1976
A retrospective cohort study of vinyl chloride workers was published by Waxweiler, et al, in Annals of the New York Academy of Sciences (ANYAS).
The Waxweiler study had found excessive number of deaths due to cancer in the liver, lung, central nervous system and the lymphatic system, cancers that were, basically, of the same pattern as those detected in the animal studies. The evidence, both epidemiological and histopathological, was interpreted as indicating that vinyl chloride was the causal agent involved.
The observation of the carcinogenicity of vinyl chloride, first in animals and subsequently in man, was said to provide strong support for the need for conducting animal bioassays prior to introduction of chemicals, and other agents, into the industrial or community environments.
1/11/76
On January 11, 1976, the VCRC met at the MCA Conference Room in Washington, D.C.
1/15/76
On January 15, 1976, Rolling Stone magazine published “The Plastic Coffin of Charlie Arthur.”
1/26/76
On February 26, 1976, Thomas Nantz, Executive VP of BF Goodrich, wrote a letter to the editor of Rolling Stone in response to article: “The Plastic Coffin of Charlie Arthur.”
4/27-28/76
On April 27, 1976, the VCRC met at the Crystal City Marriott Hotel in Arlington, Virginia.
The Panel received information about a new CDC study concerned with the potential relationship between vinyl chloride exposure and birth defects. The Group concurred that, even without evidence at odds with the reported positive findings, there was no need for additional animal testing or epidemiologic studies.
The better procedure was to attack positive studies instead of performing legitimate science of their own that might either verify or call into question the hypotheses of a causal connection between VCM exposure and birth defects resulting from the independent studies. (The authors of the studies never suggested that their studies were conclusive, but that they only demonstrated the need for additional research in order to investigate the hypothesis their studies had generated.)
On April 28,1976, the Vinyl Panel met at the Crystal City Marriott Hotel in Arlington, Virginia. Although Dr. Gaffey was not formally employed by EEH at the time of the meeting, he represented their interests as successor to TCA.
5/18/76
At some time before May 18, 1976, the MCA-coordinated vinyl manufacturers learned of reliable studies that had recently been reported by Mt. Sinai demonstrating a relationship between vinyl chloride exposure and air-ways disease in exposed PVC workers.
6/17/76
On June 17, 1976, the VCRC met at the MCA Conference Room in Washington, D.C.
6/18/76
By June 18, 1976, there was an increasing recognition among the members of the MCA Vinyl Chloride Research Coordinators that there was a need for additional epidemiologic studies of vinyl workers, and that it was evident that the gaps in the knowledge of the biological effects of VCM were not soon likely to be filled. It was recognized that most of the biological and biochemical work on vinyl chloride that had been published was of the ‘quick and dirty’ variety and published in the turmoil that followed the public disclosure of human angiosarcomas at BFG Louisville.
While this was fine for early and quick approximations, the MCA Group recognized the quick and dirty studies were inadequate for development of soundly-based strategies aimed at preventing harm to exposed populations.
The MCA Group recognized that there were sufficient questions about the published work on reproductive effects and about the supposed chromosomal effects to warrant careful review and evaluation – and perhaps even some additional studies.
The MCA Group recognized that even the available epidemiological work present had amply demonstrated an association between high exposures to VCM and an increased rates of angiosarcoma of the liver, as well as brain and lung tumors.
7/16/76
On July 16, 1976, the Chairman of the Vinyl Panel (Torkelson of Dow) wrote to Milton Freifeld (MCA) that the MCA Safety and Fire Protection Committee had requested the revision of Chemical Safety Data sheet SD-56 for vinyl chloride.
Dr. Torkelson concluded that the Vinyl Panel had already decided that SD-56 ought not be revised or reissued.
September 1976
In September of 1976, Equitable Environmental Health, Inc. (EEH, a wholly owned subsidiary of the Equitable Life Assurance Company), had submitted another report on the expanded database the MCA-coordinated vinyl manufacturers had assembled to augment the May 3, 1974 report submitted to OSHA.
The results of the new EEH study from September 1976 was understood as having confirmed the earlier reported association of various cancers with vinyl chloride exposure. Both cancer of the digestive and respiratory systems, as well as other and unspecified sites, were found to be in excess, which was mostly old news; however, the study also was interpreted as showing a dose-response relationship between vinyl chloride exposure and cardiovascular-renal diseases was not old news. However, the MCA Group would suppress the September 1976 EEH report; the most likely reason the September 1976 report was suppressed by the MCA-coordinated vinyl manufacturers since the time it was originally issued.
9/23/76
On September 23, 1976, the OHC met at the Royal York Hotel in Toronto, Canada.
The OHC decided that since OSHA no longer relied on consensus standards, there was no longer any reason for the OHC to continue liaison with ANSI.
9/23/76
On September 23, 1976, the OHC[69]) met at the Royal York Hotel in Toronto, Canada.
10/12/76
On October 12, 1976, the VCRC[70]) met at the MCA Conference Room in Washington, D.C.
10/13/76
On October 13, 1976, the Vinyl Panel[71] met at the MCA Conference Room in Washington, D.C.
