Document zQDKy5b1q7dZn7o52BQZYXrpm

FILE NAME Talc TALC DATE 2020 Oct DOC TALC311 DOCUMENT DESCRIPTION Article - Asbestos Contamination in TalcBased Cosmetics An Invisible Cancer Risk fiCheck for updates Asbestos Contamination in Based Cosmetics An Invisible Cancer Risk Tasha Stoiber,,Sean Fitzgeraldand Nneka S Leiba,, Environmental Working Group Washington DC USA 2Scientific Analytical Institute Greensboro NC USA Environmental Health Insights Volume 14 1-3 'The Author 2020 Article reuse guidelines sagepub.com/journals-permissions DOI 1178630220976558 1178630220976558 SAGE ABSTRACT The lack of regulation and adequate testing of containing personal care products in the U.S. has resulted in the contamination of cosmetics with asbestos As such the true exposure of consumers to asbestos is poorly characterized and likely underestimated In this study transmission electron microscopy analysis revealed that 3 of 21 powder cosmetic products tested were contaminated with amphibole asbestos One of these contaminated products is expressly marketed for use by children The presence of asbestos found in products demonstrates the urgency to revise cosmetics policy Further based cosmetics may be an overlooked and difficult to characterize source of exposure to asbestos a known carcinogen KEYWORDS Asbestos talc personal care products cancer risk RECEIVED October 27 2020. ACCEPTED October 30 2020 TYPE Rapid Communication FUNDING The author disclosed receipt of the following financial support for the research authorship and publication of this article Laboratory testing commissioned by EWG was supported by a grant from Yellow Chair Foundation United States DECLARATION OF CONFLICTING INTERESTS The author declared the following potential conflicts of interest with respect to the research authorship and publication of this article The authors declare that there is no conflict of interest Sean Fitzgerald has been retained by plaintiff and defense firms as a testifying expert in matters implicating asbestos and talc in personal injury CORRESPONDING AUTHOR Tasha Stoiber Environmental Working Group 1436 U Street NW Suite 100 Washington DC 20009 USA Email tstoiber@ewg.org tstoiber@ewg.org Talc is a mineral ingredient that has been used in personal care products for decades The mineral can be used to improve the texture and feel of products to absorb moisture or as an inexpensive filler Because of how and where talc is mined mineral deposits used for manufacturing products sold in the US are consistently found to be contaminated with amphibole asbestos such as tremolite and anthophyllite.,,Asbestos is a carcinogen and it is known that there is no safe level of exposure to asbestos.2 A recent survey of the Environmental Working Group's Skin Deep Database identified more than 2000 personal care products sold in the last 3 years 2018-2020 that contain talc. The products include eye shadow foundation blush face and body powders Some of these products are in the form of liquid and creams but 57 are powder products that pose an increased risk of inhalation hazards In 1976 the Cosmetic Toiletry and Fragrance Association CTFA developed specifications for cosmetic talc purity including detection of asbestos to differentiate from industrial uses However talc mined for both cosmetic use or industrial use comes from the same sources and carries the same risk of potential contamination.5 Yet the U.S. FDA does not require mandatory testing of talc supplies The voluntary testing method included in the cosmetic talc specification CTFA or the CTFA method for Asbestiform Amphibole Minerals in Cosmetic Talc specifies ray diffraction XRD to screen asbestos which lacks adequate sensitivity and specificity to screen for asbestos when compared to electron copy based methods for example To highlight the infectiveness of current voluntary screening methods and to investigate the occurrence of asbestos in containing cosmetics products we analyzed 21 based cosmetics products Table 1 The products were purchased in retail stores in San Francisco California and Washington DC and from an online retailer Samples were analyzed using Transmission Electron Microscopy TEM following procedures described in the U.S. Environmental Protection Agency Test Method EPA Quantification of asbestos structures per gram weight talc was conducted using TEM and as described in the Asbestos Hazard Emergency Response Act AHERA and Millette.7 Tremolite asbestos was detected in 3 of21 products tested eye shadow palettes and 1 toy make kit Additionally actinolite asbestos was also detected in one of the eye shadow palettes All 3 products were