Document qmKxdvNJnmN8mELkegVGdJwXK

SEWATE CC-;V1ITTEE 01! COMMERCE Subcommittee on the Environment UITriESS LIST* Hearings on Vinyl Chloride Wednesday, August 21, 1974 - '9:30 AH Room 1313 Dirkscn Senate Office Building' Dr. Irving J. Selikoff, Professor of Environmental Medicine, Mount Sinai Medical School, !)YC; Dr. Marcus Key, Director, National Institute for Occupational Safety and Health, Department of Health, Education and Del fare; Dr. Joseph Wagoner, Director of Field Studies and Clinical Investigations, National Institute for Occupational Safety and Health, HEW Dr. Umberto Saffiotti, Associate Director for Carcinogenesis, Division of Cancer Cure and Prevention, National Cancer Institute, HEW; Hr. James Agee, Assistant Administrator,'Water and Hazardous Materials, Environmental Protection Agency; Dr. Theodore R. Tcrkelson, Senior toxicologist; Health and Environmental Research Department, Dow Chemical Company; Mr. Ralph L. Harding, President, Society of the Plastics Industry Inc., NYC. Mr. Jack DeLonc, Acting President, Local 3-277, Goodyear Tire and Rubber Company, Niagara Falls, Hew York; Mr. George Shiah, Member of Local 8-277 and employee at Goodyear Tire and Rubber Company, Niagara Falls, New York. *;!ot necessarily in order of appearance # if if ASI 00001372 Hill and Knowlton, Inc. one McPherson square VERMONT AT K STREET, N.W. WASHINGTON, D. C. 20005 63R-2COO Memo to: From: Subject: R. L. Harding Jr. Jerry Blizin Report on Senate Commerce subcommittee hearing on vinyl chloride Date: August 22, 1974 Copies: Heckman, White, Nuspliger, Swetonic, Kiss Haley, McGrath Attached please find my summary of the events at yesterday's one-day hearing held by Sen. John Tunrey (D-Cal.) on "oversight" of the vinyl chloride problem, together with copies of the key prepared statements. The hearing of the Senate Commerce subcommittee on the environment was orchestrated to put pressure on the conferees handing the stalled Toxic 5 ubstances Act, as well as put some additional lev erage against industry, using vinyl chloride as the best chemical fright story currently available. I think I can say that in both the prepared testimony and the ad lib remarks presented by Messrs. Harding and Heckman, SPJ and the plastics industry established clearly for the record a position distinct from MCA and further presented to Sen. Tunney documentation of positive and responsive efforts to the vinyl chloride problem. Regards, J. B. ASI 00001373 REPORT ON HEARING OF THE SENATE SUBCOMMITTEE ON THE ENVIRONMENT, SENATE COMMERCE COMMITTEE AUGUST 21, 1974 A one-day hearing of the subcommittee on the environment, put together with barely a week's notice, was called under the chairmanship of Sen. John V. Tunney (D-Cal. ). The Senator's attached opening statement states that the hearing was called to "examine evidence on the dangers of vinyl chloride" and concludes with the observation that it is hoped the hearing will "back up" the toxic substances legislation now in conference. (For the record, the Toxic Substanc( s Act (S. 426-HR 5356) was passed last year and remains locked in conference. The conferees met on Axigust 19 and reports continue that new efforts will be made to reach compromise language re pre-market testing. ) Ignoring for the moment any question of the validity of legislative purpose for the hearing, there were some interesting last minute changes commencing with the fact that the hearing had been scheduled to begin at 11 a. m. but was changed at the last minute to begin at 9:30 a, m. Notification of witnesses was not properly carried out and there was some initial confusion as the hearings began. The lead-off witness was to have been Dr. Irving Selikoff, who arrived late. The chair then called on Anthony Maxzocchi of OCAW and two men identified workers at Goodyear's Niagara Falls plant, Jack DeLong (acting president, of the OCAW local) and George Shiah. Up till Tuesday evening, the staff of the sub committee had indicated that Mazzocclu wasn't a scheduled witness. The three had no prepared statements. ASX 00001374 -2- The men talked about their fears of VCM and Shiah described his acroostylosis condition in his hands. They said they were unaware of cancer- causing problems of VCM. until Mazzocclii told them last March. They indicated they knew one could be rendered unconscious by VCM but beyond that, weren't aware of any danger. Mazzocchi then went on to tell Tunney that these men were "a good indication of the guinea pig syndrome workers have to go through. . . the experi mentation takes place with people, not animals, . . it is inexcusable to introduce a substance and then wait to see what happens to the people.u He said pre-market testing is "absolutely essential" and said if no toxic substances law is passed, "these episodes will be repeated thousands of times with the produces introduced before testing. " He also took time to predict the forthcoming OSHA standard on vinyl chloride will be made "not on health, but on economic and political considerations. " Dr. Selikoff followed. While his prepared statement was a broad survey of the cancer probem re vinyl chloride to date, emphasis was given to his contention that there are now some "early findings" which lead to the suspicion the VCM may be mutagenic as well as carcinogenic. On page 7 of the testimony, Selikoff refers to limited studies by his staff and the