Document vy0ngzm9V3My8oQbqdaa9j9GZ
AIHC
AMERICAN INDUSTRIAL HEALTH COUNCIL
BB
I07S CENTRAL PARK AVENUE SCARSDALE, NEW YORK 10583 (914) 725-1492
August 22, 1979
TO: BOARD OF DIRECTORS COMMITTEE CHAIRMEN
OSHA OCCUPATIONAL DISEASE CONFERENCE
Gentlemen:
Earlier this month, we received word that OSHA had distributed 8,000 letters of invitation to journalists in key media across the country to attend a conference in Chicago on the subject of occupational disease. The conference will be held on September 13th and 14th at the Radisson Hotel in Chicago and Is expected to attract 150 or more media representatives.
Although the program is billed as one providing background from business and labor as well as the government, only two industry representatives were on the initial program, along with such outspoken industry opponents as Anthony Mazzocchi of OCAW, Dr. Irving Selikoff of Mount Sinai and-Dr. Samuel Epstein of the University of Illinois.
Upon learning of the program, AIHC contacted OSHA in an effort to convince the Agency to Insure that the conference provide a more balanced perspective of the issues and a number of changes have been made in the program, including the addition of Dr. Robert Scala of Exxon on reproductive health. Dr. Howard Kusnetz of Shell on economic issues and Dr. William McCarville of Monsanto on cancer in the workplace. In addition, efforts are being made to add one or more independent scientists, such as Dr. Robert Olson or Dr. Harry Demopoulos, to appropriate panels.
OSHA has also agreed to add to the program a 9:00 a.m. keynote speech on Friday morning which will provide a perspective of occupational health from Industry's viewpoint and we are working with OSHA to locate an appropriate individual to give this speech. Other changes are also likely to be made within the next week.
This subject will be discussed at some length at the August 29th Board meeting, along with recommendations from the Public Relations Conmittee with respect to AIHC's direct involvement with the press in Chicago on September 13th and 14th.
Enel.
WASHINGTON OFFICE: 1612 K STREET, N. W,, WASHINGTON, D. C. 20006 (202) 659-0060
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TRIP REPORT Z>t>< MCA HGCTfrNG 7
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15 February 1974 WASHINGTON, D. C.
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INTEROFFICE MEMORANDUM
Date February 20, 1974 ,,, t
Subject Department of Labor Hearing^----------
Washington. D. C.. 15 February 1974
To T. L. Carey ,
From
J. T. Barr
cci A. R. Adams J. L. Cost w/o attachments R. Fleming (2) J. Healy P. Kotin J. D. Kramer A. K. McMillan
Vallov Forge_____________________
(Location, Organisation, or Department)
Valley Forge
(Location, orgcniaation, or Department)
E. A. Ray w/o attachments W. M. Smith w/o attachments G. B. H. Speed w/o attachments M. Spurlock H. L. Watson w/o attachments
A fact finding hearing was announced in 39 FR 3S74 over the name of John H. Stender, Assistant Secretary of Labor, to investigate the
possible hazards of vinyl chloride manufacture and use. A copy of the notice is appended as Attachment I. Dr. W. M. Smith and I attended.
A pre-hearing conference was convened at 9:3H at which the administra tive law judge, Gordon J. Hyatt, announced the reason for the meeting,
noted the presence of representatives from the solicitor's office of NIOSH and OSHA and of Mr. J. O'Niell, Chief, Division of Health Standards of OSHA and stated that an official transcript of this
hearing would be available from the reporter and that this transcript will be the only official record of the hearing. I gave my card to
the reporter who will call me when the transcript becomes available and tell us of the cost, which will be 20e/page. At that time we
can order however many copies we wish. Please advise me of the number desired.
He then announced the order of presentation of evidence and adjourned the pTe-hearing.
c
The hearing opened at 10 a.m. and Judge 'fvatt announced that only those persons registered for presentations would be permitted to ask questions from the floor. He later made two exceptions to this ruling. The first was for Dr. Rudolph Jaeger, a bio-chemical toxicologist from the Harvard School of Public Health who did give a short oral presentation and the second was for a group which called itself the Health Research Group, and are connected with Ralph Nader's activities. They made no presentation but were active in the questioning after the judge had amended his ruling.
The first order of business was the placing in evidence of two exhibitions by Miss Evelyn Gholston from the office of the solicitor. These exhibits were the Federal Register notice of the hearing and
the notice of the intention to appear of several groups. Mr. O'Niell of OS!LA then summarized the Federal Register Notice restating the
reasons for the hearing.
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I. Mr. V. R. Rose, Acting Assistant Institute Director for Research and Standards Development at NIOSH reviewed the known information on the liver cancer situation, He began with the 17 July 1973 meeting of MCA with NTI0SH at which MCA notified NIOSH of the proposed study at industrial Rio-Tec and gave NIOSH the background information on the situation, including the result of the experiments by Dr. Viola and his publication in 1970 and 1971.
