Page 379 1 SUPERIOR COURT OF THE STATE OF CALIFORNIA FOR THE COUNTY OF LOS ANGELES 2 __________________________________ 3 TINA HERFORD and DOUGLAS HERFORD, 4 Plaintiffs 5 6 7 8 9 10 11 12 13 14 15 16 vs Case No. BC646315 AT&T CORP., a subsidiary of AT&T INC. and its subsidiary PACIFIC BELL TELEPHONE COMPANY, et al., Defendants. ___________________________________ VIDEO DEPOSITION OF DR. JOHN HOPKINS Day 2 Wednesday, August 16, 2017 at: 10:03 am Taken at: Shook Hardy & Bacon LLP 25 Old Broad Street London EC2N 1HQ United Kingdom 17 18 19 20 21 22 23 24 25 Court Reporter: DEIRDRA JORDAN Job No. 2657979 Priority-One Court Reporting Services Inc. – A Veritext Company 718-983-1234 Page 380 1 SUPERIOR COURT OF NEW JERSEY LAW DIVISION - MIDDLESEX COUNTY 2 __________________________________ 3 4 5 6 DAVID CHARLES ETHERIDGE and DARLENE PASTORE ETHERIDGE, Plaintiffs, vs Docket No. MID-L-0932-17 AS 7 8 9 10 BRENNTAG NORTH AMERICA, INC. (sued individually and as successor-in-interest to MINERAL PIGMENT SOLUTIONS, INC. and as successor-in-interest to WHITTAKER CLARK & DANIELS, INC.) et al., 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Defendants. ___________________________________ Priority-One Court Reporting Services Inc. – A Veritext Company 718-983-1234 Page 381 1 SUPERIOR COURT OF NEW JERSEY LAW DIVISION - MIDDLESEX COUNTY 2 __________________________________ 3 4 5 6 RONALD MARTIN TEUSCHER and SHANNON TEUSCHER, Plaintiffs, vs Docket No. MID-L-7249-16 AS 7 8 9 10 BRENNTAG NORTH AMERICA, INC. (sued individually and as successor-in-interest to MINERAL PIGMENT SOLUTIONS, INC. and as successor-in-interest to WHITTAKER CLARK & DANIELS, INC.) et al., 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Defendants. ___________________________________ Priority-One Court Reporting Services Inc. – A Veritext Company 718-983-1234 Page 382 1 SUPERIOR COURT OF NEW JERSEY LAW DIVISION - MIDDLESEX COUNTY 2 __________________________________ 3 IRMA VERDOLOTTI, 4 5 Plaintiff, vs Docket No. MID-L-5973-16 AS 6 7 8 9 BRENNTAG NORTH AMERICA, INC. (sued individually and as successor-in-interest to MINERAL PIGMENT SOLUTIONS, INC. and as successor-in-interest to WHITTAKER CLARK & DANIELS, INC.) et al., 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Defendants. ___________________________________ Priority-One Court Reporting Services Inc. – A Veritext Company 718-983-1234 Page 383 1 2 3 4 5 6 A P P E A R A N C E S Appearing for the Plaintiffs: SIMON GREENSTONE PANATIER BARTLETT, PC BY: CHRIS PANATIER, ESQ. BY: LEAH C. KAGAN, ESQ. 3232 McKinney Avenue, Suite 610 Dallas, Texas 75204 214.276.7680 cpanatier@sgpblaw.com lkagan@sgpblaw.com 7 8 9 10 11 Appearing for the Defendant Johnson & Johnson: TUCKER ELLIS LLP BY: SHARLA J. FROST, ESQ. 405 Main Street, Suite 500 Houston, Texas 77002 972.537.4205 sharla.frost@tuckerellis.com 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Appearing for the Defendant Johnson & Johnson: SHOOK HARDY & BACON LLP BY: KATHLEEN FRAZIER, ESQ. JPMorgan Chase Tower 600 Travis Street, Suite 3400 Houston, Texas 77002-2926 713.227.8008 kfrazier@shb.com Appearing for Whittaker Clark & Daniels: HOAGLAND LONGO MORAN DUNST & DOUKAS LLP BY: MARC S. GAFFREY, ESQ. 40 Paterson Street, PO Box 480 New Brunswick, New Jersey 08903 732.545.4717 mgaffrey@hoaglandlongo.com Priority-One Court Reporting Services Inc. – A Veritext Company 718-983-1234 Page 384 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 A P P E A R A N C E S...(continued) Attending via telephone: LEVY KONIGSBERG LLP BY: MOSHE MAIMON, ESQ. BY: DANIEL LATERRA, ESQ. 800 Third Avenue, 11th Floor New York, NY 10022 212.605.6200 mmaimon@levylaw.com dlaterra@levylaw.com (For Plaintiffs in the Lanzo matter) RAWLE & HENDERSON LLP BY: WILLIAM T. POLASKI, ESQ. Henry W. Oliver Building 535 Smithfield Street, Suite 1000 Pittsburgh, Pennsylvania 15222 412-281-5000 william.polaski@rawle.com (For Cyprus Amax Minerals Company and Imerys Talc America in NJ cases) HAWKINS PARNELL THACKSTON & YOUNG LLP BY: OLIVER BUNDY, ESQ. 455 S. Figueroa, Suite 3200 Los Angeles, California 90071-1651 213.486.8043 obundy@hptylaw.com (For Elizabeth Arden Inc., Revlon Inc., Bristol-Myers Squibb Company and Yves Saint Laurent America, Inc. in Herford case) FOLEY & MANSFIELD BY: M. AMADEA GROSECLOSE, ESQ. 300 South Grand Avenue, Suite 2800 Los Angeles, California 90071 213.283.2100 mgroseclose@foleymansfield.com (For Unilever United States, Inc. and Conopco, Inc. in Herford case) 23 24 25 Priority-One Court Reporting Services Inc. – A Veritext Company 718-983-1234 Page 385 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 A P P E A R A N C E S...(continued) Attending via telephone: ORRICK, HERRINGTON & SUTCLIFFE LLP BY: PETER BICKS, ESQ. BY: ANNE MALIK, ESQ. 1152 15th Street, N.W. Washington, DC 20005 202.339.8458 pbicks@orrick.com amalik@orrick.com (For Johnson & Johnson) HARRIS BEACH PLLC BY: MATTHEW QUIRIN, ESQ. 100 Wall Street New York, NY 10005 212.912.3505 mquirin@HarrisBeach.com (For GlaxoSmithKline in Teuscher case) COSMICH SIMMONS & BROWN, PLLC BY: LaKEYSHA GREER ISAAC, ESQ. BY: LUCY SAVORGNAN, ESQ. 100 Vision Drive, Suite 200 Jackson, Mississippi 39211 601.863.2100 lakeysha@cs-law.com lsavorgnan@cs-law.com (For Shulton, Inc., sued individually and as successor to The Shulton Group and/or Shulton, Inc.; The Procter & Gamble Company, sued as successor-in-interest to The Shulton Group and/or Shulton, Inc.; and Wyeth Holdings LLC, f/k/a Wyeth Holdings Corporation, f/k/a American Cyanamid Company, sued individually and as successor-in-interest to The Shulton Group and/or Shulton, Inc.) KING & SPALDING LLP BY: JULIA ROMANO, ESQ. 633 West Fifth Street, Suite 1700 Los Angeles, California 90071 213.443.4365 jromano@kslaw.com (For Johnson & Johnson in Herford case) Priority-One Court Reporting Services Inc. – A Veritext Company 718-983-1234 Page 386 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 A P P E A R A N C E S...