it would have found excessive risk in every scenario assuming gloves of PF up to ten.  And then using EPA's longstanding policy of aiming to reduce risk for as many exposed people as possible to one in a million, EPA would have found excessive risk in every single scenario, even if gloves of PF of 20 were used.
                  And as a side note, I do want to note that EPA's supplemental Excel file in this table shows that included scenarios have risks as high as eight times ten to the negative two, which is almost one in ten.  Yet in the draft risk assessment, EPA does not make a single unreasonable risk determination based on cancer risks from dermal exposure.  And then my fourth and final point, which I have no time to make, is that EPA underestimates exposure by failing to consider combined exposures from workers through different routes.  So it does not combine inhalation and dermal exposures.  Thank you.
                  MS. TAMUE GIBSON:  Thank you.  Mr. Denison.
                  DR. RICHARD DENISON:  Thank you.  I'm Dr. Richard Denison, also with EDF.  Let me start by making one statement that reflects on what was heard this morning.  Every time you hear EPA say that there is uncertainty or assumptions or modeling or estimations that had to be made, had to be made because of a lack of data, that is a reflection of the EPA's failure to use the authority that Congress gave it under TSCA to require the information to have been developed.  So we are now three years out with major data gaps that affect EPA's assessment, and that is a result of how they have approached this and every other one of the risk evaluations that you are all reviewing.  I do want to reflect on two serious concerns about the risk evaluation.
                  First, EPA fails to assess cancer risks from acute, short-term exposures.  EPA acknowledges that 1-BP is a mutagenic carcinogen and that linear extrapolation is warranted.  Yet the Agency has chosen not to estimate cancer risks from short term exposures.  And hence, it completely excludes that risk for consumers.  For a chemical with a mutagenic MOA, even a single direct reaction, specifically a single hit on a single target, can be sufficient to cause cancer, and, hence, acute exposures pose a cancer risk.
                  For EPA's sole rationale for ignoring these risks is that published methodologies for extrapolating from chronic to short term exposures have uncertainty.  EPA cites a 2001 NRC report for support, but that same NRC report goes on to say that cancer is a potential effect from short-term exposures.  And it cites NRC guidance specifically saying that acute exposure guideline levels should be developed using extrapolation, linear low dose extrapolation from chronic exposures.  EDF is concerned the EPA has ignored these basic principles in deciding to exclude this risk.
                  EPA erroneously assumes that acute exposures to 1-BP, including to consumers, pose zero cancer risk.  It departs from sound science by effectively adopting a threshold for 1-BPs dose response, in this case based upon the duration of the exposure as opposed to dose per se.  The only scientifically supportable approach here is for EPA to be assessing cancer risk from acute exposures using linear low does extrapolation.
                  The second issue I want to raise that came up several times is EPA's lack of access to full studies for aquatic toxicity.  All but one of EPA's aquatic tox studies it cites as sourced from dossiers available through the European Chemicals Agency, or ECHA.  EPA claims that ECHA dossiers are existing chemical assessments equivalent to EPA or ATSDR.  And it lists ECHA as the author of these studies.  These statements are false and highly misleading.  In fact, ECHA dossiers are not assessments.  They are not government documents.  They are compilations of industry studies and information submitted to ECHA that have not been evaluated for quality by ECHA or any other governmental entity.  What ECHA provides are not full studies, only study summaries prepared by the industry registrants.  EPA acknowledges it lacks access to the full studies, and it did not subject them to systematic review.  And yet it proceeds to use those studies in its analysis.
                  EPA has access to only a single full acute study on fish toxicity, and it has no chronic data whatsoever.  Instead, it extrapolates from that one study.  And then it uses the acute studies that the industry summarized to estimate chronic toxicity by applying an acute to chronic ratio of ten.  It provides no justification or citation for that value.  And even a cursory look at the literature indicates that that ratio should often be set at at least 100 in order to be protective.
                  EPA has no tox data on sediment or terrestrial organisms and instead resorts to vague arguments to assume there is no exposure, and therefore they need not assess it.  And then EPA leaps to a final conclusion that there is no risk posed by 1-BP to the environment as a whole based on what I've just described.  The SACC needs to make clear that EPA's assessment is insufficient to make that conclusion.  Thank you.
                  MS. TAMUE GIBSON:  Thank you, Mr. Denison.  Operator, do we have Robert Sussman on the line.
                  MR. ROBERT SUSSMAN:  I am on the line.
                  MS. TAMUE GIBSON:  Could you please provide --?
                  MR. ROBERT SUSSMAN:  Can you hear me?
                  MS. TAMUE GIBSON:  Yes.  Is this Mr. Robert Sussman?
                  MS. ROBERT SUSSMAN:  This is he.
                  MS. TAMUE GIBSON:  Could you go ahead with your comment, please?  You have five minutes.
                  MR. ROBERT SUSSMAN:  Thank you.  Great.  I'm Bob Sussman, and I'm here today representing Safer Chemicals Healthy Families.  We are concerned about the exclusion of air emissions from the scope of the draft risk evaluation.  EPA's 2018 problem formulation document for the evaluation highlights 1-BP's high volatility and emphasizes, quote, air as a primary medium of environmental release, close quote.
                  1-BP was added to the toxic release inventory in 2015, and during the initial round of reporting, 43 facilities reported fugitive emissions totaling 394,000 pounds.  And 26 reported stack emissions totaling 232,000 pounds.  The problem formulation notes that the TRI reports likely understate the air emissions because many admitting facilities were below the threshold for reporting.  This would include small facilities using 1-BP as a vapor degreaser, as a component of adhesives and sealants, and in dry cleaning and other cleaning operations.  For example, the draft risk evaluation estimates between 500 and 2,500 establishments using 1-BP for vapor degreasing and between 1,000 and 5,000 using the chemical as an aerosol spray degreaser.
                  The magnitude of the health risk for 1-BP air emissions is demonstrated in an exposure and risk assessment submitted to EPA by the Halogenated Solvents Industry Alliance.  Focusing on five representative facilities, the assessment concluded that, quote, 9,000 people are estimated to have a cancer risk greater than one in one million, close quote.  If more facilities were included in the analysis, the at risk population would be far higher.
                  Let me turn to EPA's rationale for excluding air emissions, which is the premise that the Clean Air Act adequately assesses and effectively manages risk to the general population.  As the HSIA assessment shows, general population exposure could be a significant source of risk and would be additive to be unacceptable cancer and other risks that users of consumer products already face.  Failure to account for this adequate risk to consumers in highly exposed subpopulations living near admitting facilities would result in an incomplete picture of 1-BP's public health impacts and lead to inadequate and unprotective mismanagement measures.
                  In addition, it is unlikely that the Clean Air Act will adequately protect against unsafe air admissions.  No chemical has been added to the HAP list since the amendments of the Clean Air Act were enacted in 1990.  The petition to list 1-BP has been pending since 2010.  While to Obama EPA made a preliminary decisions to grant the petition in early 2017, the Trump EPA has taken no action since then.  There is considerable uncertainty whether there will in fact be a HAP listing.  We shouldn't be excluding an important risk pathway from the risk evaluation based on something that will not happen.
                  Moreover, even if 1-BP is listed as a HAP, EPA would mandate technology based, not risk based, emission limits.  And they would apply only to major sources and not to the large number of smaller establishments that account for substantial 1-BP emissions.  For all of these reasons, EPA's risk evaluation should include air emissions as a significant risk pathway, and SACC should recommend that these emissions be included in the final evaluation.  Thank you.
                  MS. TAMUE GIBSON:  Thank you.  Ms. Suzanne Hartigan from EarthJustice.  Oh, I'm sorry.  I apologies.  Excuse me -- American Chemistry Council.  I apologize.
                  DR. SUZANNE HARTIGAN:  Thanks for the correction.  Good morning and thank you for the opportunity to speak to you today.  My name is Suzanne Hartigan, and I am a senior director in the Regulatory and Technical Affairs Department for the American Chemistry Council.  ACC appreciates the opportunity to provide feedback on the next draft TSCA risk evaluation for consideration by the SACC.  As the SACC peer review has been scheduled before the end of the public comment period on October 11, we've had an abbreviated time to review the documents and provide feedback for SACC's consideration.  But we will provide further detailed comments by the October 11 public comment deadline.
                  I'd like to highlight several points for the committees consideration as it reviews the draft risk evaluation for 1-Bromopropane.  First, EPA has incrementally improved some of the weight of evidence narratives in draft risk evaluation for 1-Bromopropane.  However, much work still needs to be done regarding the process of integration of evidence for cancer mode of action.  On page 158 and -9 of the draft, EPA describes their rationale for the evaluation of the evidence supporting a mutagenic mode of action.  However, the draft risk evaluation for 1-Bromopropane does not fully evaluate, discuss, or weigh the scientific evidence of the potential alternative interpretation of the data and analyses using the cancer mode of action approach.  As a result, EPA has not transparently characterized the potential risks associated not only with the default option but also the potential risks from biologically plausible alternatives as required by the risk evaluation rule.  In its TSCA risk evaluations, EPA should more clearly and transparently present biologically robust weight of evidence assessments where data integration is required, such as the OACD adverse outcome pathway methodology or the mode of action approach initially championed by the WHO international program on chemical safety, which has been adopted by EPA's Office of Pesticide programs.
                  The evaluation of the cancer mode of action should begin with evaluation of the quality of relevant studies and evidence.  However, EPA does not appear to perform the full systematic review process, including data quality evaluation and data integration according the TSCA systematic review principles and guidance for the in vitro studies.  None of the in vitro genotoxicity assays are included in the supplemental review file -- data quality evaluation of human health hazard studies.  We note that EPA does have data evaluation criteria for in vitro studies but either did not apply them or did not publish the evaluation in the docket.  There is a discussion of evidence in Appendix I 5-6.  However, it is not supported by a data quality evaluation.  The SACC should provide feedback to EPA on evaluation of the data quality of these studies and why EPA preferred to rely upon limited in vitro assays in its analysis over in vivo animal studies.
                  Further discussion in Appendix I 5-8 in the supplemental file for the human health hazard assessment, a systematic review of this point does not appear consistent with the EPA systematic review guidelines.  The SACC should consider the weight of evidence supporting a non-mutagenic threshold mode of action for tumor formation resulting from exposure to 1-Bromopropane in laboratory animals.  And in sum, the SACC should provide feedback to the EPA regarding the sufficiency of information for acceptance of an alternative mode of action.
                  Secondly, regarding the exposure assessment, we believe the SACC can provide additional input to improve the overall quality of the assessment.  ACC encourages the SACC to provide EPA feedback on its assumptions within the exposure models themselves.  We note that in the draft risk evaluation of 1-Bromopropane the assumptions are not always well described and often do not represent real world conditions.