He noted that NIOSH had requested in the January 1973 Federal Register information on the potential hazards of 23 industrial chemicals, in cluding vinyl chloride, and that a bibliography had been assembled on this subject and will be transmitted for the record.
He stated that BFG had informed NIOSH on 22 January 1974 of a possible hazard related to vinyl chloride and commended BFG for this action. He reported on the walk-through inspection of the Louisville, Kentucky BFG plant on 24 January along with representatives from the POL, CDC, and Kentucky EOL. This inspection resulted in recomcndations being made on 3D January 1974 to BFG for monitoring and improving the work situation at their plant. The same recommendation was transmitted to MCA on 31 January for distribution to the industry'. On 1 February 1974 NIOSH and CDC had a briefing for other groups on this subject. Included was NCI, FDA, NIEHS, EPA, Kentuclcy DDL, BFG, and United Rubber Workers.
NIOSH has drawn the conclusion from the evidence on hand that there is a new occupational cancer associated with the making of PVC and that vinyl chloride is the prime suspect. NIOSH will institute a joint'study with NCI on the problem and accelerate the epidemological studies.
Worker exposure is based on the fact that there are 10 companies with 1,500 workers employed in 14 plants manufacturing monomer and 23 companies with 5,000 workers in 37 plants manufacturing FVC. There are thousands of plants employing tens of thousands of workers engaged in converting PVC to finished product.
Biopsies of the four cases of angiosarcoma at BFG lmve been confirmed at the National Institute of Health who also stated that all four cases had in common a non-alcoholic cirrhosis.
It was stated that there are an estimated 20 to 30 cases per year in the entire U.S. of angiosarcoma and that this clustering of cases at BFG is significant. BFG lias told NIOSH of the European studies and - this preliminary data led them to the conviction that vinyl chloride is the causative agent.
NIOSH briefed labor and management at Cleveland on 12 February 1974 at a meeting attended by more than 100 persons where NIOSH and CDC reviewed the data and proposed a plan consisting of four points.
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1. Development of further studies on the problem. 2. Development of a medical program for surveillance and
recognition of the cancer. 3. Epidemological studies, 4. Toxicity studies.
After this open hearing ?<I0SI1 met v.'ith a small group to review the procedures to be followed. (Dr. K. M. Smith will report in more detail on this meeting.) A recommendation will be transmitted in a few weeks to DOL which will stress a sense of urgency to start a rule-making procedure. MIOSII is convinced that the situation is serious and actually is of crisis proportions. A preliminary plan was submitted as a part of the record but not given orally.
In response to a question from the solicitor's office as to what type monitoring was recommended, he stated that it should be environmental and personal monitoring for both monomer and polymer, but no specific procedures were given. The Cincinnati staff of NIOSH is available for consultation.
II. The next speaker was Dr. I. J. Selikoff, Director of Environmental Science Laboratories, Mt. Sinai School of Medicine. He began by stating that tiiis meeting was a paradox in that it was called on an emergency basis but that evidence lias been available for 23 years on serious health ''roblcms with vinyl chloride. He referred to but did not cite a reference to acute toxicity, a 1961 reference to chronic toxicity, a 1949 reference to Iivot damage in 15 of 48 workers in Russia, and "rany" references over the next 17 years on other cases. The clinical evidence includes cases of hypertension, damage to liver, skin, and bone and other symptoms.
Fie stated that we have a new problem with an invariably fatal type of cancer. He estimated the number of lenown cases at 100, putting this into a very rare category, and cited the absence of any cases of several hundred thousand biopsies at Mt. Sinai. It is not laiown if vinyl chloride effects only the liver or causes other neoplasms. It is his belief that based on other cases of carcinogens, that there will be damage to other organs.
He indicated that he knew of the ICI case and stressed the long latency period of 14 to 27 years after first exposure. Fie referred to the latency period of Thorotrast induced cases as being 21 years and predicted tliat there will be many more cases in the future if we do not learn to reverse the course of the disease. He referred to German studies which showed far more prevalent liver damage, in particular a study by Marstello which showed 19 of 20 workers had some problem, including 14 cases of liver disease and 4 of AOL. He spoke of liver and lung changes found by them in BFG workers. This apparently is a study being done at Mt. Sinai with workers from the Pottstoi*71 plant. He proposed 10 specific action points.
I
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1. Vinyl chloride and PVC be added to the carcinogens list. No safe threshold limit is known and careful work procedures are needed. Industry' data should be used to confirm this point.
2. There should be no further exposure by any route.
3. Large scale epidemological and clinical studies should be initiated.
4. There should be research for an early warning diagnosis. Some evidence may be available from early effects on other organs.
