Document 71qBoNodQjMwKpVw8yYadVzBo

JOSEPH E. SELLER JEROME H. HECKMAN CHARLES X. MEEHAN WILLIAM H. BORGHESANI. JRROBERT R. TIEHNAN WAYNE V. BLACK DAVID L. RILL MARTIN W. BERCOVICI EDWIN B. SPIEVACK PETER X. NEMKOV JOSEPH E. HADLEY CAROLS C. HARRIS WILLIAM W. PHOH LAW OFFICES Eelles and Heckman 1150 17*5 STREET, K. W, SUITE lOOO WASHINGTON, D. C. 20036 May 21, 1974 oS*W- TELEPHONE soa see-etoo CABLE ADDRESS *KELMAN' TO: All Members of SPI Food, Drug and Cosmetic Packaging Materials Committee; General Polyvinyl Chloride Interest Mailing List; Ad Hoc Liquor Bottle Committee; Plastic Pipe Institute (Executive Board); Plastic Bottle Institute (Voting Representatives); SPI Executive Committee; SPI Public Affairs Committee; VC and PVC Producers Ad Hoc Committee Ladies and Gentlemen In accordance with our now regular practice, we ar.a reporting again on the current status of federal regulatory activities and related matters affecting the vinyl chloride and polyvinyl chloride problem. As has been true for several weeks now, the major news concerns activity on the Occupational Safety and Health Administration (OSHA) front, al though we are also including an update on activities at the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA). Although none of the items we are reporting this week require specific responses by any of you, we are sure you will recognize that matters previously reported upon do carry continuing responsibilities. Following the publication by OSHA of its Notice of Intent to File an Environmental Impact Statement in connection with its proposed permanent ASI-pr 0003333 May 21, 1974 Page Two standard for occupational exposure to vinyl chloride, which contained an invtiation to provide information, we filed Comments on behalf of SPI on May 16, 1974. These Comments were substantially in the form pre viously circulated to you so we are not including additional copies at this time. The major purpose of the Comments was to inform OSHA in a formal manner of the work undertaken by the "VC and PVC Producers Committee and present a rough timetable as to when the Committee's reports could be expected. In addition, responsive to the publication of the proposed permanent standard on May 10, we are now drafting a request to extend the time for Comments for an additional 30 days, although we have been informally told by OSHA that it probably will not grant such an extension. In addition, we are preparing Comments on the proposed standard and are drafting a request for a Hearing. In connection with the Hearing which we intend-to request, our contacts at OSHA have indicated that it is "mentally scheduling" such a Hearing for "about August 1, 1974." As we understand it, it is OSHA's intent to keep the Hearing very much "on the track" and will keep presentations to very specific issues. It is expected that the Hearing record will be kept open for perhaps as much as 10 days after the Hearing closes. Then, it is OSHA's intent to try to have the permanent standard published in the Federal Register on September 5, 1974 to take effect (as required by statute) on October 5, 1974. The VC and PVC Producers Committee is presently at work gathering information that will be used in preliminary form in the Comments which will be filed before the closing date (presumably June 10, 1974). It is anticipated that the maximum amount of information that can be gathered will be presented by various experts at the Hearing. Among the type of peripheral activities that put pressures on the Agencies and that affect their ASI-PR 0003334 May 21, 1974 Page Three I actions is the charge of "withholding significant scientific findings" which appeared in the Washington Post on May 20, 1974. As many of you may recognize, and as the article acknowledges, the same story was originally reported in the May 20 edition of Chemical and Engineering News. We are enclosing copies of the C&EN article and the Washington Post story. The Chairman of the EPA's task force studying various aspects of the vinyl chloride matter, Mr. G.E. Schweitzer, Director of EPA's Office of Toxic Sub stances, reported on EPA's present activities at the Toxicology Working Group Conference on May 11 at the New York Academy of Sciences. At that time, Mr. Schweitzer announced that EPA was making available for Comment the preliminary analytical methods it is using which were reported to be sensitive to approxi,,_mately 60 parts per billion. Because of the length of the procedures, we are not including them with this letter but those interested can