                  Ventilation controls, for example, are not considered within any of the inhalation models, very likely leading to exposure overestimates.  Similarly, EPA's assumptions for dermal exposure are not well-explained.  The draft risk evaluation uses a permeability model rather than fraction absorbed model for consumer exposures.  The opposite, however, is true for the dermal occupational exposure calculations where EPA uses fraction absorbed.  The context for each model is important because permeability models ignore evaporation, and 1-Bromopropane is a high volatility chemical where evaporation is expected to play a factor in exposure.
                  Finally, the risk determination section for 1-Bromopropane could use further streamlining and clarification.  We recognize the document is draft and EPA has the opportunity to further edit the document based on feedback from peer reviewers and stakeholder comments.  However, as we commented on for the previous risk evaluations, the risk determination sections are critically important for communication to the public.  Therefore, EPA should give particular attention to the final risk determination sections and should seek to clarify the basis for the determinations and better summarize and highlight the overall determinations in order to improve the public's understanding of them.  Thank you for your time.
                  MS. TAMUE GIBSON:  Thank you.  Operator, do we have Mr. Jonathan Kalmuss-Katz on the line from EarthJustice?
                  MR. JONATHAN KALMUSS-KATZ:  I am on the line.  Can you hear me in the room?
                  MS. TAMUE GIBSON:  Yes.  Hi.  Could you go ahead and proceed with your public comment, please?
                  MR. JONATHAN KALMUSS-KATZ:  Thanks very much.  Good morning and thank you for the chance to speak.  I'm Jon Kalmuss-Katz from EarthJustice.  Today I will focus on three ways in which EPA fails to account for known exposures and risks in the 1-Bromopropane risk evaluation.
                  First, as you've heard from other commenters, EPA ignores exposures to 1-BP from ambient air, water, and soil.  As a result, EPA does not evaluate any risks to the general population.  EPA acknowledges that these risk exist.  The risk evaluation states that people who are exposed to 1-BP in ambient air also have higher levels of 1-BP metabolites in their urine.  EPA has also warned that 1-BP is, quote, sufficiently volatile and toxic to pose inhalation risks via vapor intrusion from contaminated soil and ground water.  Yet the draft risk evaluation does not consider any of those exposure pathways.
                  EPA cannot disregard 1-BP exposures merely because they could be regulated under other environmental laws.  Instead, TSCA requires EPA to evaluate all risk associated with a chemical's known, intended, and reasonably foreseen conditions of use.  The law permits EPA to consider potential regulation under other laws only at the risk management stage after EPA has completed a TSCA risk evaluation and found unreasonable risk.  Moreover, EPA has not regulated 1-BP under the Clean Air Act or the Safe Drinking Water Act.  And there's no federal law limiting the migration of soil vapor into indoor air.
                  For the last nine years, EPA has failed to act on a petition to list 1-BP as a hazardous air pollutant.  Even if that petition were granted this afternoon, it would likely be years before any new regulations are finalized, and EPA may never set risk based emission standards for many 1-BP sources under the Clean Air Act.  The unrealized possibility of regulation under other environmental laws does not satisfy TSCA's mandate to protect vulnerable subpopulations from the risks currently posed by 1-BP.
                  Second, EPA overlooked widespread evidence -- sorry.  EPA overlooked evidence of widespread exposure to 1-BP.  Biomonitoring studies have detected a urinary metabolite of 1-BP in most of the people tested, including 99 percent of pregnant women.  Despite describing this metabolite as a valid biomarker for 1-BP exposure, EPA did not consider these background exposure levels in its dose response analysis claiming that in 2016 the peer review panel for a prior 1-BP risk assessment had advised against using such data.
                  As the SACC members who served on that panel may recall, EPA's position fundamentally misrepresents the committee's recommendation.  The minutes from that Chemical Safety Advisory Committee meeting supported the use of biomarker data in order to, quote, avoid overlooking a significant exposure scenario and stated that such consideration would benefit a revised risk assessment.  Dr. Kissel said, "I think you should maybe do a little more with the existing biomarker data that you already have identified."
                  Since 2016, the ATSDR and IARC have both used that same urinary metabolite as a biomarker for 1-BP.  To the extent EPA had questions concerning the specificity of the biomarker, it has had more than three years to resolve them and ample authority to do so.   EPA's failure to do so does not excuse the Agency from considering relevant and reasonably available exposure data.
                  Finally, EPA's selected points of departure characterized 1-BP's risks based solely on animal studies even though available epidemiological data reveals neurological effects and cellular damage at much lower doses.  EPA scored all of those human studies as acceptable under its systematic review, but it questioned their reliability in an appendix to the risk evaluation.  Many of EPA's stated concerns, including the reporting of time weighted averages as opposed to peak concentration and the use of median exposure levels at the lower end of the reported range, would have biased the studies away from a finding of risk.  Yet they still reported adverse effects at levels below EPA's point of departure, confirming that EPA has understated 1-BP's noncancer risks.
                  There is no question that 1-BP presents unreasonable risk.  Only by considering all exposure pathways and all relevant data can EPA evaluate and protect vulnerable subpopulations from those risks.  The draft risk evaluation fails to do so.  We urge the SACC to advise EPA to correct those flaws.  Thank you.
                  MS. TAMUE GIBSON:  Thank you.  There's a slight change to the public commenter.  Ms. Swati Rayasam will not be providing her comment.  However, Dr. Tracey Woodruff will take her five minutes.  So in total, Dr. Woodruff will be speaking for ten minutes.  Dr. Woodruff, are you on the line?  Operator?
                  OPERATOR:  Yes, Ms. Woodruff is connected.
                  MS. TAMUE GIBSON:  Dr. Woodruff, are you on the line now?
                  DR. TRACEY WOODRUFF:  Can you hear me now?
                  MS. TAMUE GIBSON:  Yes.
                  DR. TRACEY WOODRUFF:  Okay.  Great.  Thank you.  Hi.  Good morning.  My name is Tracey Woodruff, and I'm a professor at the University of California San Francisco School of Medicine and the director of the program on reproductive health and the environment.  Today, my comments will focus on the application of systematic reviews and our concerns that will follow on to the others related to exposure assessment in the 1-Bromopropane draft risk evaluation.  Can you go to the next slide, please?  I have no conflicts to disclose.  Next slide, please.
                  EPA is required by the TSCA statute to use the best available science and the weight of scientific evidence to make decisions about chemical risk assessment.  And in the risk evaluation rule, which they codified in 2017, EPA defined this weight of scientific evidence as a systematic review method that uses a pre-established protocol to comprehensively, objectively, transparently, and consistently identify and evaluate each stream of evidence, including strengths, limitations, and relevance of each study to integrate the evidence as necessary and appropriate.  Next slide, please.
                  However, there are several important parts of this definition that are key to EPA having the best evidentiary basis for its decisions in terms of using systematic review for the evaluation, not only of 1-Bromopropane, but of the other chemicals that are being evaluated under the first ten chemicals.  So the problem with the current approach that EPA is using is that it misses critical pieces of the required methods that are required as part of systematic reviews.  So one of those critical missing pieces is creating a protocol for all the review components.
                  That is supposed to be done before EPA engages in the risk assessment.  This helps minimize bias and ensures transparency in the decision making.  This is also part of best practices that is used by all established methods for systematic reviews and has been recommended by the National Academy of Sciences in their report related to the IRIS risk assessment program.  Other elements of the method that are not consistent with best practices include a nonempirically based scoring system, which is also not recommended, use of metrics not relevant to study quality that are actually about reporting and not relevant to the quality of the studies, and they have methods that are questionable and not transparent that can exclude potentially relevant studies.  We have written about this already in a peer reviewed paper on the problems with the risk assessment method -- the systematic review method that EPA is using.  Next slide, please.
                  This is a flow diagram of the -- literature flow diagram for the environmental releases and occupational exposure data sources.  You can see that EPA has identified 52 key sources that were taken forward to data extraction and evaluation.  And 37 of these are excluded by this phrase or this process of hierarchy of preferences.  First of all, there's a lack of clarity on how EPA chose to -- and evaluated the key sources.  That's the 52.  We have previously given comments on both 1,4-dioxane and HBCD risk evaluation about how EPA has failed to give -- to have a consistent protocol despite the risk evaluation rolling out clear guidance on how to select studies.
                  Additionally, this 1-Bromopropane risk evaluation only briefly mentions this hierarchy of preferences, which is mentioned in a caption, and it is not explained.  The risk evaluation does not provide transparency in terms of what sources of information EPA relied on and which ones they excluded, which goes against the critical tenant of transparency within the systematic review process.  This hierarchy of preferences I will also note has not been through a public comment or peer review process.  So it is difficult to understand how EPA is using this method to select these studies.  So given that there are concerns about how the method is using and collecting studies, it is very difficult to have confidence in the final risk evaluation of the evidence base and thus lead to potential problems with the risk assessment itself.  Can we please go on to the next slide?
                  As I said, we've previously commented on the systematic review methods that EPA is using.  I'd like to talk about the issue around vulnerable populations and issues in EPA's exposure assessment for 1-Bromopropane.  There are many factors that can make the population at risk or more vulnerable to exposure to toxic substances, including proximity to polluting industries, social vulnerabilities, and biological susceptibility such as age, gender, preexisting conditions.  We agree with EPA that there are important susceptible time periods, but we are concerned that EPA is not adequately considering them in this draft risk assessment.  As previously has been noted, 1-Bromopropane -- the manufacturing was between 18 million to 26 million pounds, and exposures come from primarily spray adhesives, dry cleaning, and degreasing.  Can you go to the next slide, please?
                  As has been noted by the previous commenters, there are several areas that EPA is not considering in the exposure assessment.  This will have a high likelihood of underestimating exposures to 1-Bromopropane.  One is that they're not considering inhalation exposure pathways.  The reason that's given is because it's supposed to be listed as a hazardous air pollutant.  That was previously commented on by a previous commenter.  The other is is that there has been reported measurements of the metabolite of 1-bromopropane widely detected among pregnant women, as well as the population, and that there is data to indicate that there is potential for very widespread nonoccupational exposures to 1-Bromopropane.  Can you go to the next slide, please?  Next slide, please.
                  The other thing I wanted to comment on which has not been raised by the reviewers is that EPA is assuming that children may only be present for four hour periods from 3:00 to 7:00 after school, which they could have exposures that are similar to occupational non-exposure levels.  However, this has two problems.  One, it does not consider children who are too young for school or not in school and therefore may be exposed for a longer period of time and that children in family owned dry cleaners are likely to spend their time outside of school in the dry cleaner for a much longer time than is indicated by EPA.