11/ 5 - 16/76
Between November 5 and 16, 1976, an extensive critique of the September 1976 EEH report was developed by the VCRC through R.N. Wheeler and Carol Weil (both from Union Carbide), and W.D. Harris (from Uniroyal).
The changes recommended were substantive and replaced the views of the independent contractor with those of the sponsor. Particularly obnoxious was the so-called “lumping together” of copolymer resin with VCM workers into one group, despite the fact that it was the MCA-coordinated vinyl manufacturers themselves that had required this trifurcated classification system be adopted.
The increased mortality for the VCM / copolymer workers was probably good enough reason for the MCA-coordinated vinyl manufacturers to suppress the September 1976 report, in and of itself.
The criticisms directed the contractor to make conclusions that they had not made and delete information from tables that the sponsors didn’t want. The sponsors did not like the discussions of the studies demonstration of a dose-response curve for all causes of mortality either. There were many other significant editorial changes, including references to increased risks of lung cancer, leukemia, lymphomas, other and unspecified sites, digestive cancer, and of all malignancies.
11/30/76
On November 30, 1976, MCA met with Drs. Gaffey and Siegel to discuss the EEH draft report of September 1976.
11/30/76
On November 30, 1976, the VCRC[72] met at the MCA Conference Room in Washington, D.C.
12/8/76
On December 8, 1976, the OHC[73] met at the MCA Conference Room in Washington, D.C.
12/13/76
On December 13, 1976, MCA (Friefeld) wrote EEH on changes that they would like to see in report, incorporating comments from previous two memos and from the November 30, 1976 meeting of the VCRC.
Instead of using two sub-groupings, based on plants producing only PVC and all other plants, the new report would cover only one group with 9,677 members.
The analytic methods employed in the report (the methods called for in the March 20, 1975 protocols) were said to be “statistically misleading.”
The following substantive modifications of the report were said to be necessary in order to “clarify” the report and prevent it from being “statistically misleading”:
combining tables 3 and 4,
b) deleting the last 4 columns of table 5,
c) combining tables 6 and 7,
d) combining tables 8-18 with 19-24,
e) combining tables 25 and 26 with 27 and 28,
f) omitting column on type of facility and including estimate of exposure (high, medium, low) in tables 29 and 30.
A so-called draft was to be written by EEH reflecting the above changes. In this connection, EEH was furnished with the comments on the report the Vinyl Panel had received from reviewers, Mr. Wheeler, Mr. Weil, and Mr. Harris, as well as from Dr. Bell (BFG) and Dr. Smith (Air Products).
The sponsors also wanted EEH to refer in its report to the so-called opportunity for prior review by government agencies supposedly had with regard to the study based upon a July 18, 1975 letter from Mr. A.C. Clark (MCA) to personnel of the NIEHS, NIOSH, National Cancer Institute (NCI), EPA and OSHA.
Since the charge to EEH was, basically, to rewrite and re-tabulate the entire study, the MCA-coordinated vinyl manufacturers knew that it was not covered by the MCA agreement with TCA dated June 18, 1973.
1977
NIOSH reported a cross-sectional study finding that liver disease, central nervous system disease, hypertension and miscarriage were more prevalent in vinyl chloride workers.
1/24/77
The CMA-coordinated vinyl manufacturers received letter ballots specifically addressing whether the previous EHA final report should be modified so as to incorporate the numerous critical substantive changes to the EHA final report that the CMA group had dictated.
3/8/77
On or about March 3, 1977, the CMA Board resolved to support a creation of a national network of similar (against the) public interest law firms, that would nevertheless appear to be "independent."
In 1973 the Pacific Legal Foundation (PLF) had been founded by industry groups, including companies represented on the Vinyl Panel as a direct industry response to the creation of true public interest firm such as Ralph Nader’s Public Citizen, National Resources Defense Council (NRDC), and the Sierra Club.
These falsely independent appearing “grass roots” type legal organizations were to be created through a coordinated plan implemented by the National Legal Center for the Public Interest (or “NLCPI”).
The NLCPI was a national organization created specifically in order to generate a network of what was intended to appear as independent legal foundations.
The CMA-coordinated vinyl manufacturers understood that the purpose for supporting the NLCPI was in order to establish what would appear to be, but were not actually, independent regional foundations, all intended to represent the interest of the chemical industry in litigation and to form a litigation strategy for the industry.
All of these so-called independent public interest firms the NLCPI created as part of a single systematic and concealed effort were not truly independent, even of each other, since all of them were originally founded by the NLCPI, all of them were modeled on the Pacific Legal Foundation, and all had agendas favoring the American chemical industry.
3/11/77
On March 11, 1977, Dow Chemical agreed to assume financial liability for the re-grouping of critical cohorts in the EEH study as set forth in the January 11, 1971 correspondence from EEH.
The Chairman of the vinyl panel (Dow’s Ted Torkelson) caused Dow to front the money for the rest of the panel members in order to expedite the implementation by EHA of the substantive changes to its previous final report(s).
April 1977
In April of 1977, EEH was ready with another so-called final report entitled “Supplementary Epidemiological Study of vinyl chloride Workers II, Final Report.”