(continued) Attending via telephone: MONTGOMERY McCRACKEN WALKER & RHOADS, LLP BY: RONALD E. HURST, ESQ. 123 South Broad Street Philadelphia, Pennsylvania 19109 215.772.7242 rhurst@mmwr.com (For Brenntag Specialties in Teuscher case) FOLEY & MANSFIELD BY: SEANA AZAD, ESQ. 300 Lakeside Drive, Suite 1900 Oakland, California 94612 510.590.9511 sazad@foleymansfield.com (For specially appearing Whittaker Clark & Daniels Inc in Herford case) DRINKER BIDDLE & REATH LLP BY: JACK N. FROST, ESQ. 600 Campus Drive Florham Park, New Jersey 07932-1047 973.549.7338 jack.frost@dbr.com (For Johnson & Johnson in all but Herford) DENTONS US LLP BY: ERIN CARPENTER, ESQ. 601 S. Figueroa Street, Suite 2500 Los Angeles, California 90017-5704 213.243.6112 erin.carpenter@dentons.com (For Imerys Talc America, Inc. and Cyprus Amax Minerals Company) ALSO PRESENT TELEPHONICALLY: KAZAN McCLAIN SATTERLEY & GREENWOOD JOSEPH D. SATTERLEY, ESQ. DR. DAVID S. EGILMAN VIDEOGRAPHER: LINDA FLEET Priority-One Court Reporting Services Inc. – A Veritext Company 718-983-1234 Page 387 1 (On the record at 10:03 am) 2 3 VIDEOGRAPHER: The date today is August 16 and the time is 10:03. 6 7 This is the continued deposition of John Hopkins. 4 5 We are on the record. EXAMINATION: BY MR PANATIER: 8 Q Okay. 9 A Good morning. 10 Q All right. 11 Good morning, sir. So yesterday where we left off Johnson & 12 Johnson was sending samples of their talc to Fred 13 Pooley so he could work on a procedure to try to remove 14 the tremolite. 15 Do you recall that? 16 A You did show me those papers, yes. 17 Q Okay. 18 All right. Other than broad intellectual or scientific 19 curiosity and whether or not they could remove 20 tremolite, can you think of any other reason why they 21 would want to be removing the tremolite from their 22 talc? 23 A I don't know. It was obviously a research 24 project that someone decided they would like to look 25 at, but I -- you know, I couldn't comment beyond that Priority-One Court Reporting Services Inc. – A Veritext Company 718-983-1234 Page 388 1 2 3 4 on something that happened 40-odd years ago. Q removed because they perceived it to be dangerous? A 5 6 7 It is possible that they wanted the tremolite It is possible. But, again, I cannot speak for someone's thought processes from 40-odd years ago. Q 8 All right. This is Exhibit 67. (Exhibit 67 marked for identification) 9 Now, as context, sir, before we started today 10 I had you just review Dr Lewin's report to the FDA 11 about the 195 samples that he had tested in the early 12 '70s and '72; do you recall that? 13 14 15 A 1972 reviewing talc samples. Q 16 17 You did show me a publication by Dr Lewin dated Okay. One of those samples was sample 84. Johnson & Johnson Shower to Shower; correct? 18 A That was, yes. 19 Q Okay. 20 What I've handed you now is, you can see this 21 is a FDA publication. 22 the Work, it says: 23 That was You can see under Description of "The 200 commercial cosmetic talc samples 24 evaluated by Dr Lewin will be tested for asbestos by 25 refractory optical microscopy". Priority-One Court Reporting Services Inc. – A Veritext Company 718-983-1234 Page 389 1 Do you see that on the first page? 2 A Yes, that's what it says. 3 Q And if you turn to, let's see, the first 4 flag -- there should be a flag on there ... 5 A Yes. 6 Q You can see -- and I'm sorry, actually, go back 7 one page for some context. 8 There you go. You can see at the bottom it's dated 1.3.74; 9 right? 10 A Yes. 11 Q And Project -- Program Manager's signature is 12 Heinz Eiermann, who we know to be with the Division of 13 Cosmetics in the FDA; correct? 14 A Correct, yes. 15 Q All right. 16 17 And then at the top the project title is Asbestos and Other Contaminants in Talcs; right? 18 A Yes. 19 Q Okay. 20 21 22 If you turn the page, you can see I've highlighted there that, and you can see at the top: "Examination of talc samples by optical 23 microscopy according to the method published in the 24 Federal Register ... is proceeding. 25 samples (Lewin's identification) ..." As of 12/21/73, Priority-One Court Reporting Services Inc. – A Veritext Company 718-983-1234 Page 390 1 2 So we're clear those are Lewin's numbers, and he lists off the numbers: 3 "... 29, 58, 60, 84, 87, 131, 133, 134, 135, 4 136, 137 and 138 were analyzed for mineral content. 5 All contained large quantities of talc, small amounts 6 of carbonates, and minor amounts of hematite, quartz 7 and diatomaceous earth. 8 fibers of tremolite/actinolite per mg". 9 Sample #84 contained 107 Did I read that right? 10 A You read that correctly, yes. 11 Q Okay. 12 13 So let's do a little basic math, you and I. Let me go ahead and go up to the ... 14 All right. 15 that date, 12.21.73. 16 So he says as of, so we'll put This is the FDA and they find in Johnson & 17 Johnson Shower to Shower -- they find 107 fibers of 18 tremolite per milligram. 19 Is that correct? 20 A That is Dr Lewin's summary, yes. 21 Q That's not Dr Lewin's summary. 22 This is the FDA's re-examination of Lewin's samples. 23 Do you understand that? 24 A Okay. 25 Q Okay. That's not clear from here. Priority-One Court Reporting Services Inc. – A Veritext Company 718-983-1234 Page 391 1 A So who actually did the examination? 2 Q Okay. 3 4 You can see here on the previous page at the bottom, Project Manager's signature; right? 5 A Yeah. 6 Q And that's John Stuart, but here Ronald Yates 7 signed it; correct? 8 A Okay, yeah. 9 Q Okay? 10 A Yeah. 11 Q And if you turn to the page that is flagged: 12 "Examination of talc samples by optical 13 microscopy according to the Federal Register ... is 14 proceeding". 