Document 06jyR947Nj3vjxkN7eQn6djmV

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 Substances Act (S. 426-HR 5356) was passed last year and remains locked in conference. The conferees met on August 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 Maz,zocchi of OCAW and two men identified as workers at Goodyear's Niagara Falls plant. Jack DeLong (acting president of the 23217183 QCAW local) and George Shiah. Up till Tuesday evening, the staff of the sub committee had indicated that Mazzocchi wasn't a scheduled witness. The three had no prepared statements. BFG24471 -2- The men talked about their fears of VCM and Shiah described his acroostylosis condition in his hands. They Baid they were unaware of cancer- causing problems of VCM until Mazzocchi 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 tia 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.'* 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 products 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. BFG24472 (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 Letter reported 23217184 -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 ad 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 would 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 will 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. He said the preservative involved 20 percent of Japan's_protein supply and cited this an example of the critical need for pre-market testing. BFG24473 23217185 -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 Disease 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 morality 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 BFG24474 9QTITZQZ -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 regulations 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 wrapping, 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 are 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 has 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 BFG24475 23217187 -6- before 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 bO'^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 biscloromethyl ether, "a very potent carcinogen. " He said studies are 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 BFG24476 23217188 -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 Tunney 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 specific OSHA p'roblem, SPI had operated in those areas which distinguish plastic resins from the chemical field. Harding also indicated "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. Tunney 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 toxic properties? " He continued, "From what I've heard PVC has no adverse impact, but there may be contaminants, so nobody knows how many people will get cancer. BFG24477 23217190 -9We'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, are also attached. BFG24478 23217191 B.F.GOODRICH CHEMICAL COMPANY Calvert City, Kentucky DISTRIBUTION D SUBJECT: Status Report-Vinyl Chloride Situation SPECIAL NOTICE ISSUED: 5-9-74 The United States Occupational Safety and Health Administration today proposed permanent regulations for the handling of Vinyl Chloride. We have not received the full text of these regulations; however, we know in general what they contain. Under these proposed regulations, stringent precautionary measures would be required if any amount of Vinyl Chloride was detected in a work area. Vinyl Chloride is detectable in air at levels of a fraction of a part per million. The precautionary measures contained in the proposed regulations are too numerous to cover here, but they include use of air-fed respirators, vapor-proof clothing, and similar things. We recognize that in the distant past the Vinyl Plastics Industry did not have full knowledge of the hazards associated with Vinyl Chloride and that adequate precautions were not always taken. However, we believe that the regulations proposed exceed what present knowledge indicates to be necessary. The proposed permanent regulations give all interested parties until June 15 to ask for a hearing. B.F.Goodrich does plan to ask for a public hearing to contest the proposed regulations as being impractical and exceeding what is necessary for the health protection of employees. We understand that many other Vinyl producers and users will also ask for a hearing and contest the regulations as being too stringent and unrealistic. Should these regu lations be adopted as proposed, the operation of a Vinyl Plastics Industry would be impractical. Our medical investigation here at Calvert City has been slowly unfolding and is now virtually complete. We have completed the blood testing of all employees, and we have retested those who showed any abnormalities. These results were reviewed by our local doctor and by BFG medical doctors in Akron. As a result of this, some additional medical tests were performed on a few people. The results are that we see no evidence that the health of any Calvert City employee has been harmed by exposure to Vinyl Chloride. A review by medical experts of all deaths of former employees at Calvert City has not shown any indication of a death related to Vinyl Chloride expo sure. This study is nearly complete. Some time ago, we started monitoring work areas around the plant to determine the exposure to Vinyl Chloride. In general, we have found that our average exposure is well below the 50 ppm limit set by the Kentucky OSHA and the Federal OSHA temporary regulations. We have found some situations where 23218001 BFG24479 2 momentary exposure above the limit can occur and we have specified that respiratory protection must be worn on these occasions. The rules for wearing respiratory equipment must be followed without fail--this is not only good for us, but also a demand of State and Federal laws. Ve are and will work toward procedure changes and installation of vents, purge points, etc., to eliminate where possible the necessity for wearing breathing protection. There will be a meeting this week-end in New York which will bring together the medical experts who are most knowledgeable of the effect*Vinyl Chloride on humans and animals. These experts ax* oeming fswhfmll countries of the world to present their information. > It is a serious time for us as employees in the Vinyl Plastics Industry. We will keep you informed of developments. C. L. Woods Is Z008XZZ BFG24480