Document n9VLvwJeqNVMqOBKyge70m151

O' . I .? o\-vo\pVC-Tr cz JOSEPH E. SEILER JEROME E.HECXMAK CEASLES M.XEEHAK WILLIAM H.BOROBESANI.JR. ROBERT R.TIERNAN WAYXE V. BUCK DAVID L. RILL MARTIN W. BERCOV1CI JOHN S. ELDRED JOSEPH E. HADLEY, JR. CAROLE C. HARRIS MICHAEL T.MORRONE LARRY S. SOLOMON JOHN B.DCBSCS CHRISTINE A. MEAGHER SHIRLEY S. rUJXMOTO LAWRENCE P. IfALENIN DEBORAH SHOR THINKER C, DOUGLAS JARRETT EDWARD L.KORWEX law offices ^'.Keller alkd Hecemak USO ITT STREET. N. W. SUITE IOOO WASHINOTOK. D. C. 20036 April 24, 1980 TELEPHONE 202 457-UOO CABLE ADDRESS-KELKAM*' WRITER'S DIRECT DIAL NUMBER (202) 457-1116 To: SPI-PVC Safety Group SPI-PVC Safety Group Health Committee SPI-PVC Manufacturing Technology Committee SPI-PVC Communications Committee SPI-PVC Lawyers' Subcommittee He: SPI-PVC Safety Group - OSHA: Request for Information and Symposium Ladies and Gentlemen: The purpose of this letter is to bring you as com pletely up-to-date as possible concerning the Group's anti cipated response to the above-referenced Request for Infor' roation and the Symposium recently held at the National In stitutes of Health. In summary, the Steering Committee has directed the Health Committee to prepare a response to the Request for Information which/ in essence, addresses the in formation presented at the Symposium and other information related to the subject matters discussed at the time. As to the details, you are all hopefully aware from our previous correspondence that a Conference to Reevaluate the Toxicity of Vinyl Chloride, Polyvinyl Chloride and Struc tural Analogs was held on March 20-21, 1980 at the National Institutes of Health. The Symposium- was jointly sponsored by the National Institutes of Environmental Health Sciences, the National Institute for Occupational Safety and Health and the Occupational Safety and Health Administration. We are enclosing for your information a copy of the program for that Symposium as well as a list of the 196 persons in see 1-1235 April 24, 1980 Page Two v, Keixer jlsd Heckman attendance. As to the Symposium itself, a copy of the transcript has been sent to each of the members of the PVC Safety Group. Subsequent to that time, we have obtained photographs of most of the slides given in the presentations at the Symposium and have integrated the same into the transcript of the proceed ings. Copies of the transcripts supplemented with the slides will soon be available to industry members. While advising you about the transcript it should be noted that the Agency has given each of the persons who pre sented materials at the Symposium 60 days to supply it with a final paper. OSHA's intent is to amass these papers, com bined with "...selected portions of the discussion," for pub lication in Environmental Health Perspectives, an NIH publi cation. Our information is that these materials will appear in a Fall issue of this publication. For what it is worth, the consensus of opinion seems to be that the papers appear ing in Environmental Health Perspective may vary somewhat from the presentations given in Bethesda. As to the substance of that which transpired during this conference, we are enclosing the following materials for your review: 1) a ietter to the undersigned from W. Clark Cooper, M.D., a consultant to SPI in the field of the epidemiology applicable to vinyl chloride exposure; 2) a summary report that was very kindly supplied to us by Dr. John Stafford of XCI, Ltd.; and 3) a few press items which reflect the dirth of press coverage and interest in the pro ceedings. In addition to the press materials on the Confer ence, we are also supplying you with some clippings, also sent to us by Dr. Stafford, which reflect a resurgence of interest in PVC-related illnesses in the United Kingdom. Finally, we are also sending to you a very rough first draft of materials that are being assembled into a response to the OSHA Request for Information. While the enclosed materials do not contain any of the referenced at tachments, it is envisioned that the final materials will include those attachments, a complete copy of the transcript of the proceedings with the slides, all for submission by the May 9, 1980 deadline. Notwithstanding the foregoing,, because of the time constraints involved certain portions, especially the detailed review of the existing epidemiology which Dr. Cooper has been asked to prepare, may well be sub- SCC 1-1236 April 24, 1980 page Three KeIXER EscHatAiT iuitted after the May 9 deadline. For those of you who may be interested in supplying additional information comments or otherwise being of assis tance in preparing the materials for submission to OSEA, the PVC Safety Group Health Committee has meetings now scheduled for May 1 and May 8 and 9 to complete the preparation of the Comments. As always, any assistance that anyone may wish to provide would be welcomed. In addition, should anyone who is not currently working with the Health Committee group which prepared this draft of the Comments wish to attend either of those meetings, we would appreciate it if you would contact either John Lawrence at SPI or us so that we' can pro vide you with the meeting details. / As always, once you have had the opportunity to re view the materials being supplied to you, should you have any questions, comments or suggestions or need any further information concerning any of the items discussed, please do not hesitate to let us know. Cordially yours. /* Josepn Ji. aaaj.ey, >or. Enclosures U ' cc: Dr. John Stafford Mr. John-Claude Thomas Mr. Ed Group Dr. Harry Landfield Joel A. Ackerman, Esquire Mr. Ronald Evason Dr. Joseph T. Seawell v. DRAFT #1 [May 9, 1980] " Docket Officer Docket H-034 Room S6212 U.S. Department of Labor 200 Constitution Avenue, N. W. Washington, D. C. 20210 Re: Docket H-034, Occupational Safety and Health Administration Request for Infor mation on Vinyl Chloride and Polyvinyl Chloride - 44 Fed. Reg. 74928, December 18, 1979; 45 Fed. Reg. 668, January 29, 1980 Dear Sir: Pursuant to Section 4 of the Administrative Proce dure Act, as amended, 5 U.S.C. Section 553(c), and the above- referenced U.S. Department of Labor - Occupational Safety and Health Administration (OSHA) Request for Information on Vinyl Chloride and Polyvinyl Chloride and the subsequent Notice extending the time during which interested persons are invited to submit written data, views, and comments with regard to the issues described in the original Notice, The Society of the Plastics Industry, Inc. (hereinafter referred to as "SPI" and/or "The Society"), by its attorneys, hereby submits in quadruplicate certain information which is in tended to be responsive to the Agency's Request. see 1'i23S I. V. INTRODUCTION AND SUMMARY OF INFORMATION PRESENTED SPI is a corporation organized under the Not-forProfit Corporation law of the State of New York. Its 1500 member companies and individuals and 67 operating units in clude those who supply raw materials; process or manufacture plastics or plastics products? engineer or construct molds or similar accessory equipment for the plastics industry? and engage in the manufacture of machinery used to make plas tics products and materials of all types. SPI is the major national trade association of the plastics industry. The majority of its members are the processors and converters of the plastics resins and end products which represent 75% of the dollar volume of sales of plastics in this country; SPI's membership also represents 95% of all plastics materials and machinery manufactured in the U.S.A. The Society's concern with vinyl chloride and poly vinyl chloride begins with the manufacture of the ethylene dichloride vused to manufacture the monomer)^'the manufacture of vinyl chloride monomer (VCM), carries forth through its polymerization into polyvinyl chloride (PVC), continues with the various processes which convert the PVC resin into its multitude of end uses, and- includes, ultimately, the recycling or disposal of PVC products. In the United States there 2 see 1-1239 are 17 ethylene bichloride plants, .13 plants which produce vinyl chloride monomer and 42 polymerization plants. Twentytwo companies representing over 95% of the domestic VCM and PVC capacity are active members of SPI's PVC Safety Group. [This space reserved for a summary of the information which follows.] see 3 W240 II. SPECIFIC INDUSTRY RESPONSES TO INFORMATION REQUESTED (1) Experimental Test Results for Carcinogenicity of vinyl Chloride At Atmospheric Exposures Less Than 50 ppm OSHA is .aware of the studies on vinyl chloride sponsored by Imperial Chemicals Incorporated, Solvay et Cie, Montedison and Rbone-Poulenc Industries in Dr. Maltoni's laboratory in Bologna^Study. These data were reported in detail at a recent QSHA/N10SH/NIEHS supported symposium, March 20 and 21 in Bethesda, Maryland. An unedited stenographic transcript and photographic copies of the slides are attached (la). In these studies in which rats, mice and/or hamsters have been exposed to concentrations ranging from 30,000 ppm to 1 ppm. Dr. Maltoni's group has clearly shown an increase in tumors at concentrations of 10 ppm and higher. The attached suircr-ary state ment (lb) by the European sponsors quotes Dr. Maltoni and indicates that extensive statistical evaluationsof Dr. Maltoni's data ha^sbeen completed. These will be published as part of the proceedings of Club de Cancerogenese Chemique held at the Curie Foundation in Paris, France, November 10, 1979. These proceeding^/hich will be supplied to OSHA as soon as available, will contain an even more complete report of Maltoni's studies. la. Maltoni's Bethesda Talk and Slides (pages 4-50). lb. European Statement 26 February 1980. 4 see ^V In regard to the response of laboratory animals to vinyl chloride gas, the attached paper by Gehring, Watanabe and Park is extremely pertinent (1c). This paper indicates the necessity of considering the rate of metabolism and body size of different species when comparing response of different species to vinyl chloride. Attach ment (Id) is a revision of this paper to include the latest and final data fromMaltoni as cited in (la). These recalculations support even'more strongly than previously, the need to consider these factors in interpreting animal data. Differences such as those considered by Gehring, Watanabe and Park, no doubt are involved in the wide difference in the high incidence of angiosarcoma in small rodents and the much lower incidence in man. As observed by Dr. David Rail, Director of NIEHS, a wide difference exists between man and rodents (le; If). He stated that in regard to angiosarcoma the available data"predicted a cancer incidence rate 500 times higher than has so far been reported in man by epidemiological studies for vinyl chloride" (le). We know of no other animal studies at concentrations below 50 ppm. 1c. Gehring, Watanabe, Park paper. I'd. Colin Park's Recalculation for above paper (to be prepared). le. Rail's April 1977 ACS Science Writers Paper. lf. Rail's November 30, 1977 IARC Paper. see 5 1-1242 (2) Studies of Transplacental Carcinogenic and Teratogenic Effects in Humans or Animals at Any Level of Exposure to Vinyl Chloride A. Teratogenic Effects The landmark study of the teratogenic potential of VCM remains that of ^SPOrJSOflj:b L t. /C-A a*--*? J John^t^a i;^tT7st` reported i n part at the l^th Annual Meeting of the Society of Toxicology in 1975- John and her co-workers subsequently published a detailed report of the work--^, and again reiterated the findings at this most recent symposium. The authors1 published summary of this important study is as follows: "--Groups of pregnant CR-1 mice, Sprague-Dawley rats, and New Zealand white rabbits were exposed to 500 ppm of vinyl chloride 7 hr. daily during the period of major organ1ogenesis. Subsequently, other groups of mice were similarly exposed to 50 ppm of vinyl chloride and rats and rabbits were exposed to 2500 ppm of vinyl chloride. While maternal toxicity was observed, vinyl i chloride alone did not cause significant embryonal or fetal toxicity and was not teratogenic in any of the species at the concentrations tested. Maternal toxicity was more prominent among mice than among rats and _L/john, J. A., Smithy ,F. A,, Leong, B. K. J. and Schweiz, B..A. The Effects of Maternally Inhaled Vinyl Chloride on Embryonal fetal Development in Mice, Rats and Rabbits. Toxicol. Appl. Pharmacol. 39j^97"5!3 (1977)- and see 6 *"1243 rabbi ts. *' r -v._ Simultaneous exposure of some of ihe pregnant animals to vinyl chloride by inha1 ation pi us 15 percent Cthonol in the drinking water resulted in toxic effects greater than those associated with exposure to vinyl chloride alone in the three species. The maternal toxicity was enhanced to an extent greater than the embryotoxicity t C- .