1974 – PRESENT
As previously shown this secrecy was maintained by every company in the vinyl group, but most copies of documents indicating the MCA Group’s corrupt desire to defocus cancer were either destroyed or concealed by MCA-coordinated vinyl manufacturers some time after 1974.
Upon information and belief, with the exception of this case and a few cases in Louisiana filed in the early 1990s, all such documents have either been destroyed or maintained in closest confidence.
The way the sponsors originally planned to rig the study was to include only 2,500 workers, thought to comprise one-half of the employment in the American vinyl industry, and with at most half of the study population having had adequate exposure to even be at risk for occupational cancer. This was the way it stood at the time of the February 20, 1973 meeting.
At some time following the OSHA hearings on the vinyl chloride standard in the summer of 1974, the corrupt advantages to the Vinyl industry of Using a method of personnel monitoring for vinyl chloride that consistently underestimated exposure levels began to become apparent to the MCA-coordinated vinyl manufacturers: The charcoal method was Useful for the industry to mislead workers and others about their exposure, misleading the government about exposure levels in the American vinyl plants, misleading communities living near U.S. plants about their exposure levels, etc.
For the foregoing reasons, and not because charcoal monitoring gave a true, or even reasonably true, report of the actual vinyl chloride exposure levels being monitored, the industry’s use of charcoal monitors increased and, in the year since 1974 have become near universal.
Almost completely without exception, workers monitored with devices that employed charcoal as an adsorbent media never have been told, (and aren’t told today) that the monitoring results reported to them likely bore very little relationship to the true level of vinyl chloride exposure the vinyl workers had sustained.
1974 – PRESENT
At various times, whose specifics are unknown to plaintiffs, each of the MCA and CMA-coordinated vinyl manufacturers used personal monitoring methods that were dependent upon the accuracy of charcoal as an adsorbent media for vinyl chloride in order to:
(1) De-regulate areas of their plants where, supposedly, the employers had performed sufficient monitoring to preclude the possibility of employee exposures exceeding the “action level” set in the OSHA permanent standard for vinyl chloride;
(2) Inform workers of their vinyl chloride exposure;
(3) Inform management of vinyl chloride exposures sustained by their employees;
(4) Inform unions, and other employee groups, of typical levels of vinyl chloride exposure at their facilities;
(5) Provide information to the general public, including information provided to persons living in the vicinity of PVC and VCM plants;
(6) Perform initial monitoring at their own facilities where vinyl chloride exposures occurred;
(7) Perform initial monitoring at the facilities of customers, in order to determine whether such facilities were subject to OSHA’s vinyl chloride regulations;
(8) Perform periodic monitoring for their employees;
(9) (Supposedly) determine the likelihood that PVC resins sold by the MCA and CMA-coordinated vinyl manufacturers and used by PVC fabricators might foreseeably result in their exposures exceeding the OSHA action level for vinyl chloride;
(10) Provide information to the independent scientists studying the vinyl industry, etc.
1/22/74
On January 22, 1974 NIOSH informed OSHA that several workers at (BFG) Louisville died as a result of a rare primary liver cancer that attacks the blood vessels of the liver. The cancer that attacked the lining of blood vessels in the liver was called angiosarcoma. (Although angiosarcoma would sometimes be referred to as “AOL,” this new AOL is not to be confused with “AOL” as in acroosteolysis).
(Recall that this AOL was a non-malignant disorder that, even by 1974, had been already declared extinct in medical disinformation the MCA-coordinated vinyl manufacturers produced about their workers).
1/22/74
On January 22, 1974, NIOSH informed OSHA that several employees at a B.F. Goodrich PVC plant had died from a rare liver cancer, angiosarcoma.
1/23/74
On January 23, 1974, BF Goodrich (BFG) issued a Press Release on angiosarcoma deaths at Louisville.
1/25/74
On January 25, 1974, at the first meeting of the Vinyl Panel just after the public report of angiosarcoma in workers at BFG, Louisville, the Vinyl Panel voted to write to Dr. Key from NIOSH (the target of an MCA presentation on vinyl the previous July 17, 1973) reaffirming industry support and cooperation as offered in the meeting with NIOSH last summer.
The letter included a request for suggestions on how the MCA Group might best support NIOSH in the work required under the vinyl chloride Standard.
The state of Kentucky requires the reporting of suspected occupational deaths within 48 hours, and, as a result, as soon as the evidence was reviewed and confirmed, B.F. Goodrich reported the angiosarcoma deaths to NIOSH on January 22, 1974, and to the state of Kentucky on January 23, 1974.
Dr. Key of NIOSH was apprised of the study data that the group had obtained from the European vinyl industry-sponsored research. Permission to release the information to Dr. Key was obtained. The exposure levels at which cancers were found was 250 ppm – exactly the same results MCA claimed that Dr. Key was told about in the MCA presentation to NIOSH on July 17, 1973.
Yet, MCA still required a secrecy agreement from NIOSH before it even would tell them that the Italian animal studies provided near conclusive proof that vinyl chloride had caused the angiosarcomas recently reported in the PVC workers at BFG Louisville.
Mr. Anton Vittone, President of B.F. Goodrich, discussed a Press release that claimed BFG Louisville was B.F. Goodrich’s oldest plant, that employees at the plant were not given routine physical examinations, and which stated that exposure to vinyl chloride at the Louisville plant was estimated to be between 15-20 ppm TWA .
Mr. Vittone also said that Dr. Creech had become concerned about the employee liver problems before Christmas of 1973 and consulted with Dr. M.N. Johnson on January 14, 1974, and employed Tabershaw-Cooper Associates, Inc. (TCA) to study the epidemiology of the American vinyl chloride industry in depth.
After deliberation, the Vinyl Panel voted to prepare a statement for the Press with the stated criteria that it be low-key. In fact, MCA would not even release the press statement unless pressed.
The MCA-coordinated vinyl manufacturers also decided MCA should draft a letter to Dr. Marcus Key of NIOSH, reaffirming the American vinyl industry’s support and cooperation, even requesting suggestions on how the MCA Group might best support NIOSH in the work required.
1/25/74
On January 25, 1974, the Vinyl Panel and the Management Contacts for the MCA-coordinated vinyl manufacturers held a joint session at the MCA Conference Room in Washington, D.C., in reaction to the announcement of the unfolding events at Louisville.
The Panel received a presentation from Dr. Tabershaw from TCA, knowing full well that their so-called consultant on the medical issues raised by the Louisville angiosarcomas knew far less than each company representative on the Panel did about angiosarcoma and its relationship to vinyl chloride. Indeed, Dr. Tabershaw told this group of Panel members and Management Contacts that the identification of the angiosarcomas with vinyl chloride exposure was still tentative and, in what appears to be a very shameful feigned ignorance, merely emphasized the rarity of the tumor, and the unlikelihood of its occurrence in three workers at the same plant without being related to industrial factors common throughout the American vinyl industry.
vinyl chloride was identified as suspect only because it was the common denominator among the angiosarcoma cases.
The assembled group had been aware that angiosarcoma of the liver was uniquely related to vinyl chloride exposure, even at exposure levels lower than were considered safe for humans, at least since 1972.
Dr. Tabershaw told the Panel he had found no suspicious cases of any industrially related disease after investigating over 75% of the total estimated deaths (122 out of 152).62
TCA had not been told to look for angiosarcomas and they hadn’t been for them either. For that matter, since angiosarcoma is Usually a disease with decades of latency, and the TCA cohort, with its intentionally designed-in biases, was certainly and carefully over-represented with precisely the kind of vinyl workers least likely to have had angiosarcoma, workers who had begun work in the vinyl industry as little as one year before the follow period for the study initiated. The first 4,000 records the sponsors had identified as eligible for the study had been even more selectively biased than the database TCA threw together later – the 4,000-plus last-minute additions that, after the Louisville announcement, were thrown into the cohort in a rear-guard action to ward off the detection of their fraudulent manufacture of the TCA cohort.
The VCRC were delegated responsibility for providing technical backup to substantiate MCA’s offer of assistance to NIOSH; yet, all the potential delegates were still subject to a secrecy agreement that prohibited their honest participation. Further, as will be shown with regard to warnings, work practices, and industrial hygiene monitoring and analytic procedures, the Panel members providing the so-called assistance that the MCA Group undertook to provide to the government in coming months, were subject to undisclosed limitations, restrictions, and control imposed by the MCA-coordinated group.