                  So according to EPA, dry cleaners are open for 12 hours a day, six days a week.  That's 3,672 hours a year.  According to the National Center for Educational Statistics, children of school age are in school around 1,195 hours per year.  That means there are 2,476 hours that children spend not physically in school.  And there is a high likelihood that they are in the business.  This would represent a majority of children's time spent, 67 percent, in the dry cleaner with the same exposure as the other nonoccupational -- occupational nonuser's exposure and could mean a higher risk because they are also both developmentally more vulnerable to the exposures to 1-bromopropane.  So while EPA talks about presenting the full range of estimates, the lack of consideration of possibility of widespread exposures in the population, both as indicated from admittance into air as well as measurements through biomonitoring and exposure to the most vulnerable subpopulations, this can lead to scientifically inappropriate underestimated risk to the public.  Next slide.
                  Along the lines of these comments, we have recently published a paper in PLOS Biology on population susceptibility, highlighting three ways that EPA's approach under TSCA is not consistent with current science, both that there are biological and social factors that can make people more susceptible to chemicals.  EPA is not fully integrating this information into their risk assessment -- that EPA needs to consider the multitude of exposures that can lead to a totality of exposures that can lead to increased risk of exposure to chemicals, in particular 1-Brompropane, and that these practices together can lead to EPA underestimating risk and thus leading to increased risk among the population.  Next slide, please.  That's it for now.  Thank you.
                  MS. TAMUE GIBSON:  Thank you.  There are some members of the general public who wish to provide a public comment.  There are three in total.  Mr. Bob Miller, Jr., could you please come forward and provide your comment, please?  Thank you.
                  MR. ROBERT MILLER, JR.:  Thank you.  Good afternoon.  Thank you for the opportunity to speak today.  My name is Bob Miller.  I'm the Senior Director for Global Product Stewardship for the Albemarle Corporation.  We appreciate the opportunity to provide comments on the U.S. EPA draft risk evaluation for 1-Bromopropane at this peer review panel meeting of the Science Advisory Committee on Chemicals.  Albemarle Corporation is a global manufacturer of specialty chemicals among whose product line includes 1-Bromopropane as an important part of our portfolio.
                  As a manufacturer and in conjunction with leading experts and key users of our products, Albemarle has developed considerable expertise with respect to 1-Bromopropane.  For today's comment, I would like to take the opportunity to provide some additional details on behalf of my technical team in support of our written comments submitted on August 30.  Specifically, I'd like to address the determination of pulmonary tumorgenicity in humans and provide some salient points for the committee's consideration as it reviews the draft risk evaluation.
                  Albemarle has collaborated with outside experts in human pulmonary pathology to evaluate the applicability of lung tumors in mice towards predicting a potential pulmonary tumorgenicity in humans.  Lung tumors in mice induced via chronic inhalation of certain chemicals are not relevant to the risk of developing human lung cancer because mice are super metabolizers of certain chemicals as compared with rats or humans.  Mice metabolize these chemicals through cytotoxic metabolites that injure cells, thereby increasing cell proliferation rates.  Increased cell proliferation rates amplify background mutation rates resulting in a significant false positive rate for tumor development seen in the two year NTP rodent cancer bioassays.  This mechanism has been extensively described by Cohen and Ellwein (phonetic), Aims and Gold, and Mulguvocar (phonetic), among others.  Recent work by Tomasetti et al. have supported the relevance of increased cell proliferation as a risk factor for development of human cancers.
                  A number of chemicals are known to be metabolized in mice by the pulmonary P450 enzyme, CYP2E1, for example, styrene, nepheline, ethylbenzene, and coumarin.  Chemicals metabolized in the mouse lung by this have been shown to induce lung tumors through the formation of cytotoxic metabolites that damage Clara cells, induce cell proliferation, and result in the formation of bronchoalveolar carcinomas.  1-BP has been shown to be metabolized in the liver by this same mechanism.  The existence of a high level of metabolites of 1-Bromopropane in mouse liver strongly implies that pulmonary metabolism is also occurring.
                  1-Bromopropane forms the same tumor at the same location following administration via inhalation, as does the styrene, nepheline, ethylbenzene, and coumarin.  Since these substances form lung tumors in mice via enzymatic formation of cytotoxic metabolites, it can be safely assumed that 1-Bromopropane is forming lung tumors via a similar mechanism, since mice have been shown to form cytotoxic metabolites via liver metabolism.  The lowest risk numbers reported in the 1-Bromopropane draft risk assessment were derived from lung tumors in female mice only as tested in the two year inhalation study conducted on rats and mice by the NTP.
                  In our opinion, expressed in a recently published peer review manuscript, mouse lung tumors represent a level of sensitivity to chemical carcinogenesis that is much higher than would be expected in humans.  That is the NTP two year inhalation study on 1-BP suffers from interpretability issues due to problems in extrapolating bronchioalveolar lung tumors in mice to pulmonary adenocarcinomas in humans.  Reliance on this data has the effect of developing a calculated risk that is higher than warranted, and we would encourage the SACC to consider this information as you review the draft risk assessment and respond to the charge questions, many of which seek your review in support of these very points.  Thank you again for the opportunity to provide comments today.
                  MS. TAMUE GIBSON:  Thank you.  Mr. Ben Gann from American Chemistry Council, please.
                  MR. BEN GANN:  Good afternoon.  I'm Ben Gann, Director of the American Chemistry Council in the Chemical and Products in Technology Division, or CPTD for short.  We are pleased to provide comments on EPA's draft risk evaluation for 1-BP.  CPTD represents more than 60 chemical specific groups focused on the business of chemistry and issues relevant to chemical manufacturers and downstream users.  As the committee conducts the peer review process for the 1-BP risk draft risk evaluation, CPTD recommends that the Agency consider the following items.
                  First, halogenated solvents are used in industrial and commercial settings because they are essentially nonflammable and reduce the overall fire risk.  A significant need exists in the marketplace for cleaning solvents with the wide solubility parameters and excellent cleaning capabilities of 1-BP.  Limiting solvent choices could result in an abrupt and significant change for industrial and commercial facilities that are designed to handle materials rated as nonflammable.
                  Second, a condition of use that may not have been adequately evaluated by EPA is processing of 1-BP for use as a recyclable reaction solvent.  Under this condition of use, it is not intended to be incorporated into a solvent but rather is used as an intermediate in which the reaction takes place.  Third, greater context is needed for less recent air sampling data.  In January 2014, the American Conference of Governmental Industrial Hygienists decreased the threshold limit value time weighted average for 1-BP from ten parts per million to 0.1 parts per million.  Thus, engineering controls and personal protective equipment, or PPE, used to meet the recommended occupational exposure levels at the time a study was done may not meet current recommended exposure levels.  It is within this context that data for inhalation exposure pathways should be evaluated.
                  Fourth, we should not lose sight of the fact that EPA found that there was no unreasonable risk under some conditions of use, including domestic manufacturing, importation, processing as a reactant, distribution disposal, and recycling.  In addition, EPA found that there was no unreasonable risk to the environment under all conditions of use.  Fifth and finally, exposure levels for each condition of use vary depending on volume, engineering controls, and use of PPE.  EPA acknowledges that it does not have information on the effectiveness and prevalence of engineering controls despite recognizing their effectiveness in reducing occupational exposure. Although PPE is the last means of worker protection in the hierarchy of controls, EPA also recognizes the effectiveness of PPE and reached a finding of no unreasonable risk for most conditions of use where respirators were used and risk estimates did not exceed the risk benchmark for inhalation exposure.  CPTD looks forward to continuing to work with the Agency as it moves forward with the risk evaluation process.  Thank you for the opportunity to speak today.
                  MS. TAMUE GIBSON:  Thank you.  And Richard Morford from Enviro Tech International.
                  MR. RICHARD MORFORD:  I can waive my comments.
                  MS. TAMUE GIBSON:  Oh, I see.  Thank you.  Okay.  This is the end of the submission of the public for public comments.  At this time, I have the time now as 12:36.  We are ready for lunch, so we'll be back here at 1:36 to begin the charge to the panel.

                  (BREAK)

                  MS. TAMUE GIBSON:  Hello, everyone.  Hello, everyone.  The peer review meeting for 1-bromopropane -- we will begin, and I will turn it over to our chair, Dr. Portier.
                  DR. KENNETH PORTIER:  Thank you.  I guess before we start with the issue questions, I open it up for one last -- see if there's anyone from the public that wanted to make a comment before the panel.  We kind of, I don't think we rushed through it, but we had a lot of commenters this morning.  We had a lot of topics to discuss.  We want to make sure that everyone who wanted to have a say before the panel has had that opportunity.  I don't see anybody jumping up.  We'll give them 15 seconds.  Courage is waning.  Okay, we'll close that, and we'll go on with the issues.
                  EPA has provided the panel with a fairly large list of charge questions, and our DFO has set an ambitious agenda for today for us to get through four questions.  I have my doubts, but I'll do my best to do it.  And so we're going to go ahead and start, and, I guess, Dr. Anitole, you're going to be reading the questions.  And I've asked her to read the whole question for 1, 2, and 4, but she's going to shrink Number 3 because it's way too long.  Dr. Anitole.

                               CHARGE QUESTION 1

                  DR. KATHERINE ANITOLE:  Okay.  Beginning with Charge Question 1: Systematic Review.  This relates to Section 1.5 and the supplemental documentation.  To meet the scientific standards required by TSCA, EPA applied systematic review approaches and methods to support the Draft Risk Evaluation of 1-BP.  Information on the approaches and/or methods is described in the Draft Risk Evaluation as well as several supplemental documents.
                  Question 1.1: Please comment on the approaches and/or methods used to support and inform the gathering, screening, evaluation, and integration of data and information used in the Draft Risk Evaluation for 1-BP.
                  Question 1.2: Please also comment on the clarity of the information as presented related to systematic review and suggest improvements as warranted.
                  DR. KENNETH PORTIER:  Thank you.  And Dr. Blystone has the lead on this.
                  DR. SHERI BLYSTONE:  Yes, so I'm going to make a couple of comments, and then we would like it to go over to Dr. Davies.  She has some stuff to show before we get to the other members, so I want her to talk through her stuff.
                  In general, I think you've heard this comment before.  You're going to keep hearing it until it happens is that peer review is required for the screening criteria.
                  I think we have continuing challenges with clarity.  If I go to 1.2, at least I had that because I'm not necessarily an expert on systematic review, but I tried to follow some stuff through.  And, whenever I tried to follow a reference, either from the systematic review up to where does it end up in the assessment or vice versa, I seemed to get either lost or run into a roadblock or something.  And then, at some point, I just sort of threw up my hands and gave up.  But there's some challenge to following it all the way through that I think I'll spend some more time to try to come up with some ideas of how we can prove the clarity, but it is a challenge, I would just say.
                  I will mention that Dr. Portier pointed out one particular instance to me that I also found in the Systematic Supplemental File for Fate and Transport Studies.  In Table 3, there was a reference to a study in hydrolysis that was rated as low, and, under comments, it said that an article was not available.  We found that article within two minutes on Google, so it seems to suggest that I don't know how thorough all of this stuff is.  If you have one of those instances, is there more instances of that?  But I verified it with -- I have the study.  I'll give it to you, so you can have it.  It's publicly available.