15 A Yeah. 16 Q This is in 1973 and '74; correct? 17 A Correct, yes. 18 Q Lewin has already done his testing. 19 You're aware of that; correct? 20 A Yeah, sure. 21 Q Okay, and they're using Lewin's identification 22 numbers; right? 23 A Oh, got you. Okay. 24 Q So they're evaluating Lewin's report; right? 25 A Okay. Priority-One Court Reporting Services Inc. – A Veritext Company 718-983-1234 Page 392 1 Q 2 3 And Lewin's samples. And what the FDA finds is 107 fibers of tremolite per milligram; right? 4 A That's what it says. 5 Q Okay. 6 Now, how many milligrams are there in a gram? 7 A A thousand. 8 Q One thousand. 9 So if we want to know how many fibers the FDA found per gram of Johnson & Johnson's 10 Shower to Shower, we just multiply 107 by a thousand; 11 right? 12 A Mmm hmm, yes. 13 Q And that would give us 107,000 tremolite fibers 14 per gram; correct? 15 A Well, it says tremolite/actinolite. 16 Q Okay. 17 Tremolite/actinolite. That's fair, and I'll write "/actinolite" per gram. 18 Okay. 19 The next Exhibit will be Exhibit 68. 20 (Exhibit 68 marked for identification) 21 So you can set that aside. Let me take that one back, I'm sorry, because 22 I divided these into two. 23 It's the full copy. 24 25 All right. A Let me give you a new one. Here you go, sir. Sorry. Thank you. Priority-One Court Reporting Services Inc. – A Veritext Company 718-983-1234 Page 393 1 Q 2 All right. So this one if you turn -- you actually have 3 to turn to the last page to see what this is, where you 4 see the Johnson & Johnson, and I'm sorry, turn to the 5 page at the bottom marked 8248. 6 A It stops at 44. 7 Q It might be -- go a little bit closer to the 8 front. 9 A Okay, yes. 10 Q Got it? 11 Okay. So you can see this is dated November 19, 12 1973; right? 13 A Yes. 14 Q And its subject is Pooley's Response to the 15 Proposed FDA Optical Method for Detection of Asbestos 16 in Talc; right? 17 A That's the title, yes. 18 Q Okay. 19 Now we can go to the page, if you will, 20 marked 8235. 21 A Okay. 22 Q All right. 23 That's the one that at the top says 1-2; 24 right? 25 A Yes. Priority-One Court Reporting Services Inc. – A Veritext Company 718-983-1234 i ~ Y" .1976 '-ogram" t ~A']'E" 9/6173 COSMETICS Title" Asbestos and Other Contaminants in Talc P~E USE O:{LY 00679 Subprogr~_~" Aerosols & Hair Prepar~tions Project ~'ianager & ~-Lailing S3~bol' John Stuart (BF-446) Statem~.:z:t of ObJc:ctivc: --- Develop one or several methods of sufficient .sensitivity and reliability which will permit the determination of asbestos and other contaminants in talc-containing products with the necessary degree of accuracy and at concentrations at which such contaminants present a potential health hazard. Justification. The inhalation of certain asbestiform minerals is a known health hazard. The results of the determination of asbestos by x-ray diffraction in 200 commercial cosmetic talc samples by consultant to the FDA were in disagreement with those obtained by others through microscopy. This project will provide the in-house capability to perform reliable asbestos analyses and resolve the controvers on t.h~ asb~stosbcontent of the 200 commercial talc samples. ' Descrip~.cn o~ The 200 commercial cosmetic talc samples evaluated by Dr. Lewin will be tested for asbestos by refractory optical microscopy. After installation of the automated x-ray powder diffractometer and the high-temperature differential thermal analyzer, instrumental analytical methodology will be perfected to a degree that asbestos can be determined reliably and speedily at concentrations of less than one percent. The perfected methods will be published. ? C HILESTONES : i,Evaluation of Talc Samples by Optical Microscopy 2. Installation of High Temperature Thermal Analyzer 3, Installation of x-ray Diffractometer 4. Establishment of Analytical Method ? 5. #malysi~s of Talc Samples by Instrum. Method Ouarter First ! Second Third Four th ~ TECHNICAL PLAN QUARTERLY PROJECT PROGRESS REPORT COSMETICS 4o Project Title [, Project Number Asbestos and Other Contaminants in Talc 00679 6o ~f this Quarter's Activities: (Discuss accomplishments this quarter and indicate their s.ignificance to the program or project? Include~where relevant~ the rela~i~.hip ~f this quarter's work to that of previous and future quarters? if more space i~ needed~ use blank paper)? The objective of this program is to develop one or several methods of sufficient sensitivity and reliability which will permit the determination of asbestos and other contaminants in talc-containing products with the necess~?ry degree of accuracy and at concentrations at which such contaminants present a potential health~ hazard? This ist quarter efforts have been directed to establishing a? good technical base for meeting the ?program objectives. As a first milestones the installation of the High Temperature Differential Thermal Analyzer was scheduled for completion? This has been accomplished~ Further, the X-Ray Diffractometer has arrived and arrangements are underway for its installation. P~cedures are being set up for making a rough estimate of the amount of talc powinhaled by an infant during powdering~ A literature and technical review of Serpentines Amphibole and Talc mineralogy is in progress. For This purpose, the work of Lewin~ on the ?examination of asbestos in 200 talc products has been reviewed? A trip was made to ?the Smithsonian Instiin ? i ? . ??