The joint management/technical group, assembled at the January 25, 1974 meeting, agreed that the MCA would intentionally limit the disclosures it made at the forthcoming informal fact-finding hearing OSHA was holding in February of 1974. The MCA-coordinated group agreed that there would be no disclosures to the government other than a misleading history of previous MCA activities, and the identification of the companies (who just happened to be supporting animal exposure and epidemiologic studies at the time the hazard was first publicly revealed following the Louisville announcement). Specifically the MCA Group agreed to conceal all they really knew about the carcinogenicity of vinyl chloride and the history of their own knowledge of the specific causal relationship that exposure to vinyl chloride has with angiosarcoma.
1/25/74
On January 25, 1974, the joint session of the MCA members and their Management Contacts approved the appointment of “Sub-Task Groups” responsible for medical issues, work practices, and industrial hygiene and monitoring.
These groups were developed specifically in order to formulate policies that would be reasonably adequate to protect American vinyl workers and specifically to formulate the American vinyl industry’s response to new regulatory actions that every representative in attendance knew was soon to be forthcoming.
The Medical Sub-Committee was chaired by Dr. Maurice Johnson (BFG), L. H. Ballou, M.D. (Firestone), C. H. Dernehl, M.D. (Union Carbide), D. P. Duffield, M.D. (ICI, Ltd.), E. M. Dixon, M.D. (Allied Chemical), R. W. McBurney, M.D. (Diamond Shamrock), and George Roush, Jr., M.D. (Monsanto).
The Medical Sub-Task Group was delegated responsibility for developing recommended monitoring methods, diagnostic procedures, and occupational medicine. The Medical Sub-Task Group voluntarily undertook to develop reasonable standards for medical surveillance and physical examinations of, as well as diagnostic criteria and medical management for, vinyl chloride related disease.
The IH & Monitoring Sub-Committee of the Vinyl Panel was chaired by Dr. Richard Henderson, M.D. (Olin). Its members included Mr. A.M. Barnes (ICI), Dr. Z.G. Bell (PPG), Mr. H.R. Hoyle (Dow), Mr. Flynt Kennedy (Conoco), and Dr. B.M.G. Zwicker (BFG).
The Industrial Hygiene & Monitoring Sub-Task Group was delegated responsibility for developing recommended practices and guidelines for the conduct of industrial hygiene monitoring and sample analysis, and to detect promptly, and with confidence, levels of workplace exposure presenting a potential threat to the health and safety of the workers.
The Work Practices Subcommittee was chaired by R. N. Wheeler. Its members were Mr. A.M. Barnes (ICI), Mr. J.T. Barr (Air Products), Dr. Z. G. Bell, Jr. (PPG), Dr. W.J. Borne (Borden Chemical), Mr. H.R. Hoyle (Dow), Mr. H.L. Kusnetz (Shell), and Richard Meier (Stauffer).
The Work Practices Sub-Task Group undertook to identify problems and recommend operating procedures and facility designs for the manufacture, transport and consumption of vinyl chloride to limit exposures to the lowest levels consistent with safety, and secure freedom from occupational health hazards for the American industrial worker.
The foregoing Sub-Task Groups went on to develop recommendations relating to occupational medicine, work practices, and industrial hygiene and monitoring that were submitted to the government and Used in the development of industry and company standards in those areas.
In undertaking these responsibilities, the MCA Group, and its subcommittees, had a responsibility to use reasonable care in developing such standards and procedures.
1/25/74
On January 25, 1974, Best (MCA) wrote Dr. Key (NIOSH), after the Louisville angiosarcoma announcement, pledging “full cooperation” and offering their “technical expertise.”
MCA said, that NIOSH must know and appreciate, after the MCA presentation to NIOSH on July 17, 1973, that the MCA-coordinated vinyl manufacturers had a deep interest in research into problems that had arisen concerning vinyl chloride.
The MCA-coordinated vinyl manufacturers reaffirmed their strong desire to work with NIOSH on occupationally related vinyl chloride issues, pledging their full cooperation and support. Naturally, the MCA-coordinated vinyl manufacturers wanted to meet with Dr. Key and participate in any ongoing program at the earliest possible time.
1/25/74
On January 25, 1974, MCA prepared a statement in anticipation of the upcoming OSHA hearings; the MCA-prepared statement was to include its own activities and studies, but, presumably, not what it learned from the Europeans, nor when it learned of vinyl’s demonstrated toxicologic/carcinogenic effects. MCA established a Medical Sub-Committee [54] after vinyl chloride’s carcinogenic effects in humans become publicly known.
In anticipation of public hearings by OSHA on the emergency standards industry expected would be proposed for vinyl chloride the group prepared testimony for possible industry presentation. The MCA statement at the OHSA fact-finding hearings was agreed to be intentionally limited to a narrative history of the activities of the Association and the members of the group of companies supporting the animal exposure and epidemiological studies now underway under MCA’s aegis. (No mention would be made of the secret European studies conducted by Viola and Maltoni at the OSHA hearings.)
After discussing the possible steps MCA might take to retain industry initiative, it was moved, seconded and carried that MCA would immediately call Dr. Marcus Key to renew its offer of assistance and support for the studies of vinyl chloride that NIOSH was thinking about undertaking.
Mr. Best, MCA Vice President and Secretary-Treasurer, called Dr. Key at NIOSH the afternoon of January 25, 1974, and sent the confirming letter the same day.
Best’s confirmation letter stated: “We believe the technical expertise within MCA member companies could be particularly helpful in the areas of defining health hazards associated with VCM production, workplace and medical surveillance and work practices necessary to limit exposure.”
1/29/74
On January 29, 1974, the Occupational Health Committee met at the MCA Conference Room in Washington, D.C. [55]
1/30-31/74
On January 30 and 31, 1974, Dr. Dernehl (Union Carbide) indicated to the MCA LAPI Committee there may be no need to revise the label for SD-56 as approved at the January 1972 meeting, depending on the results of the toxicity investigations.
2/1/74
By 1974, Dr. Maltoni’s animal data had proven to be a key to much of the regulatory actions taken by the Occupational Safety and Health Administration.
C&EN reported in February 1974 that the lowest dose level of vinyl chloride in the Italian scientists study at which liver angiosarcoma developed was 250 ppm.
Guided, in part, by these findings, OSHA, on April 5, would set an emergency rule that lowered the permissible OSHA worker exposure level to 50 ppm from the previous ceiling of 500 ppm.
2/11/74
On February 11, 1974, MCA stated that the events at BFGoodrich had, impliedly, and for the first time, raised questions about the validity of MCA’s SD-56 for vinyl chloride. MCA promised to issue a revised edition of the vinyl chloride Safety Data Sheet (SD-56).
2/12/74
On February 12, 1974, NIOSH sponsors briefed management, labor representatives, and the 100 individuals from the VC and PVC industries in attendance, at the hearing held in Cleveland, OH.
The meeting was attended by MCA-coordinated vinyl manufacturers, who all stood silent – some even reporting that the most noteworthy thing about the presentation was the remarkable lack of knowledge about the PVC industry exhibited by the NIOSH sponsors.
2/15/74
On February 15, 1974, OSHA held an informal hearing in Washington, D.C., to decide whether it should promulgate temporary emergency standards or permanent standards. The MCA-coordinated vinyl manufacturers submitted large quantities of testimony, documentary evidence, and comments into the record at OSHA’s hearings on its proposed permanent standard for vinyl chloride exposure held in the summer of 1974.
On February 15, 1974, OSHA at last received information from the Italian animal studies demonstrating vinyl chloride induced angiosarcomas in rats at levels as low as 250 parts per million (250 ppm).
At the time this was old news to the MCA-coordinated vinyl manufacturers, who had been holding Maltoni’s 250 ppm cancers secret, since at least the Spring of 1973.In the Spring of 1973, without permission, Dr. Maltoni disclosed (to some, as yet unknown, extent) findings of vinyl’s carcinogenicity in the course of a presentation he gave on occupational cancer at the scientific conference in Bologna, Italy in 1973.
2/15/74
On February 15, 1974, “Goodrich reported the death of a fifth employee due to liver angiosarcoma.”
2/15/74
On February 15, 1974, an OSHA fact-finding hearing was held.
During this federal agency briefing, NIOSH, and other official government agencies, were advised by a BFGoodrich Company representative as to the status of an on-going study sponsored by European polyvinyl chloride producers and involving the exposure of small groups of rats to vinyl chloride MONOMER vapor.
At the time of the February 15, 1974 OSHA fact-finding hearing, the European research results reported to OSHA were mischaracterized and misrepresented as being only of a preliminary nature.