                  I've seen other in -- public comments also sort of suggested there are times where things don't quite seem to match up with the criteria in the systematic review.  There was one public comment that was talking about two studies done at the same laboratory.  The same people were rated differently, and the clarity of why that was may need to be improved.
                  So I kept hearing those kinds of questions about it.  It's difficult to sort of follow it through, and I think Dr. Davies has more to say about that.
                  DR. HOLLY DAVIES:  Yes, thank you.  I tried to follow it through.  So I do want to start by saying I do have a lot of the same comment, of course, that I had for 1,4-Dioxane.
                  DR. SHERI BLYSTONE:  Excuse me, I think we wanted to show some stuff, right, Don?
                  DR. HOLLY DAVIES:  So I can get to that, yeah.  I'll tell you.
                  DR. SHERI BLYSTONE:  So he can pull it up while you're talking.
                  DR. HOLLY DAVIES:  Okay.  I do have a lot of the same comments, of course, as for 1,4-Dioxane as EPA, of course, has not redone the systematic review, and we don't want to lose those.  Some of the parts are too stringent, some not stringent enough, not enough explanation of terms and the procedure, simplifying used more like the existing systematic reviews, confusion on the gray literature; and Tracey Woodruff also reiterated a lot of that this morning in her public comment.
                  Also, I wanted to mention the systematic review lays the foundation for the risk evaluation, the discussion of the rest of the risk evaluation will provide insight into that.  I had looked through the Draft Risk Evaluation kind of from the perspective of the systematic review, and I'm going to comment on that and not on the quality of the risk evaluation.  I'm going to try to kind of limit to not is this a good paper or did this lead to a good risk evaluation but more on how the systematic review went and look forward to insights on how the risk evaluation went.
                  So I really wanted to follow through like how this worked because I was expecting it to flow.  I was expecting a comprehensive search with the baseline of their other evaluation that were done fairly recently.  And then a comprehensive search like what was on topic and then do the data quality evaluation and then the synthesis leading.  And I'm just kind of expecting that, and I never really saw that.  As Sheri just said, that flow wasn't really there.
                  Okay.  So maybe Don could show this.  Okay.  So start with this.  This was the first figure, literature flow for fate and transport.  I started with this one.  It was smaller.  I thought it would be easier.  There's nine on-topic peer-reviewed references from the bibliography.  And then there's seven in the data quality evaluation; but, to my surprise, the seven in the data quality evaluation are completely different from the nine on-topic peer-reviewed references from the literature search.  And so it's like, where did those seven come from?  There's just this complete disconnect.
                  And so I eventually ended up coming up with figures, which is why I made this, to figure this out because there's no mention where the seven papers came from in the data evaluation, nor can I figure out this -- I never could figure out any of these.  I could not follow any of them, so I took everything, and I put it into Excel spreadsheets, which Don also has, but I don't think we need to look at all the Excel spreadsheets.  So I have Excel spreadsheets of all the data quality evaluations and all the references and then other things too so I could compare them.  So I have like 12 spreadsheets in my Excel file.
                  So, for this Figure 1.6, many things -- so, in the bibliography, there was about 981 search results.  I assume that's because they did the search again.  That's not in the bibliography.  I don't know what data screening means so much, but they excluded 98.6 percent of the references.  So I have kind of both big and small comments.  So that implies that the initial search criteria were too broad.  You're excluding 98.6 percent of them there.  The data evaluation says 18.  There's only seven in the data quality evaluation, so I don't know where that is since there's only seven in the document.  The text says they entered full screening when relevant and went into data evaluation.
                  The 12 that were unacceptable based on the evaluation criteria, none of them were unacceptable in the Data Quality Evaluation document, so I don't know what that means.  And the data extraction's not mentioned in the data quality.  And zero were added from the key in supporting, so I don't know where those extra ones came from, so I never figured that out.  I could never get the numbers to match up even by putting everything into Excel spreadsheets.
                  So I finally -- if you want to go to the next slide -- I did try to kind of figure out where things came from.  Here's my figure.  Another minor comment: it's better to use the same words even something like going from environmental hazard to ecological hazard.  It's hard to know in this when we're trying to follow it.  I guess that means something different or the same thing.  The strategy has different words than the beginning of the section versus what's in the bibliography versus what's in the data quality evaluation are called.  So this is one I was hoping it was going to kind of flow nicely with different bubbles.
                  So the nine fate didn't go anywhere, although, one of them does show up in the references and is used later in the risk evaluation.  But none of them go to the data quality evaluation.  Four of them come from existing OPP sources; and three of them, I don't know where they came from.  So that's where they came from.  So I was trying to figure all of those out.
                  I also looked at where they were used.  Table 1.1 Physical Properties -- almost none of that was in through the data quality -- the DQE.  None of those references had been evaluated.  These were used in Appendix C, and some of them in Table, I think, 2.1 in one of the tables.
                  So for occupational -- the next one's occupational -- on environmental release and occupational exposures, again, this had -- I just could never get these numbers to work for all the same reasons.  The numbers in the data quality evaluation didn't match this.  The ones that were not integrated didn't match.  Where did the key environmental ones come from?  The other thing that caught my eye here -- well, if you look down -- next slide -- you can see where these come from: Some of them come from engineering.  Some of them come from human health hazard search.
                  I ended up getting distracted here because of the criteria.  Because, what I noticed when I was looking through these, looking through the Data Quality Evaluation, was that a lot of them had scored really high for methodology, and they scored high for methodology because they were an EPA study or they came from a federal agency or they were from -- they had been published in a peer-reviewed journal or, my favorite, because it came from King County.  And so they must have used good methods because, as a former King County employee, it's always nice to know that King County is so highly thought of.
                  So I went back to the methodology document and that is not the criteria for a methodology for high, and so they weren't following the methodology.  And I did look at -- and this is where methodology is not being followed.  I don't think following it would have improved the risk assessment.  And they're different, so some evaluators scored it high for any federal agency: TURI, CARB, consultant funded by CARB, academic labs.  One of my favorites was just four letters: H-S-I-A.  That's it.  It must be high because the Halogenated Solvents Industry Association [sic] did it.  But then other ones, not ECHA, not NEWMOA, so somehow TURI was good but the NEWMOA not.  ATSDR and OSHA were sometimes were not rated high, so it was just weird, inconsistently done things.
                  So I looked and, to actually be high, the sampling or analytical methodology has to be approved OSHA or NIOSH method or well described and found to be equivalent to approved OSHA or NIOSH methods.  And one of the key things is that for the occupational -- and for this type of study, EPA explained -- and this, again, is all back in the 2018 application of systematic review -- the reason for the approach is to avoid admitting potentially valid data or information since occupational exposure and release data is often sparse.  So really, they just set this incredibly low bar, and they said that in the methodology, and so then it was very few things.  Many metrics had no unacceptable.  There was no unacceptable for sample size.  There was no unacceptable for metadata.  There was no unacceptable for several of the metrics.  And it was really hard to get the low.  And so it was setting a low bar and then not having a lot of different kind of high, medium, low and then not following the criteria they did have.
                  And then sample size and minor is another comment -- sample size is not actually sample size but whether there're statistics to describe the sample size, so it would be helpful to have criteria that are named in a more descriptive way.  Metadata is one of the criterion, and it actually is for sample types, exposure types, sample durations, exposure durations, worker activities, and exposure frequency.  So it's one criterion to cover like everything in the study, and there is no way to get an unacceptable rating in the occupational exposure rating.  So it's a very -- and this just really conflicts with the human health criteria where, if you don't bind to receptors, it's unacceptable, the whole study is out.  So it's a very different criteria for the different kinds of studies.
                  And what had caught my eye about this was, as I was going through it, it just seemed like it was not a very useful criteria when everything was high, and it wasn't differentiating.  So I went through in my spreadsheet and I looked at -- I put down for all of the occupational ones what it was.
                  Also, the models: while I was looking at the criteria, I was really surprised that one of them for the other one was models for the fate EPI Suite with one of the seven was EPI Suite.  Most of the criteria was NA, and so it got a pretty high score.  And going back to the methods document, there are no criteria for models under fate, which is why it was hard to -- for the person to rank it.
                  But there's actually, there are criteria for models for engineering and occupational exposure, and, yet, in the document, they used tons of models for occupational releases and occupational exposure, but they didn't rate any of those models.  So none of those went through this data quality evaluation even though they do in fact have criteria for them.  I don't think the criteria would have been particularly useful because, in order to be unacceptable, the model has to have like mathematical mistakes in it, so they all would have passed this incredibly low bar.  Okay.
                  So consumer and environmental, again, -- you could go to the next one -- it's going to be the same.  I can't figure out this flow, where the ten -- where they come from.  Three were from the exposure on-topic literature search.  One's from human health hazard, two or three from the existing OPPT sources.  Two of them aren't in the bibliography.  One of them was unacceptable.  A couple of them aren't acceptable actually.  Three of them had data extracted, but it's not clear why.  Several with perfect scores didn't have data extracted, so then it's not really sure how this criteria works; if they're perfect and then they don't have data extracted.  Also one of these is the draft ATSDR profile which always says, "Do not cite"; so we should probably not cite that one.  And the final ATSDR profile has the wrong year because they're both 2016, and one of them, the final, is actually 2017.
                  Also something that would improve the systematic review is consistent citations.  So some things where -- especially since the EPA has the citation source, and so things change citations.  As you're going through, it makes it hard to find them.
                  In the consumer exposures in the document, it doesn't explain -- so like when they look for consumer exposures, they don't explain why they didn't use the ones that they have that went through the data quality.  They found uses.  They didn't find them through the systematic review process, and the sources didn't go through the data quality evaluation that they mention in the text.
                  And there's other statements like, on page 115, "all three parameters had a range of documented values within literature identified as part of the systematic review."  I don't think that's true.
                  For ecological hazard, so this is -- I wonder what my -- go down to my picture, Don.
                  DON:  This one?
                  DR. HOLLY DAVIES:  Yeah, the next one, this is -- oh, that's where the consumer exposure came from -- from all different places.  The next one's ecological hazard which is a little more straight forward because there's only one of them.  You go to the next -- but again, here it says there were two in the data quality evaluation when there's only one in the document, like that's not hard to count.  I don't know where the other one is.
                  And this had more explanation in Appendix 5 -- I mean F, Appendix F.  So we know the key in supporting studies, those five are the ECHA studies.  So that at least is a little more explained but not totally.  And all of these again, have so many excluded.  But, if you go to the next slide, you can see in the environmental hazard, the ones that came from the literature search: one is the Geiger study; five of them go to human health hazard showing that all the search terms for environmental hazard included all the model organisms.  So some of the key -- like the Hanma et al., 2003, which was used for one of the PODs, was an environmental hazard.  All the model organisms, the mice and rat studies, were in environment instead of as human health, so the search terms should be fixed there.  And, of course, Richard Denison mentioned just the issue with the studies not being fully looked at, the ECHA studies.