^=22==^) . It should be emphasized that to our knowledge the conclusions Reached by John et al with regard to the teratogenic potential of VCM have not been seriously questioned. (Comment with regard to the presentation of Hatch to be added, if appropriate). Dr. John, in her presentation at the symposium,discussed briefly the results of two additional studies on the teratogenic potential of VCh which have appeared in the recent literature. The first was a report of work carried out in Hungary, the findings of which were not incon sistent with those reported by John et al. The second report, origin ating with the Institute of Hygiene and Occupational Health in Bulgaria, was available only in abstract form. Although sufficient detail was not presented in the abstract to permit a critical evaluation of the study, the reported results indicate a teratogenic response to much lower levels of VCM than would have been expected on the basis of the work of the John group. A complete assessment of this Bulgarian study would, therefore, seem essential. SCC 7 1-1244 Dr. John also mentioned the symposium presentation of Hehir-- . As far as can be recalled from Dr. Hehir's talk, as well as what can be gleaned from a prcpub 1 icai ion copy of the CPSC report^, the study did not address teratogenesis. All Fq animals were exposed, before mating. Thus, although dominant lethal effects, i.e., genetic changes in the germ cells, could be manifest in the offspring, true teratogenic events could not be revealed. It should be noted, however, that the Fq exposure did not result in any alterations in the various parameters monitored in the-fj, F2, and generations. In summary, the most completely documented study of the teratogenic potential of VCM, --vi-r. / The study of John et a--l > reveals that under the con- * / ditions of the study,inhalation of VCM by pregnant rats, mice or rabbits was not embryo or fetotoxic, nor was it teratogenic even at concentrations sufficient to cause maternal toxicity. An additional published report basically confirms the latter conclusions, while results available only in abstract form from the Bulgarian literature suggest a teratogenic effect for VCM at relatively low levels. The significance of this latter information must await evaluation of the full report. -- riehir, R. M., B1erbower, G,, Wi 11igan, D. A. , Ko1aja, G., Mar rs , G. Hinton, D. E., Dimmick, R. L. and Wiles, J. S. Toxicology, Carcinogenicity and Reproductive Effects of Single and Multiple Exposures to, V*nyT Chloride in Rats and Mice. .CPSC Prcpublicat ion Release, April 1, 1959- E ^Hehi r , R. Cancer Induction Following Single and Multiple Exposures to a Constant Amount of Vinyl Chloride Monomer. Symposium Paper No. 5 (1980). SCC 8 1-124 5 V- Further, it should be noted that the maximum do>e levels tested in the study of John et al,--2500 ppm in rats and rabbits and 500 ppm in mice-provide ample reserve for safety extrapolation from these three test species to the human situation. Finally, to our knowledge there are no reports which clearly relate birth defects in humans to maternal, or. for that matter, paternal,^-'exposure to VCM, although a few more-or-less relevant studies have been published--hf --5/ . However, these latter reports do not indicate a relationship, between population exposure to VCM in the area surrounding PVC formulating plants to birth defects. Infante et_have suggested a causal relationship between paternal exposure to VCM in the industrial setting and pregnancy outcome, although this situation would not represent a teratogenic study* (We find it interesting, although not surpris ing, that the information developed by Infante and his coworkers was not presented at the symposium, especially in view of the fact that two of the authors, Ors. Infante and Waxweller, were members of the Prograr. Planning ' Committee for the Symposium). The adequacy of the information developed --^Edmonds, L. 0., Anderson, C. E-. Flynt. J. W. Jr., and Heath, C. W. Jr. Congenital Central Nervous System Malformations, Kanawah County, West Virglnia. U.S. Public Health Service, CDC, Atlant, EPI-76-60-2 (1976). 5/cdmonds, L. D., Falk, H. and Nissim, J. E. Congenital Malformations and Vinyl Chloride. Lancet M_:1098 (1975) 6/tnfante, P., Wagoner, J.K. KcMichael, A. J. Waxwei)er, R. J. and Falk, H. Genetic Risks of Vinyl Chloride Lancet ii-.73^-35 (1976) SCC 9 1-1246 by Infante et al was almost immediately questioned-- . More recently, Haas and Schottenfie1d--8/ have leveled severe cr*it"tcisms at the Infante study, and the following is abstracted from their paper: "Analysis suggested that the number of fetal deaths per 100 conceptions was higher in the VCM-exposed group than in the comparison group. This difference was reported only for the period following vinyl chloride exposure. Adjust ments removing women who were chronic aborlers eliminated statistically significant differences. While the authors felt that these observations were likely to reflect a real difference in pregnancy outcome not attributable to either interviewer or patient recall bias, the conclu sions were based on indirect sources of Information and could not take into account the multiplicity of maternal factors known to affect pregnancy outcome. The study design precluded documenting in even the crudest manner the validity of pregnancy histories. Without such ad justments and validation, the inferences-- cannot be sustained and little light is shed on the possible asso ciation of abnormal pregnancy outcome with paternal occupational exposure to VCM," (Emphasis added). UPadd1e, G.M. Genetic Risks of Vinyl Chloride Lancet j_:l079 (197&) S/Raas, J. F. and SchottenfieId , 0. Risks to Offspring from Parental Occupational Exposures. J. Occup. hed. 2_1_:607-13 (*379) 10 see ^-1247 The latter should fairly well lay to rest the allegations of Infante et al. (The Downs .et al and McMahon reviews ofnfante's "expricnee" may also be included if necessary or appropriate). B-. Transplacental Carcinogenesis Although it has been reported that VCM can exert a carcinogenic effect transplacental the phenomenon has only been demonstrated in pregnant females exposed to high (1 ,000 or 6,000 ppmj concencrations of the material. Further, although there is no particular reason to doubt the findings of Prof. Maltoni It would be useful to Tpze^-l^^have a more detailed account of his work ban the simple summary tables made available to date. Rice-^, although not having actually studied vinyl chloride in his laboratory, reviewed the subject of ransplacenta l carcinogenesis. In discussing the above-mentioned work < f .maltoni, Rice refers to the important role of biotransformation of VC to the ultimate carcinogen, chlorooxirane. This metabolic trans ormation in the pregnant female. 