6/6/74
At least by June 6, 1974, the MCA-coordinated vinyl manufacturers knew Dr. Maltoni had found cancer at the very level the MCA-coordinated vinyl manufacturers were recommending for U.S. workers (50 ppm on an eight hour TWA basis).
The positive low-dose results the MCA-coordinated vinyl manufacturers were concealing six months after Louisville had demonstrated vinyl chloride’s carcinogenic effect in animals exposed to 50 ppm for only four hours per day. Based upon exposure time, the results the MCA-coordinated vinyl manufacturers were concealing in the Summer of 1974 demonstrated cancer at one-half the exposure level many MCA-coordinated vinyl manufacturers recommended to OSHA in 1974.
One can, then, accurately say that the levels the Americans were now keeping secret – six months after the incident at BFG Louisville – demonstrated cancer in animals at levels a full 2 times lower than what many of the MCA-coordinated vinyl manufacturers were then recommending OSHA adopt as its standard for American workers.
With knowledge of the falsity, or with a reckless disregard for the truth, the MCA-coordinated vinyl manufacturers claimed that adoption of regulatory levels at a 0, 5 or 10 ppm ceiling would prove to be unattainable for the American vinyl industry, as “the subcommittee believed that these limits were uneconomic and all but impossible to meet, based upon present technology.”
The chosen limit of 50 ppm TWA in this standard represented a serious constraint on the industry, but it was one that industry professed it was prepared to accept in the interest of worker safety. An arbitrary reduction in the acceptable ceiling concentration to 0, 5, or 10 ppm at this time was proclaimed to be, simply, a requirement for liquidation of a major industry.
6/10/74
On June 10, 1974, Marcus Key (NIOSH) responded in a letter to the editor of C&EN to the MCA’s claim that the MCA-coordinated vinyl manufacturers had informed NIOSH of results of European study, before angiosarcomas were found at BFG Louisville.
As previously shown, at this meeting, there was no mention of angiosarcoma of the liver in humans or animals, no reference to production of liver tumors in animals by another Italian investigators and no reference to Prof. Cesare Maltoni, whatsoever.
Dr. Key claimed that, in the course of the July 17, 1973 industry presentation to NIOSH, the ICI representative critically reviewed the work of Prof. P.L. Viola and pointed out that the tumors Viola had induced at very high exposure levels of vinyl chloride were of the Zymbal gland and not primary lung tumors (as Viola had claimed in his 1971 published report on the 30,000 ppm tumors).
The ICI representative (Dr. Duffield) also reported on what was characterized as incomplete, industry-sponsored studies of several rodent species at more reasonable exposure levels of vinyl chloride. Dr. Key said that several tumors interpreted as confirmation of Viola’s work had been observed.
Key had asked MCA to keep NIOSH advised of progress with the MCA study, and nothing of great significance had transpired at all (and certainly nothing like the revelation that well-conducted toxicology studies had demonstrated the occurrence of cancer at the 250 ppm level in animals exposed only 4 hours per day).
6/12/74
On June 12, 1974, Snell’s draft statement was prepared and circulated. By September 5, 1974, Snell’s final environmental impact statement was prepared.
6/25/74 – 7/11/74
By the end of the OSHA rulemaking in the summer of 1974, one of the most exhaustive databases ever relied upon by OSHA had been compiled. Over 600 written comments had been received and more than 200 separate oral and written submissions made in the course of two hearings. The official record of the proceedings exceeded 4,000 pages. The carcinogenicity of vinyl chloride for 3 animal species had been documented: rat, mouse, and hamster.
6/25-28/74 and 7/8-11/74
On June 25 through 28, 1974, and July 8 through 11, 1974, the MCA-coordinated vinyl manufacturers submitted evidence in connection with the OSHA hearings on vinyl chloride with knowledge that the evidence was either substantially false or materially incomplete
During the Summer of 1974, at OSHA's hearings on its proposed Permanent Standard for vinyl chloride, the MCA-coordinated vinyl manufacturers introduced into the OSHA H-036 Docket the following non-exclusive exhibits and sworn testimony:
H-036 Docket Number
(3.7) Statement of the Manufacturing Chemists Association.
(3.15) Testimony of V. K. Row, Dow Chemical.
(3.15-B) Published references to the Biological Effects of Vinyl chloride. Appendix I to testimony.
(3.15-C) Industrial Hygiene Surveys involving Vinyl chloride. Appendix II to testimony.
(3.17) Comment of Wayne T. Brooks, Director, Occupational Safety & Health Services, Organization Resources Counselors, Washington, DC.
(3.19) Comment of Roger W. Strassburg, PhD, B. F. Goodrich Company, Akron, OH.
(3.20) Letter and attachments of R. J. Reynolds, Manager-Vinyl chloride Shell Chemical company, Houston, TX. (NOTE: Attachments are not here).
(3.21) Comment of R. E. Widing, Vice President, Industrial Chemical Division, PPG Industries, Inc., Pittsburgh, PA.
(3.22) Comment of Elliott S. Harris, Ph.D., Dept. of Health, Education and Welfare, Center for Disease Control, Cincinnati, OH.
(3.23) Joint Comment of Bertram R. Cottine and Andrea M. Hricko, health Research Group, Washington, DC.
(3.24) Comment of Walter B. Connolloy, Jr., Assistant Counsel, Firestone Tire & Rubber Company, Akron, OH.
(3.25) Comment of T. L. Garey, Vice President-Manufacturing, Air Products & Chemicals, Inc., Wayne, PA.
(3.28) Comment of T. R. Samsell, Director, Environment Conservation, Continental Oil Company, Washington, DC.
(3.30) Comment of R. N. Wheeler, Assistant Products Manager, Union Carbide Corporation, New York, NY.
(3.30-A) Comment of John W. Whittlesey, Attorney, Union Carbide Corp., New York, NY.
(4.1) Record for Comments on Proposed Standard for Vinyl chloride: Borg-Warner Chemicals, Washington, W. Va. 26181.
(4.3) Record for Comments on Proposed Standard for Vinyl chloride: Covington & Burling, Washington, DC 20006.
(4.3-A) Record for Comments on Proposed Standard for Vinyl chloride: Covington & Burling, Washington, DC 20006.
(4.9) Record for Comments on Proposed Standard for Vinyl chloride: Chicago Magnet Wire Corporation.
(4.62) Record for Comments on Proposed Standard for Vinyl chloride: Rohm and Haas Company, Philadelphia, PA 19105.
(4.75) Record for Comments on Proposed Standard for Vinyl chloride: National Paint & Coatings Association, Washington, DC 20005.
(4.102) Record for Comments on Proposed Standard for Vinyl chloride: Industrial Vinyls, Inc., Miami, FL 33152.
(4.111) Record for Comments on Proposed Standard for Vinyl chloride: Dixie Plastics, Inc., New Orleans, LA 70152.
(4.122) Record for Comments on Proposed Standard for Vinyl chloride: Uniroyal, Inc., Washington, IN 47501.
(4.145) Record for Comments on Proposed Standard for Vinyl chloride: Monsanto company, St. Louis, MO 63166.
(4.154) Record for Comments on Proposed Standard for Vinyl chloride: The Gates Rubber Company, Denver, CO 80217.
(4.176-A) Record for Comments on Proposed Standard for Vinyl chloride: Alpha Chemical & Plastics Corp., Newark, NJ 07105.
(4.177) Record for Comments on Proposed Standard for Vinyl chloride: Chemical Fabrics & Film Association, Middletown, NY 10940.
(4.177-A) Record for Comments on Proposed Standard for Vinyl chloride: Chemical Fabrics & Film Association, Middletown, NY 10940.
(4.177-B) Record for Comments on Proposed Standard for Vinyl chloride: Chemical Fabrics & Film Association, Middletown, NY 10940.
(4.178) Record for Comments on Proposed Standard for Vinyl chloride: EOCOM Corporation, Arlington, VA 22209.
(4.199) Record for Comments on Proposed Standard for Vinyl chloride: Goodyear Chemical Plant, Plaquemine, LA.
(4.246) Record for Comments on Proposed Standard for Vinyl chloride:
(15) Statement of John Gmelch, Marketing Manager for New England Plastic Corporation. (THERE IS ONLY A COVER PAGE STATING "SEE DOCKET OFFICE STAFF)."
(20-B) Statement of Society of the Plastic Industry, Inc.: Ralph L. Harding, Jr.
(20-C) Statement of Society of the Plastic Industry, Inc.: Jerome H. Heckman.
(20-D) Statement of Society of the Plastic Industry, Inc.: Anton Vittone.
(20-E) Statement of Society of the Plastic Industry, Inc.: M. L. Keplinger, Ph.D.
(20-F) Statement of Society of the Plastic Industry, Inc.: Vince P. Ficcaglia.
(20-G) Statement of Society of the Plastic Industry, Inc.: John E. Ertel.
