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Public Meeting February 4, 2020 Page 1 1 U.S. FOOD AND DRUG ADMINISTRATION (FDA) PUBLIC 2 MEETING: TESTING METHODS FOR ASBESTOS IN TALC AND 3 COSMETIC PRODUCTS CONTAINING TALC 4 5 Moderators: Ms. Kari Barrett Ms. Janesia Robbs 6 Panelists: Dr. Kristina Hatlelid Dr. David Berry 7 Mr. Frank Hearl Ms. Deborah Smegal 8 Mr. Bradley Van Gosen Dr. Linda Katz 9 Dr. Steven Wolfgang Dr. Christopher Weis 10 11 8:33 a.m. 12 Time: 13 14 Date: Tuesday, February 4, 2020 15 16 Place: White Oak Campus 17 10903 New Hampshire Ave 18 Silver Spring, Maryland 20993 19 20 21 Job No. CS3805999 www.CapitalReportingCompany.com 202-857-3376 Public Meeting February 4, 2020 Page 2 1 INDEX TO SPEAKERS 2 3 Morning session 4 Moderated by Kari Barrett 3 5 6 Afternoon session 7 Moderated by Janesia Robbs 8 Kari Barrett 145 9 10 11 12 13 14 15 16 17 18 19 20 21 www.CapitalReportingCompany.com 202-857-3376 Public Meeting February 4, 2020 Page 3 1 * * * 2 P R O C E E D I N G S 3 * * * 4 MS. KARI BARRETT: Good morning and 5 welcome to balmy Washington in February. I want 6 to welcome everyone today to FDA's public meeting 7 on Testing Methods for Asbestos and Talc in 8 Cosmetic Products Containing Talc. 9 My name is Kari Barrett, and I'm 10 going to be moderating today's public meeting this 11 morning. And then my colleague, Janesia Robbs will 12 be joining me this afternoon as we have our public 13 comment session. So you'll be meeting Janesia later 14 on. 15 The purpose of today's public 16 meeting is to discuss and obtain scientific 17 information on topics related to testing methods 18 for asbestos in talc and cosmetic products 19 containing talc. We expect this meeting to be an 20 important step in our continued efforts to gather 21 information on this topic, and we thank all of you www.CapitalReportingCompany.com 202-857-3376 Public Meeting February 4, 2020 Page 4 1 in the room and online for joining us today. 2 Before we jump into the program, we 3 do have a few general announcements that I want to 4 make. So let me run through the list. 5 All of you in the room should have 6 received a folder at registration. In that, there 7 are a number of handouts, including the agenda. 8 There is a list of the bios. And so that's 9 helpful because as we go through the day, we're 10 not going to give extensive background on our 11 speakers since you can reference that, and that 12 will just help us move through the day a little 13 quicker. 14 Also to all of the folks who are web 15 casting in, you should also have access to the 16 agenda, the bios, and other background information 17 through the website. 18 I should note that today's meeting 19 is being webcast. It will be recorded and posted 20 on our website. We also will have a transcription 21 of the proceedings today. All of that will be www.CapitalReportingCompany.com 202-857-3376 Public Meeting February 4, 2020 Page 5 1 available. Also the PowerPoints, but give us a 2 little time. The PowerPoints take about a week to 3 get up and then the transcript and the recording 4 -- the recording, I'm not sure of the exact 5 timing, but the transcript could take up to a 6 month. So I just want to forewarn you in that 7 regard, but do check back to the meeting website 8 for updates in that regard. 9 If we do have any media or press 10 folks here, I hope that you have checked in with 11 Monique Richards. Monique, can you raise your 12 hand? 13 MS. RICHARDS: Good morning. 14 MS. KARI BARRETT: All right. There is Monique. So, 15 if you haven't checked in and you're with media, 16 please do. 17 Also, I understand we may have some 18 congressional staff here. We have Aliza Glasner 19 who is here to help with that. She's raising her 20 hand in the back. You can also reach out to 21 Monique and you can get connected with Aliza if www.CapitalReportingCompany.com 202-857-3376 Public Meeting February 4, 2020 Page 6 1 you need to. 2 I would remind everyone this morning 3 that -- a couple of things with your cell phones, 4 please be sure that you turn them off or have them 5 to vibrate. If you have multiple cell phones, 6 keep them all in mind. 7 Also, too, if you need to have a 8 conversation with someone, please do bring it out 9 in the hall so it's not disruptive to the 10 presentations. The sound in this room carries 11 very well. 12 Lunch and refreshments are available 13 in the lobby area. We mentioned earlier if you 14 were interested in ordering lunch, there is a 15 form, you do need to get that in this morning 16 before 9:30. 