However, NIOSH considered that these data (which included histopathologic examination of tissue) identified vinyl chloride MONOMER as the causative agent in the induction of tumors observed in the test animals, including angiosarcoma of the liver. NIOSH had been advised that the principal investigator responsible for conducting the European studies, Dr. Maltoni of Italy, intended to present the results of his investigations to OSHA during the public hearings in June and July of 1974. (This turned out not to be true! Dr. Maltoni told the MCA-coordinated vinyl manufacturers in private that he would not present his current finding of cancer – which manifested at the same level of exposure that most of the MCA-coordinated vinyl manufacturers would recommend OSHA adopt as the vinyl chloride exposure standard for humans [i.e., 25 to 50 ppm].)
NIOSH estimated that 10 companies, and 14 VCM plants, with more than 1,500 production workers, were involved in the primary manufacture of vinyl chloride MONOMER (VCM), and that 23 companies with 37 plants with more than 5,000 production workers were engaged in the polymerization of VCM into polyvinyl chloride (or PVC).
However, the MCA-coordinated vinyl manufacturers were aware that no one, most especially NIOSH, could accurately estimate the true number of workers employed in converting, molding, and fabricating PVC into finished products, but the number was estimated as being comprised of workers numbering in the order of tens of thousands at thousands of PVC plants throughout the country.
At the February 15, 1974 OSHA fact-finding hearings, NIOSH emphasized the need for rapid studies to determine whether health effects would be associated with end-product, or consumer, use of PVC.
Dr. Thomas Mancuso testified at the February 15, 1974 OSHA fact-finding hearings that, invariably, whenever a new occupational cancer was discovered, it was played down for fear of alarming the workers and the general public, and that, although the focus was then on experimental carcinogenicity, it was very important to note that other pathological changes occurred in the brain as a result of VCM exposure, including degeneration of the nerve cells, as well as the cerebellum, and severe chronic hepatitis.
2/19-20/74
Dow’s representative, Dr. V.K. Rowe, testified that it was Dow Chemical’s belief that OSHA’s rulemaking should not be based on conditions that existed in the past, but, instead, ought to be based on conditions as they existed at the time.
Rowe testified that there was no need for a temporary emergency standard and that, realistically, an emergency standard would result in polarization rather than constructive definition of areas of concern and constructive problem solving.
The MCA-coordinated vinyl manufacturers were advised by Dr. Mancuso that under no circumstances should anyone use the workmen’s compensation claims as an index of what in the world happened to the industrial population. In the first place, as Dr. Mancuso’s testimony made evident, the worker would not even recognize an occupational disease when he saw one, and, in the second place, the general practitioner would not recognize the disease, nor attribute it to vinyl chloride exposure. Consequently, it would not amount to a worker’s compensation claim.
2/19/74
On February 19, 1974, the Vinyl Chloride Research Coordinators (VCRC) met at the Sheraton O’Hare Hotel in Rosemont, Illinois.
On February 19, 1974, the VCRC [56] voted for the establishment of a vinyl chloride pathology center and case registry at the University of Michigan (UOM), though the MCA-coordinated vinyl manufacturers would conceal this to the present.
On February 19, 1974, Tabershaw-Cooper & Associates (TCA) was commissioned to “expand” its epidemiologic study. The scheme was to add the would-have-been “missing” angiosarcoma cases back into the study – before anyone independently noticed they had been “missing. (And they would have, in fact, been “missing” from the study had the MCA-coordinated vinyl manufacturers not commissioned TCA to “expand” the study after the BFG Louisville incident.)
The consensus of the Panel [x] on February 19, 1974, was that SD-56 needed extensive revision before being reissued. Nevertheless, revision was delayed, supposedly, until after the course OSHA would take was more clearly defined.
Either OSHA’s course has never become sufficiently defined since February 19, 1974, or there was another reason the MCA-coordinated vinyl manufacturers never did release another version of SD-56, because – as late as 1979 – cancer due to vinyl chloride exposure would – if it ever occurred – be a chronic hazard associated with the use of vinyl chloride, and chronic hazards were not things the MCA–coordinated vinyl manufacturers would allow the MCA to comment on, especially regarding the sufficiency of industry labeling warnings about chronic hazards, including cancer. (And no matter what the “official” MCA position on labeling for chronic hazards was.)
On February 19, 1974, the Panel considered, but rejected, the prospect of allowing the highly exposed cohort of workers identified by the MCA and the University of Michigan Institute of Industrial Health (UOM) in the course of the UOM “acroosteolysis” studies to be examined in order to determine whether these highly exposed workers showed an excess occurrence of cancer. MCA-coordinated vinyl manufacturers had reason to suspect that a complete follow-up examination of these workers would, in fact, indicate excess cancer rates among humans exposed to vinyl chloride fumes.
At the February 19, 1974 VCRC meeting, the Research Coordinators were advised of the sorry situation at IBT, including high rates of cannibalism, animals escaping to the wild, breeding and then returning to eat the mice they had left in the IBT cages, etc. As much as five years later, years after the VCRC deliberately avoided asking IBT for the final report IBT owed them under their contract, the Vinyl Panel still openly attested to the excellent reputation of IBT, and their integrity.
In fact, members of the MCA Group still brag about this study, today – while, of course, not revealing any of the information they had obtained and held secret between 1973 and 1978.At the February 19, 1974 meeting, MCA again deferred conducting feeding studies, as well as studies of PVC dust.
On February 19, 1974, the VCRC recognized that SD-56 required extensive revision before it was reissued. However, it never was reissued because of the MCA’s deliberate decision to violate their own rules with regard to product labeling, by not including any warnings pertaining to chronic or long-term hazards.
2/20/74
On February 20, 1974, the Vinyl Panel met at Sheraton O’Hare Hotel in Rosemont, Illinois. The Panel [57] decided that IBT should not replace the animals that had been cannibalized to date. This eventually resulted in a gross reduction in the amount of pathology the IBT studies would produce. For example, as late as 1980, only six brains from exposed animals had been saved. (This was one of the reasons why MCA deliberately refused to request the Final Report from IBT that MCA had promised would eventually be forthcoming.)
Dr. Maltoni presented the Panel with his most recent research, including additional information that had not been presented at the OSHA hearing only five days previously. The Panel was informed that, as of that time, Maltoni’s initial series of exposures of rats to VCM at levels running from 10,000 ppm down to 50 ppm, demonstrated a significant dose-related incidence at every level tested, except the highest.
The Panel received updated progress reports from TCA and received proposals to intensify efforts to trace “missing” cases. TCA also proposed to revisit the records they had supposedly been collecting, organizing, and analyzing in complete ignorance of even the existence of angiosarcoma.
During the February 20, 1974 meeting of the Vinyl Panel, Dr. Tabershaw advised the Panel that if the MCA study was to have maximum impact, it would have be accelerated and intensified. (The original contract would have to go, if the study was to at least appear to be credible.) Sponsors were reminded that April 15, 1973, was the completion date for the TCA study. Dr. Tabershaw identified specific groups of VCM or PVC workers who were considered to have a higher than usual risk of developing exposure related disease by virtue of their work history. The identified workers included: (1) those who had been diagnosed as having Acroosteolysis; and (2) those who have come to require medical attention as a result of exposure to vinyl chloride.
The secret about vinyl chloride’s carcinogenicity MCA-coordinated vinyl manufacturers had concealed since, at least, May of 1971, was no longer a secret.
As predictable, the American vinyl industry feigned ignorance of evidence demonstrating that angiosarcoma seemed to be a signal neoplasm, and a signature cancer for vinyl chloride exposure.
The publicly reported angiosarcoma cases at BFG’s Louisville PVC plant were inelegantly “worked in” after Louisville, including all the American cases that had been reported as of that time. Including 4,000 new workers and doubling the size of the study population (cohort), served to disguise the MCA Group’s successful attempt to bring the conspicuously absent, and publicly reported, angiosarcoma cases TCA had previously “missed” back into TCA’s fold, after-the-fact.
The MCA-coordinated vinyl manufacturers had known that this rare tumor, angiosarcoma of the liver (AOL), was a signature neoplasm for angiosarcoma, at least, since the Winter of 1972, years before any pathologist anywhere in the United States would ever hear of it. Even TCA, whom the MCA-coordinated vinyl manufacturers had hired to study cancer in their workers, never learned anything about angiosarcoma, or the low-dose carcinogenicity of vinyl chloride, until everyone else did – in 1974, after Louisville.
New proposals were required because, prior to the publicity surrounding the still developing situation in Louisville, thousands of previously so-called “missing” TCA cohort members, were not covered by the TCA contract. These thousands of excluded workers had been deliberately manipulated by the sponsoring companies in such a way as to exclude the very type of vinyl workers at highest risk for developing cancer.
