U.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

1 EPA

Moderator: John Shoaff September 7, 2011 1:30 p.m. ET

Operator: Good afternoon. My name is Tameka , and I will be your conference operator today. At this time I would like to welcome everyone to the Identifying Priority Chemicals for Review a nd Assessment Conference Call.

All lines have been placed on mute to prevent any background noise. After the speaker’s remarks, there will be a comment session. If you would like to make a comment during this time, simply press star then the number one on your telephone keypad. If you would lik e to withdraw your comment, press the pound key. Thank you.

Mr. John Shoaff, you may begin your conference.

John Shoaff: Thank you very much. Welcome to EPA’s webinar and audio teleconference on Identifying Priority Chemicals fo r Review and Assessment. I’m John
Shoaff with EPA’s Office of Pollu tion Prevention and Toxics.

As you saw with the reminder to the webi nar, the agenda is as follows: we’ll begin roughly 1:30 to 2:00 by presenti ng an overview of the discussion guide on the Two-Step Prioritization Process that has also been circulated and posted;. From 2:00 to 3:20, we’ll take input on questions on Step 1. From 3:20 to 3:30, we’ll take a short break, and from 3:30-4:30, we’ll take questions on Step 2, input with questions on Step 2, excuse me.

Comments will be taken in the order received. Please note that if we’re
unable to address all comments for an agenda item during the time allocated, we may need to clear and restart the comment queue to move on to the next agenda item. So, you know, alternativel y, we may also truncate the schedule with the agenda if we have enough time and depending on the number of
comments with each item.U.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

2 Please try to limit your comments to r oughly three minutes in the interest of providing time for others to provide input. We have a very large audience in participation today. So thank you for that.

And if you need assistance at any time, please press star 0 for the Operator. And if there’s not enough time for everyone to provide comments or later during the webinar, comments can also be provided electronically. Although, if provided to the webinar, they will not be viewable in real time, but we will
have them and be able to answer them in the docket.

And I’d also highlight that comments can also be posted to our discussion blog through close of business 5:00 pm on September 14. After the forum closes, EPA will place the entire discussion forum with comments included to the associated docket. With that, I will turn it over to Wendy ClelandHamnett, our Director of the Office of Pollution Prevention and Toxics.

Wendy Cleland-Hamnett: OK, thank you, John. Thanks, everyone, on the phone for taking the time to listen to this presentati on and provide us with comments this afternoon. Your input is greatly appr eciated, and we’re looking forward to hearing it.

I’ll go ahead and start the presentation. We’ll go to Slide 2. This is – Slide 2 is just to make the point that shortl y after becoming the EPA Administrator, Lisa Jackson made it clear that impr oving our chemical management program here at EPA was one of her top priori ties. And that included advocating for
reform of the Toxic Substances Contro l Act, which is the authority under which we carry out our existing chemi cals program here in the Office of
Pollution Prevention and Toxics.

The Administrator stressed she was very much interested that while we worked on reform of TSCA, that we also used the authorities that we have
under our current statute to the best of our ability to make sure that we’re doing what the American public expect s in terms of gathering data on chemicals, reviewing that data and taking action where it’s warranted.U.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

3 So we’ll move to the next slide. I want to make sure that there’s an understanding that the exerci se that we’re talking a bout here today, which is identifying the highest priority chem icals for us to review, assess and potentially take action on, is part of a larger context that our ongoing existing chemicals program in my office, Pollu tion Prevention and Toxics, that we carry out under TSCA.

So as part of that larger ongoing pr ogram, we have activities to gather information that help us to better und erstand what’s going on in the chemical industry and with chemical risks. And th at includes using te st rules to require the testing of chemicals. We’re in th e process of completing the issuance of test rules on high production volume chem icals that were part of the High Production Volume Challenge Program th at we undertook a number of years

ago.

We are also looking, as we complete that phase of the testing program, in our HPV-4 proposed rule. It should be co ming out shortly. We’ll be soliciting comment on future direction of that progr am in terms of how we best identify chemicals that might be subject to te sting requirements, as well as taking a look at whether the screening information da ta set, which is the battery of tests that we’ve been using in the HPV progr am, continues to be the best set of testing for chemicals or whet her we want to look at alternative testings. We
continue to review the data that we’v e received under the HPV Challenge and other aspects of the program and to post hazard characterizations for chemicals. We’ve been doing that for a number of years. We’ll continue to
do that.

We’ve recently published amendments to our Chemical Data Reporting Rule, and we’ll be getting a new round of reporting information on production volume, uses and other information on chemicals next year. So we are – while we’re getting ready for the submissi on of that data, we are also looking
at how best to make that data available to the publi c in ways that would both be useful, as well as how we will use it internally to improve our chemicals

program.U.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

4 We continue to work on making more heal th and safety data that are part of our TSCA holdings here at EPA, maki ng that data more accessible to the public and with a particular focus on health and safety and linking that
information to chemical ID. So we continue to work on that area.

The agency had an initial set of pr iority chemicals that Lisa Jackson announced just about two years ago now in 2009, and we issued action plans for those 10 chemicals or categories of ch emicals. We continue to implement
the actions that were identified in those plans. So we’ll be continuing to work on that. While as part of the program we’ll be identifying the next set of priority chemicals that we’ll begin to work on.

We’re working on some other rules to gather information on nanomaterials
that will allow us to bett er understand what’s happen ing in the industry with nanomaterials and what potential uses and exposures are for those. We’re working on some risk management regul ations for some other high priority chemicals, lead and mercury, under Section 6 of TSCA.

So all of that is to say that what we’re talking about today is very important in terms of identifying chemicals, which shoul d be the highest priority for us to do some in-depth assessment and take act ion on, but to say that there is a lot of other work going on in terms of unde rstanding the broade r context and the broader array of chemicals that are in commerce and subject to TSCA.

So moving to Slide 4, the goal of what we are talking about today is to identify the highest priority chemicals, to determine whether risk is significant and whether risk management or othe r action under TSCA is warranted.

And what we’re focusing on in our discussion guide and looking for your comment on is that we’re talking about ch emicals for this set of high priority chemicals, chemicals or data are (ava ilable) on hazard and where there’s an
indication that a chemical or certain uses of those chemicals might present a significant risk, that there is significant exposure.

That allows us to take advantage of work that’s already being done by EPA, by other governments, whether they’r e international or they’re stateU.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

5 governments, and allows us to move quickly to take action on these
chemicals.

One important difference between some a pproaches to prioritization that have been taken in the past or that have been proposed is that we’re looking to quickly identify some of the highest pr iority chemicals that we can begin working on, while we continue to work on better understanding the broader array of chemicals. So we’re not looking at running, you know, a large number of chemicals, thousands of chemicals, through a screening process where we’d identify everything from ve ry low concern chemicals to very high
concern chemicals. These exercises focu s more on trying to id entify that next set of high priority chemicals th at we should be working on.

Our plan is to have that set of high pr iority chemicals identified by late fall, for work in 2012 and possibly beyond 2012, depending on the number of
chemicals that we identif y through this process. Some people have asked whether we have a target number; we don’t. We’re trying to identify chemicals that you, our stakeholders, a nd we believe are the most important for us to be addressing.

And then depending on the number of ch emicals we come up with, we will work through those over time. And we an ticipate that this would be a rolling process. We’d work on the highest prior ity chemicals first, and when we were finished with those, we’d move on to a nother category of priority chemicals.