The successive additions to the study population and the improved follow-up had been accompanied by a rise in the overall Standardized Mortality Ratio (SMR) from 75 to 89. Even after analyzing the data the new way that the MCA-coordinated vinyl manufacturers had required, there still remained what was referred to as an “unexpected finding” in the relatively high death rates for cardiovascular disease and renal disease.
Documenting cardiovascular disease in vinyl chloride workers was particularly disagreeable to the MCA-coordinated vinyl manufacturers.
For this and other reasons, the MCA-coordinated vinyl manufacturers had to suppress the April 1977 EEH study, as the others had been, and would continue to be, until the time of the February report (back) dated January 1, 1978.
4/1/77
The MCA issued a revised chemical safety data sheet (SD-56), which was designated as a final draft.
4/1/77
On or about April 1, 1977, the CMA-coordinated vinyl manufacturers became aware of the published medical use of hand thermography for use in the assessment of early injury in vinyl chloride workers. Neither these nor any other potentially useful methods of so-called early detection were widely adopted by the CMA-coordinated vinyl manufacturers between 1974 and the present.
4/5/77
On April 5, 1977, the CMA, on behalf of member companies, supplemented its February 17, 1977 testimony before the National Advisory Council (NAC) of OSHA with its specific commitment to protect workers in the chemical industry from known occupational hazards.
However, the CMA’s testimony provided that unspecified qualified experts had studied the problem also, and were presumably competent enough, and possessed sufficient knowledge to see the subject, to view occupational cancer in its proper prospective, i.e., that occupational cancer was not a major public health concern.
4/6/77
On April 6, 1977, Dr. Clark Cooper of EEH wrote Dr. Torkelson, in his capacity as Chairman of the MCA Vinyl Panel, stating that the April 1977 report incorporated many of the comments that had been received from the MCA-coordinated vinyl manufacturers.
The purpose of the letter was to describe the deficiencies EEH and the sponsors recognized in private, but which were not acknowledged in the report itself. The thought was that many of the things identified in the letter would probably occur to other reviewers and it would have been a good idea to provide the mutual enemies of EEH and the MCA-coordinated vinyl manufacturers with as small a target as possible.
For one thing, Dr. Cooper pointed out that while the September 1976 draft included data on “PVC only” plants, the current study did not. Since it was generally acknowledged that individuals engaged in PVC reduction had higher exposure to VC than those engaged in making the monomer, omission of a table limited to PVC production was just going to be criticized.
The data was available and the MCA-coordinated vinyl manufacturers knew that they might be criticized for not including it, but they removed reference of it anyway.
The report did not contain an adequate description of methods. The report needed a description of the plants that were involved, how many made only VCM, how many made only PVC, how many made both VCM and PVC, how many made other polymers, the geographic distributions, etc. Information on when each plant began VC operations should have been provided showing when periods of observation began with respect to those dates, person‑years of observation by plant. Since the characteristics of the three plants added in the second phase were not given, i.e., whether they were VCM, PVC, or whatever, it was impossible to predict how they might have changed the mix. Similarly, the type of exposures experienced by the last increment of 1,110 workers was not specified, so no one was ever going to be able to answer any questions truthfully about how the 1,100 worker increment from Carbide South Charleston might have diluted the study population, since it was generally acknowledged that individuals engaged in PVC reduction had higher exposure to VC than those engaged in making the monomer.
Omission of a table limited to PVC production would undoubtedly be criticized. Data on the rate of disease in “PVC only” plants was available in the suppressed September 1976 TCA final report everyone referred to as a “draft” a year later.
Cooper thought that the final report ought to include certain basic tables, which were in the initial report and made the study more intelligible to the epidemiologist. These included distribution of birth‑years, years since first employment, and a year‑of‑birth and year‑of‑observation table showing person‑year distributions. Hire dates, death dates, and integrated exposures should also be included in the tumor case lists. The foregoing were said not to not require new calculations, and if included, in Cooper’s opinion, would clearly improve the report.
Another point was considered more serious. This related to the grading of “low,” “medium,” and “high” exposures on a 1, 2 and 3 scale. The MCA-coordinated vinyl manufacturers knew there was no factual basis for any numerical scale, and that the scale used might be blurring quantitative relationships. Also, it was not justifiable to equate a recent high exposure with one 20 or more years ago, in view of the latency aspect of the onset of vinyl chloride-related disease; a high-integrated score picked up in the 70’s was not the same as one picked up in the 50’s.
6/9/77
On June 9, 1977, EEH proposed that it be allowed to make a presentation of its report to the scientific community in San Francisco in September when the Occupational Health In The Chemical Industry (Medichem) Group held its fifth International Conference.
The Chairman of the Occupational Health In The Chemical Industry (Medichem) Group was Dr. D.J. Kilian of Dow Chemical Company.
Dr. Cooper was prepared to present the EEH paper with the concurrence of the Manufacturing Chemists Association.
In addition EEH proposed another project to show that the dangers of vinyl chloride for angiosarcoma were exaggerated in 1974, as EEH neared completion of it’s Final Report of the Mortality Study of vinyl chloride Workers. Dr. Cooper and Ted Torkelson (Dow) agreed that this study should be reported to the scientific community through an appropriate medium. During this time, Dr. Cooper made it known that he proposed to use the paper as a forum to show what a farce the whole “angiosarcoma epidemic” and “vinyl chloride catastrophe” had proven to be. (At least once the disease was defined as limited to a very rare ASL.)