5. Die necessity for an accurate method of diagnosis should be recognized.
6. A therapy program for the disease reversal must be developed.
7. We must determine the basic mechanism for the cause of cancer.
8. Laboratories studies must be made to detcimine exactly what is the causative agent.
0. Clinical studies should oo mace on woirceis ~tu deit?nnine Lne ' full extent of the problem.
10. He is not now recommending anything on restrictions of use of the end product.
He concluded by stating there had been a major failure of the pro tective program for the worker here and that no effort should bo spared, nor would any control be too rigid1 to protect the workers in the future.
III. Die third speaker was Mr. A. Mazzocchi, Legislative Director of the Oil, Chemical, and Atomic Workers International (OCAW). He began by stating that thousands of persons had been exposed to the carcinogen vinyl chloride and that emergency standards must be imposed immediately, quoting the Occupational and Safety Health Act which requires the Secretary to do so. In his opinion, industry has failed to protect the worker and there should bo instituted immediately an emergency temporary standard on the samo basis as the 14 materials presently defined as carcinogens. He made the following specific recommendations:
1. There be no measurable exposure by any route as determined by the best available analytical procedures.
2. No open vessel operation.
3. Adequate protective clothing should be furnished employees.
4. Safe work practices and employee training should be instituted.
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5. Medical and exposure records should be made available to XIOSH.
6. 'fust maintain confidentiality of employee medical records.
7. A work permit program should be instituted.
He indorsed the Anderson standards of I UP (whatever these are) and stated that the above recommendations were necessary because the present interim XIOSH standards are not being adhered to.
He castigated APCI because we failed in the 14-page (sic) statement to our employees to inform them of the long latency period, and that because the plant is only ID years old (sic) wc should expect no cases for five more years.
He emphasized that death certificates are not reliable data on the occurrence of angiosarcoma because it is often not recognized as the cause of death at that time, and biopsy reports do not become avail able until several months later.
OCAIV is conducting a survey through their union in an attempt to see how many cases of illness due to cx:x>sure to vinyl chloride may have occurred. They have used >!t. Sinai to study one plant and found many effects. (This is thought to be BFG at Pottstown.)
He. refuted in advance any attempt by industry to state that there was no problem because there were no loiown cases, and repeated that there was no safe exposure level.
IV. Professor Cosare Maltoni of the Institute of Oncology, Bologna, Italy, was the next speaker. He was very difficult to understand and pre sented many slides and tables which were too dim or too congested to record. His report has been summarized here as best I can. The official transcript will have photographic reproductions of his slides. Hie most important statement he made was that he was convinced that there was a no-effect level at 50 ppm, and that this findbig is being repeated on a larger group. In response to a question from the floor on the accuracy of extrapolation from experimental animals to humans, he stated that it was very difficult to do so accurately.
He first summarized his observation of the previous exposure studies of rats to vinyl chloride by Dr. Viola:
1. Vinyl chloride was shown to be a carcinogen by inhalation in rats at very high levels (30,000 ppm).
2* The primary effect was to cause tumors in the zynibal ear gland. The high mortality from this cause obscured many of other effects that may have been present.
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3. The lung tumors reported were the results of netastases of other tumors in the experimental animals.
Professor Jlaltoni is now conducting 13 major experiments; only three of these are far enough along to be subject to analysis. The official record of tlie proceedings will contain the many tables, slides of animal biopsies, and other data which he presented. This work is what has been referred to in some places as the "European Studies".
In Professor Maltoni's first experiment, groups of rats were exposed to varying levels of vinyl chloride for A hrs/day, 5 days/wcek for a year, and held to death. He found no evidence of tumors at 50 ppm, and there are still 3 survivors of the original 60 animals after about 2 years. A few cases were found at 250 ppm, and still more as the level increased. These tumors were of various types, primarily of the zymbal gland, but with a few of the liver, kidney and other organs. There was also metastasis to the lungs, liver, and spleen, lie also reported angiosarcomas of the neck, lungs, peritoneum, and uterus. Of interest is the fact that no tumors were found in animals exposed to 2,500 ppm vinyl acetate, a frequently-used comonomer with vinyl chloride.
In another experiment, the animals were exposed at the same rate, but only for 4 months, rather than a year. This group developed far fewer tumors, and only in the 4)rj>L>al gland, and only at exposures of 10,000'and 6,000 ppm. This experiment has only been in progress 56 weeks, and is thus incomplete.
A third experiment exposed pregnant animals between the 12th and 18th days of pregnancy. Two offspring of those exposed to 10,000 ppm developed tumors; none of the parents did except for zymbal glands. Tliis experiment is also incomplete, having been in progress 31 weeks.
Other experiments are in progress, including exposure of other species, and exposure by ingestion and injection, as well as inhalation. They are also examining the workers of one of the large PVC producers in * Italy for any medical evidence of harm from exposure.
Professor Maltoni stated that he believed these data showed a no-effcct level at 50 ppm. Dr. Selikoff thanked him from the floor for his contribution to the study.
