The Elephant in the Room Part 3 (1992-1997) 3M’s work to avoid acknowledging PFOS in our blood
Photo by Carl Bohacek©
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The Elephant in the Room: a major problem or controversial issue that is obviously present but avoided as a subject for discussion because it is more comfortable to do so [Cambridge Dictionary].
Undone Science: areas of research that are left unfunded, incomplete, or generally ignored but that….civil society organizations often identify as worthy of more research [Frickle etal 2009].
In assessing the technical viability of measuring PFOS in the blood of the general population, Part 3 (1992-1997) is unnecessary (see why in Part 1 and Part 2). Even so, it is useful to look at this time period to appreciate just how hard 3M worked to ignore The Elephant, to avoid prioritizing issues that “civil society organizations” like public health officials and the EPA would surely find “worthy of more research.”
In trace level analysis, analytical methods often have a Limit of Detection (LOD) which is defined as the minimum concentration that can be reliably detected by a method. In other words, an LOD indicates how low a level can we detect and still confidently answer the question: Is it there?
Analytical methods also often have a Limit of Quantitation (LOQ), the minimum concentration that can be reliably measured within a stated accuracy and precision, answering the question: How much is there?
When I first made my “discovery” of PFOS in the blood of the general population in 1997, all my effort was devoted to verifying the answer to the question: Is it there?Whether PFOS was present at 10 or 100 ppb didnt matter - what I had to demonstrate was that my method could accurately answer the question: Is it there?
Is PFOS in the blood of the non-occupationally exposed US population? YES
Is PFOS in the blood of baby eagles that have never left the nest? YES
Is PFOS in fish? YES
Is PFOS in the blood of people in rural Northern China? YES, at least sometimes.
Is PFOS in the blood of sheep? YES; What about Chickens? YES
Was PFOS in the blood of the US population in 1970? YES
Was PFOS in the blood of Korean War recruits sampled before the commercialization of 3M PFAS-based consumer products? NO
For reasons unrelated to science, it took months before my Is it there? method and data were accepted within 3M. Once that happened (the analysis of the Korean War recruits was pivotal), the focus of our analytical methods shifted to How much is there?
The method answering the question Is it there? was most important when we were analyzing environmental samples and samples of political or social sensitivity: blood from non-occupationally exposed humans or wildlife, samples of food purchased at a restaurant or grocery store, river water, soil from agricultural fields. Potential liability hinged on the answer to that question in those sensitive samples.
Is it there? was a less relevant question when we were supporting the various Toxicity and Epidemiology studies based on PFAS in 3M Workers’ blood. For Toxicity studies, the test animals were intentionally dosed with different PFAS so there was no question the compounds were there. So, too, in studies around 3M Workers’ blood, we knew PFOS was present in that highly exposed population. In supporting the Toxicity and Worker Epidemiological studies, we were focused on How much is there?
This distinction is important because, in the early 1990’s, when 3M finally started using LCMS* [LINK], they never developed methods designed to answer Is it there?, especially when it came to the analysis of politically sensitive matrices like environmental or human blood samples. Despite the fact that the answer to the question Is it there? is what was needed to initiate a meaningful risk assessment for global public- and environmental health, there is no evidence in the available documentation that 3M even attempted to develop an LCMS Is it there? method for PFOS in human sera prior to the work my team and I did in 1997.
For example, in 1992, 3M’s main PFAS analytical chemist (discussed in Part 2), Mr. Jim Johnson told the Fluorochemical Steering Committee he could detect 50 ppb of PFOS and PFOA in water and solvent [#2725, also see NOTE 1 below]. In 1993, he issued a report using a method with a How much is there? level of 25 ppb for PFOS in water [LINK]. Despite this success at low level PFOS analysis, I found no evidence in publicly available documents that 3M even attempted translating that work to development of an Is it there? method suitable for the analysis of PFOS in non-occupationally exposed blood (which, at the time averaged about 35ppb).
In 1994, Johnson provided data on PFOS levels in 3M workers’ blood to 3M’s Medical Department. In the published paper that includes these data, 3M cites an analytical method which is not publicly available for review [LINK]. 3M’s analytical documentation on this study is inconsistent and incomplete, with implied How much is there? limits ranging from 0 to 250 ppb [LINK, #1479, LINK, LINK].
In a 1995 study, rabbits were dermally exposed to fabric coated with a 3M PFAS. After exposure, the livers and sera of the rabbits were analysed for organic fluorine and in some cases, PFOS, to see if the dermally applied PFAS had passed through the skin of the rabbit. Dermal exposure studies were routine in 3M’s Environmental Lab. In one study, the official method has a How much is there? limit of 250 ppb PFOS in liver. However, the Study Director notes in his report that “...detectable amounts [of PFOS] are observed in the 1.28 mg/kg and fabric groups.” [LINK]
Reviewing the raw data accompanying this report demonstrates that 3M was using an unofficial Is it there? level (“detectable amount”) that was, at most, about 55ppb of PFOS in liver [LINK]. This is evidence that 3M recognized and utilized the Is it there?capability of the method (about 55 ppb), although they only formally acknowledged the How much is there? limit of 250 ppb, a level almost 5 times higher. Given that the median concentration of PFOS in the blood of the non-occupationally exposed public was 35 ppb in 1990 [LINK], 3M’s LCMS method (even without optimization) would have suitably answered the question about the distribution of PFOS in the public’s blood.