The proposal from Dr. Cooper even took a swipe at Dr. Wagoner. In the Annals of the NYAS, Dr. Joseph K. Wagoner was quoted as estimating that as many as several hundred thousand workers in the United States may have been exposed to vinyl chloride in the workplace alone. It was not known how many tens of thousands of people exposed to vinyl chloride as a result of everyday living in near proximity to a facility where vinyl chloride or polyvinyl chloride had been made. Neither was it known how many hundreds of thousands of people have been exposed to vinyl chloride as a result of using aerosol sprays that employed the chemical as a propellant and solvent. Dr. Cooper obsequiously recounted that the experience during the past three and one‑half years did not indicate such emotional and extravagant statements were warranted.
In January of 1974, no statistics were available on the extent of angiosarcoma in the general population.
EEH proposed that the MCA fund a literature search and appraisal covering the past four years, to include both the scientific literature and the public and trade press. After all, EEH had been filing final reports since 1975, and had never done a literature search for any of the papers before. EEH proposed that it be paid to prepare the EEH paper for presentation at the Medichem meeting in September in order to, as Dr. Cooper put it, set the record straight.
The paper would also present the opportunity to address the “crisis” approach to occupational and environmental health.
Dr. Cooper advised that the industry owed no apology for past failures to control harmful exposures, and hoped to place such risks in perspective.
4/12/77
By the late 1970s, as exemplified by CMA’s response the benzene Emergency Temporary Standard "ETS," it was the practice for the MCA to conceal the coordinating role it played in formulating industry responses to so-called “Single Product Problems”, (like VCM) by responding to government regulations collectively, but nevertheless on a company-by-company basis.
Part of the concerns related to the potential for such activities to be considered violations of the U.S. antitrust laws.
Prior to the late 1970s, the chemical companies coordinated by the CMA were aware that the government was still ignorant of, and therefore paying relatively little attention to, chemical emissions that occurred in the course of start-up and shut-down operations, emergency releases, and fugitive losses at chemical manufacturing facilities.
At the same time, the MCA coordinated chemical companies were further aware that such unaccounted for and unregulated losses of chemicals were actually as large as normal chemical emissions that governmental control agencies knew about and concentrated their regulatory efforts in controlling losses were estimated.
Because the parties properly recognized that a failure to report known losses could be construed as an ongoing and longstanding violation of the law, the CMA board warned member companies that these government control agencies had begun to notice the effect of this gross underestimate of the emission of toxic chemicals from manufacturing plants into the ambient environment.
August 1977
Equitable Environmental Health (EEH) presented yet another so-called final report entitled, “Environmental Study of vinyl chloride Workers Final Report,” dated August 1, 1977.
The successive additions to the population and the improved follow‑up had been accompanied by a rise in the overall‑cause Standardized Mortality Ratio from 75 to 89. Unfortunately, again, the major change was the increase in the SMR for major cardiovascular and renal disease.
EEH stated that there was less support for the hypothesis that vinyl chloride was a “weak general carcinogen” than there was in the report by Tabershaw & Gaffey (1974). However, even EEH still claimed they couldn’t yet rule out that VCM had a weak carcinogenic action in a number of sites besides the liver.
Indeed, EEH referred favorably to a recently study from Great Britain by Fox and Collier (1977) that claimed to find no evidence to support the hypothesis that cancers, other than those of the liver, were associated with exposure to vinyl chloride MONOMER. (But, what went unsaid was that they didn’t find any angiosarcomas either.)
EEH still referred to the relatively high ratio of deaths attributed to cardiovascular and renal disease as an unexpected finding, and concluded that because there was no apparent relationships with duration or intensity of exposure as defined in the study, there was no basis for relating the cardiovascular disease to vinyl chloride per se.
8/18/77
On August 18, 1977, Dick Davis, Regional Director of EEH, provided the most recent August 1, 1977 final report to the Vinyl Panel (Torkelson).
(Remarkably, as will be shown, EEH actually issued two different reports bearing the date August 1, 1977; this one was the first.)
As soon as the MCA review committee told EEH what additional changes MCA wanted to this report, EEH could produce the real final final report.
8/24/77
On August 24, 1977, Wheeler (Carbide) wrote to Dr. Torkelson about the (first) August 1, 1977 TCA final report.
Dr. Wheeler expressed his expert opinion that EEH should accentuate the positive, discuss the in between, and not try so hard to accentuate the negative. Dr. Wheeler was in favor of winding up this study quickly, even if it meant accepting the report as was.
Wheeler further observed that the most apparent conclusion was that epidemiology, as presently practiced, was too gross a tool to pinpoint a vinyl chloride problem with any certainty.
8/31/77
On August 31, 1977, Research Coordinator, Dr. W.D. Harris, wrote the Vinyl Panel alerting them that the comments by Nick Wheeler had all been germane.
However, like Mr. Wheeler, Dr. Harris felt that it was time, at last, to issue a report from EEH. It was proper that the report be low-key. It was up to industry to know how to use it. Harris emphasized Using the need for the MCA-coordinated vinyl manufacturers themselves to use the low-key EEH report dated August 1, 1977 (the first one) to show that VC had turned out to be much less of a problem than first feared and to put the whole carcinogen problem in better perspective.
