More and more, especially in light of the onslaught of television ads regarding lawsuits and large verdicts, the word “talc” is a term less associated with baby powder and more with deadly toxic dust. In many ways, the media coverage of talc is similar to the decades long social conditioning regarding asbestos. Yet, for attorneys litigating these cases in a courtroom, the science underlying talc – in fact, determining what is or is not actually “talc” – is incredibly complex. Recent regulatory activity geared towards stripping away distinctions and determinations of talc based on sound scientific principles, with a parallel move to simply regulate all talc in unison, promises to make defending talc cases exponentially more difficult in years to come. Further complicating the litigation is the fact that in traditional asbestos litigation, talc companies have now become the new “target” defendants and find themselves battling allegations that “talc contaminated with asbestos” caused an asbestos related disease. Yet, in order to combat these allegations, a sound understanding of the science behind talc and talc regulation is necessary.
The Finer Things About Talc
Talc and the asbestos minerals are both silicates. Therefore, naturally occurring talc deposits are typically found in the areas of other silica mineral deposits (e.g., tremolite, anthophyllite, and chrysotile). For decades, talc miners have extracted talc ore that either contained trace amounts of other silicate minerals or the talc mine is in proximity of a schist of another silicate mineral. During the milling process, the raw ore is screened for traces of these other minerals. Talc minerals are either platy or fibrous. Platy talc looks like stacked plates under a microscope and fibrous talc is aptly named as it looks like fibers under a microscope. Platy talc ore milled for cosmetic or pharmaceutical purposes is thoroughly screened and refined into a near pure talc powder. Fibrous talc is milled to make industrial talc products.
While fibrous talc is screened for asbestos fibers, millers want the final product to be a complex mineral composition, as it is preferred for its intended applications (e.g., ceramics). Industrial talc products can be a powder that is comprised of additional minerals, including, dolomite, tremolite, anthophyllite, transitional fibers (half talc, half amphibole asbestos), and/or chrysotile. Regulators have been well aware of the relationship between talc and asbestos given the complicated regulatory history of both asbestos and talc.
OSHA’s view of Talc
In 1992, OSHA created a detailed regulatory history of talc in relation to its asbestos regulations, given that talc is commonly found to contain asbestos minerals and sometimes transitional fibers. OSHA’s summary of the regulatory timeline was:
- 1971 – OSHA’s initial asbestos regulations apply to asbestiform and non-asbestiform.
- 1972 – OSHA’s update – “fibrous talc” (contains tremolite) is asbestos.
- “Non-asbestiform talc” (platy talc) not regulated as asbestos.
- 1974 – OSHA clarifies that all non-asbestiform asbestos is not regulated.
- Talc found to contain asbestiform asbestos remains regulated.
- 1977 – OSHA rescinds clarification – non-asbestiform asbestos regulated, again.
- 1980 – NIOSH issued its study on talc miners that linked industrial talc to mesothelioma.
- NIOSH stopped supporting this study as of its April 2011 Roadmap.
- 1992 – OSHA excludes non-asbestiform from asbestos regulations (current regulation).
- Transitional fibers are also excluded from asbestos regulations.
- MSHA, EPA and CPSC already have excluded non-asbestiform.
- 2011 – NIOSH Roadmap finds non-asbestiform asbestos does not cause mesothelioma.
- This finding is attributed to epidemiological review of New York talc.
It is apparent from just the descriptions that regulators adapted to the understanding of how the meaning of asbestos minerals and talc changed over time. OSHA identified fibrous talc as talc with tremolite, instead of the name for a specific form of talc.
How Scientists Identify Talc
The methodology and protocols for identification and differentiation between the asbestiform and non-asbestiform of a single asbestos mineral is difficult and requires a scientist to make a judgment call in the end. To complicate matters, the methodology and protocols for differentiating between asbestos minerals and talc is also a subjective determination by the scientist. The differentiation between talc and asbestos mineral is particularly difficult given transitional fibers are half fibrous talc and half amphibole asbestos mineral. “Nature’s Curveball” had been misidentified as asbestiform anthophyllite and tremolite minerals for years before microscopy techniques improved and protocols were adapted for identifying these rare minerals. It should come as no surprised that the asbestos regulations (as applied to talc) have evolved and reverted considerably since 1971. A reliable mineral identification requires a very high level of precision. Unfortunately, such small margins for error allow for exploitation in litigation.
Mineral identification and differentiation involve Polarized Light Microscopes (PLM), Scanning Electron Microscopes (SEM), and Transmission Electron Microscopes (TEM). The proper methodology is to use all three types of microscopy to make the most reliable mineral identification. Precision is of the utmost importance given even the smallest differences in data at any stage can lead a scientist to an unreliable identification of mineral and/or its form. For instance, PLM would not be used to analyze indices of refraction, TEM would not be used to determine the fluoresce of a mineral particle, and SEM would not be used to characterize the aspect ratios of a sample population. There are many more ways that expert witnesses can finesse data to make their desired conclusions appear credible to the average juror. The nuances of protocols that impact the precision of the results allow for experts to manipulate the data just enough to make fibrous talc appear to be chrysotile or anthophyllite asbestos to a juror without overtly exposing the expert witness to a Daubert challenge. These are well-settled issues among regulators and the scientific community that have unfortunately been blurred or suppressed for pecuniary gain in courtrooms.
The Impact of Regulatory Action
The exploitation of methodology emphasizes the importance of regulators to continue their role as objective identifiers and enforcers of what is and is not toxic. Given NIOSH’s Roadmap issued in April 2011, it should be well settled by now that platy talc and industrial talc does not cause mesothelioma (unless it contains asbestiform asbestos). Furthermore, the developing epidemiological studies on ovarian cancer are diminishing any notions that it is caused by talc. It should be interesting to see how regulators interpret these studies to regulate talc for its different purposes. Specifically, interested parties should watch to see what levels are set by regulators for cosmetic and pharmaceutical grades of talc. This is especially true given that the FDA’s recent actions likely contributed to lawsuits and the public pressure that caused a leading talc powder manufacturer to recall its talcum powder product, even though tests showed that the product only contained sub-trace levels of chrysotile that were well below regulatory standards.
The attorneys at CMBG3 Law LLC have represented clients in talc, products liability, and toxic tort matters for many years. We provide the most current advice by staying informed of legal, scientific and medical developments regarding a wide variety of substances and products, including talc-containing products, used by consumers every day. If you have any questions or would like more information, please contact Clifford V. Pascarella II (email him or call 617-279-8234).