Mr. Key of NIOSH asked Mm about reported positive spitum tests on the Montedison wor3:ers in Italy and he stated that he had found metoplasia but no evidence of serious change in the respiratory tract. The solicitor's office asked if there were any exposure regulations in Europe. He stated that they had been at 250 ppm but were now going as low as possible, certainly below 100 and probably to below 50. Dr. Jaeger of Harvard repeated concern expressed by others earlier that no
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primates were to be included in the studies in progress and brought out the fact that not all of Maltoni's experiments were performed with the same batch of vinyl chloride but that all sanies were very pure and analyses are on record at Montedison.
V. Mr. A. C. Clark of MCA was the next speaker and reviewed again the history beginning with the A0L experience in 1966 through the pre sent activities of the MCA. A copy of his full paper is in attachment II.
In response to a question from the solicitor's office as to whether other additives to vinyl chloride are being testeds he responded that they were not. Asked why the safety data shoot had been with drawn, he said it was to revise it in view of present information. Asked if there was a safe level of exposure, he said he could not comment. He will submit for the record reprints on the work prac tices that we instituted as a result of the AOL studies. Khan asked why no primates were being studied, it was stated that because of necessity of life-time studies, primates were not practical from either a time or cost basis and that the liver of rats is very similar in structure and function to that of mammals. Dr. Jaeger again asked about studies of other ingredients, particularly vinylidene chloride, and he was told that none arc planned. OCV' asked if he loiow of the Russian and German documents cited by Selikoff. and lie was told that he did not.
Actually many of these above questions were fielded by Dr. Johnson who sat by Mr. Clark while he made his presentation.
VI. The next speaker was Mr. A. Vittone, President of BPG Chemicals, who was accompanied by Dr. M. M. Johnson, Medical Director, Dr. R. Strassburg, Director of Environmental Affairs, Mr. L. R. Crider, Senior Scientist, and Mr. Harold J. Fast, Corporate Council and Assistant Secretary. He gave an historical review of the RFC experience in PVC beginning with their now closed Niagara Falls plant which was put into operation in 1037 and the construction of the Louisville plant in 1942 to their existing 5 operating plants. Tliey changed to ethylene-based monomer made by their own process in 1964. He described the monomer production and polymer processing operations in a very general form. He reviewed the discovery of AOL by Dr. Creech in 1964 and the events which have transpired since. He stated that their operator exposure to manual cleaning has been significantly reduced by the introduction of a hydraulic high
. pressure washer.
He stated tint their present exposure levels are below 50 ppm TWA, and tliat they were implementing most of the recommendations made by NIOSH on 31 January 1974, except where they were awaiting further clarification. He stated that they had found no other cases on reviewing the death records at all of their plants. (Note that as of now we know these statements to be incorrect). For the first time lie confirmed tliat at least two of the workers had had a 10-year exposure to vinylidene chloride, as well as the other comonomers used in their plant, but again they did not give specific individual work
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histories.
0CA1V asked if their AOL literature search revealed the European
papers referred to by Selikoff and the answer was no. They were asked
why their European operations had not informed them of the medical
situation in Europe and nave no conclusive reply. It was stated
tliat they did both spot and continuous monitoring and that their
employees see the results of the analyses. (Again, we know now tliat
as of this date they have no continuous recorders in operation.)
When asked about a liver cancer case in a daughter of one of the
workers, it was stated that this was not angiosarcoma. The medical
tests which they arc now administering at present are the SM\-12
group. They were asked again by Jaeger about any test work being
done on vinylidene chloride and they stated they had no data on it,
or on the vinyl or vinylidene content of the polyner, nor any data
on the size of the dust to which the workers are exposed except that
it was small, possibly less than 325 mesh, and that they will make
such data available. They stated that the VCL content in the silos
was about 100-200 ppm. They gave the impression that this was in
the atmosphere, but I believe that they are incorrect in this and
that this is more likely to be the content of the resin, and that the
atmospheric content will vary considerably depending on the residence
in the silo and amount of aeration, then asked which process gave
most exposure, the reply was about the same, but varies from plant
to plant, and they
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asked them.
VII.
Mr. R. J. Reynolds, Manager of Vinyl Chloride for Shell Chemical
Company, accompanied by Mr. H. L. Kuzcnet, Onager of Environmental
Health, discussed their monomer plants. The first plant was built at Deer Park in August 1071 and lias a capacity of 1,200 tons/day using the Stauffer process. Alxnit 20 persons are directly concerned with operation of the plant and 25 otliors indirectly, through such efforts as loading, shipping, maintenance, and supervision. Their second plant was built at Norco in October of 1973 and lias a 1,000 ton/ day capacity with 20 direct and 5 associated employees.
They stated that the only final exit point in their plant was for inerts vented from a high stack after scrubbing. Hie method of
scrubbing was not given but this statement implied that there was incinceration of the final purge stream. At the beginning of their
operations they used spot tests around the plant with color tubes and found no one exposed to no more than 5^0 ppm Tte\. Because the tubes
are sensitive only down to 200 ppm, they developed a gas chromatographic method which will be included in the official transcript. They estab
lished a plant standard of SO ppm maximum for vinyl chloride and - discussed the possible hazards as known at that time with their
employees in July and August of 1073 and advised their customers at
that time by their product data sheets that they believe this to be the
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propcr allowable limit.