September 1977
In September of 1977, the CMA sponsored a Workshop On Safety and Health in the Chemical Industry in New Orleans, Louisiana.
9/2/77
On September 2, 1977, Torkelson wrote other members of the Vinyl Panel, enclosing Wheeler’s “accentuate the positive” letter view.
Torkelson thought the language in the EEH report might better read “is less support than previously for view that vinyl chloride was a weak carcinogen.” Dr. Torkelson also thought the report should include a discussion of the so-called insensitivity of the epidemiologic approach EEH had taken (the “SMR approach”).
9/2/77
On or about September 2, 1977, the MCA (A.C. Clark) wrote the MCA-coordinated vinyl manufacturers notifying them of the Vinyl Panel’s option to – get, yet another, final report from EEH after all.
Clark reported that it was the view of Vinyl Panel members that the value of the EEH report would be greatly enhanced by a regrouping of so-called critical cohorts thereby providing a, so-called, more valid statistical analysis of the, so-called, data.
However, suppressing the previous August 1, 1977 report, and getting a new one, was undeniably a new study, and new studies cost money, in this case $10,500, that could easily be paid from funds already available to the Vinyl Panel.
9/8/77
By September 8, 1977, Vinyl Panel members were aware of a discrepancy between the five angiosarcomas picked up by the EEH report and the, at least, 21 documented angiosarcoma cases that had elsewhere been identified in the U.S.
9/15/77
At some time prior to September 15, 1977, each MCA-coordinated vinyl manufacturer completed a reply form that had been attached to the MCA’s September 2, 1977 letter in order to express each company’s preference with regard to killing the old study and funding a new one with its new, re-grouped, critical cohorts.
10/8/77
On 10/8/77, the European vinyl industry, including ICI, Ltd., influenced the publication of an article published in the open literature, entitled, “Angiosarcoma of the Liver in Great Britain 1973-83.
The article reported that only four angiosarcoma cases were reported a year, on average, in Great Britain, and two-thirds of them weren't really angiosarcomas at all, but had been misdiagnosed as angiosarcomas.
Out of the few remaining cases, only one single angiosarcoma case was reported to have been actually associated with exposure to vinyl chloride through the entire time between 1963 and 1973!
In one fell swoop, the angiosarcoma problem was all but eliminated in the Great Britain.
(And, as a result of undue influence by ICI and the European vinyl manufacturers, angiosarcoma was the only occupational cancer recognized as causally associated with vinyl chloride exposure in the United Kingdom, leaving the officially recognized death toll from vinyl chloride related cancer in the U.K. at a grand total of, exactly, one!)
10/11/77
On 9/22/77, MCA (Driver) wrote to EPA claiming that there was no compelling evidence for vinyl chloride to be regulated under the Clean Air Act amendments of 1977.
10/13/77
Monsanto (J. L. Striver) sent a memo to employees at Monsanto’s Springfield/Indian Orchard facility concerning occupationally related deaths.
10/20/77
On October 20, 1977, Dr. Torkelson (Dow) wrote MCA (Seawell) informing MCA that EEH had taken care of the issues that Torkelson had raised with them in his September 28, 1977 letter and that the new draft was acceptable.
The attached October 12, 1977 letter from Richard L. Davis of Equitable Environmental Health (EEH) indicated that questions raised in Torkelson’s letter to Clark Cooper on September 28 had been taken care of satisfactorily.
Torkelson’s letter had directed that when the report was distributed to the Panel, it should include a request that each company be prepared to vote on accepting the report at the next Panel meeting on January 5, 1978.
10/12/77
On October 12, 1977, EEH informed the Vinyl Panel (Torkelson) that, with the assistance of Dr. Clark Cooper, EEH had edited the final report on the Mortality Study of vinyl chloride Workers in line with the suggestions contained in Dr. Torkelson’s letter of September 28.
The letter from EEH responded in sequence to the comments of the Research Coordinators.
11/1/77
MCA (Seawell) reported that even the previous "final" EHA report had not been accepted by either the VCRC or the vinyl panel, and the vote would not be until January 12, 1978.
Dow had guaranteed the EEH contract the Panel had determined was of such importance to the chemical industry for the modification of the previous final report from EEH.
Management contacts subsequently approved, after-the-fact, the additional payments to EEH and agreed to reimburse Dow for its previous prepayment to EEH.
11/1/77
MCA (Seawell) wrote the VCRC and Vinyl Panel, advising them that questions raised by the VCRC pertaining to the findings and conclusions expressed by EEH and its previous final report had been resolved, and that this version of the EEH final report had finally been accepted.
11/10/77
In the November 1977 Issue of the Journal of National Cancer Institute (JNCI) reported a case control study that had found statistically significant (P < 0.02) findings for an association between indirect modes of exposure (including non-occupational exposures), including five angiosarcoma cases reported in individuals living closer to PVC fabrication or polymerization plants than did the matching control group. One of the cases lived only 500 feet, while others lived within 4,500 feet from the plants involved.
