Main Session November 28, 2018 Page 1 1 2 JIFSAN SYMPOSIUM 3 ASBESTOS IN TALC 4 MAIN SESSION 5 Conducted by Catherine Sheehan 6 Wednesday, November 28, 2018 7 8:04 a.m. 8 9 10 7777 Baltimore Avenue 11 College Park, MD 20740 12 (202) 857-3376 13 14 15 16 17 18 Reported by: KeVon Congo 19 20 Capital Reporting Company 21 1250 Eye Street, NW, Suite 350 22 Washington, D.C. 20005 www.CapitalReportingCompany.com 202-857-3376 Main Session November 28, 2018 Page 2 1 C O N T E N T S 2 Catherine Sheehan 3 3 Bradley Van Gosen 10 4 Gregory Meeker 29 5 Martin Rutstein 44 6 Martin Harper 77 7 Brooke Taylor Mossman 115 8 Ann Wylie 137 9 10 11 12 13 14 15 16 17 18 19 20 21 22 www.CapitalReportingCompany.com 202-857-3376 Main Session November 28, 2018 Page 3 1 P R O C E E D I N G S 2 CATHERINE SHEEHAN: Good morning everybody. 3 Since we are -- I have 15 minutes to introduce -- 4 welcome everybody. Please bear in mind that we have a 5 webinar aspect of this meeting as well. So in the 6 interest of time, I would like everybody in the meeting 7 room to take their seats, please, so we can commence 8 with the meeting. 9 So welcome, everybody. My name is Catherine 10 Sheehan, and I've been given the honor of doing the 11 opening and closing remarks. So can I have quiet, 12 please? Thank you. 13 We do have a webinar component, so we need to 14 keep that in mind as well. 15 So as part of the introduction, the symposium, 16 as you all may know -- okay. All right. The symposium 17 is organized by the JIFSAN Symposium Committee. Who 18 are the stakeholders supporting this meeting? For 19 those of you that want to know, funding is through a 20 cooperative agreement between JIFSAN and FDA. 21 The purpose of this symposium is to develop a 22 standard and methodology for analysis and testing of www.CapitalReportingCompany.com 202-857-3376 Main Session November 28, 2018 Page 4 1 asbestos, and hopefully we'll be able to achieve that 2 goal here today or at least tackle it in some form or 3 fashion in that we are providing a forum for experts. 4 We have an audience from regulators, industry, and 5 academia, so I think we are well-equipped here to 6 hopefully move this discussion along. 7 I see some folks in the audience as well that 8 I know of to work with the United States Pharmacopeia. 9 So we also -- if you don't know, the United States 10 Pharmacopeia also have a standard for talc; and we, 11 also, are very interested in the work that is going on 12 today. Of course, we will share knowledge and come to 13 a consensus on future testing approaches and adequately 14 analyzing talc containing products for the presence of 15 asbestos fibers; and this symposium will include 16 presentations and, most importantly, the concurrent 17 breakout sessions on test methods, characterization, 18 and interpretation of data. 19 So that's kind of a lineup in terms of what 20 our purpose and goals are. Let me see if I can get 21 this thing moving. 22 Tim, help. It's not moving. Technical www.CapitalReportingCompany.com 202-857-3376 Main Session November 28, 2018 Page 5 1 difficulties here. It doesn't seem to want to move. 2 All right. 3 So morning session -- briefly, we have divided 4 the morning session into three key areas: definitions 5 and mineral fibers, test methods, and a break, and then 6 followed by two sessions of presentations on the 7 interpretation of data obtained from microscopy 8 measurements. 9 The afternoon session, the breakout sessions, 10 you can see here we have -- Sessions A, B, and C will 11 be repeated to allow each attendee to have a chance to 12 participate in two of the three planned sessions. 13 Session A, test methods for analysis of talc 14 and mineral fibers in cosmetics; and Session B, 15 measurement criteria for identification and fiber 16 counting; and then Session 3 will be the interpretation 17 of the testing data. 18 So after that -- some important information 19 here in terms of housekeeping and how we're going to 20 handle the breakout. Co-moderators will pose questions 21 and record input from the audience using flip charts, 22 computers, and other audio/visual aids. In addition to www.CapitalReportingCompany.com 202-857-3376 Main Session November 28, 2018 Page 6 1 that, notetakers are available among participants, and 2 they may use recording devices. Also, transcriptionist 3 will be on site. And then immediately after the 4 breakout session, there will be a break during which 5 the co-moderators will review the input from the 6 audience and draft their summary to report out to the 7 larger group. 