RESEARCH POSTER PRESENTATION DESIGN © 2015 www.PosterPresentations.com Background: In 1973, the FDA proposed regulation to assure that cosmetic products containing talc were at least 99.9% asbestos-free. The talc companies objected, the FDA withdrew the regulation and allowed industry to self-regulate. In 1976, the talc industry proposed voluntary testing for asbestos in talc and adopted a “zero tolerance” standard for asbestos in talc. Talc mining and manufacturing companies have since claimed that their pharmaceutical and cosmetic grade talc is asbestos-free. Objective: Evaluate the claim that consumer talc is “asbestos-free” by reviewing records produced by talc mining and manufacturing companies and by other laboratories. Methods: The authors employed systematic search techniques and a grounded theory approach to review corporate documents. Talc-related documents were initially searched for asbestos-related terms. The authors conducted additional searches, focusing on terms associated with testing protocols, quality control measures, and specific talc mines and mills. The authors also reviewed depositions of individuals connected to talc litigation. Results: Industry tests indicate that talc used in cosmetics contained asbestos. The test methods adopted by the industry had a high limit of detection and therefore could never assure that talc was asbestos- free. Even with insensitive methods, company tests identified asbestos in talc mines and in talc products. Discussion: Talc-based cosmetics and powders contain asbestos. Talc companies cannot assure a “zero tolerance” standard for asbestos in talc. IARC has classified inhaled asbestos as a Group 1 ovarian carcinogen and epidemiologic studies have shown an association between talc use and ovarian cancer. The presence of asbestos in talc provides a causal explanation for this association. Disclosures: David Egilman MD, MPH is a medical consultant to patients who have developed cancer as a result of exposures to asbestos. In some cases, he has also served as an expert witness in related litigation. Joan Steffen and Triet Tran are researchers for Dr. Egilman. Ella Fassler is a consulting researcher on the same talc and asbestos litigation. Lawyers did not provide financial support for this research or input into this research. Abstract Talc-based cosmetics and powders contain asbestos. Talc companies cannot assure that talc used in cosmetics is asbestos-free. There are no known test methods with a limit of detection of zero. Despite having high limits of detection, some tests have found asbestos in cosmetic talc products. IARC has classified asbestos as an ovarian carcinogen and epidemiologic studies have shown as association between talc use and ovarian cancer. The inhalation of fibers from expected use of talc containing cosmetics provides evidence that this association is causal. Study limitations: Historic testing of talc for asbestos is limited in methodology and scope. Courts and plaintiff lawyers have agreed, without the knowledge or permission of their clients, to keep secret some of the documents reported here; these documents became public during court proceedings over the objections of J&J and Imerys. Many documents remain sealed. . As early as 1898, Dana’s Textbook of Mineralogy, a standard mineralogy textbook, mentioned that asbestos was one of the minerals associated with talc formations. 1 The following asbestiform minerals have since been found in association with talc: actinolite, anthophyllite, chesterite, chrysotile, clinojimthompsonite, jimthompsonite, tremolite, and winchite. 2,3,4,5,6,7 Fibrous (asbestiform) talc has also been found in talc deposits. 29 Van Gosen et al. 2004 found that “the talc-forming environment directly influenced the amphibole and amphibole-asbestos content of the talc deposit” and reported “consistent associations of amphibole-rich talc deposits with contact metamorphism versus amphibole-poor talc with hydrothermal processes.” 