(20-H) Statement of Society of the Plastic Industry, Inc.: Carl U. Derehl, M.D.
(20-I) Statement of Society of the Plastic Industry, Inc.: Maurice N. Johnson, M.D., Equipment Association, Inc., Arlington, VA 22209.
(20-J) Statement of Society of the Plastic Industry, Inc.: Rudolph H. Stehl, Ph.D.
(20-K) Statement of Society of the Plastic Industry, Inc.: Robert D. Soule, Ph.D.
(20-L) Statement of Society of the Plastic Industry, Inc.: Roger W. Strassburg, Ph.D.
(20-M) Statement of Society of the Plastic Industry, Inc.: Louis J. Molinini.
(20-N) Statement of Society of the Plastic Industry, Inc.: Paul Beebe, Jr.
(20-O) Statement of Society of the Plastic Industry, Inc.: Arthur A. Smith.
(20-P) Statement of Society of the Plastic Industry, Inc.: Rodney P. Becker.
(20-Q) Statement of Society of the Plastic Industry, Inc.: Philip J. Weaver.
20-R) Statement of Society of the Plastic Industry, Inc.: Working notes of SPI Kepner-Tregoe Conference.
(20-S) Statement of Society of the Plastic Industry, Inc.: Epidemiological Study of Vinyl chloride Workers by Tabershaw/Cooper Association, Inc., 5/3/74 (MCA).
(21) Statement of Joseph Fath, Vice President, Tenneco Chemical, Inc. - accompanied by Philip Scarito and Paul Lobo.
(22) Statement of John M. Peters, M.D., Harvard School of Public Health.
(23-B) Statement of John G. Barr, Technical Manager - accompanied by Paul Kotin, consultant on Vinyl chloride Monomer.
(23-C) Statement of Dr. Paul Kotin.
(24) Statement of V. K. Rowe, Director of Toxicological Affairs, Dow Chemical Company - accompanied by : Karl Oelfke, Roger Daniel, Dr. Ralph Cook, Dr. Ben Holder and Dr. Perr Gehring.
(25) Statement of Harry E. Connors, Vice President, Diamond Shamrock Chemical Company - accompanied by: Dr. Richard W. McBurney, George D. Williams, and Howard E. Everson.
(48) Statement of Todd C. Walker, President, Firestone Plastics Company - accompanied by : Francis Hoy, Walter Cannily, Lawrence Ballot, George Wilson, Robert Brookman Michael Baden and F. F. Boyd.
(55) Statement of Raymond F. Abramowitz, Technical Director, Ruco Division - Hooker Chemical and Plastics.
(56) Statement of Donald H. Francis, Director of Domestic Chemical Production, Goodyear Tire & Rubber Company - accompanied by Paul Beebe, Jr.
(57) Statement of Wayne T. Brooks, Consultant, Organization Resources Counselors, Inc.
(61) Statement of R. N. Williams, Vice President, Olin Corporation.
(65) Statement of Richard J. Hughes, Vice President, Union Carbide Corporation.
(94-A) Copy of testimony which Mr. Richard J. Hughes was to have given on behalf of Union Carbide Corporation, concerning Union Carbide's position on the proposed vinyl chloride standard. Letter of transmittal from John W. Whittlesey, Senior Labor Counsel. (Refer to Exhibits 65(a), 65(b) and 65(c)).
(94-B) Appendix to be attached to testimony of Richard J. Hughes, Union Carbide Corporation, concerning proposed standard for vinyl chloride. Letter of Transmittal from R. N. Wheeler, Jr.. (Refer to Exhibits 65(a), 65(b) and 65(c).
(96) Letter of transmittal of July 11, 1974 from W. A. Runyan, Assistant Counsel of the Goodyear Tire & Rubber Company, and information regarding the places sampled and the number of samplings taken at various Goodyear plants. (Refer to Exhibit 20(P)).
(97) Letter of Transmittal of July 3, 1974 and information on historical environmental air sampling at B. F. Goodrich plants from Dr. M. N. Johnson, Director of Department of Environmental Health, as requested at vinyl chloride public hearing. (Refer to Exhibit 20(K)).
(122) Statement of Mr. Zeb G. Bell, Jr., Director of Environmental Control, PPG Industries, expressing objection to the position taken by the American Chemical Society at the public hearing.
(124) Statement of John W. Whittlesey, Senior Labor Counsel for Union Carbide Corporation, concerning Mr. Vernon M. Jensen's testimony at the public hearing.
(135) Transmittal letter of John J. Cassidy, Attorney for Firestone Plastics Company, along with post-hearing submission and supplemental Appendix of Firestone Plastics Company.
(136) Post-Hearing Memorandum of the Society of the Plastics Industry, Inc. - Proposed Findings of Fact and Conclusions Supported by the Records. Memorandum was submitted by Jerome H. Heckman, General Counsel and Joseph E. Hadley, Assistant General Counsel (Keller & Heckman).
(137) Transmittal letter of Joseph E. Hadley, Assistant General Counsel to the Society of the Plastics Industry, Inc., and a letter of Joseph D. Banzer, Senior Research Chemist of Diamond Shamrock Corporation.
(146) Industrial Bio-Test Laboratories, Inc., Tables summarizing mortality, body weight and gross pathological findings through the eleventh month. Submitted by Ken Schadeberg, Senior Group Leader of Inhalation Toxicity.
(163) Transmittal letter from R. N. Wheeler, Jr., Union Carbide Corporation, enclosing memorandum concerning monitoring VC in work places or ambient air, control and recovery of VC emissions, and engineering projects.
(203) Memorandum from Dr. Joseph K. Wagoner, NIOSH, to Alexander Reis, OSHA, transmitting an evaluation of the Tabershaw/Cooper Associates Epidemiological Study of Vinyl chloride Workers.
7/11/74
By July 11, 1974, the chronology published by MCA in their June 1974 bulletin had created real problems for the Europeans (who correctly perceived that they were being made the scapegoat for the MCA-coordinated vinyl manufacturers, with MCA’s ridiculous claims that the secrecy agreement that had recently become a public embarrassment had been brokered with the Europeans had been anything other than reciprocal and freely and voluntarily entered by all parties.
Messrs. Barnes (ICI) and Gosselin (Solvay et Cie) were visiting the U.S. in connection with the OSHA hearings and, with the assistance of the SPI, set-up meetings with the major American Vinyl manufacturers at 4 different locations in the U.S. the week of July 11, 1974.
The Europeans were extremely upset that the MCA’s chronology was wrong in both fact and implication. The most sensitive points for the Europeans were the references to in the MCA chronology to the “’months of negotiation” involved and so-called reluctance of the European group to release their data, with the inference that MCA had to extract the information from the Europeans when it was, of course, freely given to the MCA-coordinated vinyl manufacturers.
The outcome of the evening was decision for Ralph Harding or Jerome Heckman to prepare a new chronology for distribution to the SPI ad hoc committee for their private use and not for distribution.
Mr. Barnes has stated, specifically, that he did not want any more public commotion over the affair and that he was satisfied with Dr. Key’s recent response to Mr. Barnes’ letter to the editor of C&EN.
7/11/74
At the SPI coordinated meeting of the MCA-coordinated vinyl manufacturers with the European manufacturers held in Cleveland, Ohio on July 11, 1974, two members of European producers of vinyl chloride explained their position on articles that appeared in C&E News.
The representatives of the European manufacturers were A.W. Barnes, a director of ICI Plastics, and Auguste Gosselin, the Director General for Petrochemicals at Solvay, and M. Thomas, a Director of Rhone Progil in France.
Mssrs. Barry Barnes and Ausguste Gosselin recapped the chronology of the Europeans and expressed considerable concern about the wording of the MCA’s chronology. It was related by Mr. Barnes that in their meeting on Tuesday, July 9, NIOSH indicated that they did not like the MCA chronology. Mr. Barnes said that no one in Europe knew Dr. Maltoni planned to present some of the Europeans’ preliminary findings on vinyl chloride at the April 1973 International Cancer Congress in Bologna. This presentation had been made without their knowledge or permission.
The highlights of the chronology discussed included the fact that Dr. Viola was an employee of Solvay when he undertook the study to reconstruct the bone condition known as acroosteolysis (a fact MCA had found inconvenient to disclose in its chronology that had so severely criticized the techniques Used by Dr. Viola in his studies).
7/15/74
On July 15, 1974, the American Chemical Society (ACS) entered the vinyl chloride dispute the week prior to the beginning of the OSHA hearings on the proposed Vinyl standard.
The ACS, to the horror of its many members in the vinyl industry, had come out, in essence, in support of the Government’s proposed “no detectable level” (1 ppm) permanent standard for workers exposure to the chemical.