So when we release our next set of prio rity chemicals later this fall, we would intend to, at that point, talk about the factors that we used to identify those particular chemicals, and some idea of the scope of review that we would be intending to carry out for those chemicals.

Following that at a later date, we woul d provide information on the data that
we would intend to use to review an d assess those chemicals and provide a time period where interested parties could provide us with additional
information that we did not have in our possession at that time, if they are private information holdings or things th at we just missed in doing our review so that we have that information before we move into a more in-depth review.U.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

6 OK, next slide. So quickly, what we ’re talking about here is the two-step process, and I essentially think of it as that Step 1 is a coarser step where we’re trying to cast the net and identify larger group of chemicals that could potentially become priority chemicals, and Step 2 would allow us to take a
little bit closer look at those and help us to prior itize within the chemicals that are identified in the Step 1 screen those that we might want to take on sooner, those that we might want to take on late r. That’s essentially the idea between the two steps.

So at this point, I think before we go into detailed comments on Step 1 factors and data sources, I’ll pause and, Tameka , open it up if there are folks on the lines who would like to make general comments on what we’ve presented so
far in terms of the overview or what they’ve read in the discussion guide.
We’ll do that and then we’ll move to th e Step 1 factors - pr ioritization factors - part of the discussion.

Operator: At this time I would like to re mind everyone in order to make a comment, please press star, then the num ber 1 on your telephone keypad.

Your first comment comes from the lin e of Lin Kaatz Chary, with Great Lakes Green Chemistry Network.

Lin Kaatz Chary: Great Lakes Green Chemistry Network. Thank you.

This is very encouraging and very in teresting. The one thing that I’m not seeing and perhaps it’s going to be c overed later, so I apologize if I’m jumping the gun, is that when you talk about Step 2, select chemicals for review and assessment including possibl e risk management action, are you looking – will this include also a push for alterna tives and alternatives
assessments?

I noticed that’s something that the Design for the Environment does, but I’m sort of wondering what the interactio n is and where the efforts of Green Chemistry will fit into this entire framew ork that you’ve presented? Thanks.U.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

7 Wendy Cleland-Hamnett: I’ll try to answer qui ckly to allow other people to comment, but
alternatives assessment and Green Chemis try are some of the tools we’d bring to this, so it’s really regulatory act ions and other actions. The ten Action
Plans that we’ve issued over the last couple of years, a number of them
include alternatives assessments for so me of the chemicals covered in the Action Plans, for Green Chemistry challe nges, so we expect to continue to look at that as one of the poten tial tools that we’d use.

Operator: Your next comment comes from th e line of Michael Buczynski with Church & Dwight, Inc.

Michael Buczynski: Yes, will you have slides after the conference call for those of us who cannot access the Go To Meeting?

Wendy Cleland-Hamnett: Yes. We’ll post the slides to our website.

Michael Buczynski: OK, thank you.

Wendy Cleland-Hamnett: You’re welcome.

Operator: Your next comment comes from the line of Barbara Warren with Citizens’
Environmental Coalition.

Barbara Warren: Yes, thank you very much. I’d like to mention one thing that appears missing from the Step 1, and that would be how much of the chemical is produced or used? That does not appear to occur un til the second step. And then the other question is, the biomonitoring seems to be just geared to human biomonitoring not environmental sources of data, say the USGS or other, you know, drinking water or that type of a source, and so I wanted to raise that question. In other words, prevalence in the environment.

Wendy Cleland-Hamnett: Thank you.

Operator: Your next comment comes from th e line of James Conrad with Conrad Law and Policy Counsel.U.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

8 Jamie Conrad: Hi, Jamie Conrad. I guess I had a clarifying question and a comment. The set of chemicals that you would release in late fall with an invitation for people to supply more data, is that considered Step 1?

Wendy Cleland-Hamnett: That would include through Step 2.

Jamie Conrad: So by the time it would come out in the fall, that you would have – that would be Step 2. OK.

My comment is, is this. There’s a lot of criticism of the TSCA program that there are 80,000 chemicals on the Invent ory, I’m clarifying, I’m just speaking for myself. And one would think, in light of that, th at one approach you might do is to try, as quickly as possible, to whittle that down to the ones worth being concerned about, which is what Canada did, and they took their 23,000
chemicals on their Domestic Substances List, and over six years, they whittled
that down to a set that they wanted to keep working on. You would think EPA, between an Inventory reset and some sort of screening effort like what Canada did, you could take tens of thous ands of chemicals off the list and show some progress, whereas, it seem s to me what you’re proposing now is essentially to keep biting off 10 here and 10 there with another 80,000 sort of looming out there really forever, and I ju st wonder if that really addresses the kinds of concerns peop le have identified.

Wendy Cleland-Hamnett: OK, thank you.

Operator: And there are no further comments.

Wendy Cleland-Hamnett: OK. So with that, we’ll move to Slide 6. Here, we were looking at getting comments on the prioritization fact ors that are in the discussion guide, oh I’m sorry Slide 7 – OK, they’re number 6, yes. Sorry folks, numbers are different than what I have in my presentation here.

So Step 1 questions. We’re looking to get input on the ch emicals that, sorry, the factors that we would use to select pr iority chemicals. We have six factors
listed. Some of them relate more to th e hazard side, some of them relate moreU.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

9 to the exposure side, some of them such as PBTs are probably a combination
of those.

But what we are looking for as you make your comments, looking for you to keep in mind, is whether you’d support th e use of these factors and why that is, if you believe that a given factor is not appropriate and why you would
believe that to be the case. You mi ght have comments specifically on how we approach a factor, or there might be pr ioritization factors th at you believe that
EPA should consider that we don’t have on this list. So I’d ask you to address these questions as you provide comments to us in this part of the discussion.

So do we have any comments in this area?

Operator: Again if you would like to make a comment, please pre ss star 1. And your question comes from the line of Georj ean Adams with EHS Strategies.

Georjean Adams: This is Georjean. It wasn’t clear to me that you were going to be looking at both exposure and toxicity together. It seems to me that if you’re going to be focusing on the worst first, that you’d want to look at those chemicals that had both high exposure potential and high toxi city. And it almost looks like from the way you’ve listed this, and I think I read it somewhere, that one or more, and I guess, I would recommend that it be many of the characteristics so that you were indeed looking at the highest risk.

Wendy Cleland-Hamnett: OK, thank you.

Operator: Your next comment comes from th e line of Mark Mitchell with the National Medical[Association].

Mark Mitchell: Yes, this is Mark Mitchell. I have a couple of comments. First of all I disagree with the last speaker. I think that if you’re casting a wide net, then any one of the criteria should be enough to get the chemicals into that wide

net.

My comment is that, historically, EP A and science as a whole has not been very good at predicting exposures. And this is particularly true in environmental justice communities, where part of the definition ofU.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

10 environmental justice communities, those low income and communities of color, is an unusual exposure pathway, as well as disproportionate exposure, as well as increased susceptibility.

And examples of chemicals that were thought to not have wide exposure are things like PCBs and, you know, which were, of course, outlawed in the original TSCA, as well as some TCE, which is supposed to be a industrial chemical but a lot of environmental ju stice communities are being exposed to them through brownfields, as well as some chromium-6. And these are also not the PBTs, they’re not persistent , bioaccumulative, and toxic.