8 So after the break -- after the breakout 9 sessions, all attendees will reconvene for the record 10 out session; and then each pair of the session co- 11 moderators will give time to deliver an oral summary of 12 the input to attendees. 13 During the symposium, most importantly, there 14 will be time for Q&As and if all questions are not 15 answered, they will be posted on the JIFSAN website, 16 and a summary of the meeting will be available shortly 17 after the meeting. And so the date that I have here is 18 that the moderator/speaker will present the summary of 19 the presentation or results by January 5th. So you 20 won't get anything before that date. 21 So any questions on that? One more thing, the 22 restrooms are directly behind the registration desk. www.CapitalReportingCompany.com 202-857-3376 Main Session November 28, 2018 Page 7 1 That's it. So -- 2 AUDIENCE MEMBER 1: Where will the breakout 3 sessions go? Where are the breakout sessions? 4 CATHERINE SHEEHAN: Good question, Marty 5 . Very good question. 6 Help, JIFSAN. 7 TIM: They are two corridors down behind us. 8 So if you got out of the elevators, you just go 9 straight. 10 CATHERINE SHEEHAN: Okay. I'm sure we will 11 get more information. I'll go and find out and get 12 everybody familiar with the three certain breakouts. 13 Okay. 14 AUDIENCE MEMBER 2: Catherine? 15 CATHERINE SHEEHAN: Yes. 16 AUDIENCE MEMBER 2: Could you explain a little 17 bit about the webinar and what it is and where it's 18 going and -- 19 CATHERINE SHEEHAN: Good question as well. 20 The webinar has just been communicated to me by Tim. 21 So my understanding is that we have this webinar going 22 on, and we are recording this as well. www.CapitalReportingCompany.com 202-857-3376 Main Session November 28, 2018 Page 8 1 Tim can -- I think that's all we know about 2 now in terms of they're listening to our presentations. 3 AUDIENCE MEMBER 2: Who is they? 4 CATHERINE SHEEHAN: Anybody that was invited 5 to this JIFSAN meeting that cannot attend in person -- 6 AUDIENCE MEMBER 2: Okay. 7 CATHERINE SHEEHAN: -- has the ability to 8 join by webinar, so -- 9 TIM: I do believe there's only like five or 10 six people. 11 CATHERINE SHEEHAN: Okay. Thank you, Tim. 12 All right. So with that, we'll move on. 13 AUDIENCE MEMBER 2: Is there Wi-Fi access in 14 this room? 15 TIM: Yes. I can come around and talk to you. 16 CATHERINE SHEEHAN: Okay. 17 AUDIENCE MEMBER 3: Just for technical 18 difficulties, I had -- I'm getting a message from 19 somebody that's on the webinar, but they can't hear 20 anything. They can see the screen, but they're unable 21 to do that. I don't know. Is there a way for them to 22 contact help for that? www.CapitalReportingCompany.com 202-857-3376 Main Session November 28, 2018 Page 9 1 CATHERINE SHEEHAN: I see. 2 TIM: I am -- I'm actually listening to the 3 webinar, and it's being broadcast just fine. 4 AUDIENCE MEMBER 3: Okay. 5 TIM: So -- 6 AUDIENCE MEMBER 3: Do you have, like, an e- 7 mail or something that I can have him reach out to you 8 to -- 9 TIM: Yes. 10 AUDIENCE MEMBER 3: -- get help? 11 CATHERINE SHEEHAN: Yeah, that would be good. 12 Yeah. 13 TIM: Just Tshaffer@dodwu. 14 Who needed the Wi-Fi? 15 CATHERINE SHEEHAN: Right. Yeah. If they had 16 an e-mail just in case they have any questions. Okay. 17 So in the interest of time, let's move on, and 18 then I'll navigate through this. 19 TIM: Okay. 20 CATHERINE SHEEHAN: Okay. So our first 21 speaker this morning -- very briefly introduce Brad Van 22 Gosen. He's a research geologist at the U.S. www.CapitalReportingCompany.com 202-857-3376 Main Session November 28, 2018 Page 10 1 Geological Survey, and he began his work with asbestos 2 in 2000, so if Brad could come up to the podium. 3 BRADLEY VAN GOSEN: First of all, I want to 4 thank the JIFSAN committee for the opportunity and the 5 invitation to speak here today. It's very much 6 appreciated.