7/18/74
On July 18, 1974, A.B. Steele of UCC wrote to the Executive Director of ACS claiming that the animal data on vinyl chloride MONOMER exposure was the only possible basis for any exposure limits whatsoever, and that even the existing animal evidence was self-contradictory, inconclusive and non-probative, and certainly could not be reasonably translated or related to human experience.
The Carbide letter also claimed that there was no way for the industry, with existing technology, to meet the standard proposed by OSHA.
7/26/74
At the July 26, 1974 meeting of the Organization Resources Council (ORC) in Washington, D.C., there was considerable and heated discussion about the impropriety of the American Chemical Society (ACS) adopting a position on the vinyl chloride standard without any effort to consult with individuals in the chemical industry with personal knowledge of the hazard, or of the technically feasible approaches to the problem.
Both IBM and Western Electric announced that they had decided to discontinue their corporate contributions to ACS and intended to ignore the request they had just received for a contribution of $10,000 to the ACS Centennial.
Other companies were urged to do likewise, and did, although Allied Chemical considered the legal and political complications of electing to follow that course of action to be significant.
7/30/74
On July 30, 1974, the VCRC met at the MCA Conference Room in Washington, D.C.
Dr. Torkelson informed the Panel that Dr. V. K. Rowe planned to meet with Dr. David Rall of the NIEHS, for the purported purpose of obtaining their guidance on MCA testing programs. (It was Dr. Rowe who had supplied false documentation for the Panel’s supposed full, fair, and forthright presentation of what it new about cancer to NIOSH on July, 17,1973.)
As every Panel member can only have known, this liaison with NIEHS was being orchestrated in a deliberate attempt to fabricate a pretext in the peculiar form of “advice” from an expert panel of government scientists – to discontinue every aspect of its on-going program of toxicological research except for the doomed IBT studies authorized in 1971.
The Panel recommended that data collection on the employees “originally planned for inclusion” be initiated. (However – if for no other reason than the fact that it was not covered by any existing contract with TCA – the Vinyl Panel all knew that prior to Louisville there had been no more intention to include the workers to be included in the Supplemental Study discussed at this meeting than there had been to include the 4,000 or so employees that were thrown in to the TCA cohort between the time the Louisville angiosarcomas were announced and April 15, 1974 when the Panel received its first Final report from TCA.)
The statement in the minutes for the July 30, 1974 VCRC meeting (and the next meeting’s minutes, also) that the Union Carbide records had been “belatedly discovered” can only have been known by the Panel to be untrue and that the ruse that the Carbide records had not been previously appreciated was entirely for public consumption (and for the record).
The related preposterous falsehood that Carbide’s South Charleston PVC plant, the oldest in the country, could not identify any workers other than those that had been employed within the last six years before the study began was also, on information and belief, known to be highly dubious by every company on the Vinyl Panel at the time.
The fact was the Vinyl Panel hadn’t planned on what had happened at BFG Louisville and they hadn’t planned on the increased scrutiny that the events in BFG Louisville would bring bear upon the TCA study. The Panel had not planned on ever having to answer even such basic questions about the TCA study as how it came to be that none of BFG Louisville PVC workers who developed angiosarcoma, as publicly disclosed in early 1974, had been “picked up” by the TCA study, or how it came to be that two of the largest, and oldest plants in the country (at BFG Louisville and Carbide South Charleston) had contributed so very few workers to the TCA study cohort in comparison with so many of the newer plants that had been copiously included. (It was this inclusion of vast numbers of new hires in the American vinyl industry that worked to, almost entirely, dilute both the study cohort, and the study’s empirical significance).
The Vinyl Panel knew it had no legitimate answers to give to such questions, and, the Panel was shocked that, as a result of the situation at BFG Louisville, it was a virtual certainty that questions – these questions and more – might have to be answered under the circumstances that prevailed in the wake of the public relations crisis at BFG Louisville.
Even at this early date, the Panel was already aware that their IBT studies were in serious trouble. This was as a result of the same type of misconduct that led to IBT’s criminal conviction in the early 1980s for scientific fraud, i.e., abominable conditions, undocumented ad hoc changes in protocol, animal substitution suggesting foul play, not performing the tests required for cancers the sponsors did not want to find, even outright fabrication of data, etc.
On July 30, 1974, the MCA-coordinated vinyl manufacturers voted to terminate the exposure phase of the IBT experiments after one year (i.e., on September 10, 1974).
As previously shown, the Panel was already well familiar with Dr. Maltoni’s protocol that allowed the animals in his experiments to live to the end of their natural lives. With this knowledge, the VCRC recommended, and the Panel subsequently agreed, that the animals in the IBT experiments would be sacrificed at the end of the second year of the study (allowing for a year of observation).
However, as will be shown, because of the Panel’s desire to avoid having to explain what had happened to the vinyl chloride toxicology studies at IBT to anyone, the Panel, at the last minute in the fall of 1975, required IBT to pretextually “adopt the method Dr. Maltoni” had employed (i.e., not sacrificing animals remaining at the conclusion of the second year of the study – an option the Panel had specifically rejected at this July 30, 1974 meeting of the VCRC). The real reasons for this last-minute change was not some new-found preference for the Maltoni method for terminating the observational phase of the IBT toxicology studies, instead, the true reason the Panel adopted Dr. Maltoni’s method for terminating the study was to prevent the IBT study from terminating as per the protocols, at all. This after-the-fact inclusion of missing workers was done in order prevent the results of the IBT animal studies, and the corrupt circumstances under which those studies were conducted, from ever being revealed, and the desire that IBT never publish anything further as a result of the studies MCA had sponsored. In the Panel’s estimation, completing the IBT study was never going to help them, and carried a significant chance of making, what they considered to be their bad situation, worse.
The MCA group recognized the need for, and approved the conduct of, “one-hit” or “catastrophic exposure simulation” toxicology studies. These studies were intended to determine whether a single high-level exposure to vinyl chloride would cause cancer in laboratory animals. (The study involved the exposure of thousands of laboratory animals to only a single 2-hour exposure to vinyl chloride at the 5,000 ppm level).
As will be shown, despite this admitted need, because of the financial impact such a study might have if it turned out to be positive, the Panel would soon abort this study (as well as the previously approved IBT studies supposedly intended to seek a “no effect level”).
As will be shown, the Vinyl Panel employed a fraudulent ruse involving the NIEHS “Rall Committee” recommendation – a recommendation that never occurred – in order to justify aborting the IBT studies approved at this meeting. When embarrassed that OSHA had discovered this prior to the beginning of the 1974 OSHA hearings, the MCA-coordinated vinyl manufacturers claimed the belated discovery was the result of so-called time constraints (or, in the case of Union Carbide, because records had only been belatedly discovered).
The truth, however, is at odds with this cover-story. According to this cover-story, even well known large vinyl plants, such as the Firestone PVC plant in Pottstown, PA that had been excluded from the original TCA study, were excluded as the result of an honest mistake.
However, this cover-story did not explain the exclusion of all of the workers at Carbide South Charleston, except those that had been employed within the six years immediately preceding the beginning of the TCA study in 1973.All of the Panel members knew that if it hadn’t been for Louisville, these older plants would never have been included in the cancer studies they were sponsoring at all. Moreover, the workers had been excluded from the TCA studies precisely because of (and not despite) the fact that those plants were older and therefore might possibly reveal evidence of cancer that it was the Vinyl Panel’s greatest wish to conceal.
The Vinyl Panel voted to pay TCA additional money above and beyond that specified in the original TCA contract covering the original TCA study.
The Panel decided to maintain a constant liaison with their sister organization, the Society of the Plastics Industry (SPI). This continuing relationship would be maintained not only by the overlapping membership between the company representatives participating in matters being conducted by both organizations related to vinyl chloride and occupational health, but also directly by Dr. William Rinehart from Ethyl Corporation and Mr. A. B. Lindquist from the Stauffer Chemical Company.
7/30/74
On July 30, 1974, the Vinyl Chloride Research Coordinators (VCRC) held a meeting in Washington, D.C.
The IBT studies commissioned in 1971 would eventually begin exposures in September 1973.
The “current” protocols (a work in progress that were subject to change at the sponsors whim) for the IBT studies at this time unquestionably called for termination of exposure of rats and hamsters after 1 year, and that the animals then be housed in individual cages and held for observation and sacrifice at the end of the 2nd year. Under the current understanding of IBT, the MCA-coordinated vinyl manufacturers had declined to exercise the option of extending the exposure phase of the experiments.
The Panel voted to postpone for later decision the timing and test protocols for the authorized studies seeking a no response exposure level for vinyl chloride, but voted to recommend the prompt initiation of the low dose experiments to evaluate what effect, if any, a single (2 hour) massive exposure to vinyl chloride might have on cancer risk. The exposures were intended to simulate what might be experienced in the vicinity of a vinyl chloride tank car spill.
