Document ppR3oyQKeV4KNDBd2peYex71D

FILE NAME: Talc (TALC) DATE: 2010 May 19 DOC#: TALC095 DOCUMENT DESCRIPTION: Dr. Elaine Panitz to NIOSH RE Comments on NIOSH Draft on Asbestos Fibers Elaine B. Panitz, MD MPH May 19,2010 . t Re: Docket Number 099-C Elaine B. Panitz MD MPH Occupational and Environmental Medicine P. O. Box 936, Sheffield, MA 01257 Email: epanmd@vahoo.com T el:'413 229 3390 ` Fax: 413 229 3391 May 19, 2010 Diane Miller NIOSH Docket Officer tniocindocket@cdc.goy) Robert A. Taft Laboratories 4676 Columbia Parkway (M/S C34), Cincinnati, Ohio 45226 Telephone (513) 533 8611 Re: Docket number 099-C (Comments on the Draft NIOSH Current Intelligence Bulletin on Asbestos Fibers and Other Elongate Mineral Particles: State of the Science and Roadmap for Research Version 4 January 2010) D aV iitrU U lIU # pxt T A I am a physician and internist, licensed to practice medicine m the state of New Jersey, and specializing in occupational and environmental medicine for the past 35 years I received a BA degree, with a major in biology and a minor in chemistry, from Vassar College in 1968 an MD degree from Harvard Medical School in 1972; and an MPH degree from the Medical College o f Wisconsin in 1998. I am certified by both the American Board o f Internal Medicine and the American Board o f Preventive Medicine as an occupational and environmental disease specialist. I am currently living in Massachusetts and, from time to time, serve as a consultant m occupational and environmental medicine. I have over thirty-five years of experience as an occupational disease specialist and have personally evaluated hundreds of individuals wit asbestos-related diseases. I am intimately familiar with the peer-reviewed scientific literature relating to asbestos exposures and the risks of asbestos-related diseases. I have recently been asked by plaintiff attorneys to evaluate the illness and death of a ceramics teacher from mesothelioma. Her major exposure was to ceramic dust containing fibrous talc from upstate New York. In evaluating this matter, I have reviewed most of the extensive literature surrounding asbestos-like diseases from elongate mineral particles (EMPs). ' ' Reason for Critique I am writing to express concern over inconsistent and inaccurate statements in the Roadmap statements that add additional confusion to an already confused arena. The Roadmap proposes to create broader and clearer understanding o f the important determinants of toxicity for asbestos and other EM Ps. Yet, in many sections o f the Roadmap, NIOSH appears to restrict the discussion to asbestos and its non-asbestiform analogs only, and not to other EMPs. In other sections, NIOSH often seems to exclude some or all of the other EMPs, even though they habve been heavily associated with known asbestos-like health effects (e.g. fibrous talc, winchite, richterite, erionite, fluoro-edenite). Below please find a detailed discussion of what, in my view, are inconsistent, inaccurate, or confusing comments that hinder the Roadmap 's stated goal o f broader and clearer understanding of an admittedly very difficult problem. Suggestions are made in the spirit of lending greater clarity and understanding to the Roadmap effort. The Foreword by John Howard, MD (Page i) clearly states the mission for the Roadmap. The W ork Group is trying to "summarize NIOSH's understanding o f occupational exposure and toxicity issues concerning asbestos fibers and other EM Ps.. . that will provide a broader and clearer understanding o f the important determinants o f toxicity for asbestos and othei EMPs". Dr. Howard, in my view, has properly framed the issue with this terminology. Executive Summary The Executive Summary, however, introduces major confusion to Dr. Howard s clear terminology of the Foreward. ' Paragraph 2 of Page vii, correctly points out that the term "mineral fiber has been used by non-mineralogists to encompass thoracic-size EMPs that include a) asbestiforms, b) nonasbestiforms, and c) cleavage fragments. It correctly states that asbestiform EMPs are clearly o f substantial concern, and that the non-asbestiform and cleavage fragment EMPs are less clearly of concern. Having broached the topic of EMP habit, however, the paragraph should . then mention the substantial and fractious debate concerning the determination of EMP fiber habit (i e. asbestiform v. nonasbestiform). The paragraph should point out that, regardless o EMP habit determination, other EMPs should be studied further if they have already been associated with