They used personal monitoring devices and find no readings over 50 TWA except when there are abnormal conditions which persist for short
times with exposures in the 100-200 ppm range.
Each employee is given an exam which includes a medical history, a complete physical, the standard blood work-ups, plus the SMA-12 scan, urinalysis, and a chest x-ray. There have been no abnormal findings in tlie short time that these plants have been operating and these data
are being to establish a base line for future reference.
He closed his presentation by stating that they could see no reason why normal fact finding procedures under section 6 b should not bo set.
The solicitor's office asked if there was any difference in purity in their monomer and other which is available. The answer was no. They were also asked if they were looking at other chemicals used in their plants. Again the answer was no, except for the studies at MCA which were being supported by them. Mr. Rose of NI0S1I asked how they sailed. The reply was that the best method for their particular situation which was an open plant with many wind shifts was to use a personal monitoring system which involved a bag collector to get a representative G-hour sample. The content of tins bag was later analyzed by a chromatograph.
OCAK asked if the employees had been informed of the dangers. They replied that they had.brought them up to date last year as stated and tk*at in January the Wall Street Journal article on the BFG situation was posted. In response to other questions, they stated that their employees sec the monitoring data and that any employee .medical records would be released to the employee's doctor on request.
The Health Research Group asked the cost of the MCA study. The solicitor's representative objected to the question as not being
pertinent and was sustained by the judge. There was considerable discussion as to whether their present data sheets were acceptable and proper and they agreed that they would submit both their older and their present versions, which mentions Viola's work, but that
there obviously is a need for further revisions in light of the present knowledge. They will do so and submit for the record.
VIII.
The AFL-CIO delegation was headed by Mr. Sheldon Samuels, Director Health Safety and Environmental Affairs of the Industrial Union Department, accompanied by Dr. Henry Anderson of the Mt. Sinai School of Medicine, Dr. T. F. Mancuso, University of Pittsburgh Graduate School of Public Health and Mr. Louis Beliczky, Director of Industrial Hygiene, United Rubber Workers. Mr. Samuels made a short introduction in which lie stated that if this were not a unique
tumor it might still be unnoticed and that we are now paying the price for past neglect. Dr. Mancuso called for an immediate emergency
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temporary standard that should extend to all other type cancers at all industrial chemical operations, lie said all similar chemicals should be considered suspect until proven safe and decried the lack of a requirement to prove chemicals safe before they are used. He empliasized tliat while testing is done it aimed toward toxicity and not the carcinogenic nature of the materials. He said that there were about 20,000 industrial chemicals now in use that are assumed to be safe but that many had not been tested and almost none had been tested in combination with possible cocarcinogens. He called for an immediate government program to demonstrate the safety of all chemicals both singly and in all possible combinations before they are permitted to be used.
He also expressed the strong opinion tliat there was not a long latency period, but that because of the fast rate of development of the cancer and the relatively young age of the deceased workers, a very strong carcinogen was the cause. This is in direct opposition to statements made earlier by Selikoff and Mazzocchi.
He emphasized that data taken from death certificates are not adequate and that industry should do more work to test their workers better and to give better notice to the worker and his doctor of possible hazards.
He recommended that:
1. CDC and LIOSH undertake an immediate study of the problem.
2. Hiat a crash program similar to tliat performed for the asbestos lung cancer problem be completed.
3. Tliat a government survey be made to determine the extent of the problem, and
4. That unions, the Secretary of Labor, Universities, and other groups join in the study of the causes and relation to employ ment conditions of this cancer.
He closed by quoting a 1070 statement by the Surgeon General which said that th*rc is no safe level of exposure to a known carcinogen. Mr. Beliczky also called for an immediate emergency temporary standard if it is found that workers are exposed to a grave danger, and quoted the HIOSll statement that it has been determined that a new occiqiational cancer has been found. He said that the 12 February meeting in Cleveland concluded tliat vinyl chloride was the primary suspect agent and said that medical data shows the toxicity and probable carcinogenic nature of vinyl chloride. Because there is no way that employees can participate, particularly in the enforcement of the 31 January 1974 NI05H interim standards, a permanent standard is necessary. lie proposed that this standard include a requirement for no contact with the worker as measured by the most sensitive analytical methods avail able. He did express the opinion tli.it because of the volatility of vinyl chloride, mandatory showers were not required, lie cited information tliat PVC normally contains 500-3,000 ppni monomer and asked
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for a limit of no more than 0.01* (111 ppm). It is notable that he did not ash that PVC be put on the list of carcinogens. He did demand a permit system and a registration system for monomer handling.