The MCA-coordinated vinyl manufacturers voted for an experimental protocol in which Tabershaw Cooper would extend social security follow up. The Panel also discussed, and voted to fund, bringing a fraction of the “old” Union Carbide personnel records, estimated to probably consist of 1500-2000 people. Four plants with about 800 men would be thrown in for good measure (including two that weren’t even VCM plants).
7/30/74
On July 30, 1974, and months before R.D. Gamblin of Conoco Chemical submitted data to the Foster D. Snell Study, concerning the possible economic impact of alternative standards of VCM Worker exposure levels, Gamblin submitted data for Conoco’s plant in Westlake, LA.
Foster Snell had been hired by the government to study vinyl chloride.
Several items in the questionnaire asked for information regarding equipment and operating requirements to meet a potential OSHA standard set below 50 ppm.
Conoco reported that it found it difficult to speculate upon the effect of more restrictive standards. The plant had no means of continuously monitoring VCM ambient air ceiling levels. Such equipment was on order, and when installed, would give an indication of VCM ceiling levels at various plant locations. The information they had, did not permit Conoco to even attempt to define a feasible operating level, and the associated costs, below the 25 ppm level.
On information and belief, an, as yet, unknown number of other MCA-coordinated vinyl manufacturers’ executives submitted little or no data. Yet, the companies had all discussed in great detail what level of vinyl chloride exposure they could “live with,” precisely the sort of information Snell was requesting, and in much more particular and specific terms (i.e. what ceiling level, what short term exposure limit, etc.).
8/1/74
In August 1974, the MCA-coordinated vinyl manufacturers caused to be published in the JOM, the “shorter version” of its May 3, 1974 “longer” report that was submitted to OSHA at the time of its hearings on the vinyl chloride standard.
This historical prospective mortality study of 8,384 men, who had at least one year of occupational exposure to vinyl chloride before December 31, 1972, was misleading and largely fraudulent. Notwithstanding the best efforts of the MCA-coordinated vinyl manufacturers to design cancer out of their studies, the findings were certainly consistent with the extreme multipotential carcinogenicity VCM had previously demonstrated in animals. (Although nobody but the MCA-coordinated vinyl manufacturers had known about vinyl’s demonstrated carcinogenicity until at least May, 1974.)
Although the study reported that cancers of the digestive system (primarily angiosarcoma), respiratory system, brain, and cancers of unknown sites, as well as lymphomas, occurred more often than expected in those members of the study population with the greatest estimated exposure and concluded that it was the first epidemiological study to suggest that in humans vinyl chloride may also be associated with cancer of multiple sites.
The findings of the study (and, later, the MCA-coordinated vinyl manufacturers) emphasized: (1) the overall mortality of the study population was approximately 75% of what would be expected in a comparable population of U.S. males; (2) No cause of death showed a statistically significant excess over what would be expected in a comparable U.S. male population; and (3) No deaths identified as angiosarcoma of the liver were found other than those previously identified.
8/8/74
On August 8, 1974, the MCA (K.D. Johnson) notified the MCA-coordinated vinyl manufacturers that the odor threshold for VCM that all of them had always supposedly thought was only 240 ppm (as stated in SD-56), was actually more like 2,000 ppm (8 times higher).
Since the MCA-coordinated vinyl manufacturers were told that they had based those pretty low exposure estimates on the erroneously low 240 ppm odor threshold – it logically followed that all of the previous exposure estimates had, uniformly, misrepresented actual exposures almost 8 times lower than they truly were.
So, by the simple expedient of revising the odor threshold from 240 ppm to 2,000 ppm, the historic levels of exposure that had been picked up in the TCA study were, also, 8 times higher, and the VCM that killed anyone in the study was eight times higher too.
Through this simple fraudulent practice, the MCA-coordinated vinyl manufacturers hoped to make VCM appear 8 times safer than the “uncorrected” exposure estimates for their pretextual confusion about the odor threshold of VCM. None of the sponsors questioned the wisdom of what was obviously a pretty drastic move to raise exposure estimates by a factor of eight, just like that, however all of the MCA-coordinated vinyl manufacturers were well aware that this peculiar assumption about how the exposure estimates were made at the 33 plants in the study was dubious and misleading. (The odor threshold ruse was appreciated by everybody on the Panel as purely pretextual [and false besides].)
MCA Used the Carbide (Wheeler) odor Panel study to come up with this “recently discovered” 2,000 ppm odor threshold.
8/9/74
Kenneth D. Johnson sent the 1st of Maltoni’s papers to the Technical Task Group on Vinyl Chloride Research (TTGVCR). (See March 1974).
8/14/74
On August 14, 1974, representatives of EPA, FDA, MCA, NCTR, NIEHS, NIOSH, and Dow discussed setting up a research-clearing house.
8/16/74
On August 16, 1974, the Consumer Product Safety Commission (CPSC) issued a press release that banned as health hazards household aerosol sprays Using vinyl chloride as a propellant.
8/21/74
At the senate hearings on August 21 1974, attorney Ralph L. Harding, Jr., President of the Society of the Plastics Industry, Inc., (SPI), the principal trade association of the plastics industry, and representing 1,400 members companies, representing 75% of total U.S. sales, (the Society’s vinyl chloride and polyvinyl chloride Resin Producers Committee represented more that 90% of U.S. capacity for production of VCM and PVC resins) testified that total PVC production for 1974 was 5 billion pounds, the second largest volume of any plastic produced in this country.
Vinyl chloride’s largest use was in construction, accounting for 43% of consumption; another 10% in wire and cable, 25 % in manufacture of pipe; 15% in film and sheet for packaging and coated fabrics; 10% into flooring.
The testimony emphasized the economic impact of shutting down the vinyl industry. Mr. Harding testified that the best evidence indicated that the workers who had died at BFG had been exposed to high levels of vinyl chloride for long periods of time.
The only study to date that had compared exposure levels with disease, or the lack of it, was conducted by the Dow Chemical Company at its Midland division. The results showed a general cancer increase among heavily exposed workers (above 200 ppm on a TWA for an eight-hour day), but none among workers below that level. No angiosarcomas were found. In general, the Dow study was reported to show that low levels of VCM exposure did not result in an excess of disease. Mr. Harding testified that angiosarcomas had been detected in old test animals (rats) in Italy, at exposure levels of 50 ppm. Deaths in mice had been reported at 50 ppm also.
8/21/74
In the August 21, 1974 statement of the Manufacturing Chemists Association’s Dr. Theodore R. Torkelson (employed 21 years in research toxicology by Dow) MCA testified that it had 178 U.S. member companies, representing more than 90% of the U.S. production capacity for basic industrial chemicals.
Dr. Torkelson reviewed the history of studies conducted by the MCA and others and the historic development of knowledge with regard to the toxicity of vinyl chloride.
8/21/74
The statement of Dr. Marcus M. Key, Director of NIOSH, at the 1974 vinyl chloride hearing reemphasized what the MCA-coordinated vinyl manufacturers told him and did not tell him on July 17, 1973, reemphasizing that no information about liver cancers had been given.
If there had been, he thought NIOSH would have taken an entirely different course of action in view of the widespread use of vinyl chloride.
8/21/74
Dr. Wagoner, Director of Field Studies and Clinical Investigations at NIOSH also testified at the Stender Senate Hearings about an epidemiologic study that had been conducted by the Center for Disease Control (CDC), involving 109 deaths among 930 white males exposed to vinyl chloride.57
Deaths due to each of the specific causes delineated in the CDC study were not much different than would be expected for all but one disease category – cancer. At this stage, a percent increase in deaths due to cancer beyond what would have been expected had already been observed, this difference being highly significant.
This increased overall cancer mortality risk was described as at a variance with the TCA study, which had actually shown a deficit in total mortality, possibly because of the disproportionate number of recently hired employees that had diluted the study group. These results corroborated the animal experimental findings by Dr. Maltoni showing multiple organ involvement.
The NIOSH/CDC studies also differed from the TCA criteria for including plants in the study that had not even been engaged in the polymerization of vinyl chloride for at least 15 years. The reason cited was that NIOSH knew, indeed, that they were looking for the latent effects of a carcinogen, which would appear many years after a person was initially employed. NIOSH/CDC did not include in the analysis the first five or 10 years after a person came into employment. Vinyl chloride was used in hairsprays from at least 1958 until at least April 1974.
9/5/74
By September 5, 1974, A.D. Snell’s final environmental impact statement had been prepared. Foster D. Snell Corp. retained by OSHA as its independent consultant to conduct feasibility studies and economic impact studies presented its evidence.
9/18-19/74
On September 18, 1974, the VCRC met at the MCA Conference Room in Washington, D.C. On September 18, 1974, the MCA VCRC[62]) voted to conduct low level (“low dose”) chronic inhalation studies, Using IBT; however, the vote was split on use of mice in addition to rats. All consideration of low level (less than 1 ppm) continuous chronic exposures was deferred until completion of the toxicologic studies then ongoing.
