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& U Z P fl< IC July 16, 2004 JUL I 9 20M Dr. C. W. Jameson National Toxicology Program Report on Carcinogens Bldg. 4401, Rm. 3118 79 T. W. Alexander Drive P.O. Box 12233 Research Triangle Park, NC 27709 Re: Comments on the talc nominations for the 12th RoC Dear Dr. Jameson: Luzenac America appreciates the opportunity to comment on the talc nominations for the 12th RoC review. Executive Summary Luzenac America sharply objects to the talc nomination of "Occupational exposure to talc" on the basis that the NIEHS rational for nomination, "Human epidemiological studies reporting an increase [sic] risk o f cancer among workers exposed to talc," 1is unsupported by the literature. In reviewing talc for possible listing in the 10th RoC, a review of the occupational exposure literature led to the following conclusions in the talc Background Document (BD): "In the light o f these findings, the evidence from studies o f occupational exposure to non-asbestos-containing talc is not sufficient to support a conclusion that thisform o f talc is carcinogenic. "12 "The current data indicate that inhaled non-asbestiform talc is unlikely to pose a cancer risk to humans under exposure conditions that do not impair clearance mechanisms or cause chronic lung toxicity. "3 These conclusions in the BD are further supported by results in two recently published studies by Wild et al. (2002) and Coggiola et al. (2003) of European talc miners and millers (see complete citations and summaries in Comments). The analysis of French, Austrian, and Italian talc workers constitutes the largest study groups exposed to talc not containing asbestos and the largest data record base in the world. Both studies concluded that there is no significant excess of lung cancer or excess of any other type of cancer amongst these populations. Similarly, pleural or peritoneal mesothelioma, known to be related to asbestos mineral exposure, was not found. 169 FR 28940,28944, May 19,2004 2 at 29. 3 at 71-72. 1 of 14 PLAINTIFFS EXHIBIT CAM-214 Clearly, the nomination of "Occupational exposure to talc" is unwarranted and we assert that the nomination must be withdrawn. Luzenac also protests the nomination category of "Cosmetic talc" on the basis that it fails to provide a clear and specific definition of the substance. (1) The nomination category does not utilize the scientific definition as reflected by the CAS Registry number and definition for talc that precludes the presence of asbestos. (2) The nomination does not reference the commercial definition of talc used in cosmetic products as promulgated by the Cosmetic, Toiletry and Fragrance Association (CTFA) which also precludes the presence of asbestos. (3) The nomination category is overly broad and would be understood by the layperson to encompass all cosmetic products containing talc, when in fact, it appears that the intent of the Agency is to focus only on a potential increased risk of ovarian cancer among women utilizing body powder products in a particular manner. Clarification of this nomination category is absolutely essential in order to allow for an accurate, scientific review of the literature to purge studies not based upon a "clear definition o f the agent or agents involved in human exposures. " 4 Comments Luzenac America is a leading producer of high quality talc products and we presently account for over 50% o f the talc mined and milled in the United States. All the talc products sold by Luzenac are asbestos-free5 and contain less than 1% crystalline silica. Naturally, the National Toxicology Program's (NTP) nominations for the 12th RoC listing o f "talc" in the form o f "Occupational exposure to talc" and "Cosmetic talc" are o f great concern to Luzenac and the talc industry worldwide. As such, Luzenac submits to NTP the following objections to these talc nominations in order to allow NTP the opportunity to withdraw or amend the nominations and re-evaluate their merit for formal consideration. 4NTP website - Rational for talc deferral decision: "The NTP decided to defer consideration o f listing talc in the 10th RoC and a careful review of the literature on these materials is underway to determine if a clear definition o f the agent or agents involved in human exposures can be developed." (emphasis added) 5 Luzenac America Product Statement: "Luzenac talc does not contain asbestos as defined by the United States Occupational Safety and Health Administration (OSHA), the European Directive 83/477/EEC, and the American Congress o f Governmental Industrial Hygienists (ACGIH) when analyzed by X-ray Diffraction, Polarized Light Microscopy, or Transmission Electron Microscopy. This statement is based upon verification by certified, independent laboratories." This certification is provided to our customers. 