17 The restrooms are located past the 18 registration area. If you need any help in that 19 regard, just ask the registration staff. And I do 20 want to remind people who are offering public 21 comment this afternoon -- we're going to talk www.CapitalReportingCompany.com 202-857-3376 Public Meeting February 4, 2020 Page 7 1 about this later today, but do keep in mind that 2 we are going to really be strictly adhering to the 3 time limits that have been given. We do have, for 4 those who are speaking, a light system, a green, 5 yellow, red light system. And we will, again, be 6 adhering to that. So If you have a chance this 7 morning just to kind of revisit your talk and be 8 sure you're within your time limits, that would be 9 greatly appreciated. 10 So with that, we're going to 11 actually now jump into the program. And it is my 12 pleasure to introduce our first speaker, Dr. Susan 13 Mayne, who is our director for the FDA Center for 14 Food Safety and Applied Nutrition. And she will 15 kick us off with some opening remarks. Dr. Mayne? 16 DR. SUSAN MAYNE: Thank you, Kari. 17 And good morning, everybody. I'm really pleased 18 to welcome you here to FDA for our public meeting 19 that is aimed at advancing the science surrounding 20 analytical methods, involving the testing of talc 21 and talc-containing cosmetics for the possible www.CapitalReportingCompany.com 202-857-3376 Public Meeting February 4, 2020 Page 8 1 presence of asbestos. 2 As part of our mission to protect 3 consumers, FDA monitors the market for cosmetic 4 products that may pose a public health risk. 5 In 2017, we became aware of reports 6 of asbestos contamination in certain cosmetic 7 products, including products marketed to children. 8 Currently, there is no standard 9 definition or tests for detecting asbestos, or 10 other potentially harmful elongated mineral 11 particles in talc, and talc-containing consumer 12 products, including cosmetics. 13 Accordingly, in the fall of 2018, 14 FDA formed an Interagency Working Group on 15 Asbestos in Consumer Products, which has 16 representatives from a number of federal agencies 17 to support development at a standardized 18 definition and testing methods for asbestos, and 19 other mineral particles of concern that could 20 potentially affect consumer product safety. 21 Today, we are going to hear www.CapitalReportingCompany.com 202-857-3376 Public Meeting February 4, 2020 Page 9 1 preliminary recommendations from the Working Group 2 members and others to further the development of a 3 standardized definition and testing methods to 4 improve sensitivity, consistency, and inter- 5 laboratory concurrence of asbestos testing in talc 6 used in cosmetic products, and of talc-containing 7 cosmetic products. 8 Although, we do not intend for this 9 meeting to produce any decisions or new positions 10 on specific regulatory questions, we do expect 11 this meeting to be an important step in our 12 continued efforts to gather information, including 13 data, to improve the consistency in terminology, 14 analytical protocols, and data reporting for asbestos 15 and other potentially harmful mineral particles that 16 may be present as contaminants in talc and cosmetic 17 products containing talc. And provide information 18 that can be used for future discussions on health 19 effects. 20 In closing, I want -- I would like 21 to especially thank our partner federal agencies www.CapitalReportingCompany.com 202-857-3376 Public Meeting February 4, 2020 Page 10 1 and their Subject Matter Experts for their work 2 on this issue, along with all who helped to put 3 this meeting together today. 4 We look forward to seeing the 5 feedback that we receive on the Working Group's 6 preliminary recommendations. Thank you. 7 MS. KARI BARRETT: Thank you very 8 much, Dr. Mayne. We'll now hear from our FDA 9 Office of Cosmetics Director and other 10 distinguished government scientists on the issues 11 of concern related to asbestos in talc and cosmetic 12 products containing talc. To provide an overview 13 of issues for talc-containing cosmetic products, we 14 have Dr. Linda Katz, who is our Director, Office of 15 Cosmetics and Colors for the FDA Center for Food 16 Safety and Applied Nutrition.