                  So it was in human health hazard, the next one, that I finally -- a little bit more became clear as I was looking through it because there's more explanation later in the evaluation in the human health section and in Appendix I.  So it named the foundational documents, the draft risk assessment, the NIOSH criteria, and the ATSDR tox profile.  And it was more clear about the systematic review process only being used for dose response and talking about several places.  The papers for dose response were then put through the data quality evaluation, and ones that weren't used for dose response weren't put through that.
                  There's still a lot of terms that I'm not sure are being defined, the key and supporting studies, the influential studies; it also mentions an informal evaluation for overall data quality.  At some point, I had put in all of the -- everything that had a data quality evaluation and all of the references so I could see that less than a quarter of the references went through the data quality evaluation.
                  So it's really just -- I mean, I really had been expecting from this systematic review, I had been expecting this systematic -- that this review, data quality evaluation, and integration and that was what was used to do this.  So going through this also -- and it says, papers for dose response had the data quality evaluation, other papers didn't.  Other papers are there for supporting evidence.  And some of them -- it was not mentioned in the risk evaluation, but there's one of the papers that failed the data quality evaluation was still used as supporting evidence.  I don't think it should have failed because it failed for one of those overly strict criteria where the -- it was a male reproductive study that was six weeks instead of eight weeks.  But it failed under the existing criteria and was unacceptable and then was mentioned five times in the rest of the document.  And so all of the explanation of the hazards which were just a mix of both: ones that had gone to the data quality evaluation and ones that had not.
                  Also there was an unacceptable criterion that was not rated unacceptable overall, and then the Hanma et al. has an issue.  That one was high for acute, but it failed for chronic; and then it ended up being used as the chronic POD.  So I'm looking forward to that and what people think about that in the human health because it's described in the document as high for this chronic endpoint that it's looking at, but it was rated -- it was evaluated twice in the document again; once for acute and once -- it was failed just on the one endpoint.
                  So, looking at this, there were 29 in the data quality evaluation.  It's hard to tell where they came from.  I got totally distracted again.  I couldn't find where they all came from, but the next slide shows kind of where they came from and, again, just to show where they -- it wasn't this kind of expected kind of flow of looked for human health, found human health, evaluated human health.  They kind of came from all the different bibliography topics, and I didn't end up finding where all 39 came from.
                  The human health epidemiology came from, I think, one exposure, one environmental, and one human health on the bibliography.
                  So I did look.  Not all of the studies in the data quality evaluation got into Table I-2, and I don't know why because I-2 is supposed to be the big summary.  I didn't check to see if like all the good studies.  It just seemed like there's throughout the whole thing, there's a lot of studies that were rated good in the data quality evaluation that were not integrated into the document, and there was never any explanation of why similar to what Dr. Woodruff was saying earlier in -- like they had all the studies and they were dropped off.  Even after the data quality evaluation, there were these really good studies by their criteria, and they just kind of left, so you don't see them later.  In other tables in, like, the fate and transport and such, where the tables in the document are populated by studies that didn't go through the data quality evaluation.
                  Oh, another question, and I'm trying to -- this will all be a lot more -- when I tried to put this together, one of the things I'm trying to do is gather like questions on like what does this word mean?  Like confidence rating, there's a bunch of confidence -- like is confidence rating the same thing as the data quality score?  It seems like it is, but I'm not sure.  But some tables will suddenly start saying confidence rating.
                  So then I stepped back with the big picture.  Well, if you go to the next slide, this is what I find -- that was the human health hazard assessment that they said.  The next slide is like what I think is going on.  So, looking at this, I kind of thought like, okay, so you have these foundational studies.  They talk about these key and supporting studies.  The influential ones go to the data quality evaluation but some of them just go right to the Draft Risk Evaluation.  They don't get evaluated and the Draft Risk Evaluation talks about narrative, synthesizing and integrating evidence, supporting qualitative, and more than 75 percent of them don't have data quality scores.
                  They also talk about the backward referencing, searching, and targeted supplemental searches.  We don't know what those are.  Some of those, I think, go into the data quality evaluation.  The systematic review available literature with the PICO scores that are on topic and at least in the human health ones, it's suitable for dose-response analysis; they went to data quality evaluation.  But some of them that were on topic went into the Draft Risk Evaluation without going through the rest of it.  And some of them, even if they weren't on topic, went right there.  And then there just seems to be this ongoing literature searches, communication with industry.  I put the five ECHA studies there, this informal evaluation, like this ongoing thing that's also kind of going in.
                  So this is what I kind of came up with because I kept trying to kind of think what was happening.  I think the next one was what -- this is what I hoped was happening.  This is what I thought was happening.  I thought everything was fitting into kind of different sources because it totally makes sense that you'd start with the assessments that are done and that you'd go into the data quality, but I thought the systematic review with the new systematic review was going through the data quality.  And, of course, you'd also have ongoing new information coming, but I thought it was kind of funneling through this data quality evaluation in going through this integration.  And that's kind of what I was being confused on when I kept trying to find things.
                  Anyway, so I kind of took a step back with going back to TSCA.  So the big picture is I went back, and I thought, what does TSCA really say about systematic review?  I didn't remember systematic review in TSCA, but I was mostly focused on state preemption at the time.  So, of course, TSCA says nothing about systematic review, which you guys know.  There's a new part in TSCA that says scientific standards, a new part of scientific standards, that EPA wrote into their rule into the definition of weight of evidence.  And, in the rule in the beginning of Section 1.5, it talks about, kind of implies, that TSCA requires systematic review.
                  So this systematic review doesn't show the scientific standards as Section 26 requires in TSCA.  Since most of what's going into the Draft Risk Evaluation isn't going through the systematic review.  So I don't think it's meeting EPA's description of systematic review and goes from the preamble.  I don't think it's meeting TSCA's -- showing the scientific standards.  I don't think it's bad science.  I think they're good papers; they're just not being shown through the systematic review process.
                  So that's my -- I think that would be everything so me trying to actually dig in and figure everything out.
                  DR. KENNETH PORTIER:  I'm glad you're going to write that thing up.  I mean, I followed most of it and the diagrams help, but it would be good.  Yes, Dr. Blystone.
                  DR. SHERI BLYSTONE:  This is Dr. Blystone.  Just to follow up in that you can sort of see from the way that she graphically did this why it can be a challenge to try to figure out how any particular reference was used and where it came from and where it went through.
                  DR. HOLLY DAVIES:  So, if you go to the previous one, Don, the previous one is, I think, what they actually did because you can find references and you're like, why didn't it go?
                  DR. SHERI BLYSTONE:  And it's not necessarily that any of that is incorrect; it's just is it clear?  Is it understandable why anything was done in a particular way?  And I think that that's where we -- there's room for improvement there to understand in each of those cases where the arrows went in the way that they did that that's very clearly described in the document.
                  DR. KENNETH PORTIER:  Dr. Cobb, do you have anything to add?
                  DR. GEORGE COBB:  I have a few things to add, but I will say that what we just heard covers a lot of my questions or comments, so I'm going to try to be as brief as I can.  A couple of things: on page 20, there's a part beginning industrial and commercial, and it seems to contradict the exclusion of cleaning and degreasing products, exclusion that's written on page 20.  That's more of an inconsistency comment, and I have a couple of those.  And I just entered that one to say that I have a couple of inconsistency kind of things I'll provide comment on.
                  So, on page 44 in the literature review for fate and transport, it appears to me that only atmospheric transport routes were considered.  And given that 1-BP can be applied to ground or can be introduced to the soils, groundwater is something I think we should be considering in that literature review and that's -- we can expound on that as much as we'd like but that's -- to get that in the record.
                  And I'll echo just so that I'm echoing what we just heard from a previous presenter, the exclusion criteria that were used for excluding specific papers, whether it's individually or collectively, somehow, needs to be in there that these were excluded because they didn't have measurable data or because the species wasn't properly identified or whatever that exclusion criteria would be very helpful in understanding why things were excluded.
                  Also, on page 42 of the assessment, it states that literature search terms included environmental fate and transport, engineering releases and occupational exposure, and exposure to general populations.  We heard this morning that general populations were not considered in the evaluation, so, to say that the data screening included that is misleading at best.  And so I suggest that that wording be somehow repaired, reexamined, or that a paragraph stating why specifically those things were no longer included because I believe that was part of the problem formulation that this was part of what should be considered.  I think that is it.  Thank you.
                  DR. KENNETH PORTIER:  Ms. Rudel.
                  MS. RUTHANN RUDEL:  Thanks.  I did not have anything to add.
                  DR. KENNETH PORTIER:  Do any of the panelist on the phone want to comment?  Dr. Anderson, Cory-Slechta, and Dr. Pessah?
                  DR. ISAAC PESSAH:  No comment.
                  DR. HENRY ANDERSON:  Oh, I think we've covered it.
                  DR. KENNETH PORTIER:  Dr. Pessah, did you have something to add?
                  DR. ISAAC PESSAH:  No, I just said I don't have any comments.  It's been covered pretty extensively, the concerns I mean.
                  DR. KENNETH PORTIER:  Thank you.  Anyone else on the panel wish to comment?  I don't see any flags up.  I think this would be probably our most comprehensive comment on systematic review that we've had so far.  So I look forward to having your review organized.  I look forward to having that.
                  DR. HOLLY DAVIES:  Well, actually, I forgot to say something, believe it or not.  Table 2.1 and just so that I can put it into my notes -- Table 2.1 -- so the first one says the study quality's high but, it's not in the Data Quality Evaluation.  And there's another one that says low that's also not in the Data Quality Evaluation, and I'm not sure if there's -- there's two references in one cell and the low could just be referring to one of the two references and the other ones are EPI Suite, which is just kind of weird to have done.  So there's just other examples like that.  That was when I started and said, how is it used?
                  DR. KENNETH PORTIER:  Okay.  And I'll look to EPA, do you have any comments or clarification questions of the panelists on their response.
                  DR. STAN BARONE, JR.:  Yeah, this is Stan Barone.  So thank you, Dr. Davies and Dr. Blystone, for your synthesis here.  I think you've done a very good job identifying some weaknesses in the narrative.  I think your graphics here, if we could get those sooner rather than later, that will help us in discussions that we're having on the next group of assessments.  I think you've outlined in your graphics some weaknesses in our explanation.  I think, if you looked at your last graphic, that was our goal and that was the approach that we were taking with the different disciplines.