2 of 14 The nomination for review of "Occupational exposure to talc" is unwarranted given that this exposure issue was thoroughly examined during the 10th RoC review on talc. A review of the occupational exposure literature available at that time led to the following conclusion in the talc BD: "In the light o f these findings, the evidence from studies o f occupational exposure to non-asbestos-containing talc is not sufficient to support a conclusion that thisform o f talc is carcinogenic. " 67 "The current data indicate that inhaled non-asbestiform talc is unlikely to pose a cancer risk to humans under exposure conditions that do not impair clearance mechanisms or cause chronic lung toxicity. " 1 Additionally, RG1, RG2, and the Board of Scientific Counselors Subcommittee did not find sufficient evidence to conclude that occupational exposure to "talc not containing asbestos" is carcinogenic. That consensus is further bolstered by the results reported in two recently published studies. (/) Wild P, Leodolter K, Rdfregier M, Schmidt H, Zidek T, Haidinger G. 2002. A cohort mortality and nested case-control study of French and Austrian talc workers. Occup Environ Med 59:0-7. Two historical cohorts were set up comprising all male subjects who had been working continuously for at least 1 year in a series of talc producing companies in France and Austria. The French cohort consisted of those employed at a site in the French Pyrenees and working between 1945 and 1994. The Austrian cohort consisted of the workers employed between 1972 and 1995 in one of four industrial sites in the Austrian Alps. Two nested case-control studies focusing on non-malignant and malignant respiratory diseases were set up to estimate possible dose-response relations with cumulative exposure to talc dust based on an industry specific job exposure matrix.. () Coggiola M, Bosio D, Pira E, Piolatto PG, La Vecchia C, Negri E, Michelazzi M, Bacaloni A. 2003. An Update of a m ortality study of talc miners and millers in Italy. Am JIn d M ed ; 44 (1) 63-9. The cohort was comprised o f 1,795 men who had worked for at least 1 year in the mine and/or in the factory between 1946 and 1995 Collectively, these investigations represent the largest study groups exposed to talc not containing asbestos and the largest data record base in the world. Both studies conclude that there is no significant excess of lung cancer or excess of any other type of cancer amongst these populations. Similarly, pleural or peritoneal mesothelioma, known to be related to asbestos mineral exposure, was not found. As there would be no rational in reviewing "Occupational exposure to talc containing asbestos" given that asbestos is already listed in the RoC as a known human carcinogen, we see no justification for continuing this line of investigation. Given the past health and safety concerns 6 Supra n.2. 7Supra n.3. 3 of 14 expressed by our employees and customers concurrent with the 10th RoC talc review, we were pleased to reassure them that NTP review groups were unanimous in their opinion that occupational exposure to "talc not containing asbestos" was unlikely to pose a cancer risk. Yet remarkably, less than four years later, we are once again having to counsel with our stakeholders on this very same issue. We believe that it is time for NTP to remove the unwarranted and damaging suspicion surrounding "Occupational exposure to talc" and withdraw the nomination. Luzenac also protests the nomination category of "Cosmetic talc" on the basis that it fails to provide a clear and specific definition of the substance. (1) The nomination category does not utilize the scientific definition as reflected by the CAS Registry number and definition for talc that precludes the presence of asbestos. (2) The nomination does not reference the commercial definition of talc used in cosmetic products as promulgated by the CTFA that also precludes the presence of asbestos. (3) The nomination category is overly broad and would be understood by the layperson to encompass all cosmetic products containing talc, when in fact it appears that the intent of the Agency is to focus only on a potential increased risk of ovarian cancer among women utilizing body powder products in a particular manner. Clarification of this nomination category is absolutely essential in order to allow for an accurate, scientific review of the literature to purge studies not based upon a "clear definition o f the agent or agents involved in human exposures", 8 and to allow for an objective, scientific review of the talc mineral itself. The CTFA currently defines talc utilized for cosmetics purposes as follows: DEFINITION: Talc is an essentially white, odorless, fine powder which is ground from naturally occurring rock ore. It consists of a minimum of 90% hydrated magnesium silicate, with the remainder consisting of naturally associated minerals such as calcite, chlorite, dolomite, kaolin, and magnesite, and containing no detectablefibrous, asbestos minerals ." 9(emphasis added) The CTFA definition of talc utilized for cosmetic purposes (re: "cosmetic talc") was amended on October 7, 1976 to include the criteria "no detectable fibrous, asbestos minerals." Additionally, the CTFA cosmetic talc specification was amended to include a specification ("None detected") and test method (CTFA J4-1) for certifying the absence of asbestos in cosmetic talc.10 These 8NTP website - Rational for talc deferral decision: "The NTP decided to defer consideration of listing talc in the 10th RoC and a careful review o f the literature on these materials is underway to determine if a clear definition o f the agent or agents involved in human exposures can be developed." (emphasis added) 9 CTFA Specification, Talc (no date). Attachment la 10CTFA Specification, 10-7-76, "Talc Cosmetic", Attachment lb. 4 o f 14 definitional changes were promulgated as a result of two studies, one in 196811 and one in 1976,12134 which reported finding fibrous-like materials and asbestos in some off-the-shelf consumer body powder talc products. In the latter study, half the brands had asbestos ranging from two to 20 percent. Id. This occurred