~ 7o Mile~ton.es Not Achieved~ (Identify any of thi~ quarter's mile~tones no[ met and brieflZ explain why. Aiso indicate how this will .affect project progress? If future milestones will not be accomplished as planned~ reschedule them? If more space is needed~ use blank, paper)? Milestones not achieved : NONE Latest___ RUS .R~ort indicates Compatibility Between Planned and Used YTD Positions? /~X/ Ye~ /~./ No (if no~ explain) Projec4 Ma~nager"s Si John ~uart, BF-446 ~0,. Date 9/26/73 lio Progi2~ Manager's Signature Heinz Jo Eiermann, BF-440 12, Date 9/26/73 ~O CONTINUATION OF ---_~M ~6 ~/ jram: COS~-___I_~S Sub-Program: Aerosols and Hair Preparations Project Title- ~-~bestos and Other Contaminants in Talc ist qtr0 FY 74~ Project Number: 00679 Techniques are h=-ng developed for concentration of the asbestos fraction of talc products to be e-~-azined. Among these are the use of heavy liquids for density separations? ~ kind of approach may lead to a lessening of the requirements for instrumental s~tivity while maintaining detection sensitivity? Efforts in the ~t quarter will continue in the areas outlined above? Also~ Lewin~s "talc samples" ~_i_I be examined by optical microscopy and crystallography. TECHNICAL PLAN QUARTERLY PROJECT PROGRESS REPORT rogram COSMETICS ~. Project Title 2, Sub-Program A~rosol s and Hair Preparations ' Asbestos and Other Contaminants J,n Talc oJect Number 00679 6o Description of this_~aarter~s Activities? (Discuss accomplishments this quarter and indicate their significance to the program or pzojecto Include~where re!evant~ the relationship ~f this quarter's work to that of previous, and future quarters? If mmre sp~ce i~ needed~ use blank paper)? The objective of this program is to develop methods of sufficient sensitivity and reliability to permi't the determination of asbestos and other contaminants in. ~alc-containing products with the necessary degree of accuracy and. at co~ntrations at which such contaminants present a potential health hazard? The necessary equipment for the talc inhalation study has been received, Expe.rimental work for.the purpose of estimating the amount of talc powder inhaled by an infant du.ring powdering will commence, shortly, The differential thermal analyzer has been performance-checked and standardized. As of 12/21/73 approximately 5.0 thermograms (including 18 talc samples which Dr. Lewin had investigated) were prepared and analyzed, No asbestos minerals were detected o ~o investigationa], samples of commercial talc products were analyzed by DTA and ~ptical microscopy, No .asbestos minerals were detectedo The literature and technical review of serpentin.e~ amphibole and talc mineralogy is continuing, (Continued on next page) 7o Milestones Not Achieved- (Identify any of this 'qu~rter~s milestones not met and ..... briefl~, explain why.. Also indicate how ~his will ~ffect project progress? If future mi.les~ones will no~ be accomplished as plant,.ed~ reschedule ~hemo if more ~pace i~ ~eeded~ u~e blank paper)? Installation of x-ray diffractometer has been delayed, GSA did not make the necessary utilities installation? The other project phases are essentially on target? LatesGBP__ RUS Rej~ort indicates Compatibility Between Planned and Used YTD Positions? /~ , Ye~ /~=/ No (if no~ explain) The FY 74 plan has been changed from l ol to 1o3 POS to reflect increased activity in the future.. / ,Jonn Stuart HFF-4~6 ? Heinz Jo .Eiermann HFF-440. Asbestos and Other Contaminants in Talc 00679 Examina'tion of talc samples by optical microscopy according to the method published in the l~ederal Register (39 FR 27076) is proceeding. As of 12/21/73, samples (Lewin's i,Jentification) # 29, 58, 60, 84, 87, 131, 133, 134, 135, 136, 137, and 238 were analyzed for mineral content.. Al! contained larqe qua~ntiti:~%~ of talc, small amounts of carbonates, and minor amounts o.~ .h~.atite,. ~uartz and diatomaceous earth. Sample # 84 contained 107 f~.~%ern of tre:7.'iite/actinolite per rag. sample # 87 contained 66 fibers per m~. .,,J Standard sli~s were. pre~=_~.ed with 1% and 0.1% tremolite and chrysotile in talc. Trem~]hi-~e is re&d~_l~y detectable to 0.1%. Detection of chrysotile at the 0.1% ~ is q~e_~ionable. Less than one in 20 fibers are visible at 400X. ~ ~=~aluati~n was made using Congo Red dye which preferentially stains the ~':sm~ile fibers. . TECHNICAL PLAN QUARTERLY PROJECT PROGRESS REPORT i~ - rogram Cosmetics 4o Project Title Sub-Prog&ram 2kerosols Hair Preparations Asbestos & Other Contaminants in Talc J ect Number 00679 6o Description of this ~arter's Activitie~? (Discuss accomplishments thi~ quarter and indicate their significance to the program or project? Include~where relevant~ the rela~ior~hip ef this. quarter ~s work to that of previous and, future quarters? If more space is needed~ use blank paper)? The objective of this program is to develop methods of sufficient sensitivity and reliability to permit the determination of asbestos and other tontaminants in talc-containing products with the necessary degree of accuracy and at concentrations at which such contaminants present a potential health hazard? A study was undertaken to determine the amount of talc an infant may inhale when powder is applied, to the child during diaper change? The use. conditions were simulated and exaggerated to obtained data reflecting the most severe circumstances, Baby talc was sprinkled ~nto. a platform at a rate of 200g per approximate half hour~ and air was sucked through a filter fitted with a pre-weighed filt_er paper, at a rate of 0.5 liters per minute reflecting approximate respiration rate of a child? The air filter funnel was positioned in such a way that it would be located near the mouth of the child under actual use conditions. ,~ total of 24 experiments of dispensing 200g of talc was performed? An average of 1~2 mg_ / ~0o5 mg of talc was collected,. The average time~ for dispensing the 200g of talc was 30 min_ + ~7 min. ~onsidering extreme conditions (highest amount of talc dispensed during the shortest time period, both at the 95% level of confidence.) and the 0.5 I/mir~ air flow, the amount of talc collected on the (con' 7o Mileetone~ Not. Achieved= (Identify any of this quarter's mile~tone~ not met briefl~! ~p.lain why~ ~so indicate how ~his will affect project progre~.s~ If future milestones ~ii not be acaomplish~ as pla~ed~, reschedule th~ If more ~pace is needed~ u~e blank paper)~ Because of the delay in the installation of x-ray diffractometer and the analysis of co~ercial cosmetic talc samples by optical microscopy, establishment of the analytical method for dete~ination will. be delayed beyond the fourth quarter? o Lates.t RUS Re~ort Indlcate~. Compatibility Between Planned and Used. YTD Positions? Date ,) - 2 - filter would be 0.275 Taking into consideration OSHA standards for permissible levels of asbestos fiber contamination of air (29 CFR 1910.93a) of 5 fibers / ml air on a continuous basis (8 hours per day per 5-day week) and i0 fibers / ml air as temporary exposure (15 rain. per hour per 5-hour day per 5-day week) and assuming that the difference of 5 fibers per ml air may be inhaled by an infant, and furthermore considering the equation that I000 fibers are equivalent to 0o1% of 1 mg of talc, the following condition exists: The 5 fibers per ml of air is equivalent to 5 x 10-6 mg of asbestos / ml air? Consequently, the 275 x i0-6 mg of talc may contain 5 x 10-6 mg asbestos~ which is equivalent to 1o8%. Since the OSHA standard permits inhalation of up to i0 fibers of asbestos per ml air which is equivalent to i0,000 fibers (or i0 x 1.0-3 mg) per liter~ of i0 x 10-.6 mg asbestos per ml, the maximum asbestos fiber concentration may be 3?6%? Using a safety factor of i00 would reduce the allowable level of asbestos to 0.036%o In essence this may be interpreted to mean that talc used for cosmetic purposes should contain less t'han 0?036% (360 fibers/rag) asbestos fibers and that .analytical methodology to be developed for regulatory purposes should be sufficiently sensitive to detect asbestos in talc at this ]_evelo On the other hand, applying OSHA standards somewhat more liberally and being primarily concerned about the maximum total daily intake of asbestos fibers,, and not so much about the maximum exposure of i0 fibers/ml at any time, one may extrapolate that OSHA permits an exposure time of i0 x 5 = 75 mino per day to the excess amount of 5 fibers/ml. Since the infant is exposed to talc approximately i0 x 1 mino per day, the 1.8% asbestos level may be increased to 1.8 x 70/10 = 13.5%. With a safety factor of i00, the allowable level of asbestos fibers would be reduced to 0o135% (1350 fibers/mg)? The examination by optical microscopy of the commercial cosmetic talc samples which Dr? Lewin had tested, by x-ray diffraction was continued? The following samples were analyzed according to the proposed method published in the Federal Register (39 FR 27076): #61) 88, 89, 90, 92 and 93? Our determination showed that all contained tremolite (amphibole) but none showed chrysotile. With the exception of sample #61 which was found to be free of asbestos fibers~ Dr. Lewin reported 4 - 5% chrysotile and 3 -: 5 % tremolite. Because the fiber count for a given weight percentage of tremolite varies significantly, it is impossible to establish accurate correlation between fiber count and weight. It may, however,, be stated that the high counts of tremolite observed in these samples appear to confirm the results Dr o Lewin reported for this type of asbestos fiber? The x-ray diffractometer has finally been insta.lled. Work. on. the development of a method, for the determination of asbestos with this instrument, however, has been delayed because of the analysis of some of the Lewin samples by optical microscopy. ~o commercial talc products were analyzed for mineral and asbestos content oy optical microscopy? No chrysotile was detected, however, tremolite (amphibole) was found in one sample at a level of i,i00 fibers/rag. TECHNICAL PL~2~ QUARTERLY PROJEC]. PROGRESS REPORT Program Sub-Program Aerosols and COSMETICS 4 t. i~/74 o Project Number Project Title Asbestos and Other Contaminants in Talc . 00679 Description of this ~uarter~s Activities, (Discuss accomplishments this quarta.r and indicate their significance to the. program or project. Include~where relevant~ the relationship of this quarter's work to that of previous and future quarters, If more space is needed~ use blank paper)? The object of this program is to develop methods of sufficient sensitivitv and reliability to permit the determination of asbestos and other contaminants in talc-containing products with the necessary? degree of accuracy and at concentrations at which such contaminants present a potential health hazard? The examination by optical microscopy of the commercial talc samples which Dr~ Lewin had analyzed by x-ray diffraction was continued? As of 6/14/7~ the following samples were analyzed according to the proposed method published in the Federal Register (39 FR 27076)~ 26, 37~ ~2~. 63, 70, 71, 72~ 74, 77, 80, 85, 94, 95, 99, I00, i01, 107, .i~3, 144, 145~. !48~ 149, 151, 152, 153, 16.3, and 164, DCST's results by optical microscopy tend to confirm in !54, a general, way, Dr. Lewin's findings for tremoliteo Chrysotile, however, was reported in samples 95~ 143, 165, 163~ and 164 could not be detected by which optical microscopy by DCSTo As of 6/14/74~ four collaborative and two commercial samples were also analyzed for asbestos fibers by optical m~croscopyo Statistical analysis of the talc inhalation data reported in the (continued) 7o Milestones Not Achi~ved~ (Identify any of this quarter's mil.