8 Geology of Asbestos in Talc Asbestos Test Results Total of 686 publicly available positive asbestos test results in talcs used in cosmetics from 1948 – 2017: Inadequate Testing Methods Reports of Asbestos in Cosmetic Talc Products Anti-Warnings Talc advertisements encouraged inhaled asbestos exposure In 1973, Walter C. McCrone Associates, a lab that industry used to test for asbestos in talc, stated that XRD was “less sensitive” than transmission electron microscopy (TEM), but that the “sensitivity can be increased from 0.5 - 1% to 0.1- 0.5%” asbestos (level of detection) by step-scanning. 16 Dr. Lewin of NYU recommended the same step-scanning methods and the use of an internal standard to improve the level of detection by XRD. 17 XRD Analysis Testing Method Tests for Chrysotile? Concentration step? Step Scan? Internal Standard? Reported Level of Detection? CTFA J4-1 NO NO NO NO 0.5% and above USP Yes NO NO NO Not Reported Moreover, neither the CTFA J4-1 nor the USP method specified the magnification power used for Optical Microscopy Analysis. Colgate-Palmolive stated that they used 125x power to test the talc. 22 Standard phase contrast microscopy (PCM) power is 450x. 125x cannot detect thinner asbestos fibers, and would generate false negative results. 23 In 1976, the CTFA performed a round robin test to evaluate the J4-1 method. They sent spiked amphibole samples to the FDA, Avon, Chesebrough-Ponds, McCrone, Colgate-Palmolive, Cyprus, Mennen and Johnson & Johnson. Only one lab (the FDA’s) was able to detect 0.5% tremolite by CTFA J4-1; the round robin results demonstrate a false negative rate of ~86%. 24 Despite this, CTFA never changed the method and they rely on it to this day. 20 A bathroom scale would not register any weight and a report would state “No feather detected” In 1973, Dr. Pooley developed “two techniques for preconcentration of chrysotile and tremolite in talc followed by X-ray diffraction [XRD] analysis.” Dr. Pooley found 0.05% tremolite in J&J Vermont talc. J&J disapproved of this method because “it may be too sensitive:” 15 In a 2004 submission to the National Toxicology Program regarding the question of talc’s carcinogenicity, the CTFA claimed that their talc products have been asbestos-free since the creation of CTFA method J4-1: 12 Talc Industry Claims “Zero Tolerance” for Asbestos Johnson and Johnson reiterated this position on their website in 2016: 26 Talc company corporate representatives testify that they have a “zero tolerance” policy for asbestos in talc: Johnson and Johnson 28 Colgate Palmolive 27 In 1968, Cralley et al. published two papers on the asbestos content of cosmetic talcum powders: “The 22 talcum products analyzed showed fiber contents ranging from 8 to 30% by count of the total talcum particulates with an average of 19%.” 9,10 In 1971, Harold Romer, the assistant commissioner of Air Resources for New York City raised the alarm with Johnson and Johnson (J&J) and with the FDA that Dr. Selikoff’s group at Mount Sinai Hospital had found a significant amount of asbestos in J&J talc. Through the 1970s, Drs. Rohl, Langer, Selikoff and others at Mt. Sinai continued to publish analyses finding asbestos in cosmetic talc products. 5,6 In 1972, the FDA proposed regulation of asbestos in talc, requiring a 99.9% purity for tremolite and 99.99% purity for chrysotile. 