findings of Dr. Infante of the Ohio State Health Department re alleged birth malformations in three counties where vinyl chloride operations are conducted. (However, it should be noted that when Dr. Selikoff reported on these preliminary findings on alleged stillbirths, miscarriages or malformations at the National Institute of Environmental Health Sciences meeting on VCM-PVC, held last month in North Carolina, the Occupational Safety and Health Hotter reported ASI 00001375 I -3- that so far such links were "only a suggestion. ") Nevertheless, Tunney questioned Selikoff on these allegations and both today's Washington Post and New York Times stories picked up on this. In his kd lib responses to Sen, Tunney, Dr. Selikoff stated "unequivocally" that with a Toxic Substances bill on the books VC would not have been introduced and added that right now "we need no new knowledge beyond what we have. . to detect its toxicity or carcinogenicity. " Further, he stated, "now that this plastic monomer (VCM) can cause this disease one would hope that the list of other monomers and polymers would be looked at. From where I sit I don't think this is going on, I don't think we've learned the lesson of vinyl chloride. " Tunney asked Dr. Selikoff what a finding of mutagenesis in VCM wovdd mean to humans and Selikoff said: "If vinyl chloride has a mutagenic effect we will contribute substantially to the mutagenic load on the human race, " indicating this would mean "a definite increase in defective structure of human beings. " One hope, he said--if it can be called that---would be that many fetuses would be stillborn. Earlier, he conceded to Tunney that there is no evidence to date that polyvinyl chloride without unreacted vinyl chloride is toxic. He said he hopes that EPA will have some studies in six months which wall tie this down. There was a sideline excursion by Selikoff into a discussion of Japan's problem with a chemical preservative which turned out to be mutagenic after being put into general use. lie said the preservative involved 20 percent of Japan's jjrolein supply and cited this an example of the critical need for pre-market testing. ASI 00001376 -4- "It is overstating the case to say we are risking the future of the human race? " asked Tunney. "Their future is in our hands," said Dr. Selikoff. Next there followed a panel of federal medical research witnesses. Dr. Marcus Key of NIOSH (who will retire next month); Dr. Joe Wagoner of NIOSH; Dr. Umberto Saffiotti of National Cancer Institute and Robert Shaffner of FDA. Dr, Key reviewed the NIOSH role and stated they had been informed of the cancer potential of VCM on January 22, 1974 when B. F. Goodrich made its voluntary disclosure. This point was to be cleverly used by Tunney later. Dr. Wagoner detailed the mission and status of the NIOSH-Center for Di seasc Control epidemiology study on vinyl chloride. He noted that during the study period 1950-1973, a total of 109 deaths were observed among vinyl chloride workers, whereas 105 would be expected. While the overall number of deaths was "slightly greater than expected, " the difference is a "57 percent increase in deaths due to cancer. " He said the study shows overall mortality risk is at variance with an earlier industry-wide study, and that findings are consistent with those of Dr. Selikoff as well as the animal studies of Dr. Maltoni. He said that of a current total of 21 identified angiosarcoma cases, one is noteworthy--involving a former B. F. Goodrich employee whose only known exposure was from 1950-1954, in variance with the usual longterm exposure of angio ASI 00001377 5- - cases. He died 18 years later from angio at age 41. Dr. Wagoner said the case is "consistent with the tenets of carcinogenesis - -that the carcinogenic process, even in the absence of continued exposure, is irreversible." (Attention should also be given to Wagoner's table no. 5 which refers to angio cases among non-VC polymerization workers. ) Dr. Wagoner also made passing reference to two cases of alleged community exposure (he said these cases pointed to need for more studies) and to a report of death of a worker in Hamilton County, O. "who died of inhalation of fumes while burning PVC wastes. " Senator Tunney continued with Wagoner a discussion on whether PVC "uncontaminated" by VCM is carcinogenic. Wagoner said the only data relates to unreacted VC. in discussion with Shaffner of FDA, the witness stated FDA will publish in the Federal Register "in the next two weeks" its proposed regulation:- to limit migration of momoner. In response to Tunney's question on what FDA is doing to "balance the various equities and assure that the public is protected on packaging and wrappi Shaffner stated: "All of the cancer cases thus far have been the result of inhalation. We don't know the effect of ingestion. . but we believe the limits we are posing will prevent hazards until we develop such information (from ongoing studies). I think we arc acting promptly and to the interests of the public. " Tunney protested "there must be some better way to test for public health impact," to which Shaffner replied that PVC lias been in use for more than 30 years, much before the 1958 food additives amendment which is FDA's only regulatory power which requires industry to submit a material for approval ASI 00001378 -6- beforc it is marketed. If PVC had been submitted under this act in the recent past, he added, it would have had tests. However, testing methods have also markedly improved recently and analytical, methods used prior to the 60's might not have been sensitive enough. Shaffner also noted that the food additive amendment doesn't apply to aerosol hair sprays. Wagoner added that NIOSH is about to begin a detailed study on cosmetol ogists. A small group in Salt Lake City is already under study and he said, "we are looking for a pregnancy outcome. " Tunney then read from a newspaper clip which stated that BFG workers with abnormal liver conditions are being given furloughs and asked Dr. Wagoner what this meant. 