The VCRC received a report from Dow, whom they had recently allowed to raid the animals (supposedly) being exposed to vinyl chloride at IBT in order to come up with data on the spur of the moment to create doubt as to VCM’s ability to cause genetic aberrations and mutations in workers exposed to vinyl chloride, an ability that had recently been reported by independent, and well-respected, scientists at Mount Sinai Hospital.
The Panel was specifically informed that the animals that had been used to conduct the politically motivated cytogenetic studies at Dow were the only set of tissues derived simultaneously from all rat groups under fully controlled conditions.
As a result, the Panel specifically agreed to allow Dow to take the most animated animals still surviving the cannibalism and neglect at IBT to establish the study’s (pre-ordained) conclusion: cytogenetic studies of vinyl chloride exposed rodents do not tend to support the implication of recent evidence of genetic damage Mount Sinai had recently reported in Vinyl workers, i.e., that vinyl chloride was a mutagen and caused genetic damage in humans.
9/19/74
On September 19, 1974, the Vinyl Panel met at the MCA Conference Room in Washington, D.C. On 9/19/74, the Panel[63] authorized TCA to augment the original cohort by adding back into the study some of the workers from plants that were misrepresented as having been unintentionally excluded as a result of time constraints.
Carbide was not able to locate any records on any workers except those workers—mainly recent hires—who had been employed at South Charleston within six years immediately preceding the time the TCA study began.
The Panel discussed a way that by their pretending to have based their exposure estimates upon an assumption (as falsely stated in SD-56) that the odor threshold for VCM was only 260 ppm, the troublesome demonstration of cancer even in the highly diluted TCA cohort could be dispensed with or at least called into question.
The MCA Group deliberately undertook to “manufacture doubt” about this and other evidence of vinyl’s extreme carcinogenicity. In the consideration of the MCA-coordinated vinyl manufacturers, the manufacture of doubt about unfavorable results is almost as good as the manufacture of good news (the MCA Group’s more traditional stock in trade).
A completely successful outcome in the TCA study was no longer possible.
The method the Panel used to manufacture doubt about the original TCA study as early as this was extremely simple and fraudulent.
The companies would falsely claim they had based their exposure estimates for the TCA study upon the false assertion in SD-56 that the odor threshold for VCM was on 260 ppm.
Union Carbide took the first step in perpetrating 1974’s fraudulent “odor threshold” reclassification scheme some time before 9/19/74.
On 9/19/74, Union Carbide Corporation (UCC or Carbide) wrote to the MCA-coordinated vinyl manufacturers pretending to be passing on some sort of recent discovery that VCM had an odor threshold of at least 2,000 ppm.
If the companies participating in the TCA study had truly believed VCM had a 260 ppm odor threshold (which they did not) and if their exposure estimates had truly been based upon this false assumption (which they most certainly had not been), the supposedly recently discovered high odor threshold for vinyl chloride would imply that the excess cancers TCA had found (despite the MCA Group’s best efforts) were actually the result of historic exposures that were at least four times higher than originally estimated.
Since an odor threshold four times higher than previously used to estimate exposure levels would effectively make vinyl chloride appear to be four times less carcinogenic than the TCA studies originally indicated: This would clearly be a desirable outcome for the vinyl chloride manufacturers.
The only reason the Panel decided not to go any further with this particular fraudulent scheme was their recognition that even such drastic modifications of estimated exposure levels would be unlikely to change the relative exposure indices.
The scheme to reclassify the exposure of TCA workers at a level four times higher than previous estimates was abandoned not because it was based upon two false and intentionally misleading assumptions, but simply because the MCA-coordinated vinyl manufacturers didn’t think it would work.
The Vinyl Panel voted to breach the protocols of the IBT study in the manner recommended by the VCRC on 9/19/74.
9/19/74
By September 19, 1974, R.E. Laramy, Conoco’s analytical research section group leader, who had been appointed the chief analytic chemist conducting validation studies for monitoring vinyl chloride Using charcoal at the request of the MCA Vinyl Panel’s Industrial Hygiene & Monitoring Subcommittee (Analytic Methods) was prepared to make the following conclusions in his evaluation of charcoal monitoring methods for vinyl chloride: The recovery of the vinyl chloride on charcoal was found not to be quantitative as the recovery efficiency varied from 80 to 400% (within the range tested); Charcoal did not quantitatively adsorb vinyl chloride, nothing in the system was found to have contributed to the error, except charcoal; and, finally, that charcoal personnel monitoring should not be Used in its present form in American VCM or PVC plants.
9/19/74
On September 19, 1974, the MCA-coordinated vinyl manufacturers voted to allow TCA to search through Social Security records for members of the cohort who had not been found in the course of the original study, and to allow plants not included in the May 4, 1974 report to join in the study.
The plants misleadingly described (without qualification) as having not been included in the TCA May 4, 1974 report included: Borden Chemical (Illiopolis, Ill), Firestone Plastics (Pottstown, PA), Olin Chemical (Assonet, MA), Tenneco (Pasadena, TX), as well as an estimated 500 to 600 employees of Union Carbide with significant exposures who had been terminated prior to 1964.The MCA-coordinated vinyl manufacturers were invited to submit drastically revised (upward) estimates of employee exposures, based upon what all members of the Panel[xi] can only have known were two false and pretextual assumptions: (1) that, for the first time, tests conducted by UCC had shown the odor threshold for vinyl chloride to be 2000 ppm and not 260 ppm; and (2) that this erroneously low 260 ppm value had actually served as the basis for the employee exposure levels supplied by the 37 plants involved in the original TCA study, just months earlier.
The ruse went that, because the original exposure estimates had been based upon a supposedly incorrect assumption that 260 ppm was the odor threshold for VCM, and because the true odor threshold for vinyl chloride was actually at least 8 times higher. (UCC, supposedly, only recently discovered the eight-fold error in the odor threshold of vinyl chloride, acknowledging the threshold to be 2,000 ppm, not 240 ppm.)
Dr. V.K. Rowe of Dow described, and the group discussed, the so-called “Rall Committee” of National Institute for Environmental Safety and Health (NIEHS). This committee included representatives of EPA, FDA, CPSC, NIOSH, and the DOT (Department of Transportation).
The group of MCA-coordinated vinyl manufacturers agreed to allow V.K. Rowe to act on their behalf in the following manner: Dr. Rowe was to pretextually seek advice “after-the-fact” from the NIEHS “Rall Committee” for the Vinyl Panel to use as (retrospective) justification for the decision the Panel had already made to abort the MCA’s entire ongoing toxicologic research program for vinyl chloride.
The large “low dose” studies the MCA-coordinated vinyl manufacturers were anxious to avoid conducting were designed to ascertain if a “no effect level” could be determined for vinyl chloride and large “one hit” studies involving a single two-hour exposure to 5,000 ppm vinyl chloride. These conditions were used in order to simulate the potential effect a single exposure to vinyl chloride might have on persons exposed, for example, as the result of a railway spill, or other similar instances of large one-time exposure. These low-dose inhalation studies were officially “delayed.” The group intended to have Dr. V.K. Rowe make what would have the appearance of “consultation” with the prestigious Rall Committee.
It was the preordained conclusion that the Rall Committee would recommend for the MCA-coordinated vinyl manufacturers to abort the ongoing MCA toxicologic research program in its entirety. This contrived “advice” was intended to serve as an excuse for the decision the Panel had already made to drop the low-dose and single-dose studies they had previously made a public commitment to perform. The MCA-coordinated vinyl manufacturers had already chosen to abort the ongoing toxicologic research program at IBT, and the Rall Committee’s so-called advice was just an excuse the MCA-coordinated vinyl manufacturers had developed after-the-fact.
In the time since they had made a public commitment to perform the now doomed low-dose and single-dose studies, the MCA-coordinated vinyl manufacturers had come to perceive such studies as posing an unnecessary “downside” risk (of finding cancer at low doses) without the existence of sufficient “upside” potential to justify it. Without at least the hope of a favorable outcome that might provide the MCA-coordinated vinyl manufacturers with scientific ammunition to dispute claims that even low, or isolated, single exposures to vinyl chloride resulted in some residual cancer risk, the MCA-coordinated vinyl manufacturers saw no reason to conduct the studies they had committed to perform at all. Performing these studies that the MCA-coordinated vinyl manufacturers had committed to perform was perceived in discussions conducted by the MCA-coordinated vinyl manufacturers as creating a risk that the sponsors might end up with a study that found something that the industry most certainly did not want to find – cancer at low doses, or following only a single exposure, of vinyl chloride.
The decision of the MCA-coordinated vinyl manufacturers to abort these studies had already been made and the (also soon to be abandoned) attempt to obtain a statement from the NIEHS “Rall Committee,” providing (post-hoc) the false appearance of a, at least, colorably legitimate basis for the decision to cancel the studies they had previously made a public commitment to perform, was conducted in bad faith and with fraudulent intent.