So given the premise that exposure is not very well predic ted, I would propose two things. One is that you look at production volume as a potential indicator of exposure in addition to the biomon itoring and PBT characteristics. But also, that you currently look at what’s poisoning people now. You know,
there are a number of chemicals that are out there, again, that people are currently suffering the consequences of, you know, lead poisoning, mercury, just a number of chemicals. And so I propose that, that also be a criteria, those toxics that people are currently being exposed to.

Operator: Your next comment comes from the line of Carol Kwiatkowski, of TEDX.

Carol Kwiatkowski: Hi., I just wanted to comment that I think that another factor you should
consider is chemicals identified as endocrine disruptors. Thank you.

Wendy Cleland-Hamnett: Thank you.

Operator: Your next comment comes from the line of Melanie Marty with California
EPA.

Melanie Marty: Hi, I just wanted to add in th at in addition to biomonitoring programs, since
the list of chemicals for which we have found biomonitoring information for is quite limited, that you do have to l ook at environmental media. So, there are a number of data sources including fr om the State of California and other states that could indicate widespread exposures. So you have to expand your horizon on the exposure end of things. A nd also I liked what the last personU.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

11 said about endocrine disruptors and ne urotoxic chemicals as well, which, generally, are shown to be worse in the developing organisms. Thank you.

Wendy Cleland-Hamnett: Thank you.

Operator: Your next comment comes from the line of Mark Rossi with Clean
Production.

Mark Rossi: Hello, I was just going to remove my comments because I was just going to agree with the – I was going to make the point around adding neurotoxicants and so I agree with that point, and I also agree with the point on adding endocrine disruptors. And I would also say that just reproductive and developmental effects are also important to women of child-bearing age. So we wouldn’t want to just limit chemical s at a repro-developmental toxicants of concern to children’s health, bu t it would also be for women of reproductive age. Thank you.

Operator: Your next comment comes from the line of Jennifer Canvasser with The Michigan Network for Children’ s Environmental Health.

Jennifer Canvasser: Hi, I just wanted to r ecommend that in terms of prioritization and exposure factors that chemicals which cr oss the placenta barrier or blood brain
barrier be included.

Operator: Your next comment comes fr om the line of Betsy Duncan with LyondellBassel.

Betsy Duncan: Hello, this is Betsy Duncan w ith LyondellBassel. Just a comment on the information pertaining to production vol ume as it would be a factor in potential exposure as one of your prioriti zation factors, I don’t see that in your Step 1, at all, and that’s it. Thank you.

Operator: Your next comment comes from th e line of Leonard Sweet with Labrazel.

Leonard Sweet: Yeah, my comment is, is chem icals identified by whom ? There are various lists and agencies and organizations that like to call things, for example PBTs. So my question is, identified by whom , carcinogens, IARC, NTP or OSHA orU.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

12 others. I think that’s a critical part that’s missing is who’s the voice of authority and opinion here in terms of identifying all these labels and concerns on chemicals. Thank you.

Wendy Cleland-Hamnett: Just a clarifying point on that. The next step of the process in the discussion guide that we posted online, we have a table of data sources that
we would use to inform these factor s. So for example, you know, IRIS determinations, IARC determinations a nd NTP findings, etc., listed in those tables, and we’ll actually be asking for comments on those on the next part of
the discussion here.

Operator: Your next comment comes from the line of Alex Stone w ith Washington State Department [of Ecology].

Alex Stone: Yes, hello, thank you. Just one co mment and then one sort of observation, if you will. You did mention that you’re going to be working with states, and the states are formulating written commen ts and will probably submit them at some point further on, so we’ll be prov iding more detail. But I do want to emphasize is that it’s important to work with the states that have already done a lot of this process already, so you c ould learn from what we have done and build upon that. But second of all, the so rt of general commen t is that I don’t object to your prioritization, what you’re selecting as the prioritization criteria here in Step 1 questions, but what you need to do is to cast a very broad
network of criteria to identif y the chemicals of concern.

So I agree with a lot of the comments that have been made earlier, particularly, including your broad network of chemicals that impact not just humans but the environment. And then when you have that large universe, you use those chemicals, those prioriti zation steps that you have here to
narrow focus down on the ones that are mo st important in the short term.

But, you know, I’m looking at this from the broader perspective as well, as is that it would be good for EPA to use its resources and identify this larger universe of chemicals, so that those of us who are trying to do alternative assessments and selecting safer alternatives will have more informationU.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

13 available to us on what chemicals are a nd are not viable alternatives to toxic chemicals. Thank you.

Operator: Your next comment comes from the line of Marjorie Martz-Emerson with
Hewlett Packard.

Marjorie Martz-Emerson: Thank you. I just wanted to add maybe another vote to the
comment on neurotoxins. I think in this country we are having an epidemic of neurological diseases, and I think it is very important that we not look at just, you know, some of the more familiar one s of carcinogens and reproductive toxins, that we include ne urotoxins in your list.

Operator: Your next comment comes from th e line of Liz Harriman with TURI [Toxics Use Reduction Institute].

Liz Harriman: Hi, this is Liz Harriman from the Toxics Use Reduction Institute. I’m interested to know how relatively new substances like nanomaterials might be
considered in these criteria. Little concerned that they may drop through the cracks between the existing and new chemicals programs where there isn’t enough firm information about their hazard. They’re very difficult to detect period, and yet they’re not being evalua ted before they become commercially produced.

Operator: Your next comment comes from the line of Derek Swick with API.

Derek Swick: Good afternoon. I wanted to agree with EPA not including production volume as a prioritization factor and certainly API would not support using volume itself as a surrogate for exposu re. Here, it’s important that any approach for prioritization be based on true exposure rather than an incorrect assumption that volume is highly correlat ed with exposure. I also want to recommend existing regulatory controls as a possible priori tization factor as well, adding to what’s currently on the s lide. Here chemicals or mixtures for which risks are already managed unde r existing regulatory schemes should have a relatively low priority in a prioritization scheme.U.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

14 Finally, the net that EPA is casting n eeds to include both hazard and exposure factors for prioritization. It’s important that any prioritization of a chemical be based on, at least, one hazard factor and one exposure factor, not a single factor. Here, there’s essentially no ri sk if there’s no e xposure or no hazard, and EPA’s approach to this, based on the discussion document, appears
unclear.

Operator: Your next comment comes from the line of James Cooper with the National
Petrochemical & Refiners Association.

James Cooper: Good afternoon, everybody, and nice ly done on the title of the organization. That’s perfect, thank you.

My main comment is I think ther e’s going to be a great deal of
communication that needs to be done because the Step 1 in the priority setting process is more of a regulato ry step. It really isn’t a risk assessment per se. And the more factors you add in to St ep 1, the more bogged down this process is going to be and the slower it’s going to be.

And I think we all need to keep in mi nd that this is proba bly going to end up being a multi-layered process, where you have an initial step just to prioritize where you want a study and possibly even do or conduct risk assessments. You may get some output from Step 1 th at says, we need data for some of these chemicals, and so that would resu lt, possibly, in either a section 4 test rule or a PAIR rule to collect expos ure information. So I think if, you know, if EPA takes its time to really comm unicate each step of the process and the expectations of the outputs of those step s, I think a lot of the stakeholders will realize that as you go through these layers , a lot of these considerations that are being brought up will be considered.