9/rtal ton! , C. Vinyl Chloride Carcinogenicity: An Experimental Model for Care 5 nogenes i s Studies. In "Origins of Human Cancer. Book A: Incidence of Cancer In Hua;ans.M H. H. Hiatt, J. D. Watson and J. A. Winsten, Cold Spring Harbor, Cold Spring University, 1977- 10/Ma.l toni, C, . . .' Careinogenicity Bioassays of Vinyl Chloride Monomer: ' A M^del; of.Risk Assessment on Experimental Basis. Symposium Paper No. 1 (19^0). lj/Rice, J. TranspIacenta1 Carcinogenic Effects. Symposium Paper No. 27 (19S0) see 1-1248 11 X v i as we I 1 as similar transformation in the fetus and metabolic degradation in . > _ _ both the gravid female and the fetus, emphasis the complexity of trans placental carcinogenesis. (This section to be expanded, if time permits, to more specifically define the roles of activation, degradat ion, ' transplacental transfer of both the parent compound and the ultimate carcinogen, the extremely short Ti of chiorooxIrane, and if possible including the hypotheses ,, expressed by Ghering et al--12/ . A summary statement regarding the above and the data of Ha 1 toni will also be required). l^Gehring, P. J., Watanabe, P. G. and Park, C . N. Risk of Angiosarcoma in Workers Exposed to Vinyl From Rat Studies. Toxicol. Appl. Pharmacol. :15 "21 (1579). Chloride as Predicted SCC 12 1-1249 (3) Experimental Studies of Carcinogenicity and Other Toxic Manifestations For Any Level of Polyvinyl Chloride Exposure. These Effects Should Include, But Are Not Limited to. Mutagenicity, Teratogeni city. Embryo Toxicity, and Other Trans placental Effects As Well As Cytotoxic and Cytogenic Effects on Sperm Cells. To the Greatest Extent Possible, Complete Information Concerning the Industrial Source of the Polyvinyl Chloride, the Size and Characteristics of the Particles, and Exposure Levels or Concentrations of PVC and Residual VC Should Be Included for Each Study. There are very few experimental studies of which SPI is aware in which carcinogenicity or other toxic mani festations of polyvinyl chloride exposure were studied. Two of these reports were presented during the course of the Symposium, i,.e. , the papers by Groth and Wagner. The paper by Frongia, ^t. al., cited as referenced no. 3 in the December 18, 1975 Notice, also deals with experimental expo sure of test animals to polyvinyl chloride. In addition, SPI is aware of feeding studies conducted either with poly vinyl chloride resin, polyvinyl chloride copolymer resins, or low molecular weight fractions extracted from commercial PVC resins and/or copolymers. One of these reports, a.study conducted at Harvard University is attached. Other reports are in the files of the Food and Drug Adminisration (FDA) and efforts are being made to obtain copies. As soon as they have been released to us, copies will be sent to the Docket Officer. see 1-1250 13 With regard to the papers presented by both Groth and Wagner, the specific nature and particle sizes of the samples used are not completely clear.. It is possible that when written versions of their papers become available for study, these deficiencies will be eliminated. For the present, we will only note that fine particle dispersion resins were used. As noted by Wagner, these may contain surfactants or other suspending agents. Hence, their use may result in a misattribution of the observed results to the wrong causative agent. Nevertheless, taking the reports at face value, both studies appear to be consistent in demonstrating that exposure of experimental animals to respirable PVC dust results in the retention of dust particles in the lungs with the develop ment of microphage aggregates. It is interesting to note that these experimental exposures (at least in the work of Groth with monkeys) did not result in impairment of pulmonary function. Although both authors considered that the dust induced a pneumoconiosis in the exposed animals, their re ports did not indicate the presence of fibrotic tissue which is observed in pneumoconiosis resulting from exposure to other substances such as asbestos. The observations of Groth and Wagner appear to .be quite consistent with the experimental work and observations reported by Frongia and his co-workers. Thus, it appears that in the experimental animals studied, exposure to respirable SCC 14 1-1251 PVC dust particle's results in retention of such dust parti cles for long periods of time/ perhaps for the entire life time and the development of microphagic responses to these particles. A major deficiency in all these studies is the absence of a control using a "nuisance** dust. Thus, the observations made as a result of exposure to PVC dust may be a characteris tic response to all dusts, rather than a phenomenon attributed to PVC, per se. As to the ingestion studies undertaken for the pur pose of assuring the safety of PVC packaging materials, feed ing either the whole resin or the low molecular weight (extrac table) fractions showed no observed effects up to the maximum ^yjfuantities used, _i.e. in the range of 5%-10% of the animals' diets. In this connection, one other study might be mentioned, JL .e., that conducted by CIVO/TNO in Holland, a copy of which is attached. It is mentioned here only because a porous PVC powder was incorporated into the animals' diets as the vehicle to carry vinyl chloride monomer in a feeding study intended to measure the carcinogenic response of rats to vinyl chloride monomer. In that study, while it was not one directed at PVC, there was no effect attributed to this exposure to PVC. ' Summarizing, except for the feeding studies utili zing PVC and its copolymers, studies which showed no toxic see 15 1-1252 effects attributable to PVC, SPI is not aware of any experimental studies besides those cited above, dealing with the toxicity of PVC per se. 16 see 1-1253 (4) Epidemiologic Studies of Either Vinyl Chlbride or of Polyvinyl Chloride (i.e., cohort, cross-sectional, or case-controDo_________________________________ '1 Because of the importance of this area of information. The Society postponed prepar ing^commentjj Ojnti 1 the recent Conference to Reevaluate the Toxicity of Vinyl Chlor ide, Polyvinyl Chloride and Structural Analogs had been held. Prior to this Symposium it had been speculated that, perhaps, some new epidemiologic data or information might be presented concurrently with the industry-sponsored presentation of Dr. W. Clark Cooper. This, of course, did not happen. In fact, it is The Society's view that nothing new in this area was presented at all. However, because of