11/21/77
At some time prior to November 21, 1977, the American Industrial Health Council (AIHC) was chaired by a member of the CMA Board of Directors.
The AIHC was created with a specific intention that it should maintain an appearance of independence from industry and other private interests. However, in fact, the AIHC was founded as an inter-industry task group for the specific purpose of combating the OSHA generic carcinogen regulations that had been recently proposed. The AIHC was actually the result of a joint effort on the part of MCA, the Society of Organic Chemicals Manufacturers Association (SOCMA), as well as other trade associations.
Indeed, the staff support, as well as the legal counsel for AIHC, was provided by SOCMA and charged to develop information to assist chemical companies prepare to testify before congress.
The Board of Directors of the CMA conducted a survey indicating that, exaggerations made in the course of industry generated “tort reform” propaganda notwithstanding, a recent survey of CMA companies had indicated that product liability was not considered a major problem for American chemical companies.
At some time prior to the November 21, 1977 meeting of the CMA Board of Directors, twenty-nine companies, including founding member, Mr. Richard Fleming, from Air Products, and other CMA-coordinated vinyl manufacturers founded the Chemical Industry Institute of Technology (CIIT) with a 20 million dollar, three-year, commitment with a staff of seventy-five employees whose objective was to increase industry’s collaboration in the conduct of toxicological testing.
At some time prior to 11/21/77, CMA entered a contract with the Franklin Institute Research Laboratories (FIRL) to provide MCA with information necessary for it to update the safety data sheets (such as for example SD-56).
On or about the 11/21/77 Board of Directors meeting, CMA made the seeming good faith prediction in communications with the EPA that a legal requirement for companies to notify EPA reports of substantial risk arising from exposure to chemical products under TSCA 8(e) would cause inefficient over-reporting to EPA and serious internal difficulties for the chemical industry.
As will be shown, subsequent to the adoption of TSCA 8(e), the CMA-coordinated vinyl manufacturers would, in fact, almost always, under-report information they received concerning reports of substantial risks that they received on pertaining potential adverse health effects of vinyl chloride.
Collusive (but consistent) bad faith “interpretations” between the CMA coordinated companies would encourage individual companies to join in what amounted to the American Chemical Industry’s collective disregard for the reporting obligations set forth in TSCA 8(e).
Monsanto (Roush) wrote NIOSH (Spirtas), enclosing comments on the NIOSH draft report analyzing mortality data from Monsanto’s manufacturing facility in Springfield/Indian Orchard, Massachusetts.
12/1/77
Dr. Viola published “Carcinogenicity Studies on Vinylidene Chloride,” in Environmental Health Perspectives.
12/14/77
On December 14, 1977, almost four years after the MCA-coordinated vinyl manufacturers promised to revise SD-56 following discovery of angiosarcomas in PVC workers at Louisville, Kentucky, the SFPC (whoever was responsible for assembling the safety data sheets) expressed an intention not to give high priority to the preparation of a revised SD-56.
Dr. Jay Young was the technical coordinator with responsibility for SD-56 in the mid to late-1970s.
As will be shown, it was Dr. Jay Young who resided over the termination of the entire safety data sheet program at CMA, because of a normal but unwritten policy, MCA would never place any warning of chronic (as opposed to acute) hazards on any labeling suggested through MCA. (However, the official policy of the MCA, set by its Labeling and Protective Information Committee (LAPI) in 1970, specifically required warnings to contain references to chronic hazards.)
The rationalization for the pretext for this abominable decision was as cynical as the unwritten policy was fraudulent. The decision not to place warnings on the MCA labels contained in MCA publications, a pretext for terminating the safety data sheet informational program, was not due to concern for difficulties in keeping up with federal regulations, but rather even a more preposterous excuse.
According to this pretext, the intent of the MCA/CMA safety data sheets was to provide information about what should be done at the site of a spill (this having become an important issue after 1974, but certainly not earlier).
Because the safety data sheets were supposedly based upon warning about spills, the only hazard information that should be included on the safety data sheets, as ordered, was to warn of the “effects of the cleanup,” and not the effects of the chemicals involved.
At some time prior to December 14, 1977 (and probably long prior to this date), activities like those that occurred at this time seem to be what the MCA and OHC had in mind back in the 1960s.
By December 14, 1977, the Subcommittee on Outside Organizations had the specific responsibility of monitoring the participation of MCA representatives participating in outside organizations.
The MCA Board discussed the MCA’s cooperation in an inter-committee group that had been formed by sections of American industry’s opposition to the then proposed OSHA Generic Cancer Proposal (OGCP). MCA’s statement was to include a key part of the AIHC position on the proposed OGCP.
As previously shown, the IAHC was founded and funded by the MCA, notwithstanding its independent sounding, almost patriotic, title.
By December 14, 1977, the CMA was aware that its slogan – the slogan implying that every chemical can be used safely if proper precautions were taken was admitted to be misleading by the CMA since it was not true that all chemicals can be used safely if proper precautions were taken.
12/30/77
By approximately December 30, 1977, the MCA furnished the Vinyl Panel with a copy of a recent article presented at the 1977 American Public Health Association (APHA) meeting, entitled “Birth Defects in a Community Located Near a PVC Plant.”