The Panel recognized their on-going and future misconduct would be jeopardized if the truth about the TCA study were revealed. For this reason, on information and belief, after Louisville, the MCA-coordinated vinyl manufacturers doubled the size of the TCA cohort from approximately 4,000 workers to approximately 8,000 workers. This was done for the specific purpose of concealing the MCA Group’s fraudulent manipulation of the TCA human study they had commissioned solely in order to fabricate human evidence to contradict or call into question the animal evidence they knew would eventually be forthcoming as a result of the secret European animal studies.
After Louisville, it would no longer further the MCA Group’s scheme to rig the TCA study, and very effectively prohibit TCA from detecting angiosarcomas in humans – by the simple expedient of simply not telling TCA anything whatsoever about angiosarcoma at all. Now that the MCA-coordinated vinyl manufacturers realized their study might be revealed for the fraud that it was if some efforts weren’t made to hustle some of the recently reported angiosarcoma cases into the cohort, after-the-fact, the recently amended protocols would cause the study cohort that was selected to take on, however misleadingly, at least this semblance of propriety.
By March 12, 1974, the MCA-coordinated vinyl manufacturers received copies of the TCA proposals. The MCA-coordinated vinyl manufacturers voted not to undertake a study of high-risk segments of the cohort, but to continue to employ the same “diluted” cohort they had selected prior to Louisville. (A study population that included workers with as little as one year in the industry.) What this meant was doubling the size of the diluted study without doing anything to account for the dilution itself. It meant there would be 8,000 workers most of whom had not been on the job long enough to be at risk for occupational cancer, instead of only 4,000 workers who were not at risk for occupational cancer.
The Panel recommended the reactivation of the old UOM acroosteolysis registry and expanding the registry to include all categories of occupational illness related to vinyl chloride exposure. This was the “old AOL” (Acroosteolysis was essentially Industry’s unfinished business after the February 1, 1969 UOL study had been successfully suppressed), unlike the “newer AOL” (which purportedly concerned angiosarcoma of the liver). The MCA-coordinated vinyl manufacturers had only just finished dumping the Acroosteolysis Registry unceremoniously between 1970 and 1973, when the bad news from Italy demonstrating liver cancer in the test animals at lower and lower levels of exposure began, and continued, to roll in – while the MCA-coordinated vinyl manufacturers stalled for time.
The idea was to rehabilitate the old AOL registry after all, and look for the highly exposed workers in the UOM’s acroosteolysis surveillance program (which the MCA-coordinated vinyl manufacturers invented, Used, and abandoned as soon as these highly exposed workers were realized to be the highest risk-identifiable segment of the industry’s worker population). (If the MCA-coordinated vinyl manufacturers ever seriously wanted to conduct such a study cohort, which was, at least, worth considering, because this risk might be outweighed by the enormous public relations benefit of conducting such a study, despite the obvious downside risk that it might detect disease.)
The MCA-coordinated vinyl manufacturers considered the risk of doing a study of such highly exposed AOL workers too great, however, so the study of these high-risk segments of the American vinyl worker population was never done. On information and belief, the sponsors voted not to do the study because they definitely did not want to find significant excesses of a wide variety of cancers in a highly exposed population of vinyl chloride workers.
The Panel voted to submit the interim draft of the report they had received from their Work Practices Subcommittee to NIOSH, and intended NIOSH to rely upon it.
The Vinyl Panel specifically decided not to identify the true authors of the Work Practices Sub-Task Group’s recommendations. Although falsely presented to OSHA as the personal and best considered independent judgment of the NIOSH consultants from industry, none of the work of this MCA Work Practices Sub-Committee, its Industrial Hygiene, Monitoring, and Analytic Methods Committee, or its Medical Sub-Committee would ever be honestly identified.
The MCA Committee recommendations referred to in the previous paragraph were falsely submitted to NIOSH under the personal signature of the NIOSH consultants from Carbide, PPG, and Air Products, and were misrepresented as the individual work of the NIOSH consultants. These three Panel members who had received the honor of having been asked to serve as consultants to NIOSH, but who submitted reports from MCA committees that the consultants to NIOSH also served on to NIOSH as if the reports represented their own personal recommendations.
(The NIOSH consultants who were to be the undisclosed agents of the companies represented on the MCA Vinyl Panel had voluntarily undertaken, and were charged with the responsibility, to give disinterested advice based upon their own professional opinions, and not those of their employers or industry trade groups.)
Additionally, the Panel instructed their undisclosed agents, acting as consultants to NIOSH, not to present the work of the MCA subcommittees formally, but to informally present to NIOSH as their own personal recommendations what were really the MCA Group’s position papers.
This surreptitious attempt to influence NIOSH was known by every company on the Vinyl Panel, but never disclosed.
Although they were in a position where they were obliged to do so, the Panel members who were serving as NIOSH consultants did not disclose to NIOSH important, even crucial, information they possessed by virtue of their participation in the activities of the MCA Vinyl Panel. For example, none of the reports referred to the fact that the same subcommittees on whose behalf these representatives were privately acting included such crucial information as the MCA Group’s determination that the use of charcoal as an adsorbent media for personal monitoring of vinyl chloride workers was, even in the opinion of the Chairman of their IH & Monitoring Sub-Committee [58], (Nick Wheeler, a NIOSH advisor) inconceivable because it systematically underestimated vinyl chloride exposures by multiple orders of magnitude.
2/21/74
On February 21, 1974, Union Carbide Corporation notified NIOSH of the death of a PVC worker from liver angiosarcoma.
2/21/74
On February 24, 1974, MCA withdrew SD-56 – temporarily, it claimed.
2/25/74
On February 25, 1974, OSHA held a preliminary fact-finding hearing at which Antone Vittone gave a presentation.
2/26/74
On February 19, 1974, the Work Practices Task Force and the Vinyl chloride Research Coordinators (VCRC) met, but could not come up with a threshold level below which no danger from exposure to vinyl chloride was assumed to exist.
The MCA-coordinated vinyl manufacturers’ and the Work Practices Task Force [59] suggested 50 ppm as a “working level,” related to then current knowledge and technical feasibility.
The Work Practices Task Force committee decided not to recommend a threshold level for VCM.
Ben Zwicker (BF Goodrich) identified 2 additional angiosarcoma cases that had been reported in the Wall Street Journal that day.
R.N. Wheeler (Union Carbide) notified NIOSH that Carbide had discovered a case of angiosarcoma of the liver in a worker in its plant in South Charleston, W.Va.
Dr. David Duffield (ICI) reported on a death in one of their employees in December 1972. Dr. Rinehart (Ethyl) reported that a worker died on December 28, 1973, in their Louisville PVC bottle manufacturing plant.
Dr. Maltoni was in attendance and was asked whether the onset of angiosarcoma was dose-related. Dr. Maltoni’s animal toxicity studies were reported to have produced the first angiosarcoma at vinyl chloride exposure concentrations of 2,500 ppm for 40 weeks.
The Vinyl Panel recommended that Mayo Smith be added to the seven Research Coordinators because he had been appointed as the representative of industry on an ad hoc committee for NIOSH. Union Carbide disclosed an angiosarcoma case from its PVC plant in South Charleston, West Virginia, that the Panel was told had not been included in the TCA study because Union Carbide had not identified the victim as a vinyl chloride worker.
The Panel’s Chairman (Torkelson) renewed a request for the reactivation of the UOL acroosteolysis registry, and suggested the University of Michigan as the site, with NIOSH and labor as co-sponsors. The Chairman explained to the Panel that the advantages of studying the workers that had already been identified for inclusion in the old acroosteolysis registry were two-fold: First, it could be done quickly and neatly; and, Second, it would allay fears of effects of vinyl chloride exposure on the children of vinyl chloride workers. The Panel received a typical report from IBT: of cannibalism due to lack of food, dose-related weight loss. The Panel discussed the significance of Dr. Maltoni having seen his first angiosarcoma at 40 weeks at a concentration of 2,500 ppm.
MARCH 1974
In a case report on an angiosarcoma case published in the Journal of Occupational Medicine on March 16, 1974, Dr. J.L. Creech and Dr. M.N. Johnson (BF Goodrich) wrote that there was no suspicion in the American vinyl industry of any relationship between exposure to vinyl chloride and angiosarcoma prior to the time angiosarcomas were reported at Louisville; the only previously reported association between cancer and vinyl chloride was a paper (Viola’s) that, allegedly, determined the cancers involved in an exposure study were not cancers of the liver.
