"Nondetected": The Politics of Measurement of Asbestos in Talc, 1971–1976

David Rosner, PhD, MPH; Gerald Markowitz, PhD; Merlin Chowkwanyun, PhD, MPH

Disclosures

Am J Public Health. 2019;109(7):969-974. 

In This Article

The Industry Goes on the Offensive

In the fall of 1973, the FDA announced its proposed rule in the Federal Register: "Any drug, drug ingredient, or drug packaging material containing talc that fails to meet the specifications … as determined by the method set out … shall be deemed to be adulterated in violation of … the Act" and thus not a substance "generally recognized as safe." The standard was exacting: The FDA proposed using a polarizing microscope that they believed could accurately ensure "a purity of talc at least 99.9 percent free of amphibole types of asbestos fibers and at least 99.99 percent free of chrysotile asbestos fibers."[25]

The industry reacted immediately and negatively to the proposed rule. Two weeks after the announcement in the Federal Register, the CTFA Subcommittee of Scientific Advisory Committee on Asbestos in Talc met and attacked the FDA's methodology as "not completely reliable and discriminatory," arguing it was not clear that the methods used really measured true asbestos fibers. The CTFA suggested that the methods could actually be finding nonfibrous or nontoxic materials. "[C]hrysotile might fall within the critical range of refractive indices used," the CTFA contended. Further, committee members claimed that the counting, even if accurate, would take an inordinate amount of time—perhaps six hours—for a technician to reach a "tentative identification" of the asbestos content. "The tedium effect on the person counting is obvious," the committee maintained.[26]

The CTFA organized a "round robin" test to determine the reliability of the methodologies proposed by the FDA. After distributing samples of talc from a variety of mines from a number of states, it asked various companies to have their experts determine whether the samples contained chrysotile or amphibole asbestos. The CTFA had provided samples that they had "spiked" with known amounts of different asbestos fibers to see how accurately or inaccurately the methodologies performed. The round robin test revealed "strong inconsistency" among "the different scientists applying the method to the same group of coded talc samples." The CTFA "concluded that the method published in the Federal Register does not provide a truly reliable means for the detection of asbestos in talc." Given that the methodology was "tedious and may consume as much as one half day per sample," the "subcommittee urge[d] that the Food and Drug Administration defer finalizing the proposed optical microscopic method and proceed [to a] program which would combine FDA and Industry in a strong effort to develop a truly reliable method." The CTFA subcommittee estimated "that a satisfactory method will take at least six months to a year to develop" if industry and the FDA worked together.[27] The industry was willing to challenge the FDA since some privately believed that the "FDA is reluctant to take any legal action in any problems with industry." The CTFA had been told that the FDA had "neither the money nor the manpower to pursue matters so that they will have airtight cases in scientific matters."[28]

The CTFA also challenged the government even though one representative of Johns Manville reported that some talc suppliers were distributing products with high amounts of three of the major forms of asbestos—chrysotile, tremolite, and anthophyllite—and might be lying to the government about it. R. S. Lamar of Johns Manville was specifically referring to "R. T. Vanderbilt Company talc products," which "always have and continue to contain chrysotile as a significant mineral component (in addition to tremolite and anthophyllite)." He concluded his private correspondence with another Manville executive: "It is apparent that the R. T. Vanderbilt presentation to OSHA [Occupational Safety and Health Administration], NIOSH, FDA, MESA [Mine Enforcement Safety Administration], etc. are based on something less than the truth."[29]

This struggle between the government and industry over the FDA recommendation was highly consequential. In March 1975, the objections of industry to the earlier FDA notice of rulemaking in the Federal Register had undermined the FDA's efforts to adopt stricter standards. "The Food and Drug Administration has … examined numerous talc samples of undefined grade in the past two years, using the proposed methodology," the Federal Register had announced, "and finds that approximately two-thirds of such samples are within these limitations" of 99.9% amphibole free and 99.99% chrysotile free. The implication of this was that possibly one third were not free of asbestos. "The Commissioner therefore concludes that the proposed limitations would not impose an unreasonable burden on manufacturers of talc if these limitations were adopted." But industry was objecting and, hence, "The Commissioner … decided to delay any final regulation for talc until an acceptable method for determining the presence of asbestos particles can be developed for this substance."[30]

The industry had won a major battle, and it proceeded to promulgate its own methodology, referred to as J4-1, and its own definition of talc: "Cosmetic talc is a white, essentially odorless, fine powder, ground from naturally occurring rock ore, consisting mainly of magnesium silicate … with lesser amounts of naturally associated minerals … and containing no detectable fibrous asbestos minerals [emphasis added]." J4-1 was less stringent than the FDA standard; it was only reliable to 0.5% as compared with the FDA's methodology, which claimed accuracy to 0.01%. This meant that future cosmetic talc products might, in fact, contain asbestos below the 0.5% detectable limit. Furthermore, the CFTA promulgated its own definition of talc's purity by avoiding precise statements in favor of vaguer language in its description of the asbestos content of the manufacturers' products. "After extensive discussions of advantages and disadvantages of listing a 0.5% maximum limit as opposed to 'nondetected' terminology, the Standards Committee voted for the use of … 'nondetected.' "[31] One industry representative, however, acknowledged the dishonesty in using "nondetected" as the definition for safety of cosmetic talc products: "You will notice that a talc standard definition for cosmetic talc was adopted unanimously," H. D. Stanley of Pfizer wrote to R. E. Norwood following a July 8, 1976 meeting of the CTFA. "Had I been there I would have objected to their definition. I particularly object to the section … that reads – containing no detectable asbestos minerals." Stanley pointed out the irony that a "nondetected" level depended on the adequacy—or inadequacy—of the methods used to detect it. Using an insensitive method would allow manufacturers to claim that asbestos had not been detected but would simultaneously lead to "serious breaks in communication between the buyer and the seller," who would believe that the product was truly asbestos-free.[32] This observation was not trivial and got to the heart of the problem the cosmetics industry faced. As Arthur Rohl, a researcher in Irving Selikoff's department at Mt. Sinai School of Medicine, pointed out, if the wrong methodology was used, billions of particles of asbestos could escape detection. He wrote that "Even at the lowest level of detection by x-ray diffraction, i.e., 0.25%, there would be about 109 fibers/mg. Cosmetic talcum powder, for example, which had been step-scanned and chrysotile not found might contain billions of fibers released during dusting with a half-gram dose."[33] How dangerous talc products were, then, depended on what one used to measure risk.

Industry objections to research that found asbestos in talc was noted by researchers themselves. In 1976, following publications by Mt. Sinai researchers of the presence of asbestos in commercial talcum powders bought off the shelf in local stores, representatives of the CTFA visited Mt. Sinai in an apparent effort to get the institution and the researchers to qualify, if not retract, their findings. In one such meeting, the primary authors of the Mt. Sinai studies informed the industry group that they had found asbestos in 10 samples by using x-ray diffraction and transmission electron microscopy. In a memo, the Mt. Sinai authors wrote: "Dr. Langer was somewhat disgusted by the talc industry's attitude. He said the results of his work ha[d] been known to the industry for several years but nothing was done until the … results became public."[34] A few days after that meeting, the industry was partially mollified when the dean of Mt. Sinai, Thomas Chalmers, was quoted in the media as qualifying news reports claiming that "most of the talcum powder currently on the market contain[ed] asbestos." "It is the opinion of Mount Sinai's Department of Pediatrics that baby talc is a useful and safe product," he stated to WCBS.[35]

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