It just may not be in the initial cut because if you ge t, you know, 6- 7,000
chemicals after the in itial cut, you really just wa sted a step because all you have to do is look at the IUR to get that number of chemicals.

And so, there does have to be some kind of consideration and, obviously, you know, we’re very supportive of consideri ng both hazard and exposure even inU.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

15 Step 1 because that way you’re not going to waste resources chasing something that doesn’t actually present harm. Thank you.

Operator: Your next comment comes from the line of Scott Braithwaite with Clorox.

Scott Braithwaite: Hi, I’d like to echo the same concern over the number of chemicals coming out of Step 1. I heard earlier in the ca ll that thousands of chemicals is not an ideal outcome of Step 1. I was w ondering if it’s more like a couple of hundred chemicals that you hope to identify in Step 1.

Wendy Cleland-Hamnett: I think that would be more in the ballpark of what we expect, yes.

Operator: Your next comment comes from th e line of Carol Kwiatkowski, with TEDX.

Carol Kwiatkowski: Thank you. I wanted to a dd on to the comments that have emphasized production volume as an important factor and say that from our research,.if you do consider production volume, I thi nk it’s really important that you consider global production volume and not just in the U.S. Thank you.

Operator: Your next comment comes from the line of Nelson Lawson with Pine
Chemicals Association.

Nelson Lawson: Good afternoon. I want to deal with this question of the data sources that the Agency intends to use, which is the s lide up on the screen now, and to caution
EPA about the chemical lists that come out of Canada, which were picked by computer data models, some of which were not really good.

We know from experience in respon ding to Environment Canada that a
number of chemicals of interest to us were simply misclassified by the computer models, and once we sent in the proper data to Environment Canada, they were all deemed to be ch emicals of very little concern. So I would just suggest that EP A uses its own models and its own data from the HPV program and from others rather than relying on data outside, specifically from Canada. Thank you very much.

Operator: And there are no further comments.U.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

16 Wendy Cleland-Hamnett: OK. We’ll then move on to the questions about the data sources that we would use to identify chemicals. We can put up slides that we have in
the PowerPoint that summarize the data sources. There was also in the discussion guide that was provided on the website some more lengthy tables
with a little more detailed information on the data sources, so if you have that accessible to you, you might want to look at that.

But we’re interested, again, and, you know, whether you th ink these data sources are appropriate and why. If you think some of them are not appropriate and why that would be the cas e. Are there additional data sources that you think the agency should be looki ng at and if you’ve, particularly, if you’ve proposed additional f actors for prioritiz ing, if there are particular data sources you have in mind to help inform these factors that would be useful as well. So, we’ll take comments on the St ep 1 data sources at this point.

Operator: Again to make a comment, please press star 1. Your next comment comes
from the line of Nohemi Zerbi with Department of Home [Department of Homeland Security].

Nohemi Zerbi: Good afternoon. Department of Ho meland Security, this is Nohemi Zerbi. I just wanted to alert EPA about the De partment of Homeland Security Science and Technology Directorate within the Ch emicals Sector Analysis Center has been working for a number of years on t oxicity, (inaudible) of certain list of chemicals and has actually pr ioritized these chemicals ba sed on their toxicity.

This information is on classified piece, but it can be shared with EPA. I think some EPA members have been working with DHS on this for a number of years, and we just wanted to ascertai n that we’re available to share that
information with EPA. And I don’t see us there as a source of information for

you guys.

Wendy Cleland-Hamnett: Thank you. We’ll be interested in following up with you.

Nohemi Zerbi: Thank you.U.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

17 Operator: Your next comment comes from the line of Nancy Peresco with the Dow Chemical Company.

Nancy Peresco: Hi, I would be wondering if you needed to page down a slide. You say Table 1 below, I don’t see Table 1. Thank you.

Wendy Cleland-Hamnett: You’re welcome.

Operator: Your next comment comes from th e line of Michael Bel liveau with EHSC.

Michael Belliveau: Yes, thank y ou. This is Mike Belliveau w ith the Environmental Health Strategy Center. I had a little trouble accessing the slides so pardon me if I like back up a little bit in what I want to comment on. First, I think, EPA is exactly on the right track in using its existing aut hority, which is limited, to review, identify and review priority chemicals.

I think the type of comprehensive approach that was suggested by earlier
commenter is the reason that we need TS CA reform and this is going to have to await TSCA reform before we can, we can hope to accomplish that.

Regarding the fact – this exercise is positive as it is. It’s challenging because
of the serous limitations to the availabili ty of health and safety data, and for that reason I think it’s impor tant that the agency allowed itself to consider, as a priority, a chemical for which there is very good hazard data or very good exposure data, assuming that for the othe r parameter, it ranks high for the time being until those data gaps are filled.

I think there’s such a serious lack of available information that we need to have a way of prioritizin g chemicals that we know something about but that we don’t enough about. So I would argue that either high hazard or high exposure alone should be one basis for listing a chemical as a priority.

And then my final comment is that I’m still – maybe it’s just because I’m back from vacation - I’m still soaking in the discussion guides proposal. But I’m a little confused about how Step 1 a nd Step 2 interact with each other. Wendy, you described Step 1 as a coarse sieve, but I think it should beU.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

18 conceived of as casting a broad net. The way it’s constructed now seems a
little backward.

It seems like you take a narrow set of data in which to identify potential priority chemicals in Step 1, and then do you use a broader set of data sets in Step 2? Shouldn’t it be the other ar ound? Shouldn’t we cast a broad net rather than a coarse sieve, identify lots of potential priority chemicals and then narrow down the universe. Right now, I can’t really tell how Step 2 clearly falls from Step 1.

Maria Doa: Hi, this is Maria Doa at EPA. I just wanted to clarify a l ittle bit and thanks for that question, that’s a good question. The - Step 1 is taking chemicals that we think should be focused on because they’re in children’s products and consumers’ products; because they’re PBTs; they’ve been identified of concern for children’s carcinogens.

And so we’re looking at each of th ese independently as the source of chemicals to focus on. And then we’re goi ng to take – and some of these, as Wendy said earlier, are hazards, some of them are high priority for exposure,
some of them cover both like PBTs.

We would then take that list and then apply, and then do prioritization screening in Step 2, where we would be looking at chemical release data, use data, exposure data, hazard data for the th ings that we just have exposure on. And using the Step 2 is how we woul d prioritize among those chemicals. And, you know, we would be looking acro ss those factors, you know, for the high, medium and low prioritizations.

Operator: Your next comment comes from th e line of Carol Kwiatkowski with TEDX.

Carol Kwiatkowski: Hi, this Carol Kwiatkowski with the Endocrine Disruption Exchange. I wanted to mention three other potentia l data sources you might consider. One of them is your own Endocrine Disr upters Screening Program, which I think would be very important to see the data coming out of that.U.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

19 Another is a Swedish nonprofit, ChemSec, with its “Substitute It Now!” List,
has come out with a list of 22 chemicals that are not necessarily showing up as carcinogens or reproductive or developmen t, or having developmental effects, and yet there’s clear eviden ce of endocrine-disrupting properties and so that’s an important source of information that’s being proposed to the REACH program in Europe right now.

And then, of course, the NIEHS is doi ng a lot of research on the endocrine disruptors and looking at chemicals th at may, have been on people’s radar screens for a while and unique mechanisms of action. And I think it’s important to look at those as well. Thank you.