purchased from a large online retailer In the toy make kit 1 shadow was positive out of 3 shades tested In the 2 palettes 20 and 40 of the eyeshadow colors tested contained asbestos Table 2 In this small sample set 14 of products tested positive for asbestos Similarly in an FDA investigation in 2019,9 2019,9 containing asbestos products out of 52 tested were found to be contaminated with asbestos as identified by polarized light microscopy PLM and transmission electron microscopy TEM analytical methods While the FDA issued 3 warnings in 2019 to consumers regarding the positive products the agency does not have the authority to issue mandatory product recalls and instead worked with the companies to voluntarily remove products from the market The limited testing and voluntarily action do little to address the numerous other products that continue to pose a significant risk The prevalence of contamination underscores the urgency to develop standard screening methods and regulate talc used in cosmetic products The FDA does not currently require manufacturers to use any one standard method for screening however the agency NC Creative Commons Non Commercial CC NC This article is distributed under the terms of the Creative Commons Attribution NonCommercial 4.0 License https://creativecommons.org/licenses/by-nc/4.0/ which permits commercial use reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages https://us.sagepub.com/en-us/nam/open-access-at-sage Environmental Health Insights recently formed an interagency working group to address the issue The working group has recommended the adoption of a consistent term EMP or elongated mineral particle with a minimum length to width ratio of 3 and using TEM in addition to polarized light microscopy PLM to resolve the issues of sensitivity that cause reporting of false negatives for EMPs Standard methods for both PLM TEM analysis are documented in EPA's Method for Determination of Asbestos in Bulk Building materials published in 1993.6 Additionally standard methods ISO10312 and ASTM D6281 for TEM analysis were both published in the late 1990s These methods however were designed to determine asbestos presence where it was intentionally added at levels % in the manufacturing process rather than where other Table 1. Categories of cosmetics tested CATEGORY Toy make kits Eye shadow palettes Face powder Body powder Blush Contouring palette Total NO OF PRODUCTS TESTED 7 7 3 2 1 1 21 mineral resources such as talc were potentially contaminated naturally Individual asbestos fibers especially those that can naturally occur in and with talc can remain elusive by these standardized bulk building material methods Since there is currently no one method that can be followed as written for testing asbestos in consumer products the development of a sensitive cosmetic method that routinely employs TEM is critical Table 3 Asbestos exposure is linked to numerous diseases includ- ing asbestosis lung and ovarian cancer and mesothelioma The recurrent presence of asbestos in cosmetics represents a harmful exposure that may cause potential harm to consumers Applying powder makeup containing asbestos to the face is an inhalation risk The FDA requires cosmetics to be safe yet does not specify how inhalation exposure should be assessed Further given an invisible hazard and long latency to disease it is difficult to track and characterize this type of exposure in the population Studies have shown that over 60 or greater of mesothelioma cases in women are likely attributable to occupational asbestos expo12,13 Baumann and Carbone14 found that in examining data from 1999 to 2010 mesothelioma mortality rates decreased for men in accordance with the decreased occu- pational exposure but for women the rate remained the stable suggesting cases due to causes other than occupational exposure Rates remained greater for men overall compared to women but in populations under 50 the rates were similar Despite declining use of asbestos in the U.S. mesothelioma deaths remain substantial especially among younger Table 2. Three of 21 products tested were positive for tremolite asbestos Actinolite asbestos was also detected in eye shadow palette 2 CATEGORY Toy make kit Eye shadow palette # Eye shadow palette 2 NO OF SUBSAMPLES POSITIVE AND NO OF SUBSAMPLES TESTED 1 of 3 5 of 25t 18 of 45t QUANTITATION OF ASBESTOS STRUCTURES 4.33 and 4.67 million amphibole asbestos 2.25 to 3.57 million amphibole asbestos 1.49 to 3.86 million amphibole asbestos PERCENTAGE OF ASBESTOS IN PRODUCT % 0.0004-0.0005 0.0002-0.0004 0.0001-0.0004 ASBESTOS CONCENTRATION PPM 4.3-4.6 2.2-3.5 1.5-3.8 