3/1/74
In a published article by Dr. C. Maltoni and G. Fefemine, entitled “The Potential of Experimental Tests in Predicting Environmental Oncogenic Hazards,” Dr. Maltoni discussed his study findings, which demonstrated VC’s multipotential carcinogenicity as Dr. Maltoni found animals exposed to vinyl chloride manifested Zymbal gland carcinomas, nephroblastomas, and hepatic and extra-hepatic angiosarcomas, in rats, and pulmonary tumors, mammary carcinomas and liver angiosarcomas, in mice.
Maltoni discussed when the information was shared with SPI and with CMA (1.5 years ago)
3/5/74
On March 5, 1974, the Chairman of the Vinyl chloride Panel Sub-Committee on Analytical Procedures (Dr. Richard Henderson, Olin) mailed each member of the Committee copies of analytical procedures for VCM the subcommittee had received from ICI and Dow.
Dow had rarely used activated charcoal to monitor vinyl chloride before 1974.
The MCA-coordinated vinyl manufacturers’ venture into the dubious use and outright deliberate abuse of charcoal as an absorbent media for vinyl chloride was initially attributed to the interest of OSHA and NIOSH in using that method.
Even from the earliest date, the results were unambiguously and uniformly abysmal. At 50 ppm, Using commercially available sampling tubes, breakthrough was observed for vinyl chloride in 30 seconds and reached 100% breakthrough in less than 6 minutes (at both 0.5 and 0.1 ppm). At both sample rates there was substantial breakthrough of the vinyl chloride.
Even at this time, there was already substantial agreement among the members of the IH & Monitoring Sub-Committee that, whatever else was known, charcoal should never be used without testing, and that its suitability for VCM monitoring should never be assumed.
However, following the OSHA hearings, this important information was concealed from those who most needed to know about it.
As a result, worker monitoring was a source of false reassurance to American vinyl workers and consistently reported results that were far lower than the actual exposure conditions to which the badge (and the worker) had been subjected during the time it was used to measure employee exposure.
3/6/74
On March 6, 1974, BF Goodrich reported angiosarcoma in 2 living employees.
3/7/74
On March 7, 1974, although the “independent” belief of at least some medical directors, like Lee B. Grant (PPG), was that OSHA’s rulemaking under Section 6(c) of the OSH Act was justified, at the forthcoming OSHA hearings on the vinyl chloride standard, however, Dr. Zeb Bell (and the remaining “Industry Consultants” to NIOSH) would give as their personal recommendation that OSHA initiate its regulations only under Section 6(b).
Dr. Bell also disavowed his participation in an AiCHE committee that had also recommended a 6(b) proceeding in a letter to OSHA in the Summer of 1974.
3/11/74
On March 11, 1974, the Vinyl Panel Sub-Task Group on Work Practices (upon which PPG’s Zeb Bell’ served) voted to designate vinyl chloride as a “Hazardous chemical agent,” rather than designating it as a “cancer suspect agent,”’ or as a “carcinogen.”
3/11/74
On March 11, 1974, NIOSH recommended a Standard for Occupational Exposure to vinyl chloride, containing a recommended 1 ppm PEL on an eight-hour TWA.
3/12/74
On March 12, 1974, the Vinyl Panel authorized TCA to proceed with project I - A of the proposal.
3/13/74
On March 13, 1974, after the Goodrich crisis at Louisville, NIOSH invited MCA to provide industry experts as consultants. MCA suggested, and NIOSH approved, Drs. Bell (PPG), Kramer (Dow), Johnson (Goodrich), Smith (Air Products), and Mr. RN Wheeler (Union Carbide) as consultants to NIOSH. This group first met on February 12, 1974, after a NIOSH briefing of industry and labor in Cleveland, Ohio.
3/21/74
All VCM/PVC member companies were represented by high-level management personnel at a meeting of Vinyl chloride industry Management Representatives called by Mr. Anton Vittoni, President of BF Goodrich, on March 19, 1974.
The MCA-coordinated vinyl manufacturers again reviewed the reasons charcoal methods for personal sampling were not acceptable for monitoring vinyl chloride (if a truthful report is desired) levels in the workplace atmosphere. In this connection, and by way of specific contrast with the inaccurate, but pervasive, use of charcoal monitoring methods, companies in attendance, including Conoco Chemicals, admitted that monitoring conducted Using air-bags followed by gas chromatography seemed to give reasonably reliable results.
Company representatives, including the Air Products representative openly admitted their surprise and concern that reports of average exposure levels far below 50 ppm were commonplace in the American vinyl industry, even at the oldest facilities. However, this was not a cause for celebration, but of concern. The companies discussed how their case for OSHA adopting the highest possible permissible exposure limit might be jeopardized if it was known that existing exposure levels were already lower, and sometimes far lower, than the 50 ppm TWA PEL that the industry would, for the most part, recommend to OSHA in the Summer of 1974. The industry representatives shared their mutual concern that the current low levels could jeopardize industry’s case, if it were appreciated, i.e., that NIOSH/OSHA might feel it had always been so low.
(However, it was closer to the truth to state that the historic vinyl chloride exposure levels had been near current levels, than to say the historic exposure levels were truly as high as the MCA-coordinated vinyl manufacturers would suggest to OSHA in connection with OSHA’s rulemaking procedures on its proposed vinyl chloride standard).
In the Summer of 1974, most MCA-coordinated vinyl manufacturers would recommend to OSHA that 50 ppm exposure levels calculated on an eight hour time-weighted average (TWA) be adopted as OSHA’s permanent exposure standard for vinyl chloride.
3/22/74
On March 22, 1974, Goodyear, in another press release, announced 2 more worker fatalities from liver angiosarcomas.
3/22/74
By March 22, 1974, the members of the Vinyl Panel who had not been aware of it before were certainly apprised that activated charcoal was not a suitable adsorbant media to use with vinyl chloride.
Distrust for monitoring results obtained with charcoal were privately expressed by experts employed in the vinyl industry, but who knew the truth about monitoring VCM with charcoal – i.e., that it demonstrated consistently low exposure concentrations, and had an unlimited ability to underestimate the ambient VCM levels in the monitored environment.
Once “breakthrough” occurred, there was literally no telling how much higher the true exposure levels were; All that could be said once breakthrough occurred, was that the true level of VCM exposure the employee had sustained was certainly higher than the level at which breakthrough had occurred.
Since 1974, each employer of persons subject to the vinyl chloride standard was required to conduct validation procedures for the atmospheric vinyl chloride testing they performed.
Given the industry-wide skepticism that had resulted from the industry’s uniformly unfavorable experiences with charcoal, the fact that this method was pervasively employed in the American vinyl industry would seem to indicate some mitigating factor other than accuracy existed.
In fact, the very inaccuracy of charcoal became its most Useful quality, insofar as the MCA-coordinated vinyl manufacturers were concerned. Inaccuracy of the type exhibited by charcoal-based personnel monitoring devices, apparently, came to be appreciated within the vinyl industry as American companies realized that the error introduced by the use of charcoal uniformly biased the reported results in only one direction – down; charcoal-based monitors provided industry with consistent underestimation of workplace exposures to vinyl chloride. The advantages of Using such a system became too attractive to resist. It was true that this monitoring method provided worse than worthless results and misled anyone relying upon them as to the true level of potential vinyl chloride exposure, at all but the lowest exposure levels, and under all but the most perfect laboratory conditions.
Even then, at low levels and under perfect conditions, the charcoal-based monitoring method was known to underestimate vinyl chloride exposures. As the validation procedures required by the OSHA vinyl standard would show, VCM held very weakly to charcoal when used as an absorbent media, and, in fact, under realistic exposure conditions, charcoal would actually lose vinyl chloride to the environment faster than it would pick it up.
For companies like the MCA-coordinated vinyl manufacturers, however, for whom monitoring was something done more to avoid being cited by OSHA, than for protecting workers, a method of monitoring that resulted in a report indicating a low level vinyl chloride exposure that could be given to a worker (or to an OSHA inspector) was, for all practical purposes, at least the equivalent of actually maintaining low vinyl chloride levels in the workplace – and a whole lot cheaper.
The “defect” in charcoal that made it totally inappropriate to use in order to obtain a true measure of vinyl chloride exposure had a silver lining with advantages for demonstrating regulatory compliance (or at least appearing to). Employing a method of monitoring capable of consistently underestimating employee exposure to vinyl chloride by untold orders of magnitude could come in handy. (Especially, if, as the MCA-coordinated vinyl manufacturers had unanimously claimed, compliance with OSHA’s extremely low 1 ppm standard for vinyl chloride was impossible without bankrupting the industry.)
Once breakthrough occurred in charcoal-based personnel monitors, the most that could be said about the actual ambient concentration of vinyl chloride in the atmosphere was that it was at least as high as the charcoal-measured result, but there was absolutely no way of telling how much higher the true value of the concentration really was.