asbestos-like disease. # * Paragraph 3 of Page vii discusses NIOSH's 1990 recommendation to include only asbestos and its non-asbestiform analogs in regulatory efforts. Paragraph 1 o f Page viii properly notes that this NIOSH 1990 recommendation inappropriately excluded other EMPs. and cites as examples winchite, richterite, and erionite All three are EMPs that have been associated with substantial asbestos-like disease in humans. For the same reason, NIOSH should include upstate New York and Vermont talcJTJ and fluoro-edenitefll in its examples of other EMPs associated with substantial asbestos-like disease in humans. It is rfecognized that fluoro-edenite was not yet known as a health threat when NIOSH made its recommendations in 1990, but it should now be grouped with winchite, richterite, erionite, and fibrous talc as other EMPs of substantial concern. Paragraph 2 o f Page viii correctly notes that its 1990 recommendations created confusion, causing many to infer that the nonasbestiform minerals included in the NIOSH definition are asbestos. However, Paragraph 2 should also mention that NIOSH's 1990 recommendations caused many to infer that non-asbestos other EMPs do not need to be regulated. Epidemiologic studies have made it abundantly clear that richterite, winchite, erionite, fluoroedenite, and fibrous talc cause asbestos-like disease and should be under active consideration for regulation. Similarly, Paragraph 2 o f Page ix discusses the epidemiology relating only to asbestos and its non-asbestiform analogs, and not to other EMPs. Although the paragraph suggests interest in epidemiologic studies of workers in upstate New York talc mines, it then states that talc exposures involve "predominantly nonasbestiform EMPs". This comment fails to reflect the fact that determination of EMP habit, especially in relation to upstate New York talc, is a hotly-debated (and unsettled) issue. In this Executive Summary, NIOSH should avoid making judgments in the contentious issue of whether other EMPs are non-asbestiform or asbestiform. NIOSH should focus on which of the other EMPs have shown epidemiologic evidence o f disease potential, and therefore deserve further epidemiologic study, regardless of EMP habit. NIOSH should completely remove the sentence beginning "Populations of interest.. . . NIOSH should simply amend the next sentence to read, "Populations of interest for possible epidemiologic studies include workers and others exposed to EMPs in relation to a) talc mining in upstate New York and Vermont, b) vermiculite mining in Libby, MT, c) tacomte mining in northeastern Minnesota, d) gold mining in South Dakota, e) erionite contamination in Turkey, f) fluoro-edenite contamination in Sicily, and f) any other EMPs exposure that may show epidemiologic evidence of asbest6s-like disease in the future. Note that the term "and'others" should be included, to reflect the growing evidence for asbestos-like disease m the general populations around workplaces exposed to other EMPs (e.g. Libby, MT3], northeastern MN[4], and upstate New York[5J). The remaining paragraphs o f the Executive Summary correctly return to the scientific valuation o f asbestos and other EMPs. miroauciiun , . . , Page 1, Paragraphs 1-2, of the Introduction correctly reiterates NIOSH's interest m the study o f asbestos and other EMPs. Paragraph 3 correctly notes that health effects of other non asbestos EMPs have not been studied as much as asbestos. However, Paragraph 3 then cites as examples o f other EMPs a) the amphiboles in Libby, MT, b) those encountered in hardrock mining, and c) erionite in Turkey. For clarity and consistency, NIOSH should also list the health effects o f the EMPs in upstate New York and Vermont talc mining, and e) the EMPs in the quarry near Biancavilla, Sicily. The remainder of the Introduction correctly refers to both asbestos and other EMPs. * Overview o f Current Issues 2.1 Background Paragraph 2 of Page 4 states that interest in EMPs other than asbestos fibers has been "focused primarily on fibrous minerals exploited commercially (e.g. wollastonite, sepiolite, and attapulgite)". This comment omits mentioning the other commercially exploited substances that contain fibrous minerals (e.g. fibrous talc and vermiculite containing, winchite and richterite), and omits the major interest in EMPS occurring aS contaminants in central Turkish (erionite) and Sicilian (fluoro-edenite) rocks and soils. Paragraph 2 o f page 4 goes on to note that the asbestos minerals, as well as "other types of fibrous