Three of 8 total powder shadow colors were tested in a product make kit Twenty of 63 and 45 of 120 of total powder shadow colors were tested from palettes # Two samples from the 1 containing shadow color were quantitated and 2 respectively SA maximum and minimum was reported from quantitation of 3 separate containing colors Parts per million and percentage calculations based on assuming average fiber dimensions of length of 5 ...mwidth of 0.25...mand the specific gravity of tremolite 3.15 Table 3. Analytical methods to screen talc for asbestos METHOD ADVANTAGES ray Diffraction XRD Rapid screening technique Polarized Light Microscopy PLM Transmission Electron Microscopy TEM Standard method for identification of asbestos Most sensitive method to identify asbestos DISADVANTAGES Lacks adequate sensitivity and specificity to screen for asbestos and should be used along with more sensitive methods May lack sensitivity for some materials that contain a low percentage of asbestos should be used in tandem with TEM consuming sample preparation more expensive comparatively Stoiber et al populations underlining the importance of preventing exposure from all potential sources The aim of this study was to assess asbestos contamination in based cosmetics and to call attention to the outdated methods for screening as well as bring awareness to the potential hazard in cosmetics With nearly 15 of products contaminated in a small study methods used by industries to screen talc supplies are not adequate Acknowledgements The authors gratefully acknowledge the help of their colleagues Olga V. Naidenko David Q. Andrews Alexis M. Temkin and Sydney Evans for assistance with technical review of the manuscript Carla Burns is acknowledged for product sample collection Author Contribution All authors made substantial contributions to the manuscript TS project administration conceptualization collection of samples original draft writing and editing SF conceptualization laboratory resources laboratory analysis data validation study images original draft writingreview and editing NSL supervision conceptualization writoriginal draft writing and editing All authors checked and accepted the final manuscript Supplemental material Supplemental material for this article is available online REFERENCES 1. Van Gosen BS Lowers HA Sutley SJ Gent CA. Using the geologic setting of talc deposits as an indicator of amphibole asbestos content Environ Geol 920-939 National Institute for Occupational Safety and Health Workplace Exposure to Asbestos Review and Recommendations U.S Department of Health and Human Services 1980 EWG Skin Deep Database 2020. Accessed May 2020. https://www.ewg.org/ skindeep Cosmetics Fragrance and Toiletry Association The Cosmetics Fragrance and Toi- letry Association CTFA CTFA Specifications - Tale & Cosmetic Talc 1976. repository.libray.brown.edu/studio/item/bdr:84176/ tory.library.brown.edu/studio/item/bdr:841476/tory.library.brown.edu/studio/item/bdr:841476/ Tran TH Steffen JE Clancy KM Bird T Egilman DS Talc Asbestos and Epidemiology corporate influence and scientific incognizance Epidemiology 783-788 U.S. Environmental Protection Agency Test Method Methodfor Detemination of Asbestos in Bulk Building Materials EPA 1993 MilletJeR Procedure for the analysis of talc for asbestos Microscope 11-20 FDA Releases Data from Agency's Year Long Sampling Assignment Containing Cosmetic Products for the Presence of Asbestos press release 2020 U.S. Food and Drug Administration Interagency Working Group on Asbestos in Consumer Products Preliminary Recommendations on Testing Methods for Asbestos in Talc and Consumer Products Containing Tale 2020 10 Luberto F Ferrante D Silvestri S et al Cumulative asbestos exposure and mortality from asbestos related diseases in a pooled analysis of 21 asbestos cement cohorts in Italy Environ Health 2019 11. Steiling W Almeida JF Assaf Vandecasteele H et al Principles for the safety evaluation of cosmetic powders Toxicol Lett 2018 12. Lacourt A Gramond C Rolland P et al Occupational and occupational attributable risk of asbestos exposure for malignant pleural mesothelioma Thorax 2014 13 Rake C Gilham C Hatch J Darnton A Hodgson J Peto J. Occupational domestic and environmental mesothelioma risks in the British population a control study BrJ Cancer 1175-1183 14 Baumann F Carbone M. Environmental risk of mesothelioma in the United States an emerging epidemiological issuesJ Toxicol Environ Health B Crit Rev. 231-249 15. Mazurek JM Syamlal G Wood JM Hendricks SA Weston A. Malignant mesothelioma mortality - United States 1999-2015 MMWR Morb Mortal Wkly Rep 214-218