9/27/74
By September 27, 1974, the MCA had mailed each Panel member copies of Dr. Rowe’s notes from an August 14, 1974 meeting of the so-called “Rall committee” he had attended. Except as part of the Panel’s scheme to discontinue the low-dose and catastrophic studies that they only recently approved, there was no reason for Dr. Rowe’s letter to be circulated.
The Panel considered these two studies (the low dose studies and the catastrophic exposure simulation, or “one hit,” studies) had come to appear increasingly risky, or, as it was put, provided a lot of “downside risk” and little “upside potential.” Potentially, the MCA-Group recognized, finding cancer in studies involving extremely low doses, or from a single high exposure, of vinyl chloride could be a very expensive discovery for the American vinyl industry to make.
Even if the low dose, or catastrophic, or “one hit” study were negative, such a finding would not completely rule out the possibility of carcinogenic risks from low level, or a single high level, exposure to vinyl chloride.
For these reasons, apparently after reflecting on the implications of these two studies that the Panel had only recently strongly recommended, the Panel was motivated to come up with some excuse to abort them, and did so in short order. Dr. Torkelson explained to the Panel his efforts to use Dr. V. K. Rowe to further the group’s plans to contact then NIEH “Rall” Committee. The “Rall” Committee was intended to be Used as a scapegoat for the Panel’s decision to completely discontinue the conduct of the “no effect level” and “catastrophic exposure simulation” studies that the Panel had already agreed were necessary and already agreed to perform.
But the Panel was not sincere in their so-called request for advice from the “Rall committee (on whether to conduct these two potentially very costly experiments or to abort them). Even before the “Rall committee” had the opportunity to unintentionally provide the Panel with the excuse they needed to abort the studies, however, the decision had already been made to kill the IBT studies (and fund UOL instead). The Panel already knew that no matter what the Rall committee advised (or whether the Rall committee advised at all) the Vinyl Panel most certainly already intended to find a way for them to creatively “interpret” almost anything the NIEHS group might say into compelling evidence for them to dispense with the IBT studies.
The doomed IBT studies the MCA-coordinated vinyl manufacturers had made the commitment to conduct were experiments the Vinyl Panel no longer wanted to risk conducting, it being considered particularly undesirable to have good science turn up in their bad hands. For this reason, even before the Panel had received the “advice” it supposedly was seeking, it voted not to proceed with the low-dose studies they had only recently approved. Dr. Bell from PPG strongly dissented and requested that his dissent be made part of the record of the 9/17/74 meeting. However, like any other decision that was reached by the Panel’s majority vote, PPG went along with the scheme just like everybody else.
The MCA Group voted to pay IBT to delay beginning the studies MCA wanted to drop, and agreed to pay IBT a fixed price per rodent to keep the animal cages reserved until the phony recommendation they wanted from the Rall committee was received.
The Vinyl Panel also voted to attempt to use their “The Rall committee made us do it” ruse to support their predetermined decision to reject EPA’s proposal that the vinyl industry conduct experiments to determine the risks associated with community exposures to environmental levels of vinyl chloride.
The fraudulent purpose for which the Rall committee’s so-called “advice” was being sought was so openly recognized by the Panel that, at first, the Panel actually just voted down the EPA recommendation, pure and simple. Then, realizing that, if they only waited a little while, they might be able to use the “advice of the Rall committee” to justify their rejection of the EPA recommendation and justify killing the two large toxicologic studies they had only recently publicly announced they were going to conduct, the Panel decided to wait on the Rall Committee’s recommendation before acting.
The Vinyl Panel (all of whom received reports from their advisory group, the VCRC, on a regular basis) was made aware that the advice of the Rall Committee was not being sought in good faith.
9/27/74
By the time OSHA’s hearings on its proposed permanent standard for vinyl chloride had been completed, public statements made by Steven Jellinek of the Council of Environmental Quality (CEQ), and Warren Muir had already raised serious questions concerning the integrity of the MCA-administered research program at TCA – even with the scant evidence then available to OSHA.
Over the course of the next year, the Vinyl Panel directed TCA to try to correct, the deficiencies of the TCA study that had come to the attention of such groups. However, the Vinyl Panel deliberately refused to correct, or bring to public attention, the much more serious deficiencies that had resulted from their improper influence on TCA that remained known to them only.
October 1974
Paul H. Weaver, published “On the Horns of the vinyl chloride Dilemma,” in Fortune Magazine on October 1974.
October 1974
As a result of the stormy relationship between the MCA-coordinated vinyl manufacturers and the MCA, and specifically as the result of MCA’s unauthorized disclosure to NIOSH of the 50 ppm cancers detected in animals at IBT, by approximately 1974, the SPI had taken over the MCA-coordinated vinyl manufacturers’ diligent prosecution of all the problem areas, except for animal testing and human studies.
10/2/74
On October 2, 1974, the EPA Environmental News announced pollution emission standards for vinyl chloride plants.
10/4/74
On October 4, 1974, OSHA published in the Federal Register its final rulemaking on the vinyl chloride standard, entitled “Exposure to vinyl chloride, Occupational Safety and Health Standards.”
10/9/74
On October 9, 1974, the SPI called for an industry meeting. Although the MCA-coordinated vinyl manufacturers were supposedly in competition with each other, the “problem” – openly discussed at the time – was not that the new OSHA regulations would shut the vinyl industry down: the standard, industry complained, would force it to build new, expensive plants, resulting in decreased participation in the industry as the standard would close the industry to all but those producers who could afford, manage, and execute the improved technology to comply with the new standards. (The MCA-coordinated vinyl manufacturers apparently considered this undesirable).
The industry reacted litigiously, as SPI, Hooker, and Firestone filed Petitions for Review in the 2nd Circuit Court of Appeals, and Tenneco and Air Products filed Petitions for Review in the 3rd Circuit Court of Appeals.
10/11/74
At an SPI VCM and PVC Producers Group meeting on October 11, 1974, the SPI announced it was going to file a petition for review of the permanent standard in the U.S. Court of Appeals. SPI claimed that OSHA had no substantial evidence to support the vinyl chloride standard, and that the use of respirators was impractical and a burden on employees, etc.
10/17/74
The SPI vinyl chloride Task Force met on October 17, 1974, with representatives of OSHA to interpret the new vinyl chloride standard.
10/23/74
On October 23, 1974, the SPI PAC (Public Affairs Committee) met to discuss public relations.
The PAC recognized it would be difficult to develop a homogenous approach in the area of vinyl chloride and human health, and that probably nothing could be said to mitigate the fact that vinyl chloride and human health were basically just incompatible, and that total knowledge of the extent of this irreconcilability was, by no means, at hand.
The Panel thought the most effective public education program they might develop would address itself primarily in separating, in the public’s mind, consumer goods from the raw materials they were made with, VCM and PVC. The fact that those consumer goods were manufactured from a raw material like vinyl chloride was the last thing that should be brought to anyone’s mind. Taking the positive side, then, the Committee adopted a PR program dealing primarily with the merits, benefits, assets and rightful place of PVC products in a modern industrial society.
For public relations purposes, the MCA-coordinated vinyl manufacturers recognized that the public was generally unaware of the fact that the chemical industry was in the business of converting often very toxic materials into Useful consumer products.
10/24/74
On October 24, 1974, the SPI discussed the inadequacy of activated charcoal sample collection techniques for use in monitoring vinyl chloride, despite the fact that it was already being universally employed by that time.
11/4/74
The Industrial Hygiene and Monitoring Group of the Vinyl Panel met at MCA offices in Washington, D.C., on November 4, 1974, to discuss the accuracy provisions required for monitoring under the 1974 OSHA vinyl chloride standard.
The OSHA 1974 standard for vinyl chloride required the employers demonstrate that their methods of monitoring employee exposure levels in order to establish the regulated areas within the facility, and determine that workplace exposure levels of vinyl chloride were accurate (within 50% for the ranges 0.25 ppm through 0.5 ppm; 35% for the range between the action level of 0.5 ppm and OSHA’s Permissible Exposure Limits of 1 ppm). Accuracy within 25% was required for monitoring at any level exceeding 1 ppm on an 8-hour basis.
By November 4, 1974, the group of companies represented on the MCA IH & Monitoring Sub-Committee were very well aware (and, apparently in some cases even enthused about) the value of charcoal-based monitoring methods for vinyl chloride.
The companies on the IH& Monitoring Subcommittee were informed in no uncertain terms that vinyl did not adsorb VCM satisfactorily at all to begin with. What little VCM the charcoal might pick up during the time it was exposed to VCM would Usually be lost through the process of desorption. In fact, charcoal was known to off-gas VCM previously adsorbed more rapidly than new VCM could be adsorbed; This would result in a paradoxical decrease in a monitored employee’s total exposure to VCM as the day went on, that can only have been unmistakable to any company fulfilling its obligation to validate the vinyl chloride monitoring methods it employed.