minerals", are typically associated with other minerals in geologic formations at various locations in the United States, citing Van Gosen 2007. NIOSH should name the other types of fibrous minerals, especially since the main types of other fibrous minerals discussed by the cited Van Gosen 2007 article are fibrous talc and vermiculite containing winchite and richterite. Paragraph 2 continues on to state that "the biological significance of occupational exposure to airborne particles remains unknown for many o f these minerals . This is simply untrue for the two major "other types of fibrous minerals" mentioned by Van Gosen 2007 (fibrous talc and vermiculite containing winehite and richterite). This sentence should be removed or clarified. Paragraph 3 of Page 4 states "the lack o f uniformity in the use o f terms and die lack of precision in the definitions of many of the scientific terms remain issues which cannot be resolved in this Roadmap". This unfortunate comment suggests that NIOSH is not striving for precision in its use of certain key terms, such as other EMPs. I would argue that until NIOSH resolves its lack o f consistency and clarity in the definition and use of the term asbestos and other EMPs. it will not succeed in creating a broader and clearer understanding of the Roadmap issues. Minerals and mineral terminology Section 2.2 Paragraph 4 of Page 5 states that "both asbestiform (fibrous) and nonasbestiform (massive) versions (i.e. analogs) o f the same mineral can occur in juxtaposition or matrixed together". This sentence implies that the term fibrous can substitute for the term asbestiform. While all asbestiform particles are certainly fibrous particles, not all fibrous particles are asbestiform particles. It also implies that all nonasbestiform fibers are massive. Nonasbestiform fibers can occur in a range o f habits, from massive to prismatic to acicular to very fibrous, up to but not including asbestiform fibers. This unfortunate sentence therefore implies that all nonasbestiform EMPs are massive and do not occur in fibrous forms. The sentence should be removed and replaced with the following: "Nonasbestiform fibers can occur in a range o f habits, from massive or platy or tabular, to prismatic, to acicular, to very fibrous, up to but not including asbestiform. Both asbestiform and nonasbestiform habits of the same mineral can occur in juxtaposition or matrixed together, often within a narrow geological formation". Paragraph 1 o f Page 6 addresses itself to the habits o f amphibole EMP minerals only. For greater clarity, NIOSH should address itself to a more inclusive term, such as hydrous magnesium silicates, in order to address the habits of other important but non-amphibole EMPs, such as fibrous talc and erionite. Although not amphiboles, fibrous talc (see reference 1) and erionite (see Roadmap 2.6.2, p. 35) have been associated with significant asbestos like human disease, and should be included in any listing of important EMPs. Paragraph 2 of Page 6 continues the confusion by equating the terms fibrous and asbestiform, and suggesting that acicular fibers are not fibrous. The final sentence again excludes non asbestos EMPs from the discussion. Geological Definitions . . . , , In Sectioin 2.3.1, NIOSH states that, in addition to asbestos, there is interest m related materials that may resemble asbestos (e:g. fibrous antigorite, richterite, and winchite), unrelated fibrous minerals (e.g. the zeolites erionite and mordenite, the clay materials sepiolite and palygorskite, etc.), and individual particles or fragments o f the nonasbestiform asbestos minerals". Again, it is unclear why fibrous talc and fluoro-edemte (both unrelated fibrous minerals") are not included in the listing, when erionite (another "unrelated fibrous mineral") is listed. All three non-asbestos materials (erionite, fibrous talc, and fluoro- edenite) have been heavily associated with asbestos-like health effects. The NIOSH Recommendation fo r Occupational Exposure to Asbestos Section 2 6 In 1990, NIOSH recommended microscopic methods be used to define libers as particles having 1) an aspect ratio o f 3 to 1 or greater, 2) the mineralogic characteristics of the asbestos minerals and their nonasbestiform analogs, and 3) cleavage fragments from the nonasbestiform analogs o f the serpentine minerals antigorite and lizardite, and the amphi o e minerals in the series cummingtonite-grunerite, tremolite-ferroactinolite, and glaucophaneriebeckite. This paragraph should also note that NIOSH 1990 