the Agency's interest in the subject area, SPI concluded that a detailed review of the existing epidemiology would be in order and appropriate for filing with this OSHA Docket^response to the request for this information. Accordingly, The Society has contracted for a complete analysis of all the relevant epidemiologic data. Considering the magnitude of this project, it is ob vious that it will not be finished by the May 9, 1980 dead line associated with the Request but these materials will be submitted to the Agency when they have been completed. See 17 I~I254 (5) Case "Reports and Case Series of Brain, Lympiici-hematopoietic, Lung, and Liver Cancers By Facility and Relevant Demo graphic Variables, Such As Age, Sex, Race, Date of Diagnosis Date of Death, Date of First Exposure, and Length of Exposure For Either Vinyl Chloride or Polyvinyl Chloridea_________________________________ At present. The Society is unaware of any informa tion responsive to request $5 which is not already contained in the published literature* Jowever, since the papers pre pared by Dr. John Stafford of Imperial Chemical Industries, Ltd. were not considered appropriate for presentation at the above-referenced Symposium, it has occurred to SPI that the Agency might careAto have a copy of the most recent com pilation of data on the world-wide incidence of angiosarcoma of the liver. Dr. Stafford's tables, copies of which have already been supplied (and, indeed, have been supplied on an ongoing basis) to the Director of the National Institute for Occupational Safety and Health, are a complete compila tion of liver angiosarcoma deaths due to exposure to vinyl chloride monomer through January, 1980. For background in formation on how Dr. Stafford came to be interested in keep- | \ V Q/' ing a register of the ^angiosarcoma --the liicr' cases we would refer you to the attached correspondence between Dr. Stafford and Dr. Robfins of NIOSH. see 18 1-1255 (6) Mutagenicity Study Results of Vinyl Chloride or Polyvinyl Chloride As Measured By Analysis of Human Body Flu ids, e.g.. Direct Mutagenic Testing With Peripheral Blood-Lymphocytes, NonDisjunction In Humans With YFF Sperm Test And In Vivo Cytogenetics In this area, also. The Society is unaware of any information which appears outside of the published litera ture. Examples of the literature with which we are familiar are Maltoni's sputum cytology, the mutagenicity work carried out by Imperial Chemical Industries, Ltd. and Norsk'Hydro, the last of which we understand is in the preparation for follow up stage. (The Health Committee meeting notes indi cate that both the ICI and NH studies contain strong indi cators as to the reversibility of any mutagenic effects that might be associated with exposure to vinyl chloride...this should be amplified.) see 19 1-1256 (7) Body Burden Measurments of Vijnyl Chloride In Humans SPI is presently unaware of. any published informa tion or literature'in this area. (However, could we con sider referencing the work of Selikoff in this area concern ing fat retention of vinyl chloride - can we also say some thing to the effect that the concept of calculating body burden when the subject material is a gas is meaningless - notes indicate the presence of a paper on "accumulation** by Stewart and Baratta, what is this?) - 20 see 1-1257 (10) Types of Occupations, Job Classi fications, and Industries Where Where Exposure to Either VC or PVC At Any Level May Occur, and The Num bers of Employees Involved in Each Vinyl Chloride and Polyvinyl Chloride Exposure Situation, Separated By Sex Vand Raced ________ As to the types of occupations, jobs and industries presenting a potential for exposure to either vinyl chloride or polyvinyl chloride, SP1 is unaware of any change in these areas whatsoever since the time of the initial OSHA rule making on vinyl chloride. numbers of employees involved in each exposure situation, separated by sex and race, could only be reported on a plant-by-plant basis, com- pany-by-company. As the industry trade association, SPI neither has nor collects this type of data which, in many cases, is considered proprietary information. Accordingly, the Agency will have to rely on individual company responses to this request. see 21 1-1258 (11) Appropriate Engineering Controls, Work Practices, and Personal Pro tective Equipment Available to Re duce Levels of Exposure to VC or PVC Below the Current Standards Or To the Lowest Levels Feasible_______ The Society is informed that the individual company members of the PVC Safety Group are presently engaging in the use of appropriate engineering controls, work practices and personal protective equipment to reduce levels of expo sure to vinyl chloride and polyvinyl chloride to the current ly permitted limits. As to vinyl chloride, the current standard for con trolling occupational exposure to VCM is sufficiently strin gent that great difficulty has been encountered by industry in coming into compliance with the standard that is currently in effect. Based further on the fact that because of its stringency, not all work places are at all times in compli ance with the current standard, it is most logical to con clude that the availability of additional engineering con trols, work practices and/or personal protective equipment available to reduce levels of vinyl chloride exposure to an even greater degree are either beyond the technological expertise of the industry or beyond its financial capacity. Therefore, it would further seem that the current standard is the lowest level feasible and that techniques to reduce the current exposure levels are not known. SCC 1-1259 22 w y As to PVGv^.we know of no reason to control exposure to the polymer because polyvinyl chloride is not known to us to be any kind of health hazard. As to dust which may be associated with certain oper ations involving PVC production, these dusts are currently regulated by OSHA. The use of appropriate controls to comply with these regulations is viewed by industry as adequate to protect workers from any hazard which would be associated with exposure to the dust. This being the case, extensive investigation into appropriate engineering controlswork practices and personal protective equipment available to reduce the levels of expo sure to PVC dust further are not areas known to us to have been investigated in any great detail. Of course, should information concerning this area of interest to the Agency become available to us, consideration would be given to the appropriateness of