obtain a copy from Dr. R.B. Medz, Chief, Standardization Branch, Q.A. Division (RD-687), U.S. Environmental Protection ^Agency, Washington, D.C. 20460. EPA has submitted a rather elaborate list of questions that it would like SPI and anyone else in terested to assist in answering. These questions have been turned over to a task group of the VC and PVC Committee. However, we are enclosing a copy of the list for your information. As you know, FDA is working on the problem of an interim Food Additive Regulation applicable to poly vinyl chloride packaging materials. Although it sounds familiar, our latest report as to when the Interim Regulation can be expected is still "in one to two weeks." In response to FDA's request for extraction data and analytical methodology, results have been submitted to us for transmission to FDA by a number of parties and we understand more information is on ASI-PR 0003335 May 21, 1974 Page Four its way. Once again, we urge that those who have such information forward it to the Food and Drug Administration (to either Mr. G. McCowin, Assistant to the Director of Food and Color Additives, or to the Hearing Clerk). In the alternative, those who wish can send the information to us and we will con tinue to forward it for them. With respect to medical uses of PVC, we have received no direct information but we understand information regarding monomer content of medical tubing and sheet material is being gathered and that some may already have been presented to the Food and Drug Administration. In this area, too, interested parties are again urged to submit whatever informa tion they may have. We shall continue to try to keep in as close touch with the various aspects of these problems as we can and will continue to report them by means of this weekly letter. Naturally, if any fast-breaking matter should arise, we will notify you sooner; but in any event, we shall certainly be in touch with you next week. Enclosures ASX-PR 0003336  *- -'-------- . ~ .'?A16 " MondayJlay 20, mt THE WASHINGTON POST Vinyl Chloride Cinkotl to Cancer T- .'"**. _ --*?v,, ^' Hazar< A ipt 0/ ,*.-'u.b-r ' j J! By Morton Mintz ers of -rats breathing vinyl' Maltoni observed that tumors May 10. Ho disclosed that in j WtihtalWn Post SU(f Writer chloride in a ratio of 259 parts were continuing to occur in rats he had found one liver an-; f For atleast a year, chemical firms in thc'UnitecI States and pc-r million (ppm). That was in August,,1972. At Europe -withheld significant that time,- the permissible scientific . findings linking level for workers allowed by. rats at 250 ppm, the trade magazine says. The first public disclosure of his findings came on Feb. iosarcoma at only 50 ppm, [? along with other types of tu-|! mors. i; liver cancer to gas used to make .one of the commonest the Occupational Health- and Safety Administration (OSHA) 15, ter 1974. This was 24-days af For some nine months, aj: B.F, Goodrich Co. an House-Senate conference com-! . plastics, the American Chemi- was 500 ppm, or twice as nounced that since 1971 three mittee has had a bill before it j cal Society's weekly news much. workers at its polyvinyl plant that would require manufac-1 _ magazine reports today. - In January, 1973, five in Louisville had died of an turers to test new chemicals i Fo -- The gas is vinyl chloride, months after Maltoni found giosarcoma of the liver. under rules laid down by the;!'-.- ' used to make the plastic poly vinyl chloride. The trade association of the ' ' American chemical industry, the .Manufacturing Chemists Association, joined in holding - the findings in'-confidence, Chemical and Engineering . News reports in its May 20 is- : sue. The' Italian scientist who , made the findings said that al , though preliminary, they were "predictive" of the fatal can. cers recently recognized in several workers employed in converting the gas into polyvi nyl Chloride. The scientist is Prof. Ccsare Maltoni, director of the Insti tute di Oncologia in Bologna. , In a study initiated in Septem ber, 1S71, by one of the Euro pean firms, Montedison, he discovered a rare form of can- - cor, angiosarcoma, in the liv the first rat angiosarcoma, a team of three U.S. chemical industry scientists visited him in Bologna to learn about-his work. The visit was preceded by months of negotiations with the European firms in addi tion to Motedison that had joined in sponsoring his studies: Imperial Chemical In dustries, Solvay and Rhone Progjl. But "U.S. chemical industry sources say they were bound by an agreement under