11 The Cosmetic, Toiletry, and Fragrance Association (CTFA) objected, and the FDA withdrew the proposed regulation. In 1976, the FDA allowed the industry to establish voluntary procedures for asbestos in talc used in cosmetics. In a 2004 submission to the National Toxicology Program, the CTFA admitted that talc products manufactured before they developed this test (but sold and used after) contained asbestos: 12 In March 1976, the CTFA sent the FDA a packet of eleven letters from talc mining and manufacturing companies and laboratories that tested their talc. These letters urged the FDA not to regulate asbestos in talc and assured the agency that cosmetic talc products were asbestos-free. McCrone – who tested talc for Avon, Bristol-Myers, Chesebrough-Ponds, Colgate-Palmolive, Faberge, Johnson & Johnson, Windsor Minerals, and Whittaker Clark and Daniels – claimed that cosmetic talc had never contained chrysotile and no longer contained other asbestos minerals, in contradiction to their test result records. 19 McCrone found chrysotile in 22 tests for cosmetic talc companies by March 1976 and reported asbestos in 124 tests for cosmetic talc companies from 1973 to 1976. In 1972, for example, TEM tests on Shower to Shower (performed at the U. of Minnesota Space Science Center and commissioned by McCrone and Johnson & Johnson) reported that “crysotile [sic] asbestos does exist in the specimens of [s] hower to [s]hower .” 18 In 2014, a panel of experts met to evaluate the USP method for detecting asbestos in talc. The group found that the “Limit of detection may be too high for public health and regulatory purposes” and that the XRD step “may give false-negative result[s] if used as a screening method.” 25 Later in 1976, the CTFA created voluntary method CTFA J4-1 to test for tremolite asbestos in “cosmetic grade” talc. 20 Having told the FDA that their talc never contained chrysotile, the J4-1 method did not test for chrysotile, thereby assuring that chrysotile would never again be found in talc. The US Pharmacopeia later added a test for asbestos to its monograph for “pharmaceutical grade” talc. 21 The USP and CTFA Methods both relied on a screening step using XRD followed by a microscopy step to confirm the presence of asbestos. The USP method also included an alternative screening step using infrared (IR) spectroscopy, which has also been found unreliable. 25 CTFA Method J4-1 In 1972, NIOSH studied fiber exposures to mothers and infants who used talc powders during diapering. NIOSH found that J&J Baby Powder exposed mothers to 2.2 fibers/cc on average and babies to 1.8 f/cc on average during diaper changing for about 3-4 hour/week. 13 Gordon et al. 2014 reported average airborne fiber concentrations of 4.8 f/cc during use of Cashmere Bouquet talc powder. Gordon reported that 1.9 f/cc of the fibers were asbestos; the remaining 2.9 f/cc were fibrous talc. 14 109 107 68 64 48 25 9 7 1 1 1 Anthophyllite Tremolite Unspecified fiber Talc fiber Chrysotile Asbestos Antigorite Amphibole Richterite Sillicate Serpentine 52 429 171 Positive tests by type of sample Ore Processed talc used in products Consumer powder 105 10 92 5 1 2 2 2 37 58 4 13 6 43 2 2 1 2 43 15 44 87 3 2 4 9 86 15 0 50 100 150 200 250 Colgate Cyprus/Luzenac… Eastern Magnesia J&J Johns-Manville Mennen Pfizer RTV Sierra WCD Windsor, Inc. Asbestos fibers Unspecified fiber Unspecified asbestos form Positive tests by companies 2 5 10 2 18 *103 19 8 5 1 1 15 11 2 12 2 3 21 7 7 9 11 4 7 27 11 17 9 6 0 10 20 30 40 50 60 Argonaut California Englehard Gassets Grantham Hammondsville Montana Val Chisone Vermont West Windsor Positive tests by mines & mills *Rescaled for better illustration Positive tests by mineral References 1.Dana, E., A Textbook of Mineralogy With an Extended Treatise on Crystallography and Physical Mineralogy. 1898, New York: John Wiley & Sons. 2. Veblen, D.R. and C.W. Burnham, New biopyriboles from Chester, Vermont; I, Descriptive mineralogy. American Mineralogist, 1978. 63(9-10): p. 1000-9. 3. Veblen, D.R. and C.W. Burnham, New biopyriboles from Chester, Vermont: II. The crystal chemistry of jimthompsonite, clinojimthompsonite, and chesterite, and the amphibole-mica reaction. American Mineralogist, 1978. 63(9-10): p. 1053-1073. 