supplying it to OSHA at that time. As a final comment it should be noted that inasmuch as PVC dust has not been shown to be a health hazard at levels below those to which it is currently controlled, we know of no purpose which would be served by speculating on methods to achieve the lowest feasible levels of exposure. see 23 1-1260 * III. OTHER INFORMATION WHICH INDUSTRY BELIEVES TO BE OF INTEREST TO OSHA (This section to contain materials on the following studies: CIVO, papers by Suzuki, Groth, Radike, Maltoni (sputum cytology), Tamboro, Arnaud, Fabricant, Beaumont and Hatch.) Suzuki, "Experimentally Induced Pulmonary Cancer" (pp 50-60) Report of study of Charles River mouse lung tissue following exposures to VCM at 2,500 and 6,000 ppm for 5 to 6 months, 5 hours per day, 5 days per week and a report of CDI male mice to VCM at 100 ppm, 10 ppm and 1 ppm for 4 weeks. In Charles River mice 26 of 27 showed pulmonary tumors. In CDI male mice, at 40 weeks, there were 5/9 pulmonary tumors at 100 ppm, 2/9 at 10 ppm and 1/9 at 1 ppm. In mice these are alveolar tumors in the alveolar epithelia cells, and the author concludes "that mouse lung is a sensitive organ for demonstrating the oncogenicity of vinyl chloride." He also points out that human lung cancers reported are of bronchogenic origin, so "the target pulmonary cells of vinyl chloride oncogenicity are different in human and mouse lung." He asserts that this finding is consistent with reports on polycyclic aromatic hydrocarbons, nitrogen mustards and chrome compounds. In question period it was pointed out that we may be seeing a different species response, and Suzuki stated that the target cells for vinyl' chloride in human and mice may not be the same. This presentation does not address the issues raised by OSHA's request for information, but may be used-by OSHA to strengthen the ideas of VCM's affecting the lungs of exposed persons. 24 see Groth, ''The Hovle\ of Aging on Cancer Induced by Vinyl Chloride Monomer" {pp 67-77) Report Of a Study of 473 male and 476 female Sprague-Dawley rats to a mean VCM concentration of 948 ppm for 7 hours per day, 5 days per week for a mean duration of 24.5 weeks. Rat ages were 6, 17, 32 and 52 weeks to determine if age at onset of exposure affected the exposed animal. Tne most frequently occurring tumor types in both sexes were liver angiosarcoma, pituitary adenomas and mammary tumors. The time of first diagnosis of angiosarcoma was shortest in the oldest age animals. Older rats are more susceptible to angiosarcoma than young adult rats, and female rats are more susceptible than male rats. Since Groth asked for studies designed to test the theory in humans, this report is simply another animal study which flags a need for concern. Radike, "Carcinogenic Effects of Exposure to Vinyl Chloride Monomer and Ethyl Alcohol on Rats: (pp 78-87) A report of a study of 320 Sprague-Dawley rats, two control groups and two exposed groups. One group of 80 rats had a normal diet and breathed filtered air. The second group of 80 rats had a 5% ethyl alcohol in water diet and breathed filtered air. The third group had a normal diet and was exposed to 600 ppm VCM. The fourth group had a 5% alcohol in water diet and was exposed to 600 ppm VCM. All had Purina Rat Chow as food. Exposure period was 4 hours per day, 5 cays per week for 1 year. Since some animals had more than one tumor, the rates were 82 malignant and 25 benign tumors in 80 rats exposed to VCM; 125 malignant and 26 begnign tumors in 80 rats exposed to VCM and ethanol; 91 malignant and 51 begnign tumors in 79 rats exposed only to ethanol; and 5 malignant and 11 begnign tumors in 80 rats in the control group. Of real interest is the high rate of tumors in the "alcohol only" group, a rate almost the same' as those rats exposed to vinyl chloride but no alcohol, 1.15 for alcohol only to 1.34 for VCM only, although sites are different. SCC 25 1-1262 V- Kaltoni, "Results of Sputum Cytology Among Workers Exposed to VD! and PVC" (pp 120-127) A report of a study of 6,780 Italian VCM/PVC workers, 4 swears per worker. Controls were from other industries. On classes 2 to 3, near 3, 3 and 4 findings were: 9.4 in plastics industry, 1.5 in plastic materials manufacture, 1.4 in pharmaceutical, 2.8 in metal workers, 0.9 in mining and milling, and 13.1 in chromium industry. In heavy smokers (20 cigarettes per day for as long as 55 plus years), 60,000 sputum smears showed a rate of 0.6. Tamburro, "Liver Screening Tests for VC Exposed Workers (pp 230-243) A report of about 1200 workers studied by a battery of tests at the University of Louisville since 1974. The report is essentially an evaluation of test procedures and has import only insofar as medical evaluations are concerned. Tests with high specificity, such as alkaline phosphatase, do not show as abnormal until advanced disease occurs. Grammaglutamyl transpepidase had the most positive predictive value, the highest sensitivity and the highest specificity. Indocyane Green (ICG) clearance, on the other hand, shows progressive changes and can be used to determine developing disease. - 26 SCC 1-126 IV. v- CONCLUSION (To be written.) SCC 27 1-1264 see " 1265 CONFERENCE to REEVALUATE the TOXICITY of.......VINYL CHLORIDE, POLYVINYL CHLORIDE and STRUCTURAL ANALOGUES . March 20 - 21.1980 NATIONAL INSTITUTES of HEALTH MASUR AUDITORIUM BUILDING 10 CLINICAL CENTER BETHESDA, MARYLAND >`K: v Cosponsors; i- National Institutes of Environmental Health Sclonces National Institute for Occupational Safety and Health Occupational Safety and Health Administration ' CONFERENCE TO REEVALUATE THE TOXICITY OF VINYL CHLORIDE, POLYVINYL CHLORiDE AND structural analogues t March 20-21,1980 i. National Institutes of Health '* ` 1 / Masqr Auditorium Bylldlng 10 ^ i1 ' Clinical Center Bethesda, Maryland ' ; 1 ? Cosponsor* National Institutes of Environmental Health Science* National Institute for Occupational Safety and Health Occupational Safety and Health Administration Thursday, March 20,1980 8:00 A.M. REGISTRATION 8:30 A.M. INTRODUCTORY REMARKS Dr. David Rail, NIEHS ^; SESSION 1 - CARCINOGENESIS BIOASSAYS OF VINYL CHLORIDE MONOMER Chairperson: Dr. Umberto Safflottl, NCt 8:45 A.M. 1. Carcinogenicity Bloassays of Vinyl Chloride Monomer: A Model of Risk Assessment on Experimental Basis Dr. Cesare Maltonl, Institute of Oncology . and Tumor Center, Bologna 9:45 A.M. 2. Experimentally Induced Pulmonary Cancer Dr. Y. Suzuki, Mt. Sinai Medical School 10:00 A.M. DIscusston ? 