'Wagoner replied that at this time, science cannot identify the precursor symptoms of angiosarcoma but Dr. Key added "this may mean there is liver damage from other causes and the company may not wish to add to the risk of additional liver damage. " Tunney also raised with Wagoner the possibility of general hazard from a combination of formaldehyde in permanent press fabrics with hydrochloric acid. Wagoner said at certain temperatures the combination could produce biscloromctliyl ether, "a very potent carcinogen. " He said studies arc being conducted now' to determine the potential risk and impact. The interrogation of Dr. Saffiotti was largely to establish that there is a significant time lag between the lab studies and publication in scientific journals. The questioning of a panel of four EPA witnesses saw Tunney bear down on Glenn Schweitzer, head of the office of toxic substances and chief of the ASI 00001379 7- - EPA vinyl chloride task force, on the status of the EPA environmental impact report for VCM. Schweitzer said the report is in third draft and will be ready for sub mission in three weeks. Tunney, reading from the first draft, then questioned Schweitzer closely as to why--in June--EPA recommended an ambient air standard that was at the level angio had been induced in test animals. Schweitzer said "This is a serious error for which I was responsible, " and said the report had gone out without his having seen it. The next witness was Dr, Torkelson of Dow, appearing on behalf of MCA. The testimony speaks for itself, including some new test animal results (p. 12). However, as orchestrated by the staff, Sen. Tunney at the conclusion of the testimony asked Dr. Torkelson about the Chemica1 and Engineering News story which alleged a delay by industry in transmitting data on cancer resulting from the Maltoni studies. After getting Dr. Torkelson to state that there was a close MCA relation ship until NIOSH, Tunney then began to ask why NIOSH wasn't told of-the cancer data in 1973. Torkelsen, who was not at the 1973 meeting at which the Maltoni Li 1 data was discussed (sans cancel-findings), attempted to say that there was no delay and that the industry group wanted to verify what it had. Tunney, however, said "then it appears you don't have a close relation ship unth NIOSH. It looks as if you had an adversary relationship, " adding, ASI 00001380 ? -8- "I would hope that MCA has a better working relationship with NIOSH today than it had in January, 1973. I find it somewhat incredible that the Italian data was not made available to NIOSH. . . " The hearings then recessed to allow Senator Tunncy to go to the floor for a special appearance of President Ford, after which Messrs. Harding and Heckman appeared. In the question and answer section, Harding noted that in the United Kingdom government, labor and industry were able to sit down around a table--without charge and countercharge--and come to a joint agreement on the problem and the action to be taken. He also pointed out that up until April 16 when the ad hoc PVC and VC producers committee was formed in response to a specifi- OSHA problem SPI had operated in those areas which distinguish plastic resins from the chemical field. Harding also indie, ted "if we have information, we will make it available" to NIOSH. Heckman added that there had been no past relationship with NIOSH but there had been a long-standing one with FDA in which data had been supplied on a regular, prompt and full basis. Turmey stated: "The chair has no question of the tremendous importance of polyvinyl chloride to the economy. There are clear benefits to our society. . and I have no desire to throw people out of work. . the point is what can be done to identify before a product is distributed throught society, its to.\ic properties? " He continued, "From what I've beard PVC has no adverse impact, but there may be contaminants, so nobody knows how many people will get cancer. ASI 00001381 Wo're all interested in the same things, I'm not here to suggest anybody is willfully putting out a product that is a carcinogen. " Tunney expressed his personal support for the stronger Senate version of the Toxic Substances Act. Heckman, however, added a personal note that should Congress enact toxic substances legislation, that there be proper regard for creating pre-testing conditions which are "interminable and which could keep valuable products off the market. " He cited that a 180-day pre-market time period built into the FDA act, has in practical consequence , extended for two years in some cases. Harding's statement, together with the press release, which was picked up by the Associated Press for its lead, arc also attached. 00001382 ASl