~ston~s, not m.et and briefl~x explain why? Also indicate how this. will affect project progress? If future milestones will not be accomplished as pia.nned~ reschedule them? If more ~pace i~ needed~ u~e blank paper)? Milestones Not Achieved. ~ Although the x-ray diffractometer was installed during the third quarter FY it? is presently malfunctioning? Development of x-ray analytical method will. commence when instrument is repaired? Latest___ RUS ,~e_~.ort Indicates Compatibility Between Planned and. Used YTD Positions~ /._~ ~es /__i No (if no o. ex~lain) and _Mail S ..~b~l..,., ...~ Ronald L. Yate~ I HFF-~6 ./~._/, Heinz ~rosols and Hair Preparations (00679) third quar.ter FY 74, suggested that further data be accumulated to arrJ.va at statistically significant conclusions concerning talc concentration in a~ . At the sugg.estion of the Division of Mathematics, DCST has obtained 30 additional sets of data, Regression and correlation analyses will now be carried out to determine the degree 6f dependence of experimental variables~ TECHNICAL PLAN PROJECT DESCRIPTION 1975 am: ~ DATE.: May 16, 1974 COSMETICS Project Title: Determination of Asbestos in Talc PPE USE ONLY 00679 Subprogram: Chemical Analysis and Methods Development Project Manager & Mailing Symbol : Ronaid Lo Yates (HFF-446) ~g}~ Statement of 0b~ective: Develop one or several methods of sufficient sensitivity and reliability which will permit the determination of asbestos and other contaminants in talc-containing products with the necessary degree of accuracy and at concentrations at which such contaminants present a potential health hazard, Justification: The inhalation of certain asbestiform minerals is a known health hazard? This project will provide the necessary in-house capability to perform reliable asbestos analyses? Description of Work: Instrumental analytical, methodology will be developed and perfected to a degree that asbestos can be determined .reliably at concentrations in the range of 0.1% or less. At least two instrumental techniques will have to be developed because no single method is sufficiently specific, sensitive, and accurate to accomplish the objective. Samples of commercial talcs and cosmetic talc products will be examined for asbestos at random and as needed in conjunction with the development of analytical methodology. MILESTONES io Establishment of Analytical Method ~arter First S~cend .Third Fourth x TECHNICAL PLAN QUARTERLY PROJECT PROGRESS ?REPORT , Program 2? Sub-Program ~0 Project Title Chemical Analysi~3o Quarter/FY . o~ect Number Determination of Asbestos in Talc ~ 00679 6o Description of this~uarter~s Activities? (Discus~ accomplishments this quarter and indica.te their ~ignificance to. the program or project? Include ~ where relevant~ the r~la~io~hip @f this quarter's work to that of previous and future quarter ~..o ?lf more sp~ce i~-~needed~ use Blank paper)? The purpose of this project is to develop one or several methods of sufficient sensitivity and reliability which will permit the determination of asbestos and other contaminants in talc-containing products with the necessary degree of accuracy and at concentrations at which such contaminants p?resent a potential health hazard ~ Work? started on a method for the determination of chrysotile in talc by differential ~termal analysis (DTA) 0 Pure talc samples were spiked with various levels Of chrysotileo DTA data on these samples indicate a lower detection limit of 0?5%? For a series of samples containing the same concentration o?f chrysotile neither the endotherms nor the exotherms were of equal intensity? This indicates that the accurate determination of chrysotile will? depend upon measurement of peak areas? As of September 25~ 3 compliance ?program surveillance (CPS) samples and one consumer complaint sample were analyzed for asbestos by optica! microscopy? One CPS sample contained l,iO0 tremolite fibers/mgo Asbestos was not detected in the remaining samples? 7o Milestones No~ Achieved: (Identify any of this quarter's mil~stones not met and briefl~ e~plain ~hyo ~.~o indicate how thi~ will affec~ project progress? If future mile~.~one~ will .not be accomplished a~ planned~ reschedule thean~ If more ~pace i~ needed~ use blank, paper)? No milestones were scheduled for completion during Ist quarter/FY 75? ? 8? Latest RUS ,R.~ort Indicates Compatibility B?etween Planned and Used YTD Positions? ~7 Yes // No (if no~ explain) 9~ Project Manager ~ ~ S.igna~tu~lO~ Date Ronald L~?fat?es~ HF 46 /$ ~/- ~ Iio p~~m Ma~~s S+-gnature 12o Date Heinz J~ Eiermann (HFF-4.40) TECHNICAL PLAN QUARTERLY PROJECT PROGRESS REPORT COSMETICS 4o Project Title and Methods Development 75 o Project Number Determination of Asbestos in Talc 00679 60 Description of this quarter's Activities- (Discuss accom.plishments this quarter and indicate their significance to th~program or project? Include~where relevant~ the re~la~io~hip mf this quarter's.w?rk to that of previous and future quarter~o If more space i~. needed~ use blank paper)? The purpose of this project is to develop one or several methods of sufficient sensitivity and reliability which will permit the determination of asbestos and other contaminants in talc-containing products with the necessary degree of accuracy and at concentrations at which such contaminants present a potential health hazard~ Work continued on the development of a method for the determination of chrysotile in talc by differential thermal analysis (DTA) o Although DTA is reasonably specific for chrysotile~ certain minerals~ such as large amounts of chlorite (ca i0%), cause problems when determining small amounts of chrysotile (0o5-1%)o Efforts to remove interferences by chemical means have had limi'ted success? Treatment of talc samples with dilute hydrochloric acid removed interfering carbonates? ?covery studies were done on spiked talc samples containing from 0?.5 to 5% ~nrysotileo Exotherm intensities were not as reliable as peak areas for quantitative cal~ulationso Recoveries were approximately + 20% of true values~ Samples of chrysotile from i0 different geographic locations were examined by DTAo 70 Milestones Not Achieved: (identify any of thi~ quarter's milestones not met and brief~ explain why? Also indicate how this, will .affect project progress? If future miles.tone~ will not be accomplished as p!anned~ resche4ul~ them? If more space is needed~ use blank paper)? No milestones were scheduled for completion during 2nd quarter/FY ~75o ~8o Latest RUS .Re=j~ort Indicates Compatibility Between Planned and. Used YTD Positions. ~ Ye.