10:15 A.M. Break : 10:45 A.M. ' 3, The Role of Aging on Cancer Induced , , ..... ,* J -'by Vinyl Chloride Monomer' ' ' } Dr. David Groth,NiOSH ' 11:00 A.M. 4. Carcinogenic Effects of Exposure to Vinyl . . '. Chloride Monomer and Ethyl Alocohol on Rats. Dr. Martha Radlke, University of Cincinnati. 11:15A.M. 5. Cancer Induction Following Single and Multiple Exposures to a Constant Amount of Vinyl Chorlde Monomer Dr. Robert Hehlr, CPSC. . .. SESSION II 11:30 A.M. 11:45 A.M. TOXICOLOGY STUDIES OF POLYVINYL CHLORIDE Chairperson: Dr. Peter Infante, OSHA 6. Pneumoconiosis In Animals Exposed to Polyvinyl Chloride Dust Dr. David Groth.NIOSH. 7. Results of Carcinogenesis Bloassay of Polyvinyl Chloride Or. Chris Wegner, BMRC, Penarth, Wales see .--- i ' ' ' . i-------: " - "----------------H Thursday, March 20,1980 SESSION III - SPUTUM CYTOLOGY OF VINYL CHLORIDE WORKERS Chairperson; Dr, Peter Infante, OSHA 12:00 P.M. 8. Results of Sputum Cytology Among Workers Exposed to Vinyl Chloride Monomer and to Pofyvlnly Chloride Dr. Cesare Maltonl, Institute of Oncology end Tumor Center, Bologna 12:15P.M.r Discussion 12:30 P.M. LUNCH ' SESSION IV- MORTALITY STUDIES OF WORKERS EXPOSED.rTO ' VINYL CHLORIDE Chairperson: Dr. Philip Landrlgan, NIOSH . 2;00 P.M. 9. Multiple Site Risk Analysis of Vinyl Chloride Related Cancer In Workers -- Review Dr. Peter Infanta, OSHA 2; 15 P.M. ` 110. Cohort Mortality Study of Vinyl Chloride Workers . Or. H. Weber, Der Staatllche Gewerhoarzt Fed. Republic Germany 2:30 P.M. 11. Epidemiological Study of Vinyl Chloride Workers Dr. Clark Cooper, Consultant 2:45 P.M. 12. Power Considerations In Epidemiologic Studies of Vinyl Ch/orfde Workers Dr. Jay Beaumont, NIOSH ^JliOO-P.M.- DIscussiorT 3:15 P.M.' Break SESSION V3:45 P.M, LIVER AND BIOCHEMICAL CHANGES ASSOCIATED WITH VINYL CHLORIDE Chairperson: Dr. David Groth, NIOSH 13. Epldomlologlc Review of Hepatic Angiosarcoma In the United States Dr. Henry Falk, CDC Thursday, March 20, 1980 4:00 P.M. 4:15 P.M, 4:30 P.M. 14. United Kingdom Angiosarcoma Registry ^ Dr. Peter Baxter, CDC 15. Pathology of Vinyl Chloride Induced Liver Lesions Dr. Hans Popper, Mt. Sinai Medical School 16. Liver Screening Tests for Vinyl Chloride Exposed Workers Dr. Carlo Tamburro. University of Louisville SESSION VI - INDUSTRIALHYGIENE MEASUREMENTS OF POLYVINYL CHLORIDE OPERATIONS Chairperson: Mr, James Gideon,NIOSH 4:45 P.M. 17. Polyvlnly Chloride Processes and Products rs. . Dr. R. Nick Wheeler, Union Carbide 5:00 P.M. 18. Characterization of Polyvinyl Chloride Homopolymers, Copolymers and Additives Mr. Jay Jones, NIOSH 5:15 P.M. Discussion : Friday, March 21 , 1980 SESSION VII - MORBIDITY AND MORTALITY STUDIES OF WORKERS EXPOSED TO POLYVINYL CHLORIDE Chairperson: Dr..R. Greenberg, University of Louisville 8:30 A.M. 19. Mortality Among Polyvinyl Chloride Fabricators Dr. Leonard Ch1a2ze, Georgetown University 8:45 A.M. 20. Heart Disease In the Swedish Polyvinyl Chloride Fabricating Industry Dr. Gustavo Moline, Colombia 0:00 A.M, 21. An Epidemiological Study of Respiratory Disease In United Kingdom Workers Exposed to Polyvinyl Chloride Dust Dr, Anthony Seaton, University of Edinburg 9:15 A.M. 22. Pneumoconiosis Induced by Polyvinyl Chloride Dust Dr. A. Arnaud, Marseille, France see 1-1267- Frlday, March 21, 1980 9:30 A.M. 9:45 A.M. 10:00 A.M. 10:15 A.M. 10:30 A.M. 23. An Epidemiologic Study of Pneumoconiosis In the Italian Polyvinyl Chloride Industry Dr. Guiseppe Mastrangelo, Padova, Italy 24. A Case-Control Study of Lung Cancer Among Vinyl Chloride-Polyvinyl Chloride Workers Dr. Richard Waxwellor, NIOSH 25. Review of Pulmonary Effects of Polyvinyl Chloride Exposure Dr. Ruth Lllis, Mt. Sinai Medical School Discussion Break fA- - * SESSION VIII -- REPRODUCTIVE EFFECTS OF VINYL CHLORIDE ' Chairperson: Dr. James Wilson, University of Cincinnati 11:00 A.M. .26. Transplacental Teratogenic Effects of Vinyl Chloride In Experimental Animals Dr. Jackie John, Dow Midland 11:15 A.M. ; '27. Transplacental Carcinogenic Effects Dr. Jerry Rice, NCI 11:30 A.M. 11:45 A.M. 28. Mutagenic Effects of Vinyl Chloride .* Dr. JIM Fabrlcant, University of Texas, Galveston 29. Power Considerations In Studies of Reproductive Effects Associated with Vinyl Chloride and Some Structural Analogues Ms. Maureen Hatch, Columbia University 12:00 P.M. Discussion 12:30 P.M. LUNCH > SESSION IX -.EPNOVLIYRVOINNYMLECNHTLAOLREIXDPEOASNURDELTIVOERVINYL CHLORIDE ANGIOSARCOMA Chairperson: Dr. Pier Bertazzl, Institute of Occupational Health, Milan Friday, March 21,1980 2:00 P.M. *s 30. Fugitive Emissions of Vinyl Chloride-Polyvinyl Chloride Dr. Susan R. Wyatt, EPA 2:15 P.M. 31. Case-Control Study of Liver Angiosarcoma Among Residents In New York Dr.. Nicholas Vienna, N.Y.S. Department of Health SESSION X - CARCINOGENICITY OF SOME STRUCTURAL ANALOGUES OF VINYL CHLORIDE Chairperson: Dr. Kim Hooper, University of California, Berkeley 2:30 P.M. 32. Comparative Pathology of Vinyl Chloride and Vinyl Bromide Induced Liver Pathology In Animals Dr. William Busey, Experimental Pathology Laboratories 2:45 P.M. X 3:00 P.M. 33. Review of Experimental Carcinogenesis of Vinyl Chloride Related Compounds Dr! Ken Chu, NCI ' 34. Review of Epidemiologic Study Results of Vinyl Chloride Related Compounds Ms. Rosanne Apfeldorf, OSHA ' ' 3:15 P.M, Discussion ' 3:30 P.M. Break SESSION XI - RESEARCH NEEDS and PUBLC HEALTH . INTERVENTION . 'Chairperson! Dr, Anthony Robbins, NIOSH Panel Dlxusslori: ' 4:00 P.M. . 35, Dr Dele Haddls, Center for Policy Alternatives, MIT 4:15 P.M. 36. Mr. Steve Wodka.OCAW 4:30 P.M, 37. Dr. Maurice Johnson, B.F. Goodrich . .............. 4:45 P.M. 38. Dr. IrVlng Sellkoff, Mt. Slnal Medical School SCC 1-1268 Friday, March 21,1980 6:00 P.M. 39. Dr. Joseph Wagoner, EDF 5:15 P.M. Discussion Proceedings from the Conference will be published Program Phoning Committed Dr. Richard B. Everson NIEHS, Research Triangle Park, North Carolina Dr. Peter F. Infante OSHA, Washington, D.C. Dr. Philip J. Landrlgan NIOSH, Cincinnati, Ohio Dr. Raymond E. Shapiro ' ; NIEHS, Research Triangle Park, North Carolina Dr. Richard J. Waxweller NIOSH, Cincinnati, Ohio LIST OF ATTENDEES AT VC CONFERENCE including participants) Name i- Abramowitz, B.J. 2. Adams, W.G.F. 3. Adamson, Richard H. , Dr. 4. Alarik, Lang M. 5. Anand, Vir D. 6. Anderson, Larry D. 7. Apfeldorf, Rosanne 8. Arnaud, A., Dr. 9. Baier, E.J. 10. Ballou, L.H11. Barancik, J.I., Dr. 12. Barr, John T. 13. 