at a time when evidence was accumulating concerning the human carcinogenicity of asbestos and thus the findings generated considerable press coverage and public concern.13,14 These actions by CTFA and its member companies assured the U.S. Food and Drug Administration and the public at large that exposure to cosmetic talcs (post 1976) would no longer carry the risks associated with exposure to asbestos. Luzenac also protests the nomination category of "Cosmetic talc" on the basis that it lacks clarity and is misleading to the layperson. Talc is utilized in a multitude of personal care products. This wide diversity of talc usage was acknowledged in the 10thRoC talc BD: "Talc is used in several types o f cosmetic formulations. Solid-matrix formulations include antiperspirants, lipstick, and concealing makeup. Semi-solid-matrix formulations include blushes, eyeshadows, pressed finishing powders, and base powders. Liquid-matrix formulations include cream and liquid makeups, moisturizing creams, and lotions. Loose matrix products include foot, body, and baby powders, where talc is used to carryfragrances (Zazenski et al. 1995). Current databases indicate that about 2,000 products containing talc, in some 45 different cosmetic product categories, were voluntarily registered with the U.S. Food and Drug Administration (FDA). Categories o f cosmetic products that contain talc include baby products (baby lotions, oils, powders, and creams), generic powders, blushers, face powders and foundations, men's talcum products, andfoot powders (Gilbertson 1995). " 1516 A potential listing of "Cosmetic talc" by the Agency based upon the NIEHS nomination rational of "Human epidemiological studies reporting an increased risk o f ovarian cancer among women using talc for personal use" 16 would unreasonably preclude the use of talc in all cosmetic products. Additionally, such a listing would generate health concerns amongst the general public regarding lifetime exposures to all cosmetic products which contained talc. 11Cralley LJ, Key MM, Groth DH, Lainhart WS, and Ligo RM. 1968. Fibrous and mineral content o f cosmetic talcum products. Am IndH yg Assoc J 2 9 (4): 350-54. 12 Rohl AN, Langer AM, SelikofF IJ, Tordini A, Klimentidis R, Bowes DR, and Skinner DL. 1976. Consumer talcums and powders: Mineral and chemical characterization. J Toxicol Environ Health 2 (2): 255-84. 13 Washington Post, March 8, 1976, "Asbestos Fibers Found in Baby Powder", Attachment 2. 14New York Times, March 10,1976, "Asbestos Found in Ten Powders", Attachment 3. 15 at 10. 1669 FR 28940,28944, May 19,2004 5 of 14 Clarification of this nomination category is absolutely essential in order to allow for an accurate, scientific review of the literature to purge studies not based on a "clear definition o f the agent or agents involved in human exposure. " We bring to the attention of NTP two recently published papers which specifically address the issue of the carcinogenic potential (lack thereof) of cosmetic talc. (0 Huncharek, M, Geschwind, J.F., and Kupelnick, B. 2003. Perineal application of cosmetic talc and risk of invasive epithelial ovarian cancer: a meta-analysis of 11,933 subjects from sixteen observational studies. Anticancer Research 23: 1955-60. A meta-analysis o f epidemiology studies o f perineal application o f talc and ovarian cancer was published in 2003. The analysis included sixteen observational studies and concluded that the "available observational data do not support the existence of a causal relationship between perineal talc exposure and an increased risk of epithelial ovarian cancer. Selection bias and uncontrolled confounding may account for the positive associations seen in prior epidemiological studies." (it) Wehner AP. 2002. Cosmetic talc should not be listed as a carcinogen: Comments on NTP's deliberations to list talc as a carcinogen. Reg Tox Pharm 36:40-50. Talc is not genotoxic, is not carcinogenic when injected into ovaries of rats, does not cause cancer decades after pleurodesis, and induces apoptosis in vitro in human mesothelioma cells but not in normal mesothelial cells. There is no credible evidence of a cancer risk from inhalation o f cosmetic talc by humans. Considering talc a carcinogen lacks convincing scientific documentation. Background Information The following information is provided to NTP in the event another Background Document is deemed necessary: Talc Identification Production and Mining Occupational Exposure Asbestos Association - An Historical Perspective Recommended Topics for Review Talc Identification Talc (CAS Registry Number 14807-96-6) has a specific mineralogical definition with some commercial distinctions. Mineralogically, talc is a hydrated magnesium sheet silicate with the chemical formula Mg3 SLt Oio (OH)2. Its elementary sheet is composed of a layer of magnesium-oxygen/hydroxyl octahedra, sandwiched between two layers of silicon-oxygen tetrahedra. The main or basal surfaces of this elementary sheet do not contain hydroxyl groups or active ions, which explains talc's hydrophobicity and inertness. Talc is practically insoluble in water and in weak acids and alkalis.17 17Luzenac website "Luzenac.com." All About Talc. 6 of 14 Talc crystalline structure Id. Commercially, talc products include "industrial" grades and "cosmetic" grades. Industrial grade talc products can vary considerably in actual talc content, from below 50% up to and including 99+% talc. The non-talc components of industrial talc products typically