~ /__/ No (if n.0~ explain) 9o Pro~ect Manager ~ s Signature and Mai ,S ~b~.~. . Yat~s (HFF-446) iio nag~~ SignatureIl2, Date He'nz ~o Eie~mann (I-~F-440) ~ emical Analysis and Methods Development 2nd/75 00679 It was found that there was wide variation in the intensities of the dehydroxylation endotherm and the recrystallization exotherm from sample to sample?. These results are not unexpected because chrysotile~ being a mineral~ varies slightly in composition and crystalline structure. This would mean that any quantitative results obtained would be suspect because the chrysotile in the sample would not necessarily relate to the calibration standard in a chemical and structural context, The CTFA submitted three more round-robin samples of talc for chrysotile analysis by DTA and optical microscopy? By DTA, sample A contained in excess of 5% chrysotile~ sample B contained 1% and in sample C chrysotile was not detected? Analysis by optical microscopy has not been completed? TECHNICAL PLAN QUARTERLY PROJECT PROGRESS P~EPORT Program Cosmetics " 2~ Sub-Program Chemical Analysis 3 Quarter/FY ,.~o Project Title " ~- ~ .... o Pro~ect Number Determination of Asbestos in Ta ic" 00679 6o Description of this quarter's Act+-vities.o (Discuss accomplishments this quarter and indicate their ~ignificance to the progr~ or pro]ect~ include,where relevant~ the r~a~~~p ~f this quarter's work. to that of previous and future quarters~ If more space i~ needed~ use blankpaper)~ The purpose of this project is to develop one or several methods of sufficient sensitivity and reliability which will pe~it the dete~ination of asbestos and other contaminants in talc-containing products with the necessary degree of accuracy and at concentrations at which such contaminants present a potential health hazard, Work is continuing on a method for the determination of chrysotile in talc by differential thermal analysis (DTA) o Present work involves determining at what level chlorite interferes with this determination? Preliminary data indicate. that chlorite levels of 50% can be tolerated in most talc samples? In other cases, depending on the degree of grinding and purity~ chlorite can interfere at levels of 15% due to shif.ts in the endotherms at approximately 650? and 850?C~ A more definitive .answer to this problem, will be obtained by spiking pure talc with chrysotile and various grades of chlorite? Zinc, calcium and magnesium stearate have been. studies by DTA to determine if these compounds interfere with the determination of chrysotile in talco The zinc and magnesium stearates do not interfere; the calcium compound is potentially troublesome? A similar study done on laboratory grade (continued) Milestones Not Achieved: (Identify any of thi~. quarter's milestones not met and ~ explain, why? Also indicate, how this will affect project progress? If future, milestones will not be accomplished a.s planned~ reschedule th~mo If more ~pace i~ needed~ nine blank paper)? Insufficient progress has been made in method development due to unforeseen scientific complezities to assure completion of work during ~ 4/75o Lat___est RUS ,Re_j~ort indicates Compatibility Between Planned and Used YTD Positions? Yes /~/ No (if no~ e~plain) Date 1i,. ~ Ma!~ggr~s Signature ~fginz J. Eiermann, HFF-440 magnesium carbonate indicates no interference from this compound? Mineral specimens of magnesium carbonate will be examined by DTA when obtained? Nearly all commercial, samples of cosmetic talc analyzed by DTA contain an endotherm at 740?Co The mineral responsible has not yet been identified? As of 3/28/75, DTA of approximately 75 (cao 20 during FY 3/75)of Dro So Zo Lewin~s talc samples were analyzed for the purpose of comparing analytical data? Two samples, Lewin~s #96 and #143 indicated serpentin.e by DTA. It has not been determined whether that serpentine is chrysotile or antegoriteo As of 3/28/75~ five Field Activity Surveillance samples have been analyzed for chrysotileo None was detected? TECHNICAL PLAN QUARTERLY PROJECT PROGRESS REPORT r- Program Cosmetics 2, Sub-Program Chemical Analysis 3. Quarter/FY . and Methods Development 4th/75 . Project Number Determination of Asbestos in Talc 00679 6, Description of this ~uarter's Activities: (Discuss accomplishments this quarter and indicate their significance to the program or project. Include~where relevant, the relationship ~f this quarter's work to that of previous and future quarters. If more sp~ce i~ needed, use blank paper). The purpose of this project is to develop one or several methods of sufficient sensitivity and reliability which will permit the determination of asbestos and other contaminants in talc-containing products with the necessary degree of accuracy and at concentrations at which such contaminants present a potential health hazard. Work continued on development of a method for the determination of chrysotile in talc by differential thermal analysis (DTA) 0 DTA data was obtained on seventeen minerals known or suspected to occur in talc. Data will be used to: ( I) 2) Identify minerals present in cosmetic talc samples. Determine which minerals may interfere with determination of chrysotile in talc. \s of 6/27/75, 49 Field Surveillance samples have been analyzed for chrysotile. ,one was detected at limit of method (0.5%). Thirty-two FAS samples were analyzed for tremolite using light microscopy. None was detected, 7. Milestones Not Achieved: (identify any of this quarter's milestones not met and briefly explain why. Also indicate how ~his will affect project progress. If future milestones will not be accomplished ms planned, reschedule them? If more space is needed, use blank paper). Insufficient progress has been made in method development due to unforseen scientific complexities to complete project during FY 75. 