Operator: Your next comment comes from the line of Mark Rossi with the Clean Production [Action].

Mark Rossi: Hello, this is Mark Rossi, Clean Production Action. I was curious why you didn’t have reference to any of the Eur opean lists for which there’s been, you know, quite a lot of work done. There’s the European Substances Information System, European – these are all EU dangerous substances directives chemicals, CLP - Classification Labeli ng and Packaging - and also the EU substances of very high concern.

I mean I think it’s also – even though it’ s a set of criteria ra ther than list, but to reference the Globally Harmonized System for the classification and labeling of chemicals, using the GHS criteria, because then that’s moving
towards a set of international standards versus just each country doing its own thing. Thank you.

Operator: Your next comment comes from the line of Charles Franklin with Akin Gump.

Charles Franklin: Hi, Charles Fra nklin, Akin Gump. I have someth ing – if I could just clarify one thing that I thought I h eard. Looking at the list of the factors - you’ve got the specific hazard factor s that are laid out - car cinogens, PBTs, reproductive, etc. - and then the three exposure fact ors to children’s products, consumer products, biomonitoring.U.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

20 I had in my notes, and I think it was maybe from one of the earlier slides, a reference to chemicals meeting at leas t one hazard and one exposure factor would become part of the initial group of priority chemicals for review. Is that – did I get that correctly because th at seems to suggest that there really was a melding of the exposure and hazard?

And I guess, more generally, to the extent that that’s not correct, and if really just purely exposure use is a measure, I’d be interested in - if there’s been discussion about what being on this list as a starting point means for chemicals in terms of qualifying for, you know, DfE or the Green Chemistry programs. I mean is it recognized that this is just a list, this is not an actual initial set of problematic chemicals.

Wendy Cleland-Hamnett: This is Wendy. We’ll just say that Step 1 is just that. It’s Step 1 and as we said earlier, the priorities th at we’ll be identifying for work in the program will have gone through Step 1 and Step 2. So, you know, as one of the earlier speakers said, Step 1 is the broader net and then we’ll be, you know, refining that and prio ritizing within that.

The priority chemicals we identify will be based on risk so, you know, if
there’s a chemical identified that ha s high hazard but we can’t identify significant exposure, it’s not likely to end up being a pr iority chemical or vice versa - you might have significant expos ure, but if there’s no evidence of hazard, it wouldn’t end up as a priority chem ical. I hope that helps clarify. It is a risk-based prioritization process.

Charles Franklin: Thanks.

Operator: Your next comment comes from the line of Liz Harriman with TURI.

Liz Harriman: Hi. I’m a little concerne d over your statement about “can’t identify significant sources of exposur e.” I want to reiterate the concern about the lack of robust use and exposure information. The data sources that you have there are fairly weak and vague or out of date, and it’s not that I have another suggestion of a more robust source for you, but I think it’s really important toU.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

21 focus on the hazard information for which you have more quality information. And then just consider exposure qualitat ively as a secondary consideration,
not use it as a screen because there ar e many things that could be significant exposures that are not going to show up on the few sources you have here.

Operator: Your next comment comes from th e line of Mark Mitchell with the National
Medical Association.

Mark Mitchell: Yes. I had proposed previous ly that you look at chem icals that people are currently being exposed to, toxics that people are currently being exposed to, and that are currently having health effects. And I wa nted to talk about data sources, particularly for the legacy chemicals.

There is the NATA file, the National Ai r Toxics Assessment, that talks about air toxics that people are exposed to. There is RC RA and national priority sites, the Superfund sites, and you c ould get the list of the most common exposed chemicals from there. And th en, of course, there’s lead poison, the lead levels, the blood lead levels that are obtained in many communities around the country. But, again, it’s di fficult, I think, to assess the exposure data. Thank you.

Operator: Your next comment comes from the line of Tracey Ea sthope with Ecology Center). Tracey Easthope, your line is open.

Tracey Easthope: I’m sorry, I was on mute. Yes, th anks. I wanted to reiterate a concern about
still we’re in sea of i gnorance around so many end points for chemicals, as well as exposure, and so I wanted to support comments that have been made already about casting a broader net both on exposure and on hazard end points.

And I’m wondering whether there’s a way in which this process can move us
to resolve some of the i gnorance. So, for instance, chemicals that are very persistent and very bioaccumulativ e for which we don’t have adequate toxicity data but may represent widespr ead exposure at some point because of those properties. So that would be a nother criteria that I think would be important.U.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

22 But again, if there’s a way to cast a net and then use this process to identify areas of ignorance that need to be reso lved, then we aren’t just prioritizing
chemicals based on available informa tion where we don’t have the whole
story.

Operator: Your next comment comes from the line of Nelson Lawson with Pine
Chemicals Association.

Nelson Lawson: Thank you. I’m just wondering why the whole HPV program doesn’t show up on that, on those lists there in Tabl e 1, given that there’s huge amounts of both hazard and exposure data from th e largest volume chemicals that are used in the country and the ones that proba bly need to be tackled first. Thank

you.

Wendy Cleland-Hamnett: Just a clarifying point on that. The HPV data sets show up in the Step 2 exposure as use and hazard info rmation. So, there’ll be a chance to
comment on those in the next part of the discussion.

Operator: Your next comment comes from the line of Barbara Warren with Citizens’
Environmental Coalition.

Barbara Warren: Yes, this is Barbara Warren. I was hoping that perhaps we could return to the question on the nanomaterials that was asked earlier. I was hoping maybe EPA could actually answer that questi on in terms of, you know, the lack of information on nanomaterials and what your approach would be to addressing them in this, you know, prioritization scheme?

Wendy Cleland-Hamnett: OK, for nanomaterials , we actually have been reviewing new nanomaterials that are placed on the ma rket in our new chemicals program under TSCA. And at this point, we’ve reviewed over 100 new nanomaterials, so, and as we’ve been reviewing thos e, where appropriate, actually, for many of the nanomaterials, we’ve been both requiring some controls on worker exposure, release to the environment a nd so forth, as well as asking that additional data be developed on those.U.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

23 And then on the existing chemicals part of the nanomaterials world, we have several rules under development, two of which would require the submission
of information on use of nanomaterials , production volume, exposure, etc., as well as putting in place a Significant New Use rule under TSCA that would require, essentially, the equivalent of the submission of a new chemicals
notification for certain nanomaterials.

We’re also developing a rule that requires some toxici ty testing of a sub set of nanomaterial, and we’re working internationally with OECD, the Organization for Economic Cooperation and Development, on characterization of nanomaterials, be tter understanding exposure. There’s some work sharing going on among the pa rticipants in that OECD working party to share, doing some research and testing on nanomaterials.

So there’s actually quite a bit of work underway here in my Office, as well as in the Office of Research and Developm ent at EPA, to get a better handle on what’s happening out there in commer ce with nanomaterials, as well as getting a better understanding of envi ronmental exposure, human exposure, and toxicity.

Barbara Warren: Was that Wendy sp eaking? Is that Wendy?

Wendy Cleland-Hamnett: Yes, I’m sorry, that’s Wendy.

Barbara Warren: OK, so thank you. Thank you very much.

Operator: Your next comment comes from the line of Alex Stone w ith Washington State Department [of Ecology].