include dolomite (MgCa2CC>3), calcite (CaCC^), magnesite (MgCC>3), chlorite (3Mg04Si02*H20), quartz (SiC^), and occasionally serpentines and amphiboles. Product specifications for industrial talc products are application oriented and are generally established by market and customer requirements. Specifications typically establish parameters for particle size and whiteness. Since the mid-1970's there has been an ever increasing demand for supplier "certifications" that the talc is asbestos-free.18 In recent years, these customer requests for certifications have been expanded to include that the talc not contain detectable levels of crystalline silica (0.1% ). Talc specifications for cosmetic applications are issued by the CTFA. The CTFA specification focuses on the purity of the talc. Additional product parameters are generally specified by the customer. The CTFA talc specification includes the requirement that the product does not contain asbestos. Talc utilized in cosmetic and personal care products normally contain greater than 90% talc and most present-day consumer products contain 96-99+% talc. Production and Mining For 2003, the United States Geological Survey (USGS) estimates domestic talc production of approximately 900,000 short tons (STN) and an apparent consumption of talc at just under 1,000,000 STN.19 USGS estimates that industrial talc usage (paint, paper, ceramic, plastics, etc.) accounted for over 97% of this consumption with cosmetic usage at less than 3%. Id. In mineralogical terms, Luzenac estimates that the approximate 1,000,000 STN domestic talc market can be classified into three general categories: High purity talc (95-99+% mineral talc) Talc/carbonate (60-85% mineral talc) Tremolitic talc (20-35% mineral talc) 650 - 700,000 STN 200 - 250,000 STN 100 - 120,000 STN The "high purity talc" is produced by beneficiating talc ore that contains other naturally occurring non-talc minerals (e.g., carbonates). The beneficiation process may include hand- 18 See footnote 5, supra. 19U.S. Geological Survey, Mineral Commodity Summaries, January 2004. Talc and Pyrophyllite. At 164. 7 of 14 f ^ 4 u s ld t sorting, mechanical sorting, or froth flotation.2021 The "talc/carbonate" and "tremolitic talc" products are produced from talc ore that receive minimal beneficiation. Talc mines located in Montana, Vermont, Texas, and New York accounted for virtually all of the domestic production. All of the mines are surface, open-pit operations. The soft talc rock is easily extracted with hydraulic shovels from open pit mining operations. I f high purity talc products are required, the ore is beneftciated. 21 Occupational Exposure According to the USGS, approximately 500 U.S. workers were engaged in talc mining and milling in 2003, producing approximately 900,000 STN of product. This is down from almost 700 workers in 1999 when approximately 1,000,000 STN were produced. Id. According to the National Occupational Exposure Survey conducted from 1980 to 1983, approximately 19,000 workers were potentially exposed to talc. 22 However, due to the age of the survey, substantial productivity gains, advancements in product handling, and a determined industrial and regulatory effort to reduce airborne dust exposure in the workplace, Luzenac estimates that a current exposure survey would likely yield an exposure number less than half of the survey figure conducted over 20 years ago. For a historical perspective, talc consumption in 1982 was approximately 850,000 STN.23 20Zazenski R, Ashton WH, Briggs D, Chudkowski M, Kelse JW, MacEachem L, McCarthy EF, Nordhauser MA, Roddy MT, and Teetsel NM. 1995. Talc: occurrence, characterization, and consumer applications. Regul Toxicol Pharmacol 21:218-29. 21 See footnote 17, supra. 22 U.S.EPA. 1992. Health Assessment Document for Talc. EPA 600/8-91/217 Research Triangle Park, NC, Environmental Criteria and Assessment Office, U.S. Environmental Protection Agency. 23 Luzenac internal report. 1993. North American Talc Demand Forecast. Prepared by Kline and Company. 8 of 14 Asbestos Association - An Historical Perspective The ongoing, incorrect perception by many that talc contains asbestos does have an historical basis in fact. Prior to the time when evidence was accumulating concerning the human carcinogenicity of asbestos, many commercial types of talc mined around the world did contain one or more of the six minerals eventually regulated as asbestos.24 These minerals were natural contaminants in the talc deposits. In 1972, the regulatory and commercial landscape for talc began a protracted change when OSHA published its first regulations concerning worker exposure to asbestos.25 The regulations defined asbestos as being one of the six minerals, chrysotile, crocidolite, amosite, actinolite, tremolite, and anthophyllite. These regulations were eventually revised in 199226 to properly distinguish the natural asbestos forms (re: "asbestiform") of actinolite, tremolite, and anthophyllite from the non-carcinogenic, non-asbestiform varieties of these same minerals.27 In 1976, body and baby powders containing talc became the focus of attention when a published study reportedly found asbestos in ten of 19 body and baby powders. Responding to concerns from both the public as well as regulators the CTFA amended their definition of cosmetic talc to include the criteria "no detectable fibrous, asbestos minerals." Additionally, the CTFA cosmetic talc specification was modified to include a specification ("None