excluded non-asbestos other EMPs, such as fibrous talc, erionite, winchite,-and richterite (fluoro-edenite had not yet declared itself in terms of human .disease). * Amphibole Asbestos and Other Fibrous Minerals Section 2.6.1.2 Paragraph 2 o f Page 19 cites concerns over the fact that current OSHA and MSHA asbestos definitions cover only the asbestiform varieties of the six commercially important asbestos materials. NIOSH specifically cites the problem of OSHA and MSHA regulations not including the asbestiform amphiboles winchite and richterite m Libby vermiculite exposures, and the asbestiform amphibole fluoro-edenite in the Biancavilla, Sicily exposures. NIOSH should also mention the failure of OSHA and MSHA to include exposure to Turkish erionite and upstate New York talc, both o f which have been found to contain asbestiform.fibers by at least some investigators (see below). Epidemiologic Studies , Section 2.6.1.3.1 On Pages 23-27, the NIOSH discussion of the epidemiology of upstate New York talc workers assumes that the talc EMP exposures are "nonasbestiform , and groups the talc epidemiology discussion with that on gold and taconite miners. Such a grouping suggests that the results of epidemiologic findings in talc workers have been similar to those in gold and taconite miners. In fact, studies o f talc workers have demonstrated a clear pattern of asbestos-like disease, including increased risk for pleural plaques and pneumoconiosis, a three-fold increased risk for lung cancer, and a number of reports of malignant mesothelioma in miners (see below). Studies o f gold and taconite workers have shown little or no evidence of asbestos-like disease (see below). 9 ' Upstate New York talc workers No explanation is given for designating the fibrous talc exposures o f upstate New York as "nonasbestiform", other than mentioning that the exposures have been reported to be nonasbestiform by RT Vanderbilt (Kelse 2005). NIOSH does state that die NIOSH 1980 industrial hygiene analysis o f RT Vanderbilt talc showed 4.5-15% anthophyl ite, some of which was asbestiform. But, because the NIOSH 1980 study proVed to be the subject o debate", NIOSH suggests that the asbestiform anthophyllite fibers may have been "transitional minerals" - as if the fibers were therefore no longer asbestiform, and were not to be considered biologically significant. NIOSH should clarify that a number of independent investigators and organizations, over a period of some 50 years, have found the EMPs in upstate New York talc to be asbestiform in habit (see below). Engel (1962) of the USGS, describes the talc o f upstate New York as "highly striated, fibrous bundles o f anthophyllite and talc"[6]- Rohl and Langer (1974) note the presence o f at least three asbestiform minerals (tremolite, anthophyllite, and chrysotile) m upstate New York talcs.[7] IARC (1987), after extensive review and analysis o f the world s literature, found that certain talcs (primarily from upstate New York) contain asbestiform fibers and meet the criteria for a Group 1 human carcinogen[8]. Beard (2001) at Research Triangle Institute, in an independently funded analysis found.RT Vanderbilt talc from upstate New York to contain more than 20% asbestiform fibers, including asbestiform talc (.81 /o) asbestiform anthophyllite (4.4%), and asbestiform transitional fibers (16%)[91- The 2005 USGS dataset on asbestos sites in the Eastern United States notes that the Arnold talc rainem upstate New York contains "asbestiform anthophyllite" and "asbestiform tremolite Uffl. e dataset cites as references Ross (1968)01], Van Gosen (2004)101, and Webber (2004)03], as well as Engel (1962) and Beard (2001). Van Gosen (2007) reports that regional metamorphism o f dolomitic marbles in Gouvemeur talc mining district created fibrous varieties of talc, tremolite, and anthophyllite, as well as unusual transitional fibersOitl- Webber, et al. (2004) (see footnote 14), o f the New York State Department o f Health, analyzed samples o f talc ore from upstate New York and reported that 15% of crushed Arnold pit ore was respirable. The respirable fraction contained a large proportion of asbestiform fibers, "typified by aspect ratios exceeding 10 (often in the hundreds), curved fibers, and fibers terminating in frayed ends". .When the crushed ore samples were aerosolized, the airborne fibers were found to be anthophyllite (40%), tremolite (6%), "intermediate" (48%), and talc (2%). The authors then reconstructed air concentrations ot anthophyllite asbestos near the talc