which Uhe] four European firms con trolled any release of animal test data obtained by Prof. Maltoni," Chemical and Engi Since then, tne total of con firmed victims of angiosar coma at the Goodrich facility and at other polyvinyl chlo ride plants in the United States has increased to 13 and in other countries to six. Two of the American workers sur vive. All of the others have died. On April 5, OSHA an- n .unced an emergency rule drastically lowering the per missible concentration of vinyl chloride from 500 ppm to 50 ppm. Workers engaged in manufacturing vinyl chloride and polyvinyl chloride number 6,500 in the United States and neering News says. It did not 26-000 elsewhere. name any of the American Even the 50 ppm level may firms. A key second experiment at be hazardous, Maltoni meeting of the New told a York levels of 200, 150-, and 100 Ppm Academy of Sciences and the began about July 8, 1973, when (American Cancer Society on Environomental Protection; a Agency (EPA). |!' The stalled legislation is the j F* proposed toxic substances con-!' troll bill. Senate conferees; have been waiting for Rep. i Harley O. Staggers (D-W. Va.), j chairman of the House confer-' ees, to announce his readiness j to meet, Senate sources say. j -- The House bill would re-jf. quire pre-production testing of,:'-"- only those new chemicals that 111 are listed as potentially dan-,* gerous, with results to be re- j ported to the EPA 90 days be-1 fore production is to begin. | The stronger Senate version j would require- in addition that 11 companies notify the agency! of all new chemicals consul-j cred for production, so that < the EPA could order testing of j chemicals that are not on the]' list but that may be suspect :: 1 ' * * * ' * '' '' il . n* ' ' *.*''* 4 ' P . 1 ` ' ' ' "` ** `` * 1 ' r-` ASI-PR 0003337 #< -X Withholding of vinyl chloride data hinted Foam Is Wo Problem Fight foam with this Hodag combination-- a complete line of antifoam products and the technical knowledge to apply them effectively, Superior Products FDA-approved and industrial antifoams developed over many years to meet the - toughest foaming conditions. Technology Special knowledge of surface activity helps many industries abate unique processing foams. Technical Facilities Equipped and staffed to develop just the antifoam you need. Let us help solve your foaming problems. Use this coupon to get the Hodag combination of products and technical service. Please send me information on Hodag antifoam agents for Please send sample for this purpose. Please have representative contact me. Firm ntmi Address ASX-PR^ ovunum3-3ts3A$ - City State Zip Nam* Title HODAG CHEMICAL CORPORATION 7247 N. Central Park Avenue Skokie, Illinois 60076 c European and U.S. chemical firms, to gether with the Manufacturing Chem ists Association, a U.S. trade group, held in confidence for at least a year preliminary, albeit significant, scientif ic findings on vinyl chloride as an agent causing liver cancer in rats, C&EN learned early last week. U.S. chemical industry sources say they were bound by an agreement under which four European firms controlled any release of animal test data ob tained by Prof. Cesare Maltoni, direc tor, Istituto Di Oncologia, Bologna, Italy. The first public disclosure of Prof. Maltoni's findings came on Feb. 15, 1974, in the U.S. The disclosure came after B. F. Goodrich's announcement on Jan. 22, 1974, of three deaths due to angiosarcoma of the liver since 1971, among workers at its polyvinyl chloride plant in Louisville, Ky. Subsequently, the number of confirmed cases of an giosarcoma at the BFG plant, at other U.S. PVC plants, and at plants abroad has risen steadily to a total of 19, in cluding 13 U.S. cases. 17 of the workers have died of the liver cancer; two U.S, workers are still living. The U.S. deaths date back to 1961. Prof. Maltoni's animal data have been a key to much of the regulatory actions taken by the Occupational Safety and Health Administration. In February, the lowest dose level of vinyl chloride in the Italian scientist's study at which liver angiosarcoma developed was 250 p.p.m. Guided, in part, by these findings, OSHA on April 5 set an emergency rule that lowered the per missible OSHA worker exposure level to 50 p.p.m. from the previous ceiling of 500 p.p.m. Since then, additional animal data have appeared. At a May 10-11 meet ing of the New York Academy of Sci ences and American Cancer Society, Prof. Maltoni disclosed that he had found one liver angiosarcoma in his rats at 50 p.p.m., together with several