Dr. Anderson suggested for following as a minimum medical protocol, with additional tests to be added as they become available:
1. A complete work and medical liistory to be taken on a standard form to be developed.
2. Physical examinations on a continuing basis.
3. Chest x-rays on 14 x 17 PA plates and hand x-rays annually.
4. Pulmonary function tests.
5. Complete blood and platelet work-ups and SUV12 routines.
6. Urinalysis, including glucose, blood, and protein every 6 months. These should be repeated monthly if abnormal and
' given prompt medical attention.
7. These records should be maintained and given to the personal physician upon the request of the employee.
8.' Hie government should review the data obtained from the above protocol, plus environmental data from the plant, and do additional studies as needed.
The solicitor's office asked if inhalation studies were more suitable than ingestion studies and the answer was in the affirmative. A Mr. Connelly of Firestone asked if the union lcnew of any related .deaths. Hie answer was yes, they blew of one in England and are presently investigating reports of others. Mr. Connolly attempted to joust with Dr. Anderson over the information being developed at the Pottstown plant and came out a very poor second in the exchange, primarily because of the lack of good medical records at that plant. Reference was made to a University of North Carolina study apparently carried out by Firestone on their workers, but no further information is available. It was stated by Beliczky that "you have people in your plant with liver problems".
IX. The next speaker was T>r. Rudolph Jaeger, bio-chemical toxicologist, Harvard School of Public Health. He spoke briefly on the subject that there is a possibility that PVC resin and compound may contain carcinogenic material which can be released upon use and that co monomer may be important. He emphasized the possibility of a problem with vinylidene chloride stating that in rats a short exposure to 100 ppm gave a sharp rise in sorbitol dehydrogenase. He drew the
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conclusion that vinylidene chloride is much more hepatoxi'c than is vinyl chloride, lie expressed concern over possible release of toxic agents during the processing, use, and incineration of plastic materials, with reference to the "meat-packers syndrome".
It was stated later by the judge that this oral presentation had been withdrawn and the official record would contain a copy of a pre viously published paper by Dr. Jaeger on this subject.
In a private conversation later with Mr. Rose of NI0311, Dr. Jaeger was quite insistent tliat Mr. Rose should have taken more samples from within the reactors at Louisville jind paid more attention to the vinylidene chloride content.
X. The next speaker was Dr. V. K. Rowe, Chief of Toxilogical Affairs at Dow Chemical Company. Mis was the best presentation of the day in terms of clinical details and clarity of presentation. A complete copy of his presentation and his appendix II is given in attac!imont III. His appendix I is a bibliography of literature on VCL toxicity, and is available from Dr. Smith or the writer.
He was questioned by the office of the solicitor as to whether they had examined their employees for cirrhosis and cancers and the answer was affirmative. It was also asked if they had done any work on the toxica. Ly <j PVC, and Lhe answer negative. In. Beliczky asked how much monomer there was in their PVC and he replied that he did not know exactly but it-depended on the degree of stripping. Beliczky continued with the question that since Maltoni had shown positive results at 100 ppm, how could Dow think 50 was a safe level. He replied that this was incorrect, Maltoni had positive results at 250, not 100, and their experience led them to feel that 50 was safe. Beliczky then said that if wc had followed your advice in 1061, we would have no problem now, and asked why should we treat tins carcinogen differently from the others in terns of exposure. The answer was tliat they feel the present problems are due to very high past exposures and while their study is not absolutely complete, they feel there is a safe level and that the attainment of zero exposure is impossible.
Healtli Research Group asked if monitoring was continuous over the time period referred to in their clinical studies and the answer was yes. Beliczly asked which analytical method might be accurate at 1 part/million and the answer was all of the major analytical techniques. Question - can the analyses differentiate vinylidene chloride? The answer - I do not know. Question - can the analytical instrument go down at 0.1 ppm? Answer - certainly, with time instruments can be developed at any sensitivity desired.
XI. The last speaker was Mr. H. K. Carver, Jr., Design Engineer from Dove Packaging Systems, a division of Franklin Electric. In essence, he gave a 15-ininutc sales pitch for their meat packaging machine to be used with polyethylene and polyvinylchloride which reduces the visible emission during the cutting of the film by holding the cutting wire temperature below the combustion point of the polymer.
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Tlie presiding judge then closed the hearing with the statement that the record will be kept open until S 'larch 197-1 for further written submittals but that these will not be included in the transcript of this hearing. They will be available for inspection at room 240 at 1726 M Street NV.r, Washington, D. C. .Vote tliat this is a different room number from that given in the Federal Register notice of the meeting.
Some additional information was obtained during private conversations. A Dr. Richardson of EFA referred to work done at Eppley Institute by Phil Shubick which purports to indicate angiosarcoma is always due to particulate matter. He asked particularly about the possibility of cadmium being present in the work environment. He was quite firm on the opinion that primates and not rodents should be used as test animals. I have written to him asking him to send us the information which he lias available.