mines from 1846 to 1967, using nearby lake sediment samples. They demonstrated that airborne anthophyllite asbestos concentrations a) increased more than five times over the studied time period, b)'correlated significantly (p <.01) with annual production o f local talc, and c) were much higher (p = .004) than concurrent concentrations in a control lake located upwind of the mines and mills. As discussed on Page 23, an excess of pulmonary fibrosis and pleural plaques is welj recognized to have occurred among workers exposed to fibrous talc (Siegel 194315], Kleinfeld 1955[161). NIOSH should emphasis, however, that lung cancer mortality has been consistently reported to be elevated in studies.of New Y ork talc miners (Kleinfeld 1967, Kleinfeld 1974, Brown 1980, and NIOSH 1990I7]; Stille 1982U8], Lamm 198809], Gamble 1993 [201, Honda 2002[21]), despite various study weaknesses that make doseresponse evaluations difficult. NIOSH should mention that there have been a number of mesothelioma cases reported among NY talc workers, including Kleinfeld 1955J7L], Kleinfeld 1967 and 1974, and NIOSH 1980 (see footnote 1); Vianna 1981 (see footnote 5), Honda 2002[231: Hull 2002[24], and Rubin 200605]. At least some o f the cases included reports of other markers of asbestos-like disease, including pleural plaques asbestosisor pneumoconiosis, asbestos bodies, and asbestos-like fibers m lung tissue (Klemfeld 1955, Hul 2002, Rubin 2006). ^ . Given the dramatic findings of Webber (2004) above, it is important for NIOSH to mention that the residents of St. Lawrence County are also exhibiting evidence suggestive o f asbestosrelated diseases. The mortality rate for all pneumoconioses in St. Lawrence County was 5-10 times higher than NYS rates from 1975 to 2004 (NIOSH WoRLD 2007, see footnote 5) Mortality from asbestosis specifically was 4 times higher than the NYS rate from 1995 to 2004 (NIOSH WoRLD 2007, see footnote 5). The incidence of lung and bronchus cancer lor 2003-2007 in St. Lawrence County is 43% higher than in New York State m both men and women[261. There is a higher than expected number o f lung cancer cases for 2002-20 in over half the zip codes o f St. Lawrence County, including the Gouvemeur zip code (37 cases v. 17.2 predicted)!!!]. The lung cancer incidence in Jefferson County is also elevated in both men (38%) and women (36%), compared to New York State rates.[28]. These elevated lung cancer rates do.not appear related to increased smoking rates in the local populations. Smoking rates in St. Lawrence and Jefferson counties are similar to those in the: rest^of NYS excluding NYC (22.2% v. 22.1% of adults)[29]. Mesothelioma rates from 1966 to 1981 were significantly elevated in Jefferson County, the site of some of the talc industry m New York and located only a few miles from the concentration o f talc mines m adjacent St. Lawrence County (Vianna 1981, Enterline 1987, see reference 5). In more recent years (1999-2004) the mesothelioma mortality rat.es in St. Lawrence and. Jefferson counties appear to be only slightly higher than NYS (13% and 35% respectively, see reference 5). * Vermont talc workers , \ana\ onH On Page 27, NIOSH discusses the cohort study o f Vermont talc workers (Selevan 1979), an states that "available evidence indicates that Vermont talc is free of asbestos fibers", without citations In addition to indicating sources for this statement, NIOSH should mention that several investigators have reported asbestos in Vermont talc. Zodac (1940) describes "radiating masses of fibrous actinolite" in the talc quarry m Chesier, VT[30]. Van Gosen (2004) (see reference 13) o f the USGS reports that Vermont talc deposits ini some areas host "well-developed chrysotile asbestos", citing Bain (1942)3JJ. and Cady (1963)132]. However NIOSH should also address whether Vermont talc contains asbestiform numerals other than asbestos per se. NIOSH should mention, for instance, that the companion NIOSH industrial hygiene study for Selevan (1979) found "talc shards and ribbons both m bulk talc samples and in airborne dust samples (Boundy 1979)1331. NIOSH should also mention that other studies o f Vermont talc report the presence of asbestiform amphiboles, structurally and chemically intermediate between anthophyllite and talc, and similar to those reported in e Gouvemeur talc mining district by Ross m 1968 (Veblen 1977 and Veblen 1978(34], Gosen 2004, see reference 13). * NIOSH notes that the mortality study ofVermont talc workers reveals significantly increased risk for non-malignant