4. Wylie, A. and C. Huggins, Characteristics of a Potassium Winchite-Asbestos From the Allamore Talc District, Texas. Canadian Mineralogist, 1980. 18: p. 101-107. 5. Rohl, A., et al., Consumer Talcums and Powders: Mineral and Chemical Characterization. Journal of Toxicology and Environmental Health, 1976. 2: p. 255-284. 6. Rohl, A. and A. Langer, Identification and Quantitation of Asbestos in Talc. Environmental Health Perspectives, 1974. 9: p. 95-109. 7. Cralley, L., et al., Fibrous and Mineral Content of Cosmetic Talcum Products. American Industrial Hygiene Association Journal, 1968. 29(4): p. 350-354. 8. Van Gosen, B., Using the geologic setting of talc deposits as an indicator of amphibole asbestos content. Environmental Geology, 2004. 45: p. 920-939. 9. Cralley, L., et al., Fibrous and Mineral Content of Cosmetic Talcum Products. American Industrial Hygiene Association Journal, 1968. 29(4): p. 350-354. 10. Gross, P., et al., Pulmonary Ferruginous Bodies. Arch. Path., 1968. 85: p. 9. 11. FDA, Asbestos Particles in Food and Drug [21CFR Parts 121, 128, 133]. 1973, Food and Drug Administration: Federal Register. 12. McEwen, G., Letter to Dr. C.W. Jameson, NTP RE: Call for Public Comments on 21 Substances, Mixtures and Exposure Circumstances Proposed for Listing in the Report on Carcinogens, Twelfth Edition (69 Federal Register 28940): Cosmetic Talc. 2004. 13. Dement, J., P. Shuler, and R. Zumwalde, Preliminary Report: Fiber Exposure During Use of Baby Powders. 1972, NIOSH Environmental Investigations Branch. 14. Gordon, R., S. Fitzgerald, and J. Millette, Asbestos in commercial cosmetic talcum powder as a cause of mesothelioma in women. International Journal of Occupational and Environmental Health, 2014. 20(4): p. 318-332. 15. Exhibit to Deposition of Dr. John Hopkins. August 15-18, 2017. 16. McCrone, W., Letter to FDA Hearing Clerk Re: Test Methods for Asbestos in Talc. 1973. 17. Lewin, S., Letter to WCD, X-Ray Diffraction Analysis For Asbestos in Talc No. 1621 Lo Micron. 1972. p. WCD002448 - WCD002465. 18. Hutchinson, T., INVESTIGATION OF POSSIBLE ASBESTOS CONTAMINATIONS IN TALC SAMPLES . 1972. 19. Estrin, N., Letter to Eiermann, H. (FDA) March 15, 1976, CTFA,. 1976. 20. CTFA, CTFA Method J4-1: Asbestiform Amphibole Minerals in Cosmetic Talc. 1976: p. QE-CPC00001142 - QE-CPC00001151. 21. USP, Talc Specifications. 2011, US Pharmocopeia Convention: USP Revision Bulletin - Talc. 22. Deposition of Herbert Ohlmeyer. 2011. 23. Wylie, A.G., et al., The importance of width in asbestos fiber carcinogenicity and its implications for public policy. Am Ind Hyg Assoc J, 1993. 54(5): p. 239-52. 24. CTFA, Minutes: CTFA Task Force on Round Robin Testing of Consumer Talcim [sic] Products for Asbestiform Amphibole Minerals. 1977. 25. Block, L.H., et al. "Modernization of Asbestos Testing in USP Talc,” Stimuli to the Revision Process. U.S. Pharmacopeia. 2014. 26. Johnson & Johnsons. 5 Important Facts about the Safety of our Talc. https://www.jnj.com/our-products/5-important-facts-about-the-safety-of-talc Accessed 11/1/2017. 27. Scala, D., Deposition in Polakow vs. Brenntag North America, Inc., et al. in the Superior Court Of The State Of California For The County Of Los Angeles pg. 341-342. 2016. 28. Hopkins, J., Deposition in Herford vs. AT&T et al. in the Superior Court Of The State Of California For The County Of Los Angeles pg 42-57. 2017. 29. Virta, R. L. The Phase Relationship of Talc and Amphiboles in a Fibrous Talc Sample. Bureau of Mines Report of Investigations. 1985. Conclusions Presence of asbestos in consumer talc products: Evaluating a “zero tolerance” policy 1 Never Again Consulting; 2 Brown University, Providence, RI; 3 Against Method Consulting; 4 Clinical Professor Family Medicine Alpert School of Medicine at Brown University, Attleboro, MA, [email protected] Joan Steffen 1 , Triet Tran 2 , Ella Fassler 3 , David S. Egilman MD, MPH 4