Mr. Gordon Rocand stated that Century will soon have a portable instrument available with a column which will therefore be able to separate the components in the air samples. He further stated that the Shin-Etsu technology being used ir. their new Texet plant requires a man to go into the reactor and spray the walls after every batch, and that they are working very hard on a method to eliminate this requirement.
We were told by some persons there that they, had heard that our Calvert City plant was to be inspected in the imediate future by NI0SIL- Upon checking with Mr. Rose we were referred to a Mr. J. Jones who works for Dr. Wagner in the Cincinnati office, who said that they will visit 8 of 10 plants now in operation which were built before 1953 and that other plants would be visited Inter. This would appear to remove us from the first grouping. Included in their proposed inspection will be a medical doctor, an industrial hygienist, and an environmental expert, and they expect to do mortality studies based on plant worker histories.
Mr. R. W. Van llouten of Liberty Mutual Insurance extended the sendees of the industrial hygiene group of his conr>any for whatever use they might be to us. We should contact then through their local Loss Preventive Representative who calls on our plant if we wish to use their service.
r
AP00000158
Attachments 1. Federal Register Notice 2. MCA Presentation 3. Dow Presentation 4. Dow Appendix I, Hygiene Studies
AP00000159
l
3374
'
/"V NOTICES
J
: -
Applications for disaster ltaxu aider (8) 'Whether the available information presiding officer ahall certify the record
this announcement mustbe filed not later warrants the Issuance of an Emergency thereof to the Assistant Secretary of
than March 19,1874.
Temporary Standard, or the commence Labor for' Occupational' Safety
Dated: AfiuanK II. W74.
fl .
Thomas 8. Kum. .
r1 Administrator.
ment of a regular rulemaking under sec tion 6(b) of the Occupational-Safety and
Health.____
W~TV"*** : . --- -
Signed at Washington, DAL.* this 28th
"vSttiSwt. mmr be mail* or ddlr-' ** *
P'S Doe.74-2ft79 Flted-l-*-74iBj46 am]
ered to the Office of Standards. Attn: . ____*-' ..
John twLB*i-x--x-r--e-n. Jj
Docket OSH-36. Occupational Safety - v 7 A*iiiant Secretary o/ Labor. ^ ^
0
VETERANS ADMINISTRATION
and Health Administration. Boom 803, fTB Dee. T4-8404 Filed l-*9-74;S:43 am] .' y' 1726 M Street KW. 'Washington. D.CJ.
ADVISORY COMMITTEE ON STRUCTURAL 20210. not later than February 28,1974.
SAFETY OF VETERANS ADMINISTRA The data will be available for public In .
INTERSTATE COMMERCE
'* '
TION FACILITIES ..
_____ .
spection and copying at the OSHA Public
COMMISSION
D0
Notice of Meeting
Reading Room. Room 293,172611 Street
.NW, Washington. D.C. 20210. -
The Veterans Administration gives no tice pursuanv to Public Law 92-463 that a meeting of the Advisory Committee on Structural Safety of Veterans Adminis tration Facilities will be held In Boom
Oral presentation of data will also be
received by an administrative law Judge at an informal fact-finding hearing be ginning at 10 am., e-d-t, on Friday, Feb ruary 15. 1974. Conference Room B, De-
442 at the Veterans Administration Cen- tmentol Auditorium. Constitution Ave-
INoUeeMo.494} ./'"
' " ASSIGNMENT OF HEAR1NQS " I -
7r '
'.' J*KITAir?5tlS74.
Cases assigned for hearing, postpone ment, cancellation or oral argument ap pear below and win be published only
D0
0.
tral Office. Bll Vermont Avenue, -T7W.,
Washington. DC on February 22, 1874, at 10 a.m. The committee members will review Veterans Administration con
struction standards and criteria relating to fire, earthquake. and other disaster resistant construction.
The meeting will be open to the public up' to the seating capacity of the room.
Because of the limited seating capacity
it will be necessary for those wishing to
attend to contact Mr. James Lefter. Di rector, Civil Engineering Service, Office of Construction, VA Central Office
partmentat Auditorium, Constitution
Avenue KW. between 12th and lath Streets, Washington. D.C. -
Persons desiring to appear at the hear
ing must file with j. Goodcli, Attn: Docket OSH-36, Office of Standards, Occupa
tional Safety and Health Administration.
Room 203,1726 M Street NW., Washing ton. D.C. 20210, a written notice of in tention to appear, In triplicate. Notice
should be filed as soon as possible, but will be accepted by the Management Offi cer at the liearing until the pre-hearing
conference begins. The notice should
'
once. This list contains prospective as signments only and does not include cases previously assigned hearing,dates. The hearing* will be on the Issues as - -
presently reflected In the Official Docket.. of the Commission. An fUempt will be made to publish notioes of of hearings as promptly as possible, but ' interested parties should take appropri ate steps to insure that they are notified of cancellation orpostponements of hear- "
tags in which they are interested. Ho amendments wifl be entertained after January 30,1974. .
iphone 202-389-2668). prior to Febru ary IB. 1974.
state: The name and address of the MO-60079 Cub 44, Brown* Transport Corp~ person wishing to appear; the capacity MC 130156 Sub 9, Oay Trucking Co* Ian.
a Dated: Jamiaiy 22,1974.