respiratory disease, with significantly increased risk among millers but not miners (Selevan 1979). NIOSH should also mention that a) most o f the men who died of NMRD had radiographic readings consistent with pneumoconiosis, and b) e authors concluded that the x-ray evidence supported talc as the etiology ofN M RD m the millers but that data were too limited in miners to judge their true risk. NIOSH should also mention the subsequent Harvard School of Public Health PFT and x-ray study o f Vermont talc workers, in which PFT abnormalities and small irregular opacities on chest x-ray were significantly related to years of employment and talc-years of exposure. The authors concluded that talc workers were being affected by their work exposures (Wegman 1982)1351. ` Respiratory cancer risk in the Selevan (1979) study was significantly increased among miners and not millers, a pattern similar to that in RT Vanderbilt miners and millers. NIOSH notes that the authors suggest that their respiratory cancer findings might be due to non-talc exposures. NIOSH should also note that the authors also suggest that talc may be acting in combination with other factors to' affect cancer risk. " Summary o fEMP epidemiology . , On Page 31, NIOSH then summarizes the epidemiologic studies o f cohorts exposed to "nonasbestiform EMPs". The section heading and the ensuing discussion imply that NIOSH has been tasked to consider only the other EMPs that are nonasbestiform, rather than aft other EMPs (including the asbestiforms). According to Dr. Howard's Foreward, this is not so (see Pages i-ii). This epidemiologic summary should include an even-handed review (see above) o f ail n f the other EMPs that have been heavily associated with asbestos-like disease's, including upstate New York and Vermont talcs, Libby MT vermiculite, Cappadocian enomte, and Sicilian fluoro-edenite. It should then conclude with the more limited evidence of asbestos-like disease associated with South Dakota's gold mine, and the northeastern Minnesota's taconite mines. Some Minerals o f Potential Concern Not Covered by the NIOSH REL This section belongs in the 2.6.1.3.1 Epidemiologic Studies section on Pages 22-32, as discussed above. Some Minerals o fPotential Concern Not Covered by the NIOSH REL On Page 35, the Roadmap states, in reference to EMPs, that "only for enomte has the IARC made an assessment that the evidence was sufficient to determine that it is a human carcinogen". This is simply untrue, and NIOSH should correct this sentence to properly reflect IARC's findings on talc. In 1987, IARC opined that "there is sufficient evidence for the carcinogenicity to humans o f talc containing asbestiform fibres"[36]- In fact, in 2007, IARC opined that "there is limited evidence for the carcinogenicity in experimental amma s o f talc not containing asbestos or asbestiform fibers", and classified such talc as Group 3 (not classifiable as to its carcinogenicity to humans)[37] On Page 68, NIOSH attempts to summarize key issues developed by the Roadmap. But, once again, the paragraph begins by framing its first question around "fibers from the asbestos minerals" , rather than asbestos and the other EMPs. In the next p arag ra g h (Page 69), the summary shifts back briefly to "EMPs" and mentions erionite as well as the "asbestos minerals". It even mentions non-EMPs such as quartz, and yet does not mention important other EMPs, including upstate New York and Vermont talc, Libby vermiculite containing winchite and richterite, and Sicilian fluoro-edenite. tTnfnrtunatelv this summary reflects the Roadmap's failure to define and use the term X S i t a S i " consisten, manner, as intended by Dr. Howard in the Foreward (Pages i-ii). FoX nateiy' P a i 7 0 's'Framework for Research returns to a clear and consistent use of the Lr r ^ f d o^erE M Ps., as stated by Dr. Howard in the Foreward (Pages Develop Information and Knowledge on Occupational Exposure to Asbestos Fibers and Other EMPs and Related Health Outcomes On page 86 section 3.5.2, the Roadmap again reverts to the statement that the body toowTedgeConcerning human health effects from exposure to EMPs consists prim arilyof of workers exposed to asbestos fibers and several other types of EMPs (e g. wollastonite, attapulgite, erionite). As pointed out above incomplete and misleading. I, cites two EMPs a s s o r te d with very ` evidence of asbestos-like disease (wollastonite, attapulgite), yet fails to cite other EMFs h " " w i t h asbestos-ike disease (upstate New York and Voanont talc, L,bby