                  If you go to Number 13 where all the key and supporting studies, all the critical studies for the different disciplines, go through the data quality review.  Now, we apparently did not show the flow very clearly, and I think that's what you've outlined are some weaknesses that we need to address.  And some of this has been brought up in the other comments in a sort of one-off individual kinds of issues, but I think you've done a more systematic job.  So thank you very much, and I think this will be useful for us in developing our protocols which we work currently underway for the next one, so thank you.
                  DR. KENNETH PORTIER:  Okay.  I think we're done with Question 1.  Let's move onto Question 2 on occupational exposure assessment.

                               CHARGE QUESTION 2

                  DR. KATHERINE ANITOLE:  Question 2. Occupational Exposure Assessment, Section 2.3.1 of the Draft Risk Evaluation.  EPA evaluated acute and chronic exposures to workers for conditions of use in industrial and commercial settings.  For exposure via the inhalation pathway, EPA quantified occupational exposures for both workers and occupational non-users based on a combination of monitoring and modeled exposure concentrations.  For exposure via the dermal route, EPA modeled exposure for workers, accounting for the effect of volatilization and glove use.  EPA assumed dermal exposure would not occur for the occupational non-users.
                  EPA assumed that workers and occupational non-users would be adults of both sexes -- greater than 16 years and older, including women of reproductive age -- based on occupational work permits.
                  Question 2.1: Please comment on the approaches and estimation methods, models, and data used in the occupational exposure assessment.
                  Question 2.2: Please provide any specific suggestions or recommendations for alternative data, or estimation methods that could be considered by the Agency for conducting the occupational exposure assessment.
                  DR. KENNETH PORTIER:  Thank you.  Dr. Blando, you have the lead on this.
                  DR. JAMES BLANDO:  Yes, I do.  Thank you.  This is Jim Blando here, so I guess I'm the lead discussant for Question 2.1 and 2.2, and, I guess, we'll just take Question 2.1 first, obviously.  So I know we have to verbalize all of our comments at this meeting.  I have some very specific comments that I wouldn't necessarily characterize as substantial but I think, perhaps, the best approach for us would be to have all of the discussants list their specific points and maybe rather than me leading off -- although, I'm happy to do that -- maybe we'll start with the other discussants if they want to bring their points up to the full committee.
                  The first person on our list is Dr. Henry Anderson.  He's on the phone I know.  Henry, I don't know if you had any specific points that you wanted to raise at this time for discussion.
                  DR. HENRY ANDERSON:  Well, I have a couple of points that I think we've heard a lot about the occupational exposures.  One thing I haven't seen -- and it may be in the document, but I just haven't been able to search properly to find it -- is some more information on the OSHA inspections that I think we heard a little bit in the public presentations about the number of respiratory protection violations specifically.  And, in all of the four compounds we've had so far, one of the key issues raised, both publicly and by a number on the committee, has been the appropriateness or the use of assumptions of full respiratory use continuously rather than having it be quite so either everybody's using it or we're not using it.
                  It would be helpful to put some of the information from OSHA.  I've been onto their website to try to deal with their data set on their inspections, and I just haven't been very successful at it.  But, I think, I would also ask, has EPA queried OSHA for what has been their experience with 1-BP or specifically with the respiratory protection standards that they have?  How well has that adhered to worker understanding?  There's a number of -- there's quite a bit of literature on some of that.
                  So one of my things I would say is I think the discussion in the document is not sufficient to justify the making a determination of acceptable risk around acceptable risk based on whether people are using respirators or not.  I think that's problematic, and, I think, getting more quantitative data on that would be helpful.
                  The other thing that I was struck by there's a lot of information on this chemical, specifically -- and some of the others -- on occupational information.  You have the NIOSH criteria document for 1-BP, and you have considerable experience by OSHA.  And I'm assuming, as part of the interagency review, there must be some written comments from NIOSH or OSHA about the documents, and I would -- maybe there isn't any, but, if there are, I think that would be very helpful for the committee to have copies of those comments what their -- because they're really the boots on the ground as it relates to what's going on in industry and less so in the consumer side of things.  But it would be very helpful to get what they may have responded in their comments to these documents.  So, once those exist, I would ask if EPA couldn't make those available to us because, while we have -- or I have some -- general experience in industry, I certainly don't have as much experience as both NIOSH and OSHA.  And OSHA databases don't seem to be utilized here very much.
                  So that's one of things that -- and then the other comment I had, or my question would be, it would seem would be useful in the document to have a combined inhalation and skin exposure estimate, and the skin exposure is calculated based on the air or the respiratory risk.  So that basically says that, if it's in the air, it will also get deposited onto the skin.  So it's pretty hard to have an inhalational hazard that doesn't contribute to the skin hazard.  So it would seem to me, as far as workers are concerned, it's pretty difficult to have a skin exposure without a respiratory exposure.  So it would be useful to have some combined consideration for worker health and safety.  That, I know, makes it a bit more complicated rather than just deal with skin or just deal with lungs or ingestion, but they all do combine to deal with the exposures.
                  And then, I think, as I recall, the review of some of the EPI data, specifically on the neurological side, it appeared in those studies that the humans were quite a bit more sensitive than the values that were chosen out of the animal studies.  I wasn't overly convinced that there was fatal flaws in the EPI studies.  I think they could be looked at or offered alternative set of estimates even if you end up feeling more comfortable using animal data.
                  So that's kind of some of my comments that I was -- I think the assessment or the evaluation of some of the studies as we already -- we just went through with problems, but I would think it would be helpful to have some discussion about kind of a holistic exposure to the worker which would combine the respiratory exposure and the skin exposure.
                  DR. JAMES BLANDO:  Henry, thank you very much.  If I might just add to Henry's comment because it's similar to my first comment as well.  I know we've had a lot of discussion about PPE previously, and I'm sure you guys are looking forward to hearing more discussion about PPE, but I personally have had difficulty utilizing the OSHA inspection database to do this kind of assessment for me personally.  But what I can tell you is that for myself, as personal experience, going to a lot of these facilities that handle bromopropane is that I understand the logic that an industrial facility with professional staff would be more likely to have a robust industrial hygiene program properly utilizing PPE and perhaps the small facilities or family-owned mom and pop shops would likely not have a good program.
                  I would just point out that I've also been to industrial facilities that have fairly poor industrial hygiene programs, and, in fact, I would point out that the 2008 MMWR from Dr. Perrone on the two cases, the index cases, that we had: the one being the dry cleaner and the other one being an industrial worker in a wave solder room.  That while he worked for a fairly large circuit board manufacturing company, their personal protection, the PPE, was not very effective at all.  In fact, their vapor immersion degreaser, the cooling coil, didn't work, didn't wear any PPE at all, and their ventilation was essentially basically just general ventilation in the building; so big surprise, he had very, very high exposures.
                  So, I guess, the question I put out to everybody on the panel is, while I think it's important to point out in the risk assessment document that PPE can greatly reduce risk and makes some estimates about how that might impact exposures, I do think it's also worthwhile for the risk assessment to acknowledge to any decision-maker or user of the risk assessment that, in fact, we shouldn't assume that PPE will be utilized effectively.  I do know the risk assessment and the written documents does point out estimates of pre-engineering control or PPE use or no PPE use; however, for me personally, this is maybe just a minor editorial comment is, as I read through the document, it seemed to imply to me that you really did expect that any industrial facility would, in fact, be using effective ventilation and effective PPE.  And I don't know that that should necessarily be implied.  The thought being that any decision-maker who's going to make a decision by looking at this document or anybody who might utilize this document, I think, it's important to just clearly acknowledge that we really don't know what the compliance would be with personal protective equipment, and that can make a very distinct and very large difference in the exposure and risk estimates that you might generate from this document.  So I don't know how you could reword the document or what you could add to the document to just make that even more clear, but that would be my comment piggybacking on Henry's comment.
                  Henry, I guess that's all that you had for now?
                  DR. HENRY ANDERSON:  Oh, just you've reminded me another would be, while their determination is there's no unreasonable risk in some of the manufacturing facilities, I would just point out that, even though they're a closed system, there are still repair and maintenance workers that spills or leaks or things like that are occurring at the same time.  So we have to pay attention to the types of workers in the various facilities that a manufacturing facility has all sorts of different kinds of workers that need to be looked at either as individuals with a specialized or unusual opportunity for exposure even though it may be a small proportion of the workforce.
                  And the other thing that seemed to be discounted was the use of urinetic biomarkers sort of things.  I think there's quite a bit of literature on those and of course we have the NHANES data that showed that general population is exposed to this compound as well.  So that kind of would build on what is the risk of people living in the neighborhood of facilities either manufacturing or using these materials.
                  The ATSDR review specifically mentions people who may be living in the vicinity of a facility.  And again, dry cleaning and those kind of things as smaller plants often will have a discharge.  There may be not too many people living right nearby, but that is a general population exposure that I don't think we ought to completely discount.
                  DR. JAMES BLANDO:  Thank you, Henry.  One thing about the biomarkers that were discussed, and the toxicologist would know better than I would; I was always under the impression that especially from talking to Kevin Hanley (phonetic) that the biomarkers that they looked at -- the urinary biomarkers -- weren't necessarily specific for just 1-bromopropane.  So I will tell you I have wondered, when we hear some of those estimates about general population measurements of that particular urinary biomarker, I mean, I would ask the toxicologist on the panel if, in fact, that is specific for one 1-bromopropane or less, and, Dan, I see you have a comment.
                  DR. DANIEL SCHLENK:  I brought this up three years ago, and, no, it's not specific.
                  DR. JAMES BLANDO:  Okay.  So that's important to note when we talk about those urinary biomarkers.  So why don't we move on to our next discussant just to make sure we get everyone.  Dr. Barton.
                  DR. CHARLES BARTON:  Thank you.  One of the questions I had was regarding ventilation and engineering controls.  Ventilation wasn't discussed much in the various scenarios as an engineering control, and so I wonder, was it taken into account in the modeling, you know, ventilation-wise?  I see you're nodding your head.
                  DR. STAN BARONE, JR.:  Stan Barone.  A quick answer: yes.  In many of the scenarios where we did modeling, we're looking at room exchange rates, and those room exchange rates are surrogates for ventilation engineering controls.  That's in addition to the monitoring information assessment which included room exchange engineering controls, pre and post, so there are published studies and both NIOSH studies that also looked at that.  So we have probably, out of all the assessments you've seen thus far, this one has the most analysis for the conditions of use looking at engineering controls by condition of use.
                  DR. CHARLES BARTON:  Thank you.  No further questions.
                  DR. JAMES BLANDO:  Okay.  And how about Dr. Bennett?