other types of tumors. At higher levels of exposure there were more tumors of various types, including liver angiosar comas, as he reported earlier (C&EN, Feb. 25, page 16). On April 16, MCA announced that preliminary findings on mice in its own study under way at Industrial Bio-Test Laboratories tended to confirm the Maltoni data then available publicly. And as presented by MCA before the May 10-11 meeting, the data show that under conditions of exposure of seven hours per day, five days per week, for eight months, liver angiosarcomas de velop as follows: 2500 p.p.m., 23 liver angiosarcomas; 200 p.p.m., 11; and 50 p.p.m., two. MCA's study also showed other types of tumors. Tests also have just begun at dose levels of 25, 10, and 5 p.p.m. " :> i'. ................ . it- :, wealth of new medical findings now appearing on vinyl chloride exposure, partly through the May 10-11 meeting. MCA's epidemiological study on 7123 vinyl chloride workers, for example, finds that cancers of the liver (primari ly angiosarcoma), respiratory system, brain, and cancers of unknown primary site, as well as lymphosarcoma, "oc curred more often than expected in those members of the study population with the greatest exposure," with the caveat added that although these ex cesses "were not statistically signifi cant, the findings warrant further study." And a major bias in the study is the "discovery"--too late t0 include it--of 1500 to 2000 workers with the longest exposures, up to 35 years. In August 1972 Dr. Maltoni found his first angiosarcoma in the first of a series of studies that, according to data available to C&EN, began about Sept. 5, 1971. A key, second experiment at levels of 200, 150, and 100 p.p.m. began about July 8, 1973, when it was observed that the 250-p.p.m. level "was still showing oncogenic effects." In January 1973 a team of three U.S. chemical industry scientists visited Prof. Maltoni in Bologna to learn of his results and to see his slides. Some months of negotiations with the Euro pean company group preceded this vis't. The group is made up of Monted ison, which first apprr .ched Prof. Mal toni to do the study, imperial Chemi cal Industries, Solvay, and RhoneProgil. All four were supporting the work at the time of the visit, U.S. sources say. Subsequently, the liver angiosarco mas in four U.S. deaths of workers have been judged by OSHA to be "his tologically indistinguishable" from the angiosarcoma tumors Prof. Maltoni has found. And he believes that his experi ments were "predictive" of what was subsequently recognized in man. Much remains to be answered in the way the release of the Maltoni data has been handled. There are allegations, unfounded from ail that C&EN can learn, that word of early results was passed to U.S. and Italian government officials. A major question mark con cerns what was said by MCA to the National Institute for Occupational Safety and Health in July 1973 and earlier. As the trade association testi fied before OSHA on Feb. 15, 1974, "MCA's first direct contact with NIOSH specifically on vinyl chloride led to a conference between an industry delegation, including a European representative, and Dr. Marcus Key (NIOSH director] and staff on July 17. 1973, at which time the MCA program was presented in some detail, and study protocols, industry statistics, and selected items front the scientific liter ature were provided," MCA has shed .... i .a,. , ,, -I,,. .., .... . FW5! EFA QUESTIONS FOR SPI (SOCIETY OF PLASTICS INDUSTRY) line or top 55-153 pro leers by sales volume `list of top 50-100 PVC products by valued of plastic in product amounts of unreacted monomer in above products list of PVC compounding plants by name, location, p employees, polymer used, products line, quantities produced ^ 5. list of PVC fabrication plants^by name, location, P empolyees, polymer used, fabrication methods utilized, quantities produced 6.- levels of VCM in plants in 4. and 5. by plant area and detection method utilized l1 7. levels of VCM beyond the plants and detection method (s) used 8. -levels of VCM in water effluents 9. 'decomposition products from various incineration conditions for PVC and quantities of PVC involved ." *f - - .10 amounts of VC leaching out of landfills and total amount PVC buried to date .11 toxicity of PVC resin and products .12 epidemiology studies of workers 13. population within square mile of plants 14. substitutes for VC and PVC 15. Future PVC markets New products New workers for old products 16. Additives used in PVC products \' ASI-PR 0003339