This is an example of 3M’s reluctance to formally define an Is it there? level although in practice, lower detection limits were achieved, discussed and utilized for decisions about products.
More to the point, the method referenced for the analysis of liver, above, was the same method used for analyzing sera. The method that I used as a starting point for MY investigations into PFOS in the sera of the general population in 1997 was essentially that same method used in 1995. Although ultimately my team and I optimized the method to perform with an Is it there? level of ~100 parts per trillion (ppt)-1 ppb for 14 different PFAS in sera [LINK], in 1997, when I began looking for PFOS in blood, the method functioned for me, as it did in 1995 with an unofficial (and undocumented) Is it there? level around 50ppb.
What I did in 1997, others at 3M were doing no later than 1995. They just werent documenting it or using the method on samples with social or political sensitivity, like blood collected from the public. And they definitely were not trying to optimize the method to lower the Is it there? level. [BTW, it was VERY straightforward to optimize the method and drop the Is it there? level two orders of magnitude [LINK]].
With 3M’s avoidance of sensitive research topics in mind, we can finally assess the corporation’s relationship with Dr. Jack Henion and his consulting company, Advanced BioAnalytical Services (ABS), a “GLP-compliant, premier contract research and service laboratory ” founded by Henion in 1993 [Link].
After avoiding consultation with LCMS experts for over 10 years (remember how Philip Morris got Henion on board in 1983?), at some point in the early 1990s, 3M finally hired Henion and ABS. Publicly available documents indicate that, rather than hire one of the premiere LCMS labs in the country to develop a critically important Is it there? method for PFOS in the blood of the non-occupationally exposed population, in 1995, 3M hired ABS “for composition identification and ambient temperature stability” of 6 PFAS (that is, to characterize the purity and stability in water and solvent of several 3M fluorochemicals) [LINK]. In another project, 3M hired ABS to investigate the invitro (in a test tube) metabolism of 4 PFAS exposed to rat and human hepatocytes (liver cells) [LINK]. This second study was more involved analytically, but it was not essential in defining the public health risk associated with wide-scale contamination of PFOS, which should have been a priority.
Hiring ABS to characterize composition identification and ambient temperature stability of PFAS standards is like hiring a James Beard award winning chef and asking her to make you breakfast using only eggs and salt from the local mini-mart. The scrambled eggs might be ok, but fulfilling that very limited request does not take advantage of the skills and expertise of the chef.
Prior to 3M’s TSCA 8(e) notification filed in May 1998 [#2602], I can find no documentation indicating that 3M ever hired ABS to develop an LCMS method specifically designed to characterize PFOS or PFOA in the blood of the general population or to develop a method with the goal of answering the Is it there? question about PFOS in non-occupationally exposed blood.
The question raised to 3M in 1975 by Guy & Taves’ isolation and characterization of PFOS from the blood of the general population [e.g. #1123, #1145, LINK Ex J, #1121] - the academic study that launched decades of research and executive attention within 3M - continued in the 1990’s to (officially) go unanswered. Because the question was (officially) unasked, it remained (officially) unanswered. Thus, when the topic of PFOS in the blood of the general population came up, 3M could shrug their shoulders, and continue denying the existence of The Elephant, when asked Is it there?
As a reminder, according to 3M scientists, 3M’s scientific record as relates to PFOS is intentionally incomplete: the truth may be undocumented or hidden [LINK, #2543, LINK]. 3M’s intentional subjugation of data concerning PFOS in the blood of the general population complicates the reconstruction of 3M’s history and thus, there are limits on the utility of searching through 3M documents (at least those available publicly) to find the truth. As members of the contaminated public trying to understand why it took 23 years for the company to take action on an issue with global health consequences, we’re left only with those pieces of information that were created (instead of explicitly NOT created) and those that slipped out.
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*I use the acronym LCMS to refer, generally to the technique inclusive of any form of ionization (e.g. thermospray, electrospray, ion spray, particle beam) and any form of mass spec (e.g. quadrapole, tandem quadrapole, ion trap, TOF).
[Note 1] This document states that Johnson could detect 50 parts per MILLION in water. However, 50ppm is almost certainly a typo for 50 parts per BILLION. A detection level of 50ppm was so high as to be not worth reporting. An environmental research proposal written by one of Johnson’s colleagues nearly 6 months BEFORE the meeting minutes with the typo [#1372] is based largely on studies that depend on compound-specific analytical tools capable of ppb-level detection: “...equipment and advances in analytical methods development in the 3M Environmental Laboratory show great promise in overcoming the difficulties in detecting and quantifying fluorochemicals in environmental matrices such as groundwater, soil, sediment, compost, wastewater, and plant and animal tissues. These advances in analytical methods make this proposal possible.” The research proposal would not have been viable with an analytical tool limited to 50ppm (or 500ppb, for that matter).