Alex Stone: Hi there. Yes, two quick comment s. One, again, a good reason to coordinate with states, we addressed the exposure i ssue a little bit in what we did as well out in Washington State when we identif ied our chemicals of high concern to children, and one way we got around the – or one solution we had was rather than try to prove exposure, we used the potential for exposure so that saved us from having to prove a dire ct line of exposure.U.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

24 But if a chemical is found in human s or, you know, it’s found extensively in consumer products, etc., there’s a large potential for exposure and, therefore, that sort of gravitated the chemicals th at had toxicity criteria, very similar toxicity criteria that you ’re using in your prioritiz ation scheme, up to the top
of the list.

So I would recommend that – but I thought I read that in what you had written as well, but I thought it may be goo d to emphasize that a potential for exposure I think is one way to handle that issue. And then the other thing is for criteria, you may want to also incl ude the sensitization criteria. You know, skin, eye, respiratory, etc., and one of the reasons is that, you know, there’s been a large increase in a lot of thes e related diseases, asthma and allergies and things like that. So there’s obv iously a very direct – and for some chemicals there seems to be a connection, so I’d include that in your criteria as well. Thank you.

Operator: Your next comment comes from the line of Stephanie Castorina with IPC [Association Connecting Elect ronics Industries].

Stephanie Castorina): Yes, thank you. I just want ed to make a comment in regards to the risk versus hazard discussion and just beca use there’s a lack of necessary data shouldn’t be a justification for using a hazard assessment over a more comprehensive risk assessment, and I was pleased to hear EPA say that this is a risk-based prioritization process. Thank you.

Operator: Your next comment comes from the line of Derek Swick with API.

Derek Swick: Thank you. I have a few comment s I wanted to make. First, EPA really
needs to consider information availabl e from ECHA, the European Chemicals Agency, much of which is available on ECHA’s public website through a very easy to use chemical substance search mechanism. API would also encourage
EPA to coordinate with ECA and also industry to leverage work being
conducted under REACH.U.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

25 I think the value here is informati on on exposure. Information developed under REACH, specifically the chemical safety reports, is recently generated, it’s fresh, it’s new, and certainly for the oil and gas industry and various groups of petroleum products, that expos ure information is some of the most comprehensive information available.

My second point, it’s puzzling that T oxCast is not mentioned on the screen and in the document. EPA launched ToxCast in 2007 to develop ways to predict the potential toxicity and also to develop an approach for prioritizing thousands of chemicals that may need toxicity testing. Here EPA should carefully consider which data, which approaches, tests and test results and other information could be leveraged from ToxCast for this specific EPA chemical prioritization activity.

And finally, I want to make the point th at it’s imperative that any data source for prioritization be managed by the pub lic sector or government. I know the “Substitute It Now!,” or SIN list, was mentioned earlier and certainly this process should not drop from NGO-mana ged lists to prioritize chemicals for further EPA work. Thank you.

Operator: Your next comment comes from th e line of Michael Bel liveau with EHSC.

Michael Belliveau: Yes, Michae l Belliveau, Environmental Hea lth Strategy Center. A couple of thoughts about data sources. I would think that EPA would want to rely on its exposure tasks data base that was announced in June, the data base of chemical exposure studies, as an impor tant source of information in addition to the toxicity refe rence data base.

Also I’m wondering, I didn’t see any me ntion in the discussion guide of reliance on the peer reviewed scientific literature. I would think that EPA would want to be open to relying di rectly on such primary research, you know, of course, a lot of the NIEH S-funded research is published in Environmental Health Perspective as we ll as there being many other credible journals. You know, shouldn’t that be included as well?

Operator: And there are no further comments.U.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

26 Wendy Cleland-Hamnett: All right, thank you, Tame ka. We’ll move then to – in the agenda, we talked about having a break between the Step 1 discussion and the Step 2 discussion, but given that we’re running ahead of our schedule here, I’m just going to decide that we’ll move on and discuss Step 2 and work through that and depending on how long that takes we c ould take a break or we could just have an early conclusion to the discussion.

So, Step 2, we have data sources that we would use to take that more refined look to help us decide ou r priorities for work within the number of chemicals that are identified in Step 1.

So again, we have some slides, but I’d encourage you to look at the discussion guide that was provided, if you printed that out or it can be pulled up on our website, to look at the tables in the discussion guide.

So again, we’re looking at questions such as are there additional data sources beyond those listed in Tables 2 and 3 that should be considered? Should any – are any of them not appropriate from your perspective and that would be helpful to know why you think that shoul d be the case. And are there certain
data sources that should be consider ed more important in the agency’s analysis than others? And why you woul d see that to be the case or not.
Thanks.

Operator: Again, to make a comment, please press star 1. Your first comment comes
from the line of James C ooper with the National Petrochemical & Refiners
Association.

James Cooper: Thank you. It’s not just a questi on of data sources. I think something that would benefit both the agency and all stak eholders is the agency establishing - and this could be true a multi-stakeholder process - but establishing a set of criteria by which data sources and the data itself be judged and make it as transparent as possible because there ar e many different lists out there, many
different data bases.

And, you know, some of the lists may be older data bases, some have been called into question because of sampling or sampling sizes or things of thatU.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

27 nature, especially when you get into some of the older biomonitoring
databases.

So I think if the agency where to de velop and publish criteria and open it up for comment or stakeholder input, that would create a lot of transparency and, you know, allow the agency then to actua lly weight different data and, you know, those weighting factors should also be transparent. And, I think, it would serve the agency well in the long run, that way a lot of the decisions
would be well understood and not called in to questions so much. Thank you.

Wendy Cleland-Hamnett: This is Wendy. Just before we go to the next comment, I’ll provide the web address for the discu ssion guide for those of you who might not be able to access it right now. It’s blog.epa.gov/chemprioritization, I think
that’s all one word. C-h-e- m-prioritization. Thanks.

Operator: Your next comment comes from th e line of Melanie Mart y with CA EPA.

Melanie Marty: Hi, this is Melanie from CAL EP A. Just a reminder that there are a lot of
other state level data bases for envi ronmental exposure s, including air monitoring networks in California a nd elsewhere, and water monitoring
networks in California and elsewhere. And I realize we’re one state but one in eight people live here, so - one in eigh t people in the United States lives in
California.

And ditto the risk assessment activities in California, Minnesota, Massachusetts, Connecticut, New York, there’s other states that have done publicly and peer reviewed assessments of chemicals that haven’t been done by the USEPA, so there’s another sour ce and I’ll send in those sources into the blog so you guys can get them. Thanks.

Operator: Your next comment comes from the line of Erin Yager with Pratt & Whitney.

Erin Yager: Yes, I just wanted to reiterate the comment that I also do not believe that NGO-managed lists should be considered as data sources but that the EU data, particularly that derived through REAC H, should definitely be considered here, just it would help, I think, companies trying to comply with all of theseU.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

28 regulations to have a more internatio nal approach than to have to follow different regulations throughout ever y country. So harmonization would definitely be advantageous.

Operator: Your next comment comes from the line of Carlos Thomas with SEHSC [Silicones Environmental Health and Sa fety Council of North America].

Carlos Thomas: Hi, this is Carlos Thomas with SEHSC. I really wanted to reiterate a couple of the comments that were made earlier, with respect to the data sources. And
I think this is true with the data sources used for Step 1 and Step 2, so I really
think all of these data sources should really be held to extremely high standards with respect to, not only scientific veracit y, but also peer review because I really think some of the ma rket place implications associated with an inappropriate indictment of these chemicals really can’t be understated.