Humidity, concurrent exposures to common chemicals that interfered with analysis, and high-level exposures were also known unidirectional biases that worked together to all but assure that every use of charcoal as an adsorbent media for VCM would grossly underestimate most exposures, while intermittent or short-term high exposures would almost be missed entirely.
The validation tests the group had attempted had only demonstrated the complete inadequacy of charcoal for use in vinyl chloride monitoring at all but the lowest flow rates and at the lowest levels tested, and, even then, only under optimum laboratory conditions. At its November 4, 1974 meeting, the IH & Monitoring Sub-Committee of the MCA Vinyl Panel engaged in a collective legal “interpretation” of the accuracy provisions for atmospheric monitoring under the OSHA vinyl standard.
Since charcoal demonstrated the capacity to cause errors of literally unlimited magnitude, the committee came up with a bad-faith “interpretation” of the OSHA accuracy requirements that completely exempted this potentially incalculable error from the accuracy provisions in their entirety. According to this patently bad-faith “interpretation,” agreed to by each member of the IH & Monitoring Sub-Committee, OSHA standards applied strictly to the analytical portion of the monitoring process, and had no application, whatsoever, to the “sampling portion” of the process. (The amount of error would be limited only by how high the exposure was since once breakthrough occurred, any additional exposure simply was not measured.)
Every company represented on the committee as of November 4, 1974, can only have known that the extremely creative “interpretation” in which they were collectively engaging was a cynical fabrication and an utter pretext. Nonetheless, the representatives of the committee, unanimously adopted this cynical Interpretation with Dr. K.D. Johnson, of MCA, left as the sole dissenter. Every vinyl manufacturer present agreed with they others to “interpret” the Vinyl standard’s accuracy provisions in such a way as to allow them to ignore the gross one-sided bias introduced by the use of charcoal as an adsorbent media.
According to the MCA-coordinated vinyl manufacturers, because the incalculable error that led to gross systematic underestimation of exposure levels occurred “in the sampling portion” of the monitoring process (the part that used charcoal), the MCA-coordinated vinyl manufacturers’ collective self-serving and cynical “interpretation” of the vinyl chloride standard would leave them free to generate misleading monitoring results that consistently underestimated true exposure levels (exempting the “charcoal trap” from the accuracy provisions of the vinyl chloride standard).
In fact, the Vinyl Standard says nothing whatsoever about “sampling portions,” or “analytic portions,” but, instead, regulates the accuracy of “monitoring and measurement” in their totality, their aggregate. The Vinyl Panel, basically, just invented the so-called distinction between “sampling portions” and “analytic portions” of whole cloth.
The group knew that OSHA had made an error in drafting the vinyl standard, and, as a result, the standard mistakenly read that the NIOSH Manual of Analytical Methods contained an accurate method for monitoring vinyl chloride.
Every member who cynically seized upon this obvious printing error having an excuse for it to disregard the known inadequacy of charcoal for use in personnel monitoring, knew the truth – that the accuracy of monitoring the charcoal had been stated to be unknown by the most recent NIOSH publication on the subject. (In contrast, this inaccuracy was very well appreciated by the MCA-coordinated vinyl manufacturers.) The members of the Vinyl Panel’s IH & Monitoring Sub-Committee openly discussed the fact that the charcoal method could not be used accurately in plant laboratories and that there was virtually no correlation between fixed point and personnel monitoring results.
11/12/74
An MCA delegation did meet with the Rall Committee in Bethesda, November 7, 1974.
Dr. Joe Wagner of NIOSH reported on epidemiologic studies conducted at two of the five facilities in the country that they considered had received the most intense exposure to vinyl chloride. These two plants included the B.F. Goodrich plant in Louisville and the Firestone PVC plant in Pottstown, PA. The MCA-coordinated vinyl manufacturers were aware that the Waxweiler and Wu cohorts referred to a cohort of workers from these same two plants.
11/22/74
On November 22, 1974, the Public Affairs Committee (PAC) of the SPI VCM-PVC Producers Committee advised the Steering Committee that since government and media attention were likely to be great in the near future, SPI planned to lay out an extensive and unprecedented media, governmental and educational campaign to influence public opinion, and the government. A substantial budget was included.
Developments over the past two months had demonstrated quite clearly that media interest in vinyl chloride was still strong and was likely to remain so for some time to come. Governmental interest was likewise considerable, with regulatory agencies such as OSHA, NIOSH, EPA, FDA, and CPSC still deeply involved in various aspects of the overall problem.
Other groups whose attitudes and positions were also of concern to the industry included Congress, industry employees, fabricators and their customers, the financial community and the general public.
It was important, therefore, that a continuing program of public-government relations be adopted. The general objectives of such a program were to:
1. Obtain, to the extent feasible, balanced coverage by the media of the vinyl chloride problem so as to mitigate the negative effect that one-sided, erroneous or exaggerated articles could have on the various audiences.
2. Create an atmosphere within Congress favorable to the VCM-PVC industry and responsive to its problems.
3. Educate fabricators, their customers and the employees of both with regard to the presently known health facts about vinyl chloride, how the OSHA standards affect them, and to reassure them of the value and safety of finished PVC products.
These three general objectives were to be advanced through the following recommended program:
1. Press Relations: When appropriate, responses should be made to governmental, medical, organized labor, environmentalist, etc. activities and announcements having a potential negative effect on the PVC industry. Extensive monitoring of media activities should be continued. When required, assistance should be given to reporters, feature writers, etc. preparing stories on vinyl chloride.
2. Political Conditioning: A steady but low-key informational program was to be conducted to gradually develop within Congress a relatively small body of informed, interested and effective Senators and Congressmen who can and would be ready to become an active support group for the VCM-PVC industry when developments require. The program was to entail identifying target Senators and Congressmen; establishing contact; providing information and responding to questions; evaluating contacts and questions to determine attitude and degree of interest and willingness to support the industry. Contacts were to be made primarily by Producer Committee member-company Washington representatives and company executives in home districts.
3. Education Program: A series of booklets were to be prepared in consultation with SPI staff and VCM-PVC industry experts for member company use in helping fabricators, their customers, and the employees of both better understand the various aspects of the overall vinyl chloride problem. An initial three booklets were recommended as follows:
a. A relatively short, easy to read illustrated booklet for the employees of fabricators and their customers satisfying the training program required by the OSHA standard.
b. A primer for fabricators and their customers on the effect on them of the OSHA standards what the requirements are, how best to comply, potential compliance problems, etc.
c. A booklet on the value of PVC products to our society. It would also contain a section emphasizing the safety of finished PVC products.
12/6/74
On December 6, 1974, the SPI VCM / PVC Producers Group met and approved the budget discussed at the November 22, 1974 meeting.
The public affairs proposal that had been reviewed and recommended by the Steering Committee was presented on behalf of the PAC by Mr. Lane (Ken Lane). Lane pointed out that a fourth objective was to be added to the SPI program that would emphasize the differentiation between vinyl chloride and polyvinyl chloride.
12/11-12/74
On December 11, 1974, the VCRC met at the MCA Conference Room in Washington, D.C. The next step in the Panel’s[64] scheme involving the Rall committee was discussed. Dr. Howard Kusnetz (Shell) admitted to the Panel that the Rall committee did, in fact, have a great interest in studies of late developing health problems from single massive exposure to vinyl chloride.
At this time, the Panel certainly did not think that the Rall committee had somehow recommended that MCA halt the last-minute toxicology studies of the type MCA had publicly announced it was going to conduct at IBT. (Low-dose and single exposure studies.)
The MCA scheme required some sort of set-up meeting, similar to the manner V.K. Rowe’s notes from the July 17, 1973 MCA presentation to NIOSH falsely reflected that MCA had told NIOSH in that meeting about cancer at 250 ppm, now Dr. Rowe was to attend a meeting with the Rall committee and come away with notes reflecting a recommendation of some sort. The recommendation would supposedly support the MCA Group’s preordained conclusion that the scientific community would not benefit from low-dose studies of vinyl chloride and single exposure studies.
Although the Panel itself acknowledged privately that the Rall committee had not reviewed MCA’s proposed protocols and had not made any recommendation to them, one way or the other, the MCA Group would soon formally terminate their on-going vinyl toxicity program and all of their publicly announced projects.
After extensive discussion, and by unanimous vote, the VCRC recommended that, “in consideration of the counsel of the Rall committee,” all further experimental investigations involving repeated exposures of laboratory animals to low concentrations of vinyl chloride would be postponed indefinitely. (And everyone on the Panel knew that postponed indefinitely was a euphemism for terminated.)