Additionally, the charcoal adsorbent media was very precise, although completely inaccurate. This meant that charcoal-based monitoring results could be repeated, thereby appearing to be valid to an analyst performing the desorption (when, in fact, the monitor results consistently underestimated exposure to vinyl chloride.
On March 25, 1974, the MCA draft [of the OSHA work practice standard] as indicated, was a compromise. The labeling and sign wording was first written as ‘cancer suspect agent,’ which followed the other 14 carcinogenic wording that appeared in the January 29, 1974 Federal Register. The industry did not like it.
APRIL 1974
By the Spring of 1974, PPG, and other MCA-coordinated vinyl manufacturers, became aware of the carcinogenicity of vinylidine chloride (VCD).
4/15/74
In mid-April, MCA disclosed that its research showed angiosarcomas at 50 ppm.
Maltoni disclosed in the coming month of May that he had found angiosarcomas at 50 ppm. At some time prior to April 15, 1974, and subsequent to the May 10-11, 1974 meetings of the New York Academy of Sciences (NYAS) on vinyl chloride, the MCA-coordinated vinyl manufacturers began to receive secret result data from the low-dose studies Maltoni had been conducting at levels even lower than 250 ppm level (the 250 ppm level that the MCA-coordinated vinyl manufacturers had concealed between late 1972 and the time following the discovery of angiosarcomas at BFG Louisville, the previous February). The group learned that Maltoni was able to say that he had discovered angiosarcomas in the 50 ppm group of rats.
On April 15, 1974, the U.S. Manufacturing Chemists Association (MCA) publicly disclosed that the research it had sponsored at IBT had also demonstrated angiosarcomas at 50 ppm – but, this time in mice.
4/3/74
At some time prior to the 4/3/74 publication of an article in Chemical Week, entitled “PVC Producers Gird for Battle Against Cancer,” Dr. Zeb Bell – Manager of Environmental Control and Industrial Health for PPG – a man who had full knowledge of the particulars of the MCA-European secrecy agreement and its subject – misrepresented that the American vinyl industry was just as dumbfounded as the government was about VCM’s recently demonstrated carcinogenicity.
Dr. Bell falsely reported that the American vinyl industry, having had no more knowledge than that available to the government, had been complacent before January 1974 (Louisville), but had since insisted on strict compliance with work rules. Also misrepresented was that, while ACGIH had lowered its TLV to 200 ppm in 1972, OSHA had, with the same knowledge as that available to the American industry, left its Permissible Exposure Limit (PEL) for VCM at 500 ppm.
4/5/74
On April 5, 1974, OSHA enacted an Emergency Temporary Standard (ETS) that reduced its Permissible Exposure Limit (PEL) from 500 ppm to 50 ppm with new monitoring and respiratory protection requirements. This was the same standard that, as described above, the ACGIH had promulgated and the MCA-coordinated vinyl manufacturers had suppressed in 1962.
4/8/74
On April 8, 1974, the Proposed Work Practices Standard that the MCA-coordinated vinyl manufacturers submitted to OSHA was represented as an honest attempt to protect workers without imposing impossible or uneconomic limits on the industry. The Proposed Work Practices Standard suggested dropping the use of TLV’s or PELS entirely, replacing them both with working level concentration (WLC). At this point all members of the MCA-coordinated vinyl manufacturers were advised that Maltoni did not wish to be quoted that 50 ppm was safe for man.
4/8/74
At the MCA Board of Directors meeting held April 8, 1974, the Board discussed the official policy of the MCA not to become involved in individual product problems due to potential antitrust issues. The Board discussed whether this supposed proscription precluded MCA’s coordination of actions taken in concert by individual companies in connection with the pending development of an OSHA regulatory standard on vinyl chloride, concerning which substance MCA was currently administering a research project to develop toxicologic data.
4/8/74
By April 8, 1974, the MCA Executive Committee anticipated that OSHA’s permanent standard on vinyl chloride would establish a “non-detectable” limit which, even as early as this, was recognized as a 1 ppm standard.
4/9-12/73
Between April 9 and 12, 1973 at a Cancer Detection and Prevention, Symposium in Bologna. Dr Maltoni lectured on Occupational Carcinogenesis. Although the title of the paper said nothing about Vinyl chloride and cancer, the presentation appears to have used data from the then secret low dose cancer studies Dr. Maltoni was then conducting for the European vinyl manufacturers.
4/10/74
On April 10, 1974, the MCA reported preliminary finds of angiosarcomas in mice to OSHA, NIOSH and EPA.
The study reported a measurable excess of digestive cancers, especially liver, respiratory cancers and other unspecified cancers, which brain cancers predominated. Table 5 contained a Proportionate Mortality Ratio (PMR) analysis. The MCA-coordinated vinyl manufacturers required the elimination of Table 5 and every reference in the April 15, 1974 TCA Final Report to TCA’s analysis of the proportionate mortality ratios (PMRs) of American vinyl chloride workers as compared with the proportionate mortality of American males over the age of 15. In view of the animal evidence, the so-called independent contractor, TCA, emphasized the consistency of the PMR analysis from TCA’s study with PMR analysis of the animal findings that were considered to have demonstrated the multipotential carcinogenicity of vinyl chloride.
At page 16 of the April 15, 1974 TCA Final Report, TCA discussed Table 9 of the report that compared men with less than 5 years vinyl chloride exposure to men with more than 5 years of exposure. A startling exception to the mortality of the less than 5 year group was the mortality the more than 5 year group showed for malignancies of other and unspecified sites. This category (consisting mainly of primary brain cancer) showed a slight negative association with levels of exposure (SMR of 145 for low exposure versus 108 for high) but a strong positive relationship with length of exposure (86 for short exposure versus 176 for long exposure). The latter figure was considered to be statistically significant at the 1 percent level, causing TCA to conclude, in clear terms, that the malignancies were related to the duration of exposures, but not to levels of exposure as measured in this study.
4/15/74
On April 15, 1974, OSHA, EPA, and NIOSH got information from the MCA that 2 of 200 mice exposed at 50 ppm for 7 hours a day had developed angiosarcoma.
On the same day, the MCA-coordinated vinyl manufacturers received the first so-called Final Report from TCA.
4/16/74
On April 16, 1974, Firestone Plastics Co., in its press release, announced an angiosarcoma death of a Firestone PVC plant employee.
4/16/74
At the end of a Vinyl Panel meeting held April 16, 1974, a quick meeting of the Vinyl chloride Research Coordinators was held to discuss the angiosarcomas found in the IBT studies.
Originally, the VCRC agreed to take no action pending more information to be obtained as quickly as possible. Some action the following day was planned, however.
The following day, without consultation with the Research Coordinators or the industry sponsors, MCA informed NIOSH, OSHA, and EPA of the new IBT study findings of angiosarcoma. The MCA-coordinated vinyl manufacturers never authorized MCA to release the IBT data showing vinyl chloride’s carcinogenicity at 50 ppm. For once, however, the MCA had refused to go any further in coordinating the American Vinyl manufacturers’ concealment and took it upon itself to report what the MCA-coordinated vinyl manufacturers even as late as this still wanted to conceal.
The anger of the sponsoring companies was swift to follow and before the smoke lifted the MCA would come very close to loosing the vinyl chloride research program in its entirety. By the end of the week, the reaction of many of the MCA-coordinated vinyl manufacturers was one of belligerence and betrayal; many companies went so far as to openly question the value of their continued membership in the MCA, and - in light of MCA’s refusal to continue its concealment of the IBT cancers at 50 ppm – specifically questioned whose side MCA was on besides its own. (There is no indication MCA ever saw its way clear to disclose the Europeans’ much more thorough documentation of cancer at 50 ppm, or, since the European exposure regimen called for only four hours of exposure per day, as previously stated, arguably at ½ that level.)
At all times since the MCA betrayed the corrupt confidences of the MCA Vinyl Panel in 1974, and until the present, the MCA-coordinated vinyl manufacturers have covered up and concealed the whole controversy that resulted from MCA’s unprecedented refusal to participate in the American manufacturers’ continued concealment. The fact that one of the reasons the MCA-coordinated vinyl manufacturers almost jumped ship from the MCA around the time of the 1974 OSHA hearings was MCA’s unauthorized disclosure of the IBT 50 ppm results to the U.S. government (as well as MCA’s refusal to participate - at least formally - in the American manufacturers’ recommendation of a 50 ppm standard for American workers) has been concealed by the MCA-coordinated vinyl manufacturers since 1974.The concealment was to conceal their own misconduct and in order to allow MCA to continue its important role in coordinating the industry’s concealment of information on the hazards of vinyl chloride for years to come. For the foregoing reasons, since 1974, all of the involved American companies have continually concealed what is perhaps the only instance in which MCA, for once, betrayed its loyalty to the MCA-coordinated vinyl manufacturers to protect their interests in favor of its duty under U.S. government regulations to protect American workers, and to the American public.