Some of the sources that have been liste d really have not been subject to peer review, some of them haven’t been open ed to public scrutiny and then some of the other ones also rely on either modeling techniques or using physical chemical properties as surrogates for environmental behavior. I think we really need to look at that very carefully before we seriously consider any of these sources. Thank you.

Operator: Your next comment comes from the line of Derek Swick with API.

Derek Swick: I’d like to make another comment with regard to a few of the international comments made earlier. Looking through the discussion guide, there is no mention of the prioritization efforts of other countries, specifically Canada, Japan and Australia. I do note that from our perspective, Canada is ahead of the U.S. in the area of chemical prioritization. From 1999 to 2006, the Canadian government completed pr ioritization of approximately 23,000 chemicals on its Domestic Substances List. And the Canadian government is now in the process of further asse ssing 4,300 chemicals, approximately, through its chemicals management plan. We would encourage EPA to look to
Canada for both data sources and categorization approaches.U.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

29 A more specific comment I have is on the data sources in Table 2. I have some concerns about how EPA might use data from the Toxics Release Inventory, the TRI, for the prioritizati on process. The TRI comprises data on
releases and transfers of chemicals reported annually by facilities subjected to the TRI reporting rules.

EPA and others have used TRI data, in many models and analyses that range in quality. Some are good, some not so. One recent example is EPA’s RSEI model, or the Risk Screening and Envi ronmental Indicators tool, which EPA has essentially developed as a screening risk type model combining TRI data
with hazard data.

We mention RSEI here only as an example of what can and does go wrong when EPA attempts to take TRI data and build models around it as a substitute for conducting proper human risk assessmen t. And the concern is that taking
the TRI data with hazard data and no t doing a risk assessment, I think what can result potentially is garbage and we certainly do not want that through this prioritization process. We don’t object to TRI as a da ta source as long as it is
used within its limitations and in a sc ientifically sound manner. Thank you.

Operator: Your next comment comes from th e line of Lin Kaatz Chary with Great Lakes Green Chemistry Network.

Lin Kaatz Chary: Thank you. I just wanted to reite rate a couple of things that people have said. I’m extremely concerned about any dr ift away from looking at hazard and focusing weighting exposure more heavily. And the reason for that is that not only do we not have a lot of informati on about exposure, bu t the information that we do have on exposure has been changing very rapidly over the past several years.

As we learn more, we have discovered that chemicals which we did not think had exposure potential, in fact did turn out to have exposure potential. And the PBT chemicals, PBDEs, are some of th e examples of that. So I think it’s really important to take into consider the hazard of chemic als and that relates to the question of biomonito ring also where I really th ink we have to put some emphasis on that because one of the defi cits that we have in understandingU.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

30 exposure information is that there are diffe rent ways - is that we don’t have a lot of information about syner gy of chemicals interacting.

We don’t know – we aren’t – traditio nal exposure models do not show us information about generational exposures. They also - traditional exposure models focus more on linear dose respons e models and don’t take into account timing of exposure which can be very significant.

So I’m not, you know , speaking in favor of just putting any chemical willynilly on a list – excuse me, I’m sorry - but I do think there has to be a very
critical balance to understa nd the shortcomings of exposure and that’s why we lean toward – why we really encour age looking at the hazard potential of chemicals because something that we say does not have exposure potential now - doesn’t have x, y, or z pathway now - we may discover next year or in a couple of years that we were incorrect about that, and espe cially with those chemicals with which we have so little information in general.

So I really wanted to reiterate thos e, you know, my support for really focusing on a hazard perspective and really u nderstanding that, you know, when we make a mistake about exposure, it’s usua lly an irrevocable mi stake. We can’t go back and unexpose people. But if we make a mistake about hazard, we can always take something that we t hought was hazardous off the list and, therefore, I really do – I agree with having peer reviewed data but also to really understand the ques tion of biomonitoring.

Operator: Your next comment comes from the line of Liz Harriman with TURI.

Liz Harriman: Hi. So I would hate for EPA to hold up the process by trying to evaluate each data source and check for peer review and check for quality. I think if you have information, you should just feed it i n. Because of all the data gaps and all the questionable data from all sour ces, I’d encourage EPA to do a reality check when you get done.

Don’t rely strictly on a particular ranking methodology. Instead, apply expert judgment to your results when you ge t done, understanding the information that went in. I think that will help address both the concerns of the NGOU.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

31 community about the lack of information and about the industry community
concerns with sources that aren’t ne cessarily of the highest quality.

Operator: Your next comment comes from th e line of Michael Bel liveau with EHSC.

Michael Belliveau: Yes, thank you. EPA has listed some very good data sources, some others have been suggested by the commentors. I don’t really see a discussion in the discussion guide regarding how exposure data, for example, how those data will be used. I would strongly urge EP A to consider aggregate exposure to a given chemical from all sources in cluding non-TSCA sources for purpose of prioritizing because this of course mirrors real world exposure and, you know, please don’t parse apart limited expos ure sources but consider them in
aggregate.

Another comment, I’m sure EPA will apply appropriate caution to the Inventory Use Reporting data. The chemical use information in there is not generally specific enough and exposure data, although it may shed some light in some cases on work exposures of concern, is also extremely limited and the new chemical data reporting requirements won’t become fully operative for several years. So please a pply caution to IUR data.

And lastly, with regards to the comments by several of my colleagues regarding what a great job Canada has done. I would encourage them to join us in achieving a meaningful reform of the Toxic Substances Control Act [TSCA].

You know, Canada’s multi-y ear process followed amen dment of their federal statute and until we get TSCA reform, EPA’s only going to be able to do limited things with regards to prioriti zation. I think, basi cally, they’re on the right track with this proposal. Thank you.

Operator: Your next comment comes from the line of Georjean Adams with EHS Strategy.

Georjean Adams: I’d like to get some cl arification. I thought wh en you opened up, Wendy, you were talking about this as being a way to prioritize chemical s that have knownU.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

32 risk and to identify those with the highest risk, i.e., something that might drive
toward a SNUR or Section 6 rule or th e like, as opposed to the prioritization system that will drive towards identifying where we need to collect more information about either toxicity or e xposure to a tailored Section 8 rule.

If the focus is on known risk, i.e., information that you have in your possession through these various data bases, then I think you’ ll come out with some chemicals that, yes, need actio n now. And you can proceed through all the different tools that you have. If it’s identifying chemicals that you would default to an assumption of high risk, then I think it’s a different ballgame entirely.

I think you’re much better off, and we would actually get some things accomplished, if we focused on known risk and started whacking those down and then have the parallel separate pa th that is looking for how to collect better information on both toxicity and exposure.

Operator: Your next comment comes from the line of Pamela Schwingl with REACH.

Pamela Schwingl: Hi, I wanted to agree with the previous speaker about not holding up the process with a lengthy review of all the data sources but there’s a parallel - in the parallel world of epidemiology studies and evaluating clin ical trials using meta analysis.

You know, you can - there are weigh ting factors and there is a very formalized method, but there’s also more qualitative review, and I would suggest that there would be extra panels that could look at a more qualitative review after some selection and to weight these, to weight these data sources. So I would not want to hold up the pro cess for a lengthy evaluation of the data
sources first.