By`direction Of t*w AdralnlgtratAT
mil] .
ROTUS H. WILSON,
in which he will appear; and the approx - MC 13S383 Sub 3, Southern
imate amount of time reaulred for the presentation. The notice should also In clude. or be accompanied by,-a brief'
Logistics, Inc.. MO 136230, Xntentats Ware-
bousing. oip., now oalgntd Uvcb' 13. 1B74. m be Item at the HDllder Xna-- Downtown, 375 Fledmaos Avenue, Atiante,
Associate Deputy Administrator. statement. of (he presentation .to be Ge.
;fr Doc.74-3448 FUe4 i-2-74;8:46 am]
made.
W-Oi Sub-No. S. MoAUlater Lighterage Line.
Beginning at 9:30 am., e.d.t.. on Feb Xno, A W-tS7 ub-Ko. e, ifoAUlater
G DEPARTMENT OF LABOR
ruary 15, 1974, the presiding Adminis trative Law Judge will hold a pre-hearing
Office of the Secretary '
'conference in order to establish the
order time for the presentations, and
POSSIBLE HAZARDS OF VINYL CHLORIOE MANUFACTURE AND USE
in order to settle any other matter relat ing to the proceedings.
Brothezs. Ine^ now assigned February , 1974, at New Torle, NT- la eaneeUed and transferred to Modified Procedure. VC-019SS. CentrepellsTYanafer Celiac, now
assigned Pebmary 6,1974, at JeJXerson City. Mo* is cancelled and reassigned Febru ary *, 3974. In Boom SOS. Federal Office
Request for Information and Notice of The oral proceedings shall be reported Bldg* 911 Walnut Street.
city. 3lo.
Fact-Finding Hearing
verbatim. The use of prepared statements Vo. S5717. Southern RaUwsy Company--Peti
0
GDB.0
j Notice is hereby given that the OcJettpational Safety and Health Admin-
listr&tion Is requesting information on {possible hazards associated with the manufacture and/or use of vinyl chlo
ride ichloroethene, Chemical Abstracts
Service Registry Number 75014).
The Administration requests Informa
tion including/ but not necessarily lim
ited to:
> <1> The toxicity of vinyl chloride:
< 12) The toxicity of other chemicals ln-
volved in the manufacture and-nse ef
vinyl chloride; *"
,
13) The technologies Involved In the ... production and use of vinyl chloride: .
- (4) Employee populations potentially or actually exposed to vinyl chloride or
other chemicals, and involved to the pro-ducUon and/or use cf vinyl chloride; .
IS) Epidemiological studies of effectsof vinyl chloride and other chemicals in the manufacture or me of vinyl
by witnesses is encouraged. All documents that are intended to be submitted should
be submitted in triplicate (original and
two copies).
The administrative law Judge shall
have all the powers necessary or appro
priate to conduct a fair and full Informal hearing. Including the powers:
la) To regulate the course of the hear
ing;
"
r
<b) To dispose of procedural requests,
objections, and comparable matters;
(d To
th- presentations to
matters pertinent to the requested In-
formation;
<d> To regulate the conduct of thoee
present at the hearing tor appropriate
means;- '
>-.
<e) Xn his discretion, to question and
'pe_r_m___i_t. questionin_g of an.y w. it_n_e__s_s_;_a__n__d
<n Tn his discretion, to keepthereeonl open for a reasonable stated time to re
ceive written d&to from any person who
tion for Declaratory Order. NO. 35717 Sub
X, loutarin* and Nashville BaUroed Com
pany-Petition for Decleratory Order--Be-
fund Buie--Bectrical Appuaocee, con-
tinned to March 19. U74. at the Offices pf the Internets Ooramcrcc Oonunlselon.
Washington. DXf. -
`
MC 30473 Chab 15, Uise City Tracking Com
pany. Xnn* bow assigned February 4. 1974.
at Chicago, Hi, la-postponed indefinitely.
MC 3202 Sub 447, Roadway Exprew, ino, now
assigned February 25, 1974. at -Cleveland.
Ohio. Is eaaoeUed and the application is
_ '-JRoaxn .*=Y.:
Dvwaxn, -
feentanr.
-
r IHtDocW Miiain l-30-74;t:4SamJ
?r
y~
: \-fr
FOURTH SECTION APPLICATION FDR , ..y^- V. *Fl IFF
;^-.^~^^-`'v^)v>'J*Nuar35,t974...
. An application, as summarized has been filed requesting relief from the
'
chloride on populations, employee or otherwise; and
has participated in the oral proceeding. rFollowing the close of the hearing, the
requirements of Section 4 cd the Inter
state Commerce Act .to permit common
AP00000160