8, Latest.__ RUS .Re_~ort Indicates Compatibility Between Planned and Used YTD Positions, /.~/ Yes // No (if no. explain) Date FDH .~_~~:~ 1976 May 19, 1975 Cosmetics ~ PROJECT ~TLE. Determination of Asbestos in Talc PROJECT DE$CRiPTION PPES USE ONLY? 00679 SUBPROGRAM, Chemical Anal?ysis and Methods Development PROJECT MANAGER & MAILING SYP[BOLo Ronald Lo Yates (HFF-446) ~TAT~~ O~? O~~~V~ Develop analytical methods for the determination of asbestos in talc-containing cosmetic products~ at concentrations of 001% or lesso , JUSTIFIC@~TI~ The inhalation of certain asbestiform minerals is a known health hazard? This project is expected to provide the necessary in-house capability to perform appropriate asbestos determinations and the analytical methodology for proposal of a regulation on asbestos in talco . ~$CRIPTI~ OF WOR~.~ DCST has methods for the determination of serpentine (chrysotile and antigorite) by differential thermal analysis at a level of 0?5% and of tremolite by step-scanning x-ray diffraction? at a leve! of 0?3%? Floatation methods will be developed to concentrate sepentine and tremolite in order to be able to determine these minerals at 0o1% concentration?. MILESTONES, Method for concentration? of chrysotile~and tremo!ite by fioataDion 2853 TECHNICAL PLAN QUARTERLY PROJECT PROGRESS REPORT :ogram ..~sm~t~cs !20 Sub-Program Chemical Analysis 3o Quarter/FY and l~~c~s I~v~lo~t:~nt ls~/76 4. Project Title o Project Number Determination of Asbestos in Talc 00679 6o Descri~f this Quarter's Activities.: (Discu~ accomplishments thi~ quarter and indicate: their ~ignificance to the program or project? Include~where relevant~ the r~la~i~hip of this quarter~s work to that of previou~ and future quarters~ If more spgce i~ needed~ use blank The purpose of this project is to develop one or several meth3ds for sufficient sensitivity and reliability which will permit the determination of asbestos ar~ other conta~:inants in talc-containing products with the necessary degree of accuracy and at concentrations at which such contaminants present a potential health hazard?. Due to separation of John Stuart from gov~t service~ no methods develo_~T~nt investigations were done during ist quarter/FY 76? DCST has continued the differential thermal? analysis (DTA) of ~liance Program Surveillance? samples of ~cial cosmetic talcs for serpentine (chrysotile) minerals~ As of 9/19/75, 28 of these sanples have been analyzed? Serpentine was not detected in any san~les0 ,tiation of investigation to develop floatation me~s for the concentration of chrysotile in talc? ~les will depend on manpower availability and project priorities? Milestones? Not Achieved: (Identify any of this. quarter's milestones not met and briefi2i explain why? Aiso indicate how this will affect project progress? If future milestones, will not be accomplished as, planned~ reschedule them? If more space i~. needed~ use blank paper)? No milestones were scheduled for conpletion during ist/76o 8o Latest RUS.~Re~p~ort Indicates Compatibility Between Planned and Used YTD Positions? /~ Yes /_~./ No (if no~ explain) below budget due to resignation~ 9o Project Manager~ Signature 1.0o Date ii~. ~ ~ Signature 1.2~ t~ ? TEC|IN.I.CAL PLAN QUARTERLY PRO~EC']" PROGRESS REPORT ,_o Program Cosmetics 4o Project Title 3. Quarter/FY 2. Sub-Program Chemical Analysis and Methods Development 2nd/76 o Project Number Determination of Asbestos in Talc 00679 6o Description of this______~Oua~t~er's Activities? (Discuss accomplishments this quarter and indicate their significance to the program or project? Include~where relevant~ the rel.ation~.hip of this quarter~s work .to that of previous and future quarters? If more space i~ needed~ use blank paper)? The purpose of this project is to develop one or several methods of. sufficient sensitivity and reliability which will permit the determination of asbestos and other contaminants in talc-containing products with the necessary degree of accuracy and at concentrations of which such contaminants present a potential health, hazard. Due to lack of specialized personnel and certain necessary instrumentation, no significant work was done on methods development during 2nd quarter/FY 76? Routine analysis of consumer talc samples by differential thermal analysis (DTA) continued? Serpentine was not detected in any? of these samples? Some x.~ray diffraction 'data was obtained from talc, chrysotile and tremolite samples? The m~in purpose of this effort, however, was to familiarize a staff member ~ith the peration of the computerized x-ray diffraction unit? Because of limited resources in regard to instrumentation and trained personnel, the only project plannedrelating to methods development is Sample enrichment by f!oatation in order to detect lower levels of serpentine by DTA. Initiation of this project will depend on manpower availability and project priorities? 7 Milestones Not Achieved' (Identify any of this quarter's milestones not met and brieflX ezpi~zin why? Also indicate how thi~ will affect project progress. If future milestones will. not be accomplished as planned~ rescheduie them~ If more ~pace ia needed~ use blank paper), No milestones were scheduled for completion during 2nd quarter/FY 76? Latest RUS i