detected") and a newly developed test method (CTFA J4-1) for certifying the absence of asbestos in cosmetic talc. As concerns over the potential health effects of asbestos began to emerge, various agencies and organizations found it necessary to distinguish the category of talc "not containing asbestos" from talc "containing asbestos." Presently, this talc differentiation is incorporated into regulations, recommendations, reports, health summaries, and specifications published by the following organizations: American Congress of Governmental Industrial Hygienists (ACGIH) National Institute of Occupational Safety and Health (NIOSH) Occupational Safety and Health Administration (OSHA) International Agency for Research on Cancer (IARC) Cosmetic, Toiletry, and Fragrance Association (CTFA) Food Chemical Codex (FCC) California Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop 65) International Programme on Chemical Safety (IPCS) International Labour Organization (ILO) International Chemical Safety Cards (WHO/IPCS/ILO) 24 IARC. 1987a. Talc. IARC Monographs on the Evaluation o f Carcinogenic Risks to Humans. 42: 185-224 Lyon, France, International Agency for Research on Cancer 25 FR 37:11318 26 FR 57:24310 27Zazenski RJ. 1998. The commercial significance o f talc. Comments Toxicol, Special Issue on Talc 6(5):313-26 9 o f 14 T a b le 1. Sum m ary o fp u b lish e d specifications f o r talc "co ntaining" a n d "no t containing asbestos. " Organization Specification Remarks ACGIH Talc containing no asbestos fibers - TLV-TWA, 2 mg/m3, A4 - Not Classifiable as a Human Respirable particulate fraction. Carcinogen ft******************************************** Talc containing asbestos fibers - TLV-TWA, Use asbestos TLV; however, should not exceed 2 mg/m3, respirable particulate fraction "Evidence is ample that the dust or particulate of non-fibrous talc, consisting almost entirely of platiform talc crystals and containing no asbestos, carries a relatively small respiratory hazard for exposed workers." ******************************* A l -Confirmed Human Carcinogen. NIOSH Talc (containing no asbestos and less than 1% quartz) - TWA 2 mg/m3 (respirable dust) Symptoms: Fibrotic pneumoconiosis; irritation eyes OSHA TABLE Z-l LIMITS FOR AIR CONTAMINANTS It should be noted that OSHA Talc (containing asbestos): use asbestos limit: see 29 CFR proposed adopting the ACGIH TLV 1910.1001 of 2mg/m3 in the 1989 Final Rule on Talc (containing no asbestos), respirable dust: see Table ! Air Contaminants (54FR2332 et. Z-3 seq.). The U.S. Circuit Court of *********************************************** ; Appeals remanded this rule and the TABLE Z-3 MINERAL DUSTS Talc (not containing asbestos): 20 mppcf limits are not currently in force. Talc (containing asbestos) Use asbestos limit. IARC Talc not containing asbestiform fibres is not classifiable as to its carcinogenicity to humans (Group 3). ********************************************* Talc containing asbestiform fibres is carcinogenic to humans (Group 1). ; CTFA FCC Specification: Fibrous Amphibole (Asbestiform Tremolite et al) - "None detected" Talc Definition: "Talc is...and containing no detectable fibrous, asbestos minerals." Talc derived from deposits that are known to contain associated asbestiform minerals is not food grade. Prop 65 CHEMICALS KNOWN TO THE STATE TO CAUSE CANCER OR REPRODUCTIVE TOXICITY: Talc containing asbestiform fibers. 10 of 14 Listed April 1, 1990 IPCS ILO WHO IPCS ILO Talc (Silica and Fibre Free) - TLV: 2 mg/m3 as TWA Talc (Silica and Fibre Free) - TLV: 2 mg/m3 as TWA Talc (Silica and Fibre Free) - TLV: 2 mg/m3 as TWA The substance may have effects on the lungs, resulting in talc pneumoconiosis. The substance may have effects on the lungs, resulting in talc pneumoconiosis. The substance may have effects on the lungs, resulting in talc pneumoconiosis. Recommended Topics for Review In the event the preparation of another talc Background Document is deemed necessary, Luzenac recommends that it include reviews of talc pleurodesis and "system distribution." Talc Pleurodesis During the 10th RoC review of talc, it was noted by several commenters that the talc BD did not sufficiently address the issue of talc pleurodesis for the treatment of pneumothorax and pleural effusion. Pleurodesis provides a human model for studying direct injection of the pleura with talc and should be included in a comprehensive evaluation of talc pathology. One such study is cited here, but a more thorough literature search and evaluation by knowledgeable experts should be considered for this specific subject. Research Committee o f the British Thoracic Association and the Medical Research Council Pneumoconiosis Unit. 1979. A survey of the long-term effects of talc and kaolin pleurodesis. B rJ D is Chest 73:285-88. In a study specifically devised because o f the suggestion that talc might be carcinogenic, the authors surveyed 199 o f 210 patients who underwent pleurodesis with iodized talc or kaolin 14 to 40 years previously, and found there was no increase in incidence of lung cancer, and no occurrence o f mesotheliomas. 92 of the 210 were treated with talc. Kaolin was included due to its chemical similarity to talc and its propensity for producing pulmonary fibrosis with prolonged and heavy exposure (though no carcinogenic effects had been observed). Systemic Distribution In reviewing the issues of deposition, clearance, and retention of talc not containing asbestos, the 10th RoC talc BD concluded: "Ingested or inhaled non-asbestiform talc particles are unlikely to be absorbed into the systemic circulation and distributed to other parts o f the body. " 28 28 at 71-72. 