vermiculite containing winchite and richterite; and Sicilian fluoro-edemte). In die last sentence of the same paragraph, the Roadmap seeks ,0 ensure a clear science base h a T S Tupport a formal recommendation for control of occupational exposures 0 aU L e s t l o r m " p h ib o le fibers". This terminology is recommendation to only asbestiform EMPs, eliminating nonasbestiform EMPs. It further lim it; the recommendation to amBhifeoles, eliminating both erionitel andJ s*a^ w and Vermont talc, which are heavily associated with asbestos-liie disease. NIOSHshould this terminology to all asbestos and other EMPs, in the interest of clarity consistency with Dr. Howard's Foreward. ; The next paragraph then speaks o f "EMPs from nonasbestiform amphiboles" and seeks to compare theirhealth risks to those of asbestiform amphiboles. Although it is important to . nonasbestiform EMPs as well as the asbestiform EMPs mentioned above, the EMPS (such as erionite and upstate New York and Vermont talc). This entire section is crippled by its ever-changing term.no ogy^ would be greatly strengthened if it used the terminology asbestos and other EMf c in co " w a r d 's Foreward, and the Framework for Research section on Page 70. Conduct Selective Epidemiological Studies o f Workers Exposed to Asbestos Fibers and Other limiting, in that the mineral talc, although a magnesium silicate, is not considered to be on the amphiboles. A sTtated^ndte Roadmap Executive Summary, this document is intended to define the f c iS ic 1 M e a l research issues that ne.ed ,0 be addressed ,0 ensure drat workers are optimally protected from health risks posed by exposure to asbestos fibers and other EMPs. To make to point more vivid concerning other EMPs, the cover of the Roadmap mclndes a remarkable USGS photograph of upstate New York talc fibers[38]. The Roadmap must now effectively frame its epidemiologic discussion to include all other EMPs - both asbestiform and nonasbestiform - beyond the six types of asbestos and their non-asbestiform analogues. The EMP health problems in Libby, MT (wmchite, nchtente), Cappadocia (erionite), Biancavilla (fluoro:edenite), upstate New York and Vermont (fibrous talc) northeastern MN (taconite), and perhaps others, cry out for proper overview, analysis, and further investigation. NIOSH must follow through on its promise to protect humans from asbestos and other EMPs - all o f them - or it will miss, or misinterpret, current and future opportunities to prevent EMP disease. ^ Yours truly, Elaine B. Panitz, MD MPH 111 Fibrous tele: a) Kleinfeld M, Mcssite j, Kooyman 0 , et al. Mortality among talc miners and millers In New York State AEH 1967 May; 14; 663-667; b) Kleinfeld M, Messite J. Mortality expenence among talc irrtm ilow -n n sm d y R ^ rH E T A T o 3 9 0 - "o65R . T, V rJLbiltC om pany.O ouvem eor, New York, 1990; SelevanSO, Dement M Wagoner IK, e, al. Modality patterns among m ined and mrl.ers of non-asbestiform rale; prelnnmmy renort J Environ Pathol Toxicol 1979; 2: 273-284. m Fluoro-edenite: a) Comba P, Gianfagna A, Paoletti L. Pleural mesothelioma eases m Btancavdla are related to a new fluoro-edenite fibrous amphibole. Arch Environ Health 2003; 58(4)229-232. b) iggen A-Pasetto R'Belli S;Bnmo C;Di Maria G;Mastrantonio M;Trinca S;Uceelli R;Comba P. M orn ity om c ont obstructive pulmomuy disease and plenral mesothelioma in an area contaminated by nature edenite) Seand J Work Environ Health 2004 Jun;30(3);249-52; e) Bruno C;Comba PiZona A. " effects o f fluoro-edenitic fibers; epidemiological evidence and public health prionr.es. Ann N Y Aead Se. 2006 Sep;1076:778-83. ` ` [31A TSD R Mortality review. Mortality in Libby, Montana, 1979 to 1998. August 8,2002 . .He - -- 'mortality rewew.html; Peipins LA, Lewrn M, Cmnpoluoe, S, et al Radiographic abnormalities and exposure to asbestos-contaminated vermrculite in the community Libby M o n f J , USA. EHP 2003 Nov; 111(14); 1753-1759; Horton DK, Bove F, Kapil V. Select mortal, and ermcer incidence among residents in various US e ,, TM i t i . . that received asbestos-con.amui.ted vermiculite ore from Libby, Montana. Inhal Toxicol 2008; 20: 767-775. 41 Minnesota Department o f Health. Cancer incidence rates in nonheastem Minnesota wnh an emphasts on mesothelioma. MCSS Epidemiology Report 03:1. February 2003; Minnesota Department of Health. Mesothelioma in Northeastern Minnesota and Two Occupational Cohorts. 