The authors considered that their study of communities in Laval, Quebec did concur, in part, with those in the American studies that had demonstrated higher birth defect rates, although the variety of other pollutants in Shawinigan, Quebec founded the analysis and prevented a positive link to any particular pollutant, whether it was vinyl chloride or any other teratogenic agent. However, the authors found that in seven of the nine years covered by the study, the frequency of congenital defects was higher in the exposed community and that both sexes were effected equally.
The need for further research was emphasized.
The SPI and MCA would often refer to this paper in the reviews of the literature on this subject they would publish in years to come.
1978
In 1978, David D. Doniger published an article in the Ecology Law Quarterly, entitled “A Short Course in the Law and Policy of Toxic Substances Control; A Case Study of Vinyl chloride.”
In this study (which was not unknown to the CMA-coordinated vinyl manufacturers and was collected and disseminated by companies, like Dow, who never made any known attempt to correct misstatements contained therein).
At some time between 1974 and 1978, the MCA-coordinated vinyl manufacturers misinformed Judy Pitcher, Acting Director, Division of Special Economic Studies, at the Consumer Product Safety Commission (CPSC) that because of increases in the price of vinyl chloride (and for no other reason), sometime in late 1973, or early 1974, all of the manufacturers of aerosol products stopped using vinyl chloride as a propellant, and that there was no evidence to support any speculation that those companies cessation of vinyl chloride use just prior to the discovery of angiosarcoma in humans at BFG Louisville that had been motivated by insiders’ information about the cancer hazard.
A single set of minutes for the VCRC from January 30, 1983, is sufficient to show that the unknown vinyl industry insiders who provided this information (and similar information elsewhere) did so with wanton and reckless disregard for the truth of what they were saying about the American producers’ use of vinyl chloride in aerosols.
At the January 30, 1973 VCR meeting, the MCA actually compared the value of avoiding what was dramatically described as “unlimited potential product liability claims” with advantages that the industry’s withdrawal from the aerosols market would likely bring, i.e., “premature attention on industrial hygiene aspects of the problem.” (If aerosols had been taken off of the market, someone, a customer perhaps, might have asked why and could not be told that the reason was the manufacturers’ secret knowledge that cancer had been discovered at levels over two times longer than were allowed under current OSHA standards and far lower than would be received in the course of and in an ordinary use of vinyl chloride propellants.)
In fact, in 1971, the industry considered the possibility of studying beauticians instead of vinyl chloride workers, out of recognition that their exposure to vinyl chloride was at least as high as those of the industry’s most heavily exposed PVC workers, and would be fairly easy to identify.
January 1978
The EEH final report entitled “Epidemiological Study of vinyl chloride Workers, Final Report” was actually completed in February 1978 when the second version of the August 1, 1977 update was revised again and back-dated to January 1. However, as this is the date on the published report, plaintiffs will refer to it with the January 1, date.
1/3/78
At a VCSA meeting held January 3, 1978, the MCA-coordinated vinyl manufacturers discussed the fact that a target organ for VCM was the circulatory system, specifically including the linings of small blood vessels (arterials) and not, as they knew was commonly misunderstood, specific sites such as the liver and the lungs. This explains why vinyl chloride first attacks the “fingers” with Reynaud’s Syndrome and why acroosteolysis only follows when the bones begin to dissolve as a result of the degeneration of the blood vessels that were supposed to supply the bone with blood.
Similarly, vinyl chloride was also reported to cause cirrhosis and enlargement of the spleen because constricted and blocked blood vessels increased back-pressure.
Remarkably, the mortality studies conducted by the MCA-coordinated vinyl manufacturers have consistently shown statistically significant deficits in mortality due to cirrhosis; yet, notwithstanding the open recognition of facts such as those discussed at this January 3, 1978 meeting, the discrepancy between the known facts about vinyl chloride and the reported facts referred to in the MCA-coordinated vinyl manufacturers’ studies had never been disclosed as having any potential significance.
1/11/78
On January 11, 1978, the VCRC, in the course of discussing the EPA National Emission Standards for Hazardous Air Pollutants (NESHAPS), discussed the possible conflict between SD-56 and pertinent government publications on vinyl chloride.
The VCRC voted to accept the current draft of SD-56 in its present form.
The Research Coordinators recommended that the document in its final form should be back-dated to have the same date as when circulated to the entire Panel for comment, i.e., April 1977.
Under the proviso that modified pages of the text (i.e., pages 19, 20, 23, and Table V) be incorporated as replacement for the same numbered pages and tables in the second of two so-called final reports from EEH (both of which were dated August 1977), a motion was made, seconded and carried that the Research Coordinators accepted the second of the EEH “Final Reports” (the phrase “Final Reports” was placed within quotation marks even in CMA’s own minutes), and recommended that the Panel also accept it.
1/12/78
On January 12, 1978, the Vinyl Panel[xv] approved the modifications of the EEH report set forth by the VCRC the previous day, and added a section of their own indicating that the incidence of brain cancer was not related to either duration of exposure or intensity of exposure to vinyl chloride.
The Vinyl Panel further recommended that a new page be structured reflecting the date of report correction, i.e., January 1978, and that the sixty copies of the August, 1977, so-called, “final report” in MCA’s possession be corrected and all pages not of a matching type be retyped.