Between December 11 and 12, 1974, in a similar manner, the vinyl chloride Panel also terminated (i.e., postponed indefinitely) the single exposure studies that had been intended to simulate the effect of a single high exposure to vinyl chloride, under circumstances similar to a single chemical sill or derailment.
As evidence that the whole Rall committee scheme was nothing but a fabrication concocted on the fly by a vinyl Panel that didn’t really care how convincing the reasons they gave “for the record” were, the MCA Group even Used the Rall committee, whom they acknowledged hadn’t even seen nor heard about MCA’s protocols, when the Panel terminated the on-going massive spill simulation studies on December 12, 1974, referring, and stating for the record, almost as if it were an after-thought, that this termination was “pending the receipt of recommendations from the Rall committee.”
If additional evidence that this entire ruse was being conducted in bad faith was required, in fact, the MCA Group never asked the Rall committee about the toxicologic study they had already successfully killed; any attempt to actually consult with the Rall committee was treated as a pointless formality.
The VCRC authorized payment of $20,000.00 to IBT that was not covered by any contract that existed between the Vinyl Panel and IBT. As part of this same payment, the MCA Group included the charges that had accrued at IBT for chamber rental during the period of time their chambers were held in reserve while the Panel developed its clumsy NIEHS cover-story, only to abandon even the pretext when the MCA Group decided that the NIEHS cover-story was so good there was no reason for them to actually play the story out, and, for example to formally ask the Rall committee anything about their protocols.
The Panel members were specifically advised that, in truth, the Rall committee had not been told anything specific about the MCA program and had never given the MCA Vinyl Panel advice about anything.
The whole thing was a set-up from the beginning and all the sponsors can only have known.
12/12/74
On December 12, 1974, the Vinyl Panel[xii] met at the MCA Conference Room in Washington, D.C.
Since 1974, whenever the MCA (or any of the MCA-coordinated vinyl manufacturers) have ever said anything publicly about the European secrecy agreement that was in effect prior to the discovery of angiosarcoma at BFG Louisville, they have, at least, implied that the secrecy agreement with the Europeans was no longer in effect and had been terminated following the disclosure of the Louisville angiosarcomas in early 1974.
At some time prior to the December 12, 1974 meeting of the Vinyl Panel, the Vinyl Panel[65] had requested the Europeans’ permission for them to terminate the 1972 secrecy agreement. In response to the MCA Group’s inquiry on December 12, 1974, the Vinyl Panel was specifically advised that they were all still subject to the written secrecy agreement they had signed with the MCA Group in 1972. As far as the Europeans were concerned, there was no desire to change the status of the secrecy agreement – even this long after Louisville.
Perhaps even as amazing as the continuance of the European secrecy agreement even after Louisville, the companies, the MCA Group was specifically advised that the same old secrecy agreement those companies said – when they said anything publicly – had ended following Louisville, was, in fact, still in effect, and that each company on the Panel was obliged to respect it as it applied to any new data submitted to the Panel through confidential channels.
At the time of the December 12, 1974 meeting of the Vinyl Panel at which the continued effect of the European secrecy agreement was discussed, the membership of the MCA-coordinated vinyl manufacturers had grown to include a number of American companies that had not become officially subject to the secrecy agreement prior to the time they joined the Vinyl Panel (as the result of a recruitment drive the Panel conducted following the public disclosure of angiosarcomas in workers at BFG’s Louisville facility).
A specific and express condition of membership that was accepted by every new vinyl manufacturer who joined the Vinyl Panel after 1974, was an agreement that the new companies were to be subject to all previously existing secrecy agreements. As previously shown, these secrecy agreements had been formally entered into in 1972, and earlier.
By this point in time, all the companies represented on the Vinyl Panel were certainly advised of the serious allegations of misconduct with regard to the 1972 European secrecy agreement that had been made even by such conservative bodies as the A.A.A.S. in Science Magazine.
The companies fully understood what subscription to this secrecy agreement implied.
On December 12, 1974, the MCA Group discussed its supervision of the work-up of data from the old Union Carbide personnel records from South Charleston. As shown, such studies were either not done at all, or done in a fraudulent manner.
The Panel reviewed IBT activities since the time of the last meeting and authorized a $20,000 payment to IBT for unspecified extraordinary expenses incurred while conducting the chronic inhalation studies. The sponsors already knew that IBT was, and would continue to be, in serious trouble from the standpoint of integrity. The Panel would soon completely give up on these studies completely, and postpone them indefinitely. Dr. Keplinger, who was authorized by the Vinyl Panel to receive special payments at its December 12, 1974 meeting, would, along with others at IBT, (and, arguably, with Monsanto) go on to be charged and convicted by a federal court in Chicago, Illinois, of scientific fraud conducted during the same period of time it had been performing work for the MCA Group and its member companies regarding vinyl chloride.
Additional evidence of IBT’s, the so-called independent contractor, collusion with the sponsors to fabricate the results of the studies they conducted (not revealed in the course of the criminal proceedings) was that the director of IBT, Dr. Joseph Calandra, was the undisclosed Medical Director of Beaumont Chemical, which was operated by PPG Industries, a founding member of the MCA Vinyl Panel.
Although Dr. Calandra received a salary from his undisclosed work for PPG, his work was undisclosed for a reason: Dr. Calandra had no real duties as the Medical Director of Beaumont Chemical. He did not live in Beaumont. He got the check in Illinois.
The Panel also voted to give IBT an additional $50,000.00 that was not covered by any existing contract to cover unknown and undecided “future contingencies.” The only example of such contingencies available at the time was the payment IBT received for “rental fees” during the time empty inhalation chambers were held in reserve while the MCA Group attempted to fraudulently obtain so-called advice from the government to drop their publicly announced toxicology program.
Although the Panel knew better, the record reflects the IBT low-dose and single dose studies were being “held in abeyance,” during the time the discussions with the federal agencies were supposed to be conducted. The Panel knew that statements concerning the Rall committee that were placed “on the record” of their Panel (and even at levels as high as the MCA Board of Directors), were, in fact, completely false; In fact, no “discussions” were ever conducted as previously described.
It was under these circumstances that the MCA Group gave IBT the additional $50,000.00.
At the time of the December 12, 1974 meeting of the Vinyl Panel, the member companies were advised of unpublished Dow studies indicating that the combination of alcohol with vinyl exposure increased maternal toxicity in animals (rabbits, not mice). The Panel received progress reports on the cytogenetic studies Dow had conducted. Dow had been allowed the (undisclosed) right to remove significant numbers of animals from the on-going experiments at IBT to conduct the Dow cytogenetic studies.
The purpose for the Dow study was specifically to develop political/scientific evidence to counter or call into question recently reported independent studies showing genetic damage sustained by humans exposed to vinyl chloride.
Although the Panel had allowed Dow to significantly deplete the animal population in the IBT study (without disclosing it) when NIOSH requested histological material from the IBT study, the MCA Group decided to allow NIOSH only access to existing materials, and took great care to see that there was no significant loss to the IBT study. The Panel agreed NIOSH would not be granted physical custody of any IBT material.
The Panel proceeded with the next step in their on-going scheme involving the Rall committee.
Although the Panel openly recognized it had not received the formal recommendation from the Rall committee they claimed to be waiting for, they went ahead and killed the low-level chronic inhalation studies anyway. Although the MCA-coordinated vinyl manufacturers would claim that the Rall committee had somehow suggested they do so when, as the Panel members very well knew, that nothing whatsoever had occurred between the Rall committee and the Panel.
The very most that could be said, honestly, was their Chairman had telephoned a few members of that large committee and come away with the convenient “interpretation” that the Rall committee had discounted the value of the studies, such as those the Panel had already decided not to conduct. Therefore, the committee knowingly abandoned any attempt to receive any recommendation from the Rall committee.
Even though they had been going through the pretextual motions of delaying the initiation of their studies, and had actually paid rent for the animals they weren’t exposing, the group dropped all pretense of seeking the advice of the Rall committee (advice they claimed they had been waiting on). The Panel formally recommended the termination of their “no effect level/low-dose studies” studies.
Purely for the sake of appearances, one must think, the termination of this study was specifically stated to be in consideration of the counsel of the Rall committee. However, the Panel knew what they had put in their resolution was untrue and that the Rall committee hadn’t given them any advice at all. (The recommendations of the Rall committee would never be sought either.)
The Panel also falsely claimed in their minutes that the Panel was “postponing indefinitely” the study until they heard from the Rall committee. Again, the recommendations of the Rall committee on this study were never actively sought by the MCA Group.
12/13/74
The Manufacturers of vinyl chloride filed petitions challenging the validity of the OSHA standard for vinyl chloride in several districts of the U.S. Court of Appeals.
On Dec. 13, 1974, these different suits were consolidated in the U.S. Second Circuit Court of Appeals. Four employees from the Canadian plant of B.F.Goodrich in Shawinigan, Ontario, were reported to have died of angiosarcoma during previous 6 years