Operator: And there are no further comments.

Wendy Cleland-Hamnett: OK, I would just before we close, I would offer one more time if
there are folks who haven’t had a chance to speak yet or if you want to make aU.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

33 general comment before we close the webinar, now would be your opportunity and then I’ll just ma ke a brief closing remark.

Operator: Again, to make a comment, please press star 1. Your next comment comes from the line of Kate Winnebeck with the New York City State Pollution.

Kate Winnebeck: Hi, this is Kate Winnebeck fr om the New York State Pollution Prevention Institute. And my comment is more, I gue ss, for the whole proc ess in general. And I would be really interested i n, kind of stepping back and looking, or maybe it’s really at the end, how you’re going to prio ritize some of these attributes, I’ll call them . You know, at the end of Step 2, you’ll have hundreds of chemicals, maybe a thousand chemicals, and kind of have bits and pieces of information for each one of those.

You know, what’s really the next st ep and how do you prioritize that and really get a manageable number? You know, so I’m really looking forward to how that process is going to work as well. Thank you.

Operator: Your next comment comes from the line of Pat Rizzuto with BNA.

Pat Rizzuto: Actually it’s Pat Ri zzuto with BNA. Hi, Wendy.

I’m just curious. After EPA has gathered these lists of chemicals that will be the Step 2, that will have completed Step 2, come out in the fall, how do you
deal with the absence of information? Under the FIFRA scheme, there are consequences if a pesticide does not have data. Ho w do you provide incentives under TSCA for companie s to provide you that data?

Wendy Cleland-Hamnett: This is Wendy. Well, I think I mentioned earlier in the presentation during the beginning of th e discussion that there’ll be a timeframe after we provide the list of pr iority chemicals that we’ll be working on, where we’ll provide, here’s the data th at we - or the sources of information
that we intend to use to inform our revi ew and assessment. And at that point,
there’ll be a time where if folks believe there is better information, more up to date information, information we haven’t seen before, that they’ll be able to provide to us before we do a more in depth review.U.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

34 So I think in some ways, that’s simi lar to the Canadian process where they basically said, here’s the information we have and we’ll be proceeding with
this information unless other information is provided for us to consider.

So I think if folks want us to be using, you know, the most accurate up to date information and they believe they have information of that type that EPA doesn’t have, there’ll be an opportu nity for them to provide it.

Pat Rizzuto: So the incentive is a built in, sort of a worser case, we’ll make worser, more risky conclusions, unless you provide us the data.

Wendy Cleland-Hamnett: Well, yeah. We’ll use th e best information that we have available to do that. And, you know, unlike the pesticides program, which is a registration program, we’re not a registration program, so we don’t require a set of information for every existing chem ical that’s on the Inventory. So we are in a different position with TSCA than in the case of FIFRA and the
FFDCA .

Pat Rizzuto: Thank you.

Operator: Your next comment comes from the line of Tyrone Wilson with Portland
Cement Association.

Tyrone Wilson: Yes, thank you. My question goes back to, I guess, the comment that was
made at the start of the webinar. I thi nk the presenter mentioned that the, that this information was going to be placed in the docket at some point. Can you give us some indication about the time frame for that and, you know, when all
of this material will be accessibl e through the docket. Thank you.

Operator: Your next comment comes from the line of Liz Harriman with TURI.

Liz Harriman: I just want to thank EPA for the work on the chemical action plans to date. The ones that you’ve done so far have b een very helpful. I appreciate the
focus on action and on safer alternatives . We would rather that EPA spend their precious resources trying to move us forward towards safer alternatives rather than dwelling on getting every last piece of data and information on things that could probably be better substituted with safer substitutes.U.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

35 And in line with that, in terms of the expert judgment, you can’t make a criteria out this, but the likelihood of wreaking havoc down the road is something that we try to pay attentio n to in Massachusetts. And there are definitely some substances out there that may not end up scoring super high because of a lack of data, but certainly have the likelihood of really being a next generation significant problem. Thanks for all your hard work.

Operator: Your next comment comes from the line of Haroon Mahgerefteh with
Infineum.

Haroon Mahgerefteh: Hello, it’s Haroon. I had a general comment in rega rds to all of these efforts. When that - for completing th is effort, you always need to consider minimizing the amount of animals and preferably use the models. The second thing is the harmonization that we need to conduct our actions and align all of these efforts with EU REACH to minimize the burden on the industry. Thank

you.

Operator: Your next comment comes from the line of Sarah Brozena with ACC.

Christina Franz: Hi there. This is Christina Fr anz from ACC, actually, pa rticipating with Sarah Brozena of ACC. We attended the session in person this morning and won’t take up much time here, but we did want to alert the participants in this webinar that ACC has developed a priori tization tool which integrates hazard and exposure and identifies or evaluates – proposes to evaluate chemicals against objectives, comprehensive criteri a, and we have posted that on EPA’s blog and are offering that as a supplement to augment EPA’s work in prioritization and once again, we want to thank EPA for hos ting this dialogue and hope that it will be something that we will continue in the future. Thank

you.

Operator: Your next comment comes from th e line of Michael Bel liveau with EHSC.

Michael Belliveau: Thank you. I thought the br ief exchange between Pat Rizzuto and Wendy was really illustrative. Pat, you put y our finger on the crux , the weakness of our entire chemical management system which is that right now, all theU.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

36 incentives are to not generate data and so it’s important that this exercise that EPA has proposed overcome that disincen tive to provide data. I think one way to do that is to be prepared to li st on your candidate list of chemicals in Step 1, those chemicals for which we ha ve partial data, if, for example, a chemical for which you know has high hazard but we are lacking for the time being any publicly available exposure data, or chemicals that we know the public is widely exposed to but we don’t know enough about the hazard. In proposing or naming such chemicals, this will in turn create an incentive for
those that have access to such data or who have a stake in continued use of that chemical to step forward and provi de data, which is what we need. So please be prepared to do that to overcome this barrier. Thank you.

Operator: And there are no further comments.

Wendy Cleland-Hamnett: Well, this is Wendy. I just want to, again, thank everyone who has been on the line with us today, particul arly those who’ve provided comments and suggestions and questions. We ve ry much appreciat e the thought that you’ve put into this. Lots of thoughtfu l suggestions and questions that we’ll be taking into consideration, and we very much appreciate it.

In response to one of the last few comments, there was a question. We will be posting a summary of what we’ve heard in the course of this webinar, in meetings that we’ve had, and also po sting comments that are posted to the discussion blog. The discussion blog, if you are interested in providing further written comment, will be open through 5:00 p.m. on September 14, [2011].

So if there’s additional information, th ere’s an ability if you want to provide links to data bases, articles, so forth and so on, you can do that in the discussion blog and we’d en courage you to do that.

So the summaries, we plan to be pos ting within several we eks of the close of the discussion blog. So, that would be , we hope by the end of the month or shortly thereafter. And I th ink that’s it, unless, John, there is anything else we need to mention. Again, thanks to ev eryone for caring about the work that weU.S. Environmental Protection Agency Tran script: Chemical Pr ioritization Webinar

37 do here. It’s very important work, an d we’re glad that you’ve shared your thoughts with us on it. And with th at we’ll close the discussion.

Operator: Thank you all for participating in today’s conference call. You may now
disconnect.

END