On information and belief, MCA seems to have made this disclosure to the U.S. government, not as a result of any newly found appreciation of its ethical and legal responsibilities, but rather because its lawyers considered the risk of not doing so, too great, and the risk of MCA’s loss of future business from sponsoring companies, too small, for the MCA not to meet its duty to disclose. This was especially true in view of the near unanimous recommendation by the MCA-coordinated vinyl manufacturers that OSHA adopt a 50 ppm standard for human exposure – a standard for human exposure that was at least as high, and arguably twice as high, as levels of exposure that had already been demonstrated producing cancer in study animals – not only in the still secret European studies, but even in the MCA Group’s own studies, then being conducted at IBT. It was also reasonable for MCA to foresee that the MCA-coordinated vinyl manufacturers would have no choice but to endorse the MCA’s unauthorized disclosure of the 50 ppm IBT angiosarcomas, albeit after-the-fact.
4/16/74
On April 16, 1974, MCA announced that preliminary findings on mice in its own study under way at Industrial Bio-Test Laboratories tended to confirm the Maltoni data then publicly available, and as presented by MCA before the May 10 and 11 meeting; the data showed that under conditions of exposure of seven hours per day, five days per week, for eight months, liver angiosarcomas developed as follows: 2500 ppm, 28 liver angiosarcomas; 200 ppm, 11 liver angiosarcomas; and 50 ppm, two angiosarcomas.
MCA’s study also showed other types of tumors. Also, IBT was reported to have already begun its “low-dose” studies at levels of 25, 10, and 5 ppm. A major bias in the study was the “discovery” – though, too late to include them – of 1,500 to 2,000 workers with some of the longest exposures (up to 35 years before the beginning of the study).
4/19/74
On or about April 1974, the Management Representatives of the SPI served a similar oversight and control function for SPI committees concerned with vinyl chloride as the MCA Management Contacts did for its Vinyl Panel.
On April 19, 1974, A.B. Steele (Union Carbide) wrote to industry Management Contacts for the SPI about the need for the American vinyl producers to form a SPI-sponsored VCM/PVC Industry Management Committee within the Society of the Plastics Industry (SPI) as a direct result of the industry’s ongoing difficulties with MCA’s newfound gratuitous integrity.
Supposedly because the charter of the MCA made it awkward to have specialized segments of the industry operating under its sponsorship, the VCM/PVC Industry Management Committee held an ad hoc meeting in Washington, D.C., April 16, 1974, and decided to form a permanent action group within the Society of the Plastics Industry where Bylaws of the SPI were compatible with the industry’s present needs.
In the recent past, the industry’s coordinated efforts to cope with the regulations by OSHA, NIOSH, EPA, and FDA had been handled by the management representatives of the group of VCM and PVC producers involved in the vinyl chloride research program administered by the MCA.
The American vinyl manufacturers admitted that, at least until MCA’s unauthorized act of honesty, the MCA-coordinated vinyl manufacturers had consistently acted as a single, unified group in dealing with OSHA, NIOSH, EPA, FDA, and other agencies of government; Rather than each producer acting as an independent agent, the group had acted collectively.
A survey conducted by the MCA-coordinated vinyl manufacturers showed, at some time prior to April 19, 1974, that PVC suspension producers then believed that a realistic present goal for plant operations was 25 ppm, with a 50 ppm TWA PEL and a 30 – 40 ppm ceiling.
4/24/74
On April 24, 1974, OSHA published its Notice of Intent to file an Environmental Impact Statement (EIS) in the Federal Register.
4/26/74
On April 26, 1974, the U.S. federal government issued an emergency suspension order concerning registrations for certain indoor aerosol products containing vinyl chloride, and published a notice of intent to cancel registrations on July 19, 1974, in the Federal Register amended with a list of products.
MAY 1974
In May 1974, the MCA published an article in its newsletter, The MCA News, entitled “Study Shows Death Rate Average for VC Workers.”
Although the total number of cases was small, there did appear to be suggestive dose-related increases in the incidences of cancers of the urinary organ and the brain in the workers exposed for longer durations, as compared with their counterparts, who, at the time of death, had worked for shorter periods in jobs exposing them to vinyl chloride.
5/1/74
On May 1, 1974, Mr. N.K. Walters (duPont) reported to the SFPC that a committee had been formed under the Chairmanship of Mr. Leo Teplow with the objective of establishing the American National Standards Institute (ANSI) as the primary consensus standard-setting body in the United States.
It was anticipated that representatives of ANSI, OSHA, industry and labor would participate in the alternative consensus standard-setting body the MCA had contemplated. The Committee then sought the support of MCA management in establishing ANSI as the new leading consensus standard-setting body.
5/3/74
On May 3, 1974, MCA representatives reported that with the reports from the Industrial BIO -TEST Laboratories, Inc. (IBT) that mice in the 50 ppm exposure group were experiencing malignant tumors, including angiosarcomas of the liver, industry was left without an identifiable “no-effect” exposure level for vinyl chloride at which there was no direct evidence of adverse toxicologic effects.
The MCA-coordinated vinyl manufacturers recognized that a new series of experiments was necessary.
As advised by representatives of U.S. federal agencies, the Vinyl Chloride Research Coordinators (VCRC) had recommended to the Vinyl Panel that the MCA-coordinated vinyl manufacturers should undertake a new series of experiments in an effort to demonstrate, if possible, a no-effect level in animals.
5/3/74
The April 15, 1974 TCA Final Report was suppressed, causing TCA, on May 4, 1974, to issue a substantially modified (new) Final Report, entitled “Epidemiological Study of vinyl chloride Workers, Final Report to MCA by Tabershaw/Cooper Associates, Berkeley, CA.”
The MCA-coordinated vinyl manufacturers submitted this report to OSHA. The report emphasized that no cause of death showed a statistically significant excess over what would be expected in a comparable U.S. male population, and that no new deaths identified as angiosarcoma of the liver had been picked-up by the MCA study.
The study still demonstrated that cancers of the liver (primarily angiosarcoma), respiratory system, brain, and cancers of unknown primary sites, as well as lymphosarcoma, occurred more often than expected in those members of the study population with the greatest exposure to vinyl chloride.
The significance of the excess cancer rates, however, was deliberately downplayed and diminished in the May 3, 1974 version of the TCA report. The emphasis on “statistical significance” contained in TCA’s May 3, 1974 (modified) Final Report replaced TCA’s emphasis on the consistency of the animal data, the proportionate mortality analysis, etc., in its suppressed April 15, 1974 version of the Final Report.
TCA’s May 3, 1974 (modified) Final Report even made a relatively straightforward statement of its study findings. The May 3, 1974 TCA report was not, however, completely sanitized of all evidence of excess mortality from digestive cancer, respiratory cancer, cancer of other and unspecified sites and lymphosarcoma. Further, there appeared to be a relationship demonstrated in the study between cancer rates and exposure.
The May 3, 1974 TCA report examined, further, the association between vinyl chloride exposure and angiosarcoma of the liver and the digestive cancers to quantify the contribution angiosarcoma had made to the study’s observed mortality pattern. TCA attributed the mortality pattern in this cause group (digestive cancers) entirely to angiosarcoma. The fact that these angiosarcomas were included in the study only after-the-fact, with thousands of workers added after the crisis at BFG Louisville was, of course, not mentioned.
5/6/74
On May 6, 1974, the Director of Packaging Service of the SPI wrote to its PVC Producers Ad Hoc Committee (whose membership, for the most part, overlapped with that of the MCA Vinyl Panel) requesting their cooperation in responding to a questionnaire.
The recipients were told that the purpose of the questionnaire was for the specific purpose of creating data the SPI thought might prove Useful in the forthcoming OSHA hearings on its proposed permanent VCM standard.
The recipients of the letter were specifically advised that the data generated as a result of this questionnaire must show that significant numbers of people had been involved in the survey, and that they had been exposed long enough for the disease to become evident.
The recipients were specifically advised that SPI was soliciting the data to allow SPI to at least derive the implication that TWA exposure levels were at least 50 ppm and possibly higher, in the years prior to discovery of cancer in vinyl workers at BFG Louisville.
The use of this questionnaire was an early example of the international vinyl industry’s concerted exaggeration of the time-weighted average (TWA) of VCM exposure levels that were ordinarily found in vinyl manufacturing facilities in the years prior to 1974.