2007 Update. Center for Occupational Health and Safety, Chronic Disease and Environmental Epidemiology Section, Minnesota Department of Health, St. Paul, MN. December 7,2007: http://www.health.state.mn.us/ divs/hpcd/cdee/mcss/documents/nemesol 207.pdf. 5] Vianna NJ, Maslowsky J, Roberts S, et al. Malignant mesothelioma. Epidemiologic patterns in New York State New York State J Med 1981 Apr: 735-738; Enterline PE, Henderson VL. Geographic patterns for pleural mesothelioma deaths in the United States, 1968-81. JCN1 1987 Jul; 79(1): 31-37; NiOSH. WorkRelated Lung Disease (WoRLD) Surveillance System: Malignant mesothelioma: mortality. htiF //www2.c<fr Pnv/drds/Wor1dReportData/SectionDetails.asp?ArchiveID-lfeSectionTitleID7; NIOSH. ^ Work-Related Lung Disease (WoRLD) Surveillance System: All pneumoconiosis: mortality, and Asbestosis: mortality. http://www2.cdc.gov/drds/WorldReportData/ FignrRTahleDetails.asn?FigureTablelD-500&GronpRefNumber=F01-Q.3b; [6] Engel AEJ. The prercambrian geology and talc deposits of the Balmat-Edwards district, northwest Adirondack Mountains, New York. US Geological Survey, Open File Report, preliminary, 1962. 71 Rohl AN, i anger AM. Identification and quantitation of asbestos in talc. EHP 1974,9.95-109. 8] 1ARC Monographs on the Evaluation o f the Carcinogenic Risk of Chemicals to Humans. Silica and some silicates (talc) 42: 185-224,1987. , ., 91 Beard MR, Crankshaw OS, Ennis JT, et al. Analysis of crayons for asbestos and other fibrous materials, and recommendations for improved analytical definitions. Center for Environmental Measurements and Quality Assurance, Research Triangle Institute, 2001 Feb 28. T101 Van Gosen BS. Reported historic asbestos mines, historic asbestos prospects, and natural asbestos ,, A r e n a s in the Eastern Unted States. US Oeologieal Stave, Open-File Report 2005-1189 Version 2.0 (http://pubs.usgs.gov/of/2005/1189/pdf/Plate.pdf). . [ i n Ross M, Smith WL, Ashton WH. Triclinic talc and associated amphiboles fromGouvemeur mimng district, New York. The American Mineralogist 1968 May-Jun; 53: 751-769. 121 Van Gosen BS, Lowers HA, Sutley SJ, et al. Using the geologic setting of talc deposits as an indicator of amphibole asbestos content. Environmental Geology 2004; 45: 920-939. 13} Webber JS, Jackson KW, Parekh PP. Reconstruction of a century of airborne asbestos concentrations. Environ SciTechnol 2004; 38:707-714. . . . [ 14~| v a n Gosen BS. The geology of asbestos in the United States and its practical applications, nviron Engineer Geoscience 2007 Feb; XIII(l): 55-68. [151 siegal W, Smith AR, Greenburg L. Report on study of talc miners and millers in St. Lawrence County. The Industrial Bulletin 1943 Nov: 434-437,468. [161 Kleinfeld M, Messite J, Tabershaw 1R. Talc pneumoconiosis. AMA Arch-lndust Health 1955; 66- . 17} See reference 1. , , 18} Stille WT, Tabershaw IR. The mortality experience of upstate New York talc workers. J Occup Med 1982 Jun; 24(6): 480-484. , . , [191 f amm SH, Levine MS, Starr JA, et al. Analysis of excess lung cancer risk m short-term employees. Epidem 1988; 127(6): 1202-1209. tA . _ [2Q-1 Gamble JF. A nested case control study of lung cancer among New York talc workers. Int Arch Occup Environ Health 1993; 64: 449-456. , [2 H Honda Y, Bealk C, Delzell E, et al. Mortality among workers afa talc mining and milling facility. Ann Occup Hyg 2002; 46(7): 575-585. [221 Kleinfeld M, Messite J, Tabershaw IR. Talc pneumoconiosis. AMA Arch Indust Health 1955, 6 - . [231 See footnotes above_____ . [241 Hull MJ, Abraham JL, Case BW. Mesothelioma among workers in asbestlform fiber-bearing talc mines h New York State Ann occup Med 2002; 46(Suppl 1). 132-135. , , [251 Rubin E. Letter to J.K else,R T Vanderbilt Company, Inc., dated November 8, 2006 (http: www.c c.gov niosh/docket/pdfs/NIOSH-099/0099-053007-kelse_sub.file3.pdf). M V nrt State Cancer Registry. Cancer incidence and mortality by county and gender, St. Lawrence County^2003-2007 /hm //ww.health.stateJB^ ^ " nuiW'wAyw healtli-Sb'te nuns/statistics/canoer/repistrv/pdf/voiumeLEdf)- Lawrence County cancer mctdence by tap code, SU-auuenoe C" * m 2 2006 (http7/www health.state.ny.us/statiStics/cancer/registry/zipcode/lung/stlawrence^tm) S Hew York d a n c e r Registry. Cancer incidence and mortality by county and gender, Jefferson and http://www.healdi.smte.ny.us/prevennoti/prevention agenda/indicators/coun^/jefferson. ). ^ T m l c f r of asbestos and silica. B rH ndus, Med 1982; 39:233-23*. [3 6 ] ,ARC Monographs on ,h . Evaination of the Carcinogenic Risk of Chemicals to Humans. Stlic. and some silicates (including tale) 42:1 M t ^ talc not con,,ining 2007; 19(Suppl 1): 213-228. . `