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  • Talc Processing

    Talc Processing

    11.26 Talc Processing 11.26.1 Process Description1-9 . Talc, which is a soft, hydrous magnesium silicate (3Mg0 4Si02 H20), is used in a wide range of industries including the manufacture of ceramics, paints, paper, and asphalt roofing. The end-uses for talc are determined by variables such as chemical and mineralogical composition, particle size and shape, specific gravity, hardness, and color. There is no Source Classification Code (SCC) for the source category. Over 95 percent of the talc ore produced in the United States comes from open-pit mines. Mining operations usually consist of conventional drilling and blasting methods. Figure 11.26-1 is a process flow diagram for a typical domestic talc plant. Talc ore generally is hauled to the plant by truck from a nearby mine. The ore is crushed, typically in a jaw crusher, and screened. The coarse (oversize) material then is returned to the crusher. Rotary dryers may be used to dry the material. Secondary grinding is achieved with pebble mills or roller mills, producing a product that is 44 to 149 micrometers ( m) (325 to 100 mesh) in size. Some roller mills are designed to use heated air to dry the material as it is being ground. Hammer mills or steam- or compressed air- powered jet mills may be used to produce additional final products. Air classifiers (separators), generally in closed circuit with the mills, separate the material into coarse, coarse-plus-fine, and fine fractions. The coarse and coarse-plus-fine fractions then are stored as products. The fines may be concentrated using a shaking table (tabling process) to separate product containing small quantities of nickel, iron, cobalt, or other minerals and then may undergo a one-step flotation process.
  • What We Know About Subduction Zones from the Metamorphic Rock Record

    What We Know About Subduction Zones from the Metamorphic Rock Record

    What we know about subduction zones from the metamorphic rock record Sarah Penniston-Dorland University of Maryland Subduction zones are complex We can learn a lot about processes occurring within active subduction zones by analysis of metamorphic rocks exhumed from ancient subduction zones Accreonary prism • Rocks are exhumed from a wide range of different parts of subduction zones. • Exhumed rocks from fossil subduction zones tell us about materials, conditions and processes within subduction zones • They provide complementary information to observations from active subduction systems Tatsumi, 2005 The subduction interface is more complex than we usually draw Mélange (Bebout, and Penniston-Dorland, 2015) Information from exhumed metamorphic rocks 1. Thermal structure The minerals in exhumed rocks of the subducted slab provide information about the thermal structure of subduction zones. 2. Fluids Metamorphism generates fluids. Fossil subduction zones preserve records of fluid-related processes. 3. Rheology and deformation Rocks from fossil subduction zones record deformation histories and provide information about the nature of the interface and the physical properties of rocks at the interface. 4. Geochemical cycling Metamorphism of the subducting slab plays a key role in the cycling of various elements through subduction zones. Thermal structure Equilibrium Thermodynamics provides the basis for estimating P-T conditions using mineral assemblages and compositions Systems act to minimize Gibbs Free Energy (chemical potential energy) Metamorphic facies and tectonic environment SubduconSubducon zone metamorphism zone metamorphism Regional metamorphism during collision Mid-ocean ridge metamorphism Contact metamorphism around plutons Determining P-T conditions from metamorphic rocks Assumption of chemical equilibrium Classic thermobarometry Based on equilibrium reactions for minerals in rocks, uses the compositions of those minerals and their thermodynamic properties e.g.