                  DR. STEVEN BENNETT:  Yeah, sorry.  It's Steve Bennett.  A couple of questions or clarifications: I think one of the things that I looked at this and I'm going to focus a little on the aerosol spray degreasers -- to some on there who have some of the most background -- but I want to make sure that the estimates that they're describing are representative of today's market.  I think they reference a 2002 study for an estimate for about a thousand to five thousand business using 1-bromopropane, and it's unclear if that's still the current practice or the current number of the businesses.  And I think of the changes of the institution of the OSHA PELs as well as the AC -- I never get that acronym -- ACGIH TLV as well as the 2016 risk assessment, how much an impact that's had out in the marketplace?  And I don't know.  That an area of, I think, that if there's a way to clean some of that up, that would be helpful.
                  Certainly, I think, in comparison to the 2016 products that were listed in the document versus those that are listed in the preliminary document for here, there's fewer.  And I certainly know that within our membership there's fewer companies that have an interest in this methodology, so I just want -- I don't want to belittle the concerns but make sure that that's accurately representative of the current marketplace.
                  Another piece that I'll raise is of a little of our same issue we'll go into the consumer question which we have in Number 3 is oftentimes these products, especially in the aerosol space, our design for commercial industrial uses; but they may be available to consumers.  They're not designed for consumers, but they may be available and try to vary how to differentiate between those, clearly understand that you need to take the appropriate risk to ensure that they don't get into the wrong users.  That a trained users, if they're going to using it in there, but there's clearly you have to have that differentiation there with as much as possible, granted, I know, there's a variety of regulatory authorities that come into play and certainly you want to make sure.  But that's a piece that's somewhat in there.  I'll just kind of put those out there.
                  DR. JAMES BLANDO:  Dr. Kissel.
                  DR. JOHN KISSEL:  I have multiple comments.  First, I'd like to note one of the public comments that we got that wasn't presented orally today was from Adam Finkel who's the second former highly placed official at OSHA who has bothered to kind of take issue with the way EPA is dealing with the PPE here, and I think some of those comments should be taken to heart.  A couple of points that he made -- one has to do with -- which I haven't heard anybody make -- had to do with breakthrough.  Compounds with this kind of vapor pressure tend to break through.  This is the same problem with methylene chloride that you can't tell when your respirator isn't actually doing anything anymore and it may actually be exhausted in way less than an actual work shift.  And so there's lots of opportunity for people who think that they're wearing a respirator to be exposed to basically whatever the ambient concentration is; and I think that's cogent point because my experience is, even in places where people are encouraged to wear respirators, there's not checking as to what the capacity of that respirator is on a regular basis and their replacement may, in fact, lag the exhaustion of the device.
                  Secondly, we have -- there's reference to a hazard alert from OSHA which I quote says, "1-BP easily travels through most glove materials."  Now, that's pretty vague, but apparently only relatively sophisticated and expensive gloves will actually stop BP from getting to skin, so we have another level.
                  Many places aren't going to provide gloves, that it would be up to the workers to provide their own gloves.  And they may, for economic reasons, not change those gloves out very often, or they may buy the cheapest things that they can get at the hardware store because they think they're protected when they're not.
                  And so, unfortunately, the reference or the citation for this alert is a textbook which I couldn't get to online, and so I don't know how thoroughly that's been tested.  I don't know how materials have been challenged with 1-BP, but this seems like a compound for which the glove protection factor is even a worse assumption than usual.  So that's a problem.
                  Another thing pointed out by Adam Finkel was that actual OSHA data tend to have air concentrations in the tens of parts per million, and I didn't find air concentrations like that in this document.  And part of that is it's kind of unclear sometimes whether the air concentrations are post-control or pre-control so it's a little hard to follow.  It would be better if the document was a little more clear on what the starting concentration is and what the effective concentration is after some type of protection.
                  Also with respect to the dermal exposure, most of the dermal exposure seem to be starting with a number in the vicinity of two grams per day of exposure to the material.  In our previous encounters with HBCD and 1,4-Dioxane, I think those kinds of estimates were coming from EASE, which is a European exposure model, but I'm not sure where that came from.  In this document, I couldn't find any basis for that starting point.  Once I had the starting point, I could reproduce the calculations and see how you got the doses, but I didn't see justification of what that starting point was and that's, again, that's that transparency issue.
                  With respect to multipathway exposures, this compound -- generally, you would anticipate on the basis of its physical/chemical properties that inhalation would swamp dermal vapor uptake.  But one, there's some reason to believe that the theoretical estimates of how available this thing is dermally might be off the mark a bit.
                  And, secondly, once you put respiratory protection on, then you elevate the importance of those other pathways.  So, if you decided that you didn't have to worry about dermal vapor because it was only ten percent of what inhalation would be, but then you put a ten X correction factor on the inhalation, you haven't cut the exposure to ten percent of what it was; you've cut it to 20 percent of what it was because you have to add back in the 10 percent that was dermal vapor.
                  And so, if you're going to do calculations where you're making assumptions about these protection factors, then it's important to add back in those other pathways which may have been discounted because you would traditionally expect, in an unprotected version, that they wouldn't be important, which, again, plays into the aggregate dose.  It would be good to see aggregate doses.
                  The last comment I had was about the Frasch studies.  So you're using Frasch et al. for a fraction absorbed, which there's been comment about why flip back and forth between fraction absorbed and permeability approaches and you really don't need to flip back and forth.  You could use the Frasch data to get to a permeability approach.  Basically, you can see in the Frasch data -- that's really a good paper --  you can see in the data that you've got competition between stuff evaporating and stuff being absorbed.  And what's going on in those experiments is the evaporation rate is high enough that, basically, the experiments get cut off very rapidly.  And the dermal absorption is basically, how long is the reservoir still on the skin?  But the uptake that Frasch found was actually quite rapid.
                  So the permeability coefficient that is implied by the NIOSH equation, that EPA is using and the consumer data, produces a permeability coefficient from water that's about a third of what the Frasch data suggests; and this is quite possible.  The overall maximum flux, the experimental maximum flux, reported by Frasch is about 30 times the theoretical maximum flux that you would get from using the NIOSH approach.  And that's actually within the air bounds of these kinds of calculations.  When you're doing prediction of behaviors based upon physical/chemical properties and the physical/chemical properties themselves can be an order of magnitude off when you're talking about log Kow and some of the other things, vapor pressure.
                  There's pretty wide error bars on those estimates, and so there's suggestions here that this compound goes through skin much faster than from the Frasch empirical results.  There's reason to believe that this compound is underestimated by the traditional methods, and that's potentially a problem, both on the occupational side and on the consumer side because those numbers are getting used.
                  One other thing to mention -- so it is a kind of timed experiment.  Basically, you can get dermal exposure.  If you unoccluded skin, it's basically how fast does this stuff evaporate because that's when the experiment is basically called off.  Frasch, to his credit, actually measured the wind speed in the hood where he was conducting this work and came up with .3 meters per second, 30 centimeters per second, which is about three times the number that Frasch and Bunge recommend as a typical indoor velocity for -- and I brought this up last time -- hood velocities tend to be faster than actually human experience indoors.
                  So it's possible that that one of the reasons that that stuff evaporated so fast in the Frasch experiments is that the wind velocity was actually quite high, and the mass transfer coefficient on the gas side varies as the velocity to the .78 power.  So, basically, the evaporation rate would go down by a factor of about two and a half if you cut that wind speed down to a tenth of a meter per second instead of three-tenths of a meter per second.  And so that would allow more uptake and so that .0016 percent absorbed would be too low probably for a scenario in which the wind speed wasn't that high.  So those are my comments for now.
                  DR. JAMES BLANDO:  Thank you, Dr. Kissel.  So I just had a couple of comments to add as well.  I just wish I could see what I'm doing here.
 Sorry.
                  UNIDENTIFIED FEMALE:   It's okay.
                  DR. JAMES BLANDO:  All right.  I just had a couple specific comments, and I know I have to verbalize all these comments for them to be included in the record.
                  The first comment that I had in addition to some of the things that have already been said, on page 39 of the supplemental occupational information, there's discussion about a 90 percent reduction from a push-pull LEV-type ventilation system.  I was just curious, and I think it would be important for EPA to describe in the document why they decided on that ventilation system for that degreasing open-top degreasing system.  I know, in some of the facilities that I've been to, I haven't seen that used with degreasers -- not that they aren't; I'm sure they are -- but that 90 percent reduction, I would presume, assumes that the operation of that system is done properly.  I know that with push-pull ventilation systems, if your supply and exhaust does not balance properly which is, from an engineering perspective, is very common with those systems; you can actually make situations worse.  So you certainly don't want to blow the vapor out into your workspace, so, I think, EPA should maybe add some more discussion about why that system was picked and perhaps just make a note about the operation of that system and some of the challenges that sometimes people face in the real world with operating those systems.
                  The second point I had was on page 84 in the supplemental occupational information, EPA stated that using the NAICS and SOC codes may overestimate the number of workers exposed which is certainly very reasonable, although, I would just -- in my opinion, it's just an editorial comment -- I thought that perhaps that rather than saying overestimates since you really don't know if you don't go to the facilities, it might be better to say you might not have a very precise estimate as opposed to assuming it's an overestimate.
                  Page 86 in the supplemental information, EPA notes and assumes that the workers remain in the respective exposure zones, and that this may overestimate their exposure.  While this true for the workers, I would point out that for the occupational nonusers, it's very possible that they too might not remain in their nonworker far-field zone.
                  I know when I've been at facilities, it's not uncommon for workers to be friends with people in the plant.  I know I was at one of the facilities that we sampled and one of the clerks spent a lot of time talking to the operator of the dry-cleaning machine, so there was definitely mixing both ways.  So it might be better to rather than characterizing that always an overestimate, although it might overestimate for the worker, it might underestimate for the occupational nonuser.
                  Page 87 on the supplemental information for occupational, EPA discusses using a constant emissions scenario and points out the exposures that likely vary over time -- which, of course, I'm sure they do -- and indicated that this might overestimate exposures by using a constant emission scenario.  I would just argue from a variability in air levels, as we showed in our 2010 paper with the dry cleaners, you can have -- if you have really significant magnitude in your variability, it's kind of hard to say that assuming if constant exposure's going to be an overestimate; it might actually be an underestimate.  If you look at our real-time TBA analysis that we did with those dry cleaners, in that paper, I think, one could argue that unless you assumed a really high constant emission rate, I'm not so sure that it would be an overestimate.  So perhaps you could be more tentative in saying that would be an overestimate, maybe rather say that it all depends on the specific scenario whether it would be an over- or underestimate.
                  Page 87 supplemental information post engineering controls assuming 90 percent reduction was based on TCE.  I would just say for the engineers that it would be important to keep in mind that 1-BP is -- if I understand and remember correctly -- 1-BP's much more volatile.  I don't know what impact that would have on your assessment of engineering controls.  I do know that in some cases when we had folks who were heating this product that the higher volatility resulted in a higher emission rate when they compared it to using TCE.