2/7/78
Dr. Torkelson wrote to Joe Seawell (Project Manager, vinyl chloride, MCA) on February 7, 1978, and recommended that MCA distribute a new version of the report to the sponsoring companies that contained the modifications the VCRC and the Vinyl Panel had suggested the previous January 11 and 12.
Dr. Torkelson cautioned the Vinyl Panel that they should make every effort to assure that distribution of previous reports and draft reports in their possession be stopped. The so-called January 1978 report was designed to replace all previous reports, and there was a serious concern expressed by the MCA Group that so many “final reports” from EEH were floating around that confusion was likely to result if all the prior reports were not destroyed.
The yellow title page Dr. Torkelson included was recommended in order to distinguish the most recent final report from all the so-called final reports that had preceded it.
Finally, Dr. Torkelson suggested that all the previous so-called final reports be destroyed to avoid what he referred to as potential confusion.
Dr. Torkelson informed the group that the January 1, 1978 final report was considered to be the last step in the MCA-coordinated epidemiologic research on vinyl chloride and that EEH (through Dr. Michael Utijean, who was, by no coincidence, soon to be employed by Carbide, was, at last, going to be allowed to publish a report from its study in the open literature.
At this time, the MCA-coordinated vinyl manufacturers had already made a commitment (that had specifically been added to the report at the request of the Vinyl Panel to conduct a five-year update of the study. (As will be shown, no five-year update was ever conducted, and even the ten-year update was not published for another thirteen years, in 1991.) Even this belated publication was made without authorization from the MCA-coordinated vinyl manufacturers and the Vinyl Panel accused the independent contractor who had published it of breach of contract.
Dr. Torkelson also expressed a commitment to somehow complete the, already three year overdue, Industrial Bio‑Test animal study in the near future.
2/14/78
On February 2, 1978, EEH gave yet another version of the report it had written in August of 1977, and had already revised several times since then.
2/14/78
On February 14, 1978, the MCA (Seawell) sent the Vinyl Panel the most recent final version of the EEH paper, entitled “Epidemiological study of VC workers, Final report.”
The report now bore the date January 1978.
The February 14, 1978 report, bearing the date January 1978, claimed that, as a result of this study, there was less support for the hypothesis that vinyl chloride was a “weak general carcinogen” than indicated by the original report by Tabershaw & Gaffey (1974).
Seawell directed each sponsoring company to take necessary action to assure that distribution of all previous “draft final” and progress reports be terminated immediately as all previous reports had been rendered obsolete by the enclosed document dated January 1978. The findings of the earlier reports were emphasized to have been less accurate and less complete than the January 1978 report.
MCA was to mail copies of the January1978 report to all pertinent government agencies.
Of the 12 brain tumors, 7 were reported to have occurred in workers from plants producing only PVC, 2 were in plants producing both PVC and VC (one of which also produced copolymers), and 2 were reported to have occurred in plants producing only homopolymers or copolymers. One brain cancer had been found in a plant producing only VC. There was reported to be no apparent relationship between the occurrence of brain cancer and two of the exposure indices used in the study: maximum exposure and total integrated exposure.
The EEH report claimed that it was difficult to interpret the significance of this finding of an apparent excess of brain tumors, as a result of the absence of definite confirmation by either autopsy or craniotomy in 8 of the 12 cases.
EEH claimed in the report that it was quite possible that some of the 12 cases might have been secondary brain tumors, with unrecognized primary sites, or other non‑malignant space‑occupying lesions in the cranial cavity.
The EEH report admitted that it was difficult to say to what extent the EEH study population overlapped that of a cohort previously studied by Waxweiler for NIOSH, a study that had shown statistically significant excesses in brain cancer, and, perhaps, had included some of the present cases.
The EEH report admitted that in view of all the above, further investigation of the question of malignant brain tumors in workers exposed to vinyl chloride should be pursued.
Notwithstanding the long recognized inadequacy, if not utter complete irrelevance, of the exposure estimates employed in the study as reported, EEH claimed that any association between causes of death and occupational exposure had to be based on a rates of excess mortality that increased as one or more of measures of exposure increased.
2/19-24/78
Between February 19 and 24, 1978, the Vinyl Panel [74] IBT Audit Subcommittee met at the IBT Industrial BIO-TEST Laboratories and at the Sheraton Inn, both in Decatur, Illinois.
Subsequently the group issued a report documenting near incredible misconduct at IBT, including substitution of healthy animals for animals that had died and other evidence that even the Audit Task Group admitted was strongly indicative of foul play.
The audit tasks group was also given responsibility for evaluating the original 23-month IBT draft report that had previously been submitted to the government in light of the audit they had just conducted.
6/14/78
On June 14, 1978, the VCRC [75]met at the MCA Conference Room in Washington, D.C.
6/18/78
On June 18, 1978, the CMA Vinyl Panel[xvi][76], the VCRC and the vinyl chloride Subcommittee met at the University of Louisville in Louisville, Kentucky.
11/20/78
On November 29, 1978, SPI published a booklet, entitled “PVC, Health and Safety,” and caused it to be publicly disseminated on behalf of the MCA-coordinated vinyl manufacturers. [77]