11 of 14 *1 aum & nac, This conclusion was surprising, and we think in error, given that the BD cited references of Henderson et al. (1975), 9 Pratt et al. (1985)9320 and Werebe et al. (1999).31 We believe a more comprehensive study of the literature on systemic distribution demonstrates a distinct possibility that non-toxic particulates of low-solubility (e.g. talc) can be introduced into the circulatory system by inhalation and ingestion, which in turn can result in systemic distribution with minimal clinical significance. This mechanism offers a plausible explanation for finding microscopic, birfringent particulates deeply embedded in ovarian tumors as well in normal ovarian tissue (removed from breast cancer patients).32 It also offers a credible explanation for finding talc in 100% of the controls (unexposed) in the findings of Heller et al. 33 Given that talc is widely used in food (chewing gum, candy), OTC drugs (antacids), and pharmaceuticals (excipent, tableting, coatings),34 ingestion by consumers is more frequent and widespread than may be apparent if the focus is only on exposure to talc utilized in cosmetic products. The potential for inhalation of ultrafine airborne talc particulates can be stipulated for applications of consumer body and baby powders. A sampling of some of the studies not reviewed by NTP is presented herein, but a more thorough literature search and evaluation by knowledgeable experts should be considered for this specific issue. (/) Abraham JL. 1979. Documentation of environmental particulate exposures in hum ans using SEM and EDXA. Scan Electron Microsc. (2):751-66 (/'/) Lee KP, Trochimowicz HJ, Reinhardt CF. 1985. Transm igration of titanium dioxide (T i02) particles in rats after inhalation exposure. Exp Mol Pathol. Jun;42(3):331-43. (iii) Kringsholm B, Christoffersen P. 1987. The nature and the occurrence of birfringent m aterial in different organs in fatal drug addiction. Forensic Sci Int May-Jun;34(l-2):53-62. (/v) Anani PA, Ribaux C, Gardiol D. 1987. Unusual intestinal talcosis. Am JSurg Pathol N ov;ll(ll):890-4. 29 Henderson WJ, Evans DM, Davies JD, and Griffiths K. 1975. Analysis o f particles in stomach tumours from Japanese males. Environ Res 9:240-249. 30Pratt PC, George MH, Mastin JP, Roggli VL. 1985. Crystalline foreign particulate material in hernia sacs. Hum Pathol Nov; 16( 11): 1141-6. 31 Werebe E, Campos et al. 1999. Systemic distribution of talc after intrapleural administration in rats. Chest Jan. Vol. 115, No. 1, pp. 190-193. 32 Henderson WJ, Joslin CA, Turnbull AC, and Griffiths K. 1971. Talc and carcinoma o f the ovary and cervix. J Obstet Gyngecol Br Commortw 78:226-272. 33 Heller DS, Westhoff C, Gordon RE, and Katz N. 1996a. The relationship between perineal cosmetic talc usage and ovarian talc particle burden. Am J Obstet Gynecol 174:1507-10. 34 See footnote 20, supra. 12 of 14 (v) Takenaka S, Karg E, Roth C, Schulz H, Ziesenis A, Heinzmann U, Schramel P, Heyder J 2001. Pulmonary and systemic distribution of inhaled ultafine silver particles in rats. En Health Perspect. Aug: 109 Suppl 4:547-51 (v/) Oberdorster G. 2001. Pulm onary effects of inhaled ultrafine particles. Int Arch Occup Environ Health. Jan:74(l):l-9 In conclusion: 1. The nomination of "Occupational exposure to talc" is unwarranted and we assert that the nomination be withdrawn. 2. The nomination category of "Cosmetic talc" is seriously flawed because it fails to provide a clear and specific definition of the substance. Additionally, it is overly broad and is misleading to the layperson. 3. Should it be deemed necessary to prepare another talc Background Document, we recommend it should incorporate reviews of talc pleurodesis and systemic distribution. We regard these issues and recommendations of great consequence and trust they will receive careful attention. Respectfully, [Redacted] Daniel D. Harris President Luzenac America, Inc. 345 Inverness Drive South Centennial, CO 80112 Phone: 303-643-0401 Fax: 303-643-0446 E-mail:dharris@luzenac.com Attachments Luzenac America Inc. 345 Inverness Drive South, Centennial, CO 80112 USA (800) 325-0299 (303) 643-0400 Fax: (303) 643-0446 13 of 14 ATTACHMENTS la, lb, 2, and 3. TOTAL 4 PAGES 14 of 14 July 15,2004 Dr. C. W. Jameson Re: Comments on the talc nominations for the 12th Rrr ATTACHMENT la C7VFv4 Specification . TALC DEFINITIO N: Talc is an essentially white, odorless, fine powder which is ground from naturally occurring rock ore. It consists of a minimum of 90% hydrated magnesium silicate, with the remainder consisting of naturally associated minerals such as calcite, chlorite, dolomite, kaolin, and magnesite, and containing no detectable fibrous, asbestos minerals. TEST C o lo r........................................... O d o r............................. . ......... .. Identification............................... SPECIFICATION METHOD As specified by the buyer and showing no change after heating As specified by the buyer 1. Close match to CTFA spectrum-IR with no indication offoreign materials or 2. (Alternate) Close match to X-ray Powder Diffraction File No. 19-770, published by ASTM, showing the most intense reflections at d values about 9.35,1.53, and 4.95A Heat 1 to 2 g at 200C for 5 minutes. CTFA G 3-1 S lip ............................................. L u stre......................................... Water-Soluble Iro n .................... Water-Soluble Substances___ As specified by the buyer As specified by the buyer Passes test 0.1% maximum Acid-Soluble Substances . . . . . Screen T e s t............................... Loss on Ig n itio n ......................... A rsenic (as As) ............................ Lead (as Pb) ............................ Fibrous Amphibole (Asbestiform Tremollte et al.) . . Free Crystalline Silica (Q uartz). As specified by the buyer 6,0% maximum 100% through 100 mesh 98% minimum through 200 mesh Finer grades; as specified by the buyer 6.0% maximum 3 ppm maximum 20 ppm maximum None detected As specified by the buyer USP (Current) USP (Current) (Reaction and Soluble Substances) CTFA E 32-1 CTFA C 6-1 CTFA E 36-1 CTFA E i - i , Parts l-A and it CTFA E 2-2, Parts l-A and II CTFA J 4-1 CTFA J 5-1 (DTA) Alternate.' CTFA J 5-1 (X-ray) k* * * * The Cosmetic, Toiletry and Fragrance Association CTFAMojjMNamK TALC | July 15, 2004 Dr. C. W. Jameson Re: Comments on the talc nominations for the 12* RoC ATTACHMENT lb COSM ETIC TALC '/ ' TALC COSMETIC St-ur ~ -' wo-n 10-7-? D E FIN ITIO N : Cosmetic Talc is an essentially white, odorless, fine powder, ground from naturally occurring rock ore. j t It consists typically of 90% hydrated magnesium silicate, having the ideal formula M gtfSijOaehiOH), with the remainder consisting of naturally associated minerals such as calcite, chlorite, dolomite, kaolin and mag nesite, end containing no detectable fibrous, asbestos minerals. TEST C o lo r ....\ ................. ...................... O d o r ............................................. Identification ................................... i' 1 i S lp . . . ! ......................... ................. Lustre ......................... . . . . . . . . . . . W eter-Solubte Ir o n .................... ... Screen T e s t..................................... i W ater Soluble S u b s ta n c e s .......... A d d Soluble S u b stan ces.............. L o ts o f Ignition ........................ A ra e n ic (a s A # )............. Lead (as P b ) ..................... .. R b ro u sA m p N b o le......................... (A sb ekfo rm Trem olile et ai) Free Crystalline S ilic a ................... (Q uartz) i SPECIFICATIO N As specified by the buyer and showing no change alter healing As specified by the buyer Positive: 1. Close match to CTFA Spectrum-- JR with no indication of foreign m aterials OR 2. (Alternate) Close match to X -ray . Powder Diffraction Fite N o. 19-770, pubrtshedbyASTM, showing the most Intense reflections at d values about 9.3$, 1.53 and 4.59 A A s specified by tea buyer Do. Passes test 100% through 100 mesh 98% minimum through 2 00 m esh Finer grades: as specified by the buyer 0.1% maximum As specified by the buyer e.0% maximum < 0 % maximum 3 ppm maximum 20 ppm maximum None detected METHOD H eat1to 2g at20(rC fot 5 minute* CTFA G 3-1 ASTM D 934-74 USP XIX , page 437 C TFA C 6-1 U S P X IX , page4 8 7 . See test lor "Feection and Soiuble Substances* CTFA E 32-1 U S P X IX . page 487 CTFA F 1-1, Parts l-A and II CTFA F 2-1, Parts t-A and R CTFA J 4-1 As specified by tee buyer A* * CTFA J 5 -1 (DTA) Alternate: CTFA J 6-1 (X-ray) Oopyi>flMOTOTg'tliComft.TcHwyandF'gi * n ^ * M (* rtDrtiln Mofiortoa afO m CtFASfm itrd.tJw fiotfny*pwtflwN<wMWwtaapiffli*sfeftAOT7)wOaMie!te7yWyn0ftMmfle*aK*et*t,*>a ?J F--nthSHttKW ,, Wwntopfw*. a c 20005 July15,2004 Dr. C. W. Jameson Re: C o m m e n ts o n th e ta lc n o m in a tio n s fo r th e 12 RoC ATTACHMENT 2 .................. 'JHE WASHINGTON 1'0 5T Momhv.Mrrhs,i:t ---------------------------------------------- ------------ - Asbestos Fillers Found in Baby Powder By Marian Burros Wuhlncton Po't Stall Writn Asbestos fibers, which are found in thousands of prod ucts from food to building insulation, have been discov ered in nine of 19 body and baby powders studied by re searchers at Mt. Sinai Hos pital in New York. . Asbestos can cause me sothelioma, a rare form of chest and abdominal cancer, and asbcstosis, scarring of lung tissue. In 1972 Dr. Wil liam J. Nicholson of Mt. Si Officials of Colgate Palm olive, which makes Cash mere Bouquet, Sterling Drugs, Inc., manufacturer of ZBT Baby Powder and of Coty said they are certain their products are safe. They said no asbestos had been found in their testing. The manufacturer of Rose mary Talc could not be reached for comment. The other powders studied were Ammen's Medicated Powder; Avon Bird of Para tent of the powder, the re searchers purchased seven more samples. Five of them had 1,800 ppm or more of nickel; two had fewer than 710 ppm. Langer said re searchers "don't know if the nickel is hazardous at high levels." __ Dr. F. William Sunderman, .Jr., head of the de partm ent of laboratory med icine at the University of Connecticut and an expert . on nickel, said: "We're try ing to find out which nickel compounds do cause cancer nai reported that these dis dise Beauty Dust; Diaperene and which don't Certain eases caused nearly 40 per *" Medicated Body Powder; nickel compounds are car cent of the deaths of New Johnson's Baby Powders, cinogenic when inhaled; York-New Jersey asbestos one made in England and others are n o t" workers. ' - one in the United States; Johnson & Johnson's as Dr. Irving j . Selikoff of Johnson's Medicated Pow sociate director for public Mt. Sinai, a leading expert der; Mennen Bath Talc; affairs, Robert Kniffin, said on occupational disease, Yardley After Shave Pow the