                  Page 88, one of the points that I had, which is towards the end the supplemental info, for the dry cleaning under the uncertainty point number 2, EPA stated that the small near-field volume results in a large spike in concentration when the machine doors open, find the residual 1-BP solvent is assumed to be instantaneously reused into the near field.  In reality, the residual solvent will likely be released continuously over a period of time.  I would not agree with that.  I think our video exposure monitoring data clearly shows that, in fact, the scenario you do have when somebody opens up the front door is you do get a really rapid spike in that near-field zone, and I would argue that the operators and machine are not really going to -- when they're trying to pull clothes out of the machine, they're not necessarily going to be able to just walk away from the machine.  So I would not agree with that uncertainty point number 2 that it would be a constant release over a period of time.  That's not what we observed in our video exposure monitoring results which, if anybody would like to see, I could show them.  I have it here on my computer.
                  Page 84 in the Draft Risk Assessment -- I'm going to skip that; that's not that important.  One of the other clarification points -- EPA, in the Draft Risk Assessment, discusses and utilizes the terminology of the 8-hour TWA and the 12-hour TWA.  As you guys know, OSHA has a specific policy on extended work shifts, and I think it would just be clear when you're using the terminology of, especially for the 12-hour TWA, to make sure to the reader that -- and I'm assuming what your 12-hour TWA is a denominator of 12 hours -- but the only confusion that, I think, could occur is that for an industrial hygienist looking at that, if they think you're following the OSHA extended shift policy, they might think it's actually over an eight-hour period and that you're sampling the eight hours of worst exposure.  What you're really doing is computing it over 12 hours, I just think you need to be clear in the document when you're saying 8-hour TWA or 12-hour TWA that you just clarify for the reader, especially if it's an industrial hygienist that's reading it, that you're not referring to the OSHA extended shift policy where, even though it might a 12-hour shift, you're only supposed to sample 8 hours to follow the OSHA policy.  So, if you're not doing that, I would just make sure that that's clear.
                  And then on page 103 -- so I'm getting to the end here -- on page 103 in Appendix B, the calculation for acute concentration computation, to me, was a little unclear.  You essentially had an eight-hour TWA multiplied by the exposure duration divided by the averaging time.  What felt unclear to me about that was that the eight-hour TWA implies that time is already figured into the calculation.  So it's sort of you have an eight-hour TWA that is trying to account for a time-weighted average -- time's already included -- and then you're multiplying it by another timed term which is exposure duration divided by averaging time.
                  I presume what you're trying to do with that calculation is adjust your eight-hour TWA for somebody who works longer than an eight-hour shift if that's what you're trying to do there.  But what I thought was confusing about it, to me, is when I was looking at that computation was that the eight-hour TWA already presumes that you have time figured into the calculation.  So, primarily editorial, but I would just clarify so that a reader can really understand what you're really talking about.
                  And then the last comment was from Dr. Portier who sent me an email about the Tank Truck and Railcar Loading and Unloading Release and Inhalation Exposure Model.  Dr. Portier noted that -- not to speak on your behalf, but I'll just mention I didn't forget -- that in the draft document, it wasn't cited anywhere although it was described in the supplemental information.  So, if there is no citation because that's something custom that you guys have done, at least in the draft document, you might want to refer or put a citation to the supplemental info so, if somebody wanted to get that information, they know exactly where to look.  Did I cover --
                  DR. KENNETH PORTIER:  I was going to say, subsequent to my note -- this is Ken Portier -- I kept tracking -- I don't know.  You get obsessed with some of these things.  I wanted to know where that model, that Tank Truck and Railcar Loading and Unloading Release and Inhalation Exposure Model, came from.  First, it's got the longest name of a model I've ever seen.  But it refers to the supplemental information, and you go to the supplemental information and you, essentially, have the same information as the document.  It doesn't take you anywhere, but I think I tracked it down to ChemSTEER.  And there's loading and unloading module in something called ChemSTEER, which is a model that's out there and it's been evaluated.  And so I'm assuming all these parameters that are talked about go into that document somewhere, but it's not clear.  I mean, you really have to search to come up with that.  You dig and dig and dig.
                  One of the questions I wanted asked back to you and other panelists is there are a lot of models used in this especially the occupational exposure and what your opinion was about the adequacy of the use of those models.  I mean, I think this particular tank truck model sounds reasonable to me.  I didn't see anything about the model that raised a flag, but I don't know the models like some of you know those models.
                  DR. JAMES BLANDO:  I would just say -- not being a modeling guy, more of a field guy -- I have an inherent bias that I like to see monitored data actual, what I would call real data -- all the other models would hate me for saying that.  But I did note when I read your report that you seemed to indicate that you had fairly decent agreement for the models and the actual sampling data that you had, and that felt like a good thing to me.  I don't know if other folks have an opinion on that, but I felt that was very strong.
                  DR. KENNETH PORTIER:  This is Ken Portier.  I just remember back in 2016 when we looked at this.  The panel had a lot of discussion especially about the exposure modeling -- the open and the close, and the inner and the outer space -- and all of that is back in here and I think is cleaned up and is written clearer than the document back in 2016.  And I just kind of wanted to say that I appreciate the EPA putting the effort to kind of clean that up as one of the recommendations from the panel.  Dr. Davies.
                  DR. HENRY ANDERSON:  I would agree with -- it was helpful with how -- well, they didn't provide the data for that as to how close it was that there seemed to be reasonable consistency between the actual measured data and the modeled data.  I think that's an important statement to make as a tendency is to use models and then pretty soon you really are -- there's no data that it's based on but earlier when the model was first constructed with different chemicals and things.  So I think that's helpful.
                  But the other thing that I think is getting better that way is not to be quite too emphatic about the results that come out that you have to be willing to accept that, qualitatively, the high and the low are different but actually having a linear relationship or whatever between them may not be quite so accurate.  So I think the variability in it is something you need to be able to say, if they're usefully used, then they're very helpful.  But they tend not to be quite so quantitative as they're often used.  I would say qualitatively they're very helpful.
                  DR. KENNETH PORTIER:  Dr. Davies.
                  DR. HOLLY DAVIES:  I was just going to say that I also wanted to get other people's opinion because it was laid out well, the pictures were nice, the end, the agreement, was nice, so it was explained well, but I do like the monitored data also.
                  DR. KENNETH PORTIER:  Dr. Kissel.
                  DR. JOHN KISSEL:  So I would like to add that I think everybody who was just talking about modeling was talking about air models, and, you know, air is a relatively friendly medium.  It's well mixed.  You can assume that you have a well-mixed tank and not be too far off with air.  Surfaces don't work like that all.  And I would say that the dermal encounter modeling as the current state of the art is extremely primitive.  And, if anybody can guess within one or two orders of magnitude how much stuff you're actually going to contact on your skin, you're doing pretty well.
                  Oh, and if I could add, I amend my prior comments because I noticed on my -- I left one thing off.  In the evaporation study that Frasch et al. did, they put gauze on top of their device because they were trying to mimic a rat study that had been done.  One possibility is that the gauze actually wicked the materials away from the surface and caused it to evaporate more rapidly than it would have otherwise, so that's another little caveat.
                  DR. KENNETH PORTIER:  This is Ken Portier.  I'm a modeling guy rather than a monitoring guy because I've worked with people collecting data.  There's so many opportunities for bias, whereas, a model is a, I think, exercise where you're really putting it together, and it should come together and work.  But I'm also one that says you've got to calibrate it and validate it, and that's why I like the fact that they're using this kind of more peer-reviewed models which in my mind equates to something more like a validated model.
                  But it's only as good as the inputs going into the model, right.  And then we've seen some previous examples where we didn't agree with the quality of the inputs going in.  And I just kind of question back to you guys was whether you felt that the data going into these models was of enough quality that you could believe what came out of the model, like the EPI Suite stuff.  I mean, these things seem to depend a lot on the EPI Suite outcomes, and I, personally, don't know how to judge the quality of that, but I'm hoping somebody on the panel does.
                  DR. JAMES BLANDO:  I could add that I know when we've done things like interworker comparisons or even with the same worker over different shifts, we have found you can have really wide variability.  I know a lot of the sites that I go to there's always one guy or girl -- I'm very bad -- is like the sloppiest of the sloppiest worker.  And, when you compare their exposures to somebody else who's a little more diligent, you can find -- I know we have found coefficients of variation greater than a hundred percent between workers on the same shift on the same floor.  So that's one issue you could have when you're trying to model that that you could have this extremely wide variability that, I imagine, would impact the models as well or the outputs that could come out of a model.  I don't know if other folks have the same experience, but that's definitely been my experience.
                  MS. TAMUE GIBSON:  I just want to say something real quick, please introduce yourself when you speak, yeah.
                  DR. JAMES BLANDO:  That was Jim Blando.
                  DR. KENNETH PORTIER:  Thank you for reminding us.  Ken Portier here.  The other aspect is the high, medium, low exposure levels.  I mean, do you agree or feel that those are a fairly good description of the range of exposures, especially in the occupational setting which is the -- did you guys look at that?  Dr. Anderson, do you want to join in?
                  DR. HENRY ANDERSON:  No, I mean, my concern with all of this is there tends to imply precision in modeling that isn't necessarily there, and I would agree that, depending on what goes in and what you use, it makes quite a bit of difference as to what comes out of the model.  And high, medium, and low -- I didn't specifically try to go through all of the literature to see what's out there.  That might alter that.  I'm not sure the high levels are really truly reflective as how high things can get or did get in the past.
                  I think that's the other comment that I didn't say much about as it's hard to know how much outreach was made to industry to get information from them or how responsive they were, but we did have some written comments about how the discharge rates when you rely on TRI data from 2016 and we're now three years later what they currently are.  It would be helpful if there was some kind of a survey through the industry, or industry organizations, and kind of ask them, and they pull together some information, and then kind of take a look at that as part of the added information.  I mean, just relying on what's in the literature, the choice of where you go to do your studies is often made by who will let you in or agree to doing this study, so it isn't necessarily reflective of the industry, especially when you get into the smaller facilities.  I mean, the dry-cleaning studies, I think, really show that.
                  DR. KENNETH PORTIER:  Thank you.  Dr. Blando, I'm going to ask whether you've got enough for Question 2.2 as well or whether you had additional comments on that.
                  DR. JAMES BLANDO:  Just for me personally I just had one short brief comment for Question 2.2, but I don't know about the other discussants if they had significant -- to add so we'll do that, okay?
                  So for Question 2.2, please provide any specific suggestions or recommendations for alternative data estimation methods that can be considered by the agency for conducting occupational exposure assessment.  I just have one quick comment, and then we can ask the other discussants.
                  For me, the only other sources of data that we've used in the past, that it wasn't clear to me if you guys used them or not used them, was I know we identified -- in the dry cleaning study that we did, we identified users of 1-BP through the minor source permit program through our Department of Environmental Quality.  The air permits.  People have to submit those air permits and those have identifiers and have information that can be useful for identifying.