5/10-11/74
On May 10 and 11, 1974, a conference dealing with the, supposedly, recently discovered toxicity of vinyl chloride was published in Annals of the New York Academy of Sciences. Many representatives of the MCA-coordinated vinyl manufacturers participated in the conference.
5/10/74
On May 10, 1974, based on the record it had developed since its rulemaking began the previous February, OSHA published a comprehensive proposal for its final vinyl chloride standard. Exposure was to be maintained at a level of 1 ppm.
Although the OSHA PEL established 1 ppm as a permissible exposure level, that level was not detectable Using the monitoring methods employed at the time; it was too low. OHSA’s final standard was generally understood to be a 1 ppm standard, although sometimes referred to (usually misleadingly) as a “no detectable level” vinyl standard.
5/10/74
On May 10, 1974, OSHA published a comprehensive proposal. Exposure limits were set at a “no detect level” Using methods sensitive enough to detect exposures as low as 1 ppm within a specific degree of accuracy.
Notice of Hearing was published May 24, 1974, and the hearings were held in Washington, D.C., between June 25 and 28, and between July 8 and 11, 1974.
After the hearings, OSHA contacted Foster D. Snell Corp.’s independent consultant to conduct feasibility studies and economic impact.
5/10/74
In the Spring of 1974, additional data appeared at a May 10 and 11, 1974 meeting of the NYAS (New York Academy of Sciences and America Cancer Society). Dr. Maltoni disclosed that he had found one liver angiosarcoma in his rats at 50 ppm, as well as angiosarcoma and several other types of tumors.
5/11/74
On May 11, 1974, the VCRC met at the Delmonico Hotel in New York, New York. The group [60] decided set the exposure levels for the low-dose IBT animal studies they had made a commitment to conduct. As will be shown, in coming months, the MCA–coordinated vinyl manufacturers fabricated an excuse to abandon these large, low-dose animal studies (and the also large, but increasingly troublesome, “one-hit” single-exposure studies) supposedly based upon the (fabricated) advice from a high-ranking, and well-respected, NIEHS Committee, which was chaired by Dr. David Rall.
The Vinyl Panel also decided to conduct a chronic cancer study involving the exposure of a large number of animals to a single two-hour exposure of 5,000 ppm vinyl chloride. This study was to meet the same fate as the low-dose / no-effect level studies, i.e., they would both be aborted under false pretext.
Both of the studies referred to in the two previous paragraphs were based upon the following cover-story, a story that, for reasons set forth with more particularity below, each member of the Vinyl Panel can only have known was false: That NIEHS had advised the MCA-coordinated vinyl manufacturers that low-dose studies and catastrophic exposure studies were not needed by scientists in the U.S. who were studying the toxicology of vinyl chloride, and that scant resources dictated an industry course of action more likely to be valuable to the scientific community (like, say, funding Dr. Carlo Tamburro at the University of Louisville).
5/13/74
On May 13, 1974, R.N. Wheeler, Jr., Chairman of the MCA Work Practices Group on vinyl chloride Research, in a letter attached to a proposed standard asserted that exposures at the plants where angiosarcomas had been discovered were very high, emphasized that the disclosed angiosarcoma cases came primarily from 2 plants – BF Goodrich Louisville, KY, and Goodyear Niagara Falls, NY.
These two plants, Wheeler claimed, were not indicative of the other 14 monomer and 33 PVC resin plants where the disease had supposedly not occurred.
While the exposure levels were reported not to be clearly defined at the plants, the MCA Work Practices document falsely reported that exposures at Union Carbide and Dow had fallen between 20 and 50 ppm, in what presumably was some sort of remarkable contrast with the rest of the industry and at the affected plants where levels were reported, in seeming good faith, to have been ten times that level, i.e., between 200 and 500 ppm on an 8 hour TWA.
The MCA Work Practices document suggested OSHA adopt as its permanent occupational exposure limit for vinyl chloride a maximum exposure level of 50 ppm TWA with a maximum Short Term Exposure Limit (STEL) of 75 ppm .
5/20/74
On or about the week prior to May 20, 1974, an article in Chemical and Engineering News (C&EN) made the first known allegations that MCA had kept secret information about liver cancers for at least a year.
The so-called vinyl scandal stayed in the media’s attention for only a few months in the Spring and Summer of 1974. The scandal was largely unappreciated and unexplored because of the enormous amount of attention the country was giving to the dramatic developments in the Watergate affair.
The reported events were only that European and U.S. chemical firms, together with the Manufacturing Chemists Association, a U.S. trade group, had held in confidence for at least a year preliminary, albeit significant, scientific findings on vinyl chloride as an agent causing liver cancer in rats.
5/28/74
At a meeting of The vinyl chloride Safety Association (VCSA) held May 28, 1974 (on the eve of the hearings on the OSHA vinyl chloride standard), the vinyl manufacturers agreed that OSHA should adopt an 8 hour TWA average of 20-30 ppm as its exposure limit; A 40-50 ppm ceiling exposure was to be permitted without respiratory protection; Signs were to state “Hazardous to Health” and not “Cancer Suspect Agent” (although no-one had put up any signs anyway); Reports to OSHA were considered unnecessary paperwork.
At the 5/28/74 VCSA meeting, the vinyl company representatives each candidly admitted their company’s real views on TLVs, admitting what TLV they thought they could “live with.”
The companies in attendance even discussed the need for these competitors not to get carried away and act independently and not in concert with the rest of the American vinyl manufacturers. Specifically, these competitors in the vinyl industry discussed the reasons why a company (say, with newer, cleaner plants) should not accept a low PEL that the majority could not live with.
The MCA-coordinated vinyl manufacturers decided that they needed to stick together, as it was discussed that most all of the industries represented felt that they could meet a 25 ppm TWA with a short-term ceiling of 40 to 50 ppm, proved with a short time excursion clause.
5/31/74
By the end of May 1974, as the result of extensive testing, the members of the Industrial Hygiene and Monitoring, Analytic Methods Subcommittee of the MCA Vinyl Panel had concluded that it was completely inconceivable why anyone would want to monitor vinyl chloride Using charcoal adsorption as the personnel monitoring method. Whether there existed a suitable method for monitoring vinyl chloride at all, the charcoal method was unacceptable by any reasonable standard.
All the charcoal-based monitoring results were very precise though, despite grossly under-representing the actual exposures. Therefore, by virtue of charcoal’s uniform and consistent underestimation of occupational exposure levels of vinyl chloride, industry could present an appearance of compliance with government occupational regulation.
Exposures of different badges to the same amount of vinyl chloride under the same circumstances would appear accurate because they all would be completely inaccurate in a consistent manner.
6/5/74
On June 5, 1974, the MCA Executive Committee discussed the MCA’s 5/24/74 press release setting forth its chronology of the historic development of knowledge concerning the toxicity of vinyl chloride, which purported to address the allegations recently leveled against the MCA-coordinated vinyl manufacturers in C&EN and the Washington Post, etc.
The sentiment favored review by public relations personnel on similar occasions in the future.
6/5/74
At a meeting held on June 5, 1974 [61], the MCA-Group learned the MCA would not report Maltoni’s 50 ppm findings at the OSHA hearings.
6/6/74
Within a month, on June 6, 1974, Dr. Maltoni reassured the MCA-coordinated vinyl manufacturers that he would not present his positive findings of vinyl’s carcinogenicity at 50 ppm at the OSHA hearings – the same 50 ppm level the MCA-coordinated vinyl manufacturers were suggesting OSHA should adopt as its standard for American workers.
In their MCA submission on OSHA’s Proposed Work Practices Standard, the MCA-coordinated vinyl manufacturers set forth what they claimed were their guiding objectives in making their recommendations: Workers in the American vinyl industry must be protected from hazards related to vinyl chloride exposure.
The Work Practice should not impose impossible or uneconomical limits on the monomer or resin industry, but should eliminate many of the past practices which may have caused or contributed to the health hazards attributed to workplace inhalation of vinyl chloride.
The MCA-coordinated vinyl manufacturers recommended a concentration of 50 ppm TWA as their exposure limit, purportedly based upon nothing more than the paper Torkelson & Rowe published in the American Industrial Hygiene Association Journal in 1961.
The MCA-coordinated vinyl manufacturers knew that no-one else submitting information to OSHA’s 1974 rulemaking procedure knew what they were concealing – 6 months after human angiosarcomas were publicly reported at BFG Louisville – a report that reliable industry sponsored toxicology had shown cancer in animals exposed to 50 ppm vinyl chloride on a four-hour TWA.