nickel in the talc is said, "We do not know a d er and Yardley Original "harmless" because ."it is safe threshold level fob a Body Powder. None of them biologically inert" and won't carcinogen like asbestos." contained asbestos. One, react with body,tissues. Once .asbestos fibers enter Diaperene, contained no A study revealed last Sep the body, he said, they stay talc. I t is made of corn tem ber by Dr. J. C. Wagner there. starch. of the Pneumoconiosis Re Researchers at M t Sinai's Department of Environmen tal Medicine tested one sam ple each of 19 body and The Food and Drug Ad ministration said in 1972 it would propose regulations to govern the use of asbes tos-contaminated talc in cos search Unit at Penarth, Wales, raised the question about the safety of talc it self, the major ingredient in powders. Wagner found baby powders. Arthur M. metics. The director of th at a s b e s t o s-free talc Langer, head of the physical sciences section of the de partment, said nine samples FDA's division of cosmetics technology, Heinz J. Eir- mann, said recently the agency had not issued regu caused fibrosis, lung scar ring in the test animals "at the same rate as asbestos." Epidemiological studies contained asbestos fibers in lations because i t had not have shown that talc work quantities ranging ,from "2 found a "fast method" for ers develop talcosis, anoth to 20 per cent" determining the presence of e r form of lung scarring, The powders with the asbestos at low levels. The from exposure to large greatest concentration of as sophisticated method used amounts of the mineraL bestos fibers, ranging from 8 to 20 per cent, were ZBT Baby Powder with baby oil. Cashmere Bouquet Body Talc, Cotv Airspun Face Powder and Rosemary Talc. Bauer & Black Baby Talc, which is no longer on the market, had a 15 per cent concentration of asbestos fi bers, the researchers found. Smaller amounts of asbes tos fibers--under 5 per cent -- were found in Faberge Brut Talc, Yardley Invisible Talc, Yardley Black Label Body Powder, Meunen Shave Talc and English Leather After Shave Talc. at M t Sinai, electron mi According to Selikoff, the croscopy, be said, was too time consuming and expen amount of talc that must be inhaled to cause tissue scar sive. ring or cancer in humans is The M t Sinai researchers, ' not known. who have conducted the study under a grant from the National Institute of En vironmental Health ' Serv Ices since 1973, also inves-. tigated the powders for the presence of other metallic 1 elements, including nickeL With the exception of Rosemary Talc and Diape- j tene which contained no nickel, 16 of the powders contained from 4 to. 710 parts per million (ppm) of nickeL A sample of John iI son's Baby Powder con tained 2,200 ppm. Surprised at what they re garded as a high nickel con- J u ly l5 ,2004 Dr. C. W. Jameson Re: Comments on the talc nominations for the 12thRoC ATTACHMENT 3 The New York Times Wednesday March 10.1976 Asbestos Found In Ten Powders "'. Ten out of 19 body and baby powders tested at Moiint Sinai Hospital here were contaminated with asbestos 'fibers' capable of causing a rare form of chest and abdominal cancer, researchers have reported. ., i i Dr,'Arthur Kohl, who conducted the tests with Dr. Arthur ;Langer, said of the findings: `There is no firm evi , denceon low-level or intermittent 'clo su re, auch as from ,,using talcum powder. We don't know for sure what the 'dangerlevel is." - The researchers said the contamination usually was found in the talc used in the .pbwders. Asbestos fibers can cause mesothelioma, a chest and .abdominal cancer; -.and can' also result in the -scarring of -lung tissue and : gastro-intestinri difficulties, Dr. Rom said. .. , The researchers said that 10 of the 19 American samples- contained from 2 percent to 20 percent asbestos , fibers with the highest concentration in ZBT Baby Powder with Baby Oil. Cashmere Bouquet Body Talc, Coty Airspun . Face Powder and Rosemary Talc range, from 8 percent to 20 percent asbestos f i b e r s . ^ > , v : - Bauer & Black Baby Trie, which ,is no longer on the market, had a 15 percent concentration.. Other powders containing less than 5 percent hsbestos'Were Fabergd ' Brut;Talc, Yardley Invisible Tricv Yardley Black Label' . Baby Powder, Mennen .Shave Trie-and English Leather : After Shave Talc. ' *'; . 'S-i -r-r '? The manufacturers thit,could be reached for comment said that they were convinced ,,that their products were' safe and that their own tests, had shown no asbestos. . Only the manufacturer of Rosemary could not be reached. ; . The products that the researchers found uncontaminated . with asbestos fibers were .Ammeris Medicated Powder, Avon Bird of Paradise Beauty jDust, Diaperene Medicated BodyPowder; tyro Johnson's Baby Powders (one made here , and one m Britain), Johnson's . Medicated Powder, Mennen Bath Talc, Yardley ;'After Stave Powder and Yardley Original Body Powder:, t w rv The tests, at M t Sinai, which Federal health officials described as the country's leading research facility looking - into the possible dangers of asbestos, used an electron microscope, Which Heinz J. Eirmann, director of cosmetics ' technology in the Food and Drug Administration, said was ! too expensive and time-consUiping for his agency to use... e_. The experiments at M t Sinai, which Dr. Rohl described ' i*tthe only significant -inquiry on the subject -ew r held, were financed by a . irant from the National Institute of Environmental Health Services and were begun in 1973.