'Baxter, Peter, Dr. 14. Baumslag, N. , Dr. 15. Beatty, Patrick 16. Beaumont, Jay 17. Bertazzi, Pier, Dr. 18. Bierbower, George W. , Dr. 19. Benya, Ted 20. Bell, Zeb G., Sc.D. 21. Berger, Jerry Affiliation Hooker Chemicals and Plastics I.C.I. Office of Science and Technology Policy N.I.H. Food and Drug Administration E.P.A. O.S.H.A. Clinique de Pneumo- phyisiologie, France Diamond Shamrock Corp. Firestone Case Western Reserve University Air Products C-D.C. H.E.W. Shell Development Co. N.I.O.S.H. Occupational Health Studies Group C-P-S.C. Ethyl Corporation P.P.G. Industries Shell Oil Company SCC 1-1269 Name v , 22. Berger, Paul 23. Bodamer, James W. 24. Breen, Catherine * 25. Brody, Judith 26. Bunn, William 27. Busey, William, Dr. 28. Carroll, William F. 29. Cassidy, John J. 30. Chen, C.T., Dr. 31. Chi, Ken 32. Chiazze, Leonard, Dr. 33. Chu, Ken 34. Cohen, Frances H. 35. Cooper, Clark, Dr. 36. Coppola., Joseph C. 37. Corcoran, Larry 38. Cosmides, George J. , Dr; 39. Cotten, O. Paul 40. Crisqrio, L.A. 41. Daigre, G.W. 42. Dedrick, R.L. 43. Diaz, Filadelfo T. 44. Dimmick, W. Fred Affiliation E-P.A. T.R.W. Environmental Engineering Co. Mannington Wills New York State Health Department Duke University Experimental Pathology Laboratories . Firestone Plastics Co. Firestone Company O.S.H.A. Reliance Insurance Co. Georgetown University N-C.I- Maryland Occupational Safety and Health Consultant Pantasote, Inc. E.D.F. N.I.H. Great American Cleaning Corp. Union Carbide Corp. Dow Chemical Company N.I.H. Firestone Tire and Rubber Co. E.P.A. SCC 1-1270 Name 45. Downs, Tom 46. Dunnigan, Paula C., Dr. 47. Ertel, J.E. 48. Everson, Richard 49. Falk, Henry, Dr. 50. Fabricant, Jill, Dr. 51. Farrar, Grover I*. 52. Fishbein, Leon, Dr. 53. Flake, Raymond E., M.D. 54. Flint, George S. 55.. Ford, Gary L* 56. Fountos, Barrett N. 57. France, Laureen 58. French, John E., Dr. 59. Froemming, Neil 6 0. Fukushi, Nobuo 61. Gabbett, James F. 62. Gaudette, Leo E., Dr. 63. Gideon, James 64. Goralski, Debra 65. Gherghel, Radii 66. Gottesman,'Roy T., Dr. 67. Gosztonyi, R.E., Fr.M.D. 68. Gough, Robert G. 69. Greenberg, Richard A., Dr. 70. Group, Edward D., Dr. i Af fillation / University of Texas B. F. Goodrich Co. Pantasote, Inc. N. I.E.H.S. C. D.C. University of Texas American Hoechst Corp. Borden Chemical Co. Dow Chemical Co. Tenneco Chemicals Stauffer Chemical Co. O. S.H.A. U.S. Brewer Association F.D.A. BNA Publications Nippon Zeon of America, Inc. ' Georgia Pacific T.O.M.A./P.A. N.I.O.S.H. Mobil Chemical Co. Allied Chemical Corp. Tenneco Chemical Co. Tenneco Chemical Co. Cincinnati Milicron 3 '^ University of Louisville Exxon Chemical Co. SCC i- 1*71 COA H in CO 00 Name 71. Groth, David, Dr.. 72. Hadley, Joseph E. 73. Hall, James J. 74. Hamilton, L. Leslie 75. Hardy, Helen T. 76. Haring, Marie 77. Harmison, Lowell T. , Dr. 78. Harper, Philip J. 79. Harris, Walter D. 80. Hatch, Maureen Hattis, Dale 82. Hegyeli, Andrew F. 83. Hehir, Robert M., Dr. Henry, Timothy, Dr. Hinderer, Robert K* 86. Hook, A.W. 87. Hooper, Kim 88. Hooper, Carl R. 89. Hunter, D.H. 90. Hurley, J. Fenton 91. Infante, Peter F., Dr. 92. John, Jaqueline A. 93. Johnson, Clifford A. 94. Johnson, Maurice Affiliation N.I.O.S.H. Keller and Heckman Conoco Chemical Co. HealthvIndustry Manufacturers Asso. Navy Environmental Health Center N.I.O.S.H. Public Health Service N.Y.S. Health Department Dniroyal, Inc. Columbia University M.I.T. N.C.X. C.P.S.C. F.D.A. B.F. Goodrich Co. Anaconda Aluminum University of California Gulf Science and Technology Co. Tenneco Chemical Co. Institute of Occupational Medicine, Edinburgh O.S.H.A. Dow Chemical Co. Goodyear Tire and Rubber Co. B.F. Goodrich Co. SCC 1-1272 Name 95. Jones, Jay 96. Jones, M. Bruce 97. Kennedy, Harriett 98.'Kilquor, Robert 99. Kokon, Jack 100. Kordalski, John S. 101. Knarr, Richard 102. Landrigan, Philip, Dr. 103. LaRose, George E. v. 104. Laundrie, Robert W. 105. Lawrence, John R. 106. Leineweber, J.P. 107. Lilis, Ruth 108. Lin, Chin, Dr. 109. ;tloyd, J. William, Dr. 110. Lynch, Jeremiah 111. Maltoni, Caesar, Dr. 112. Marcer, Guido 113. Marcus, William L. 114. Maroney, W.P. 115. Marrack, David 116. Mastrangelo, Guiseppe 117. McClendou, Janet S. 118. McElheny, Victor K. Affiliation N.I.O.S.H. Mannington Mills N.C.I. Armstrong Cork Co. I.C.X. Americas Veterans Administration Stauffer Chemical N. I.O.S.H. Whittaker, Corp. General Tire Society of Plastics Industry Johns-Manville Corp. Mt. Sinai School of Medicine F.D.A. O. S.H.A. Exxon Chemical Co. Instituto Di Oncologia, Bologna Instituto Di Medicina Del Cavordo E-F-A. Ball Corp. Fort Bend Medical Division University of Padova Jacob-Medinger Co. Cold Spring Harbor Labs. see i-1273 Name 119. MeGaughy, Robert E. 120. McNamara, B.P. 121. Mekarg, Toshio 122. Miller, Richard A. 123. Misra, Krishna P., Dr. 124. Molina, Gustavo 125. Montgomery, Kristie L. 126. Morris, linda E. 127. Mubeijie, Debdas, Dr. 128. Nelson, K.W. 129. Nesbitt, Jeffrey 130. Norris, J.M. 131. Olson, William A. 132. Oubre, Robert R. 133. Omenin, Gilbert S., Dr. 134. Palshaw, Mary W. 135. Park, Russell A. 136. Patterson, Alexander 137. Peggi David G. 13.8. Perk.owski, Regina F. 139. Popper, Hans, Dr- ' 140. Posner, Herbert S., Dr. 141. Potyondy, Istavn 142. Potyondy, Martha 143. Radike, Martha Affiliation E.P.A. U.S. Army Borden, Inc. PVC Belting Co. F.D.A. Servicio Secional Salud Medillian, Colombia General Motors Co. N.C.X. Environmental Control Co. ASARCO Anaconda Co. Dow Chemical Co. C.F.R. Servicio Dow Chemical Co. Executive- Office of the President Stauffer Chemical Co. Firestone Plastics Co. W.R. Grace and Co. General Motors Corp. General Food Corp. Mt- Sinai Medical School. N.I.E.H.S. Dow Chemical Co. Shintell, Inc. University of Cincinnati SCC 1-1274 Name , 144. Rail, David, Dr. 145. Ramsey, Michael D. 146. Rauts, Rebecca 147. Renzo, Mattuissi 148. Rhoads, Russell H. 149. Rice, Jerry, Dr. 150. Ringwood, Robert C. 151. Roggi, P.E. 152. Rosensing, William 153. Rosnick, Andrea 154. Rupp, William 155. Ryerson, David W. 156. Robbins, Anthony, Dr. 157. Saffiotti, Umberto, Dr. 158. .Saia, Bruno 159. Sauerhoff, M.W. 160. Sarokhan, Brenda 161. Scott, Kathryn 162. Seaton, Anthony, Dr. 163. Selikoff, Irving, Dr. 164. Shah, Hasmukh 165. Shapiro, Raymond, Dr. Affiliation N.I.E.H.S. Liberty Mutual Insurance Chemical and Engineering News Occupational Health of Montedison American Haescht Film N.C.I. M. & T. Chemicals, Inc. Stauffer Chemical Co. V.A.H. Hill and Knowlton Co. Tenneco Chemicals, Inc. I.C.I. Americas N.I.O.S.H. N.C.I. Institute of Occupational Health - Italy Stauffer Chemical Co. American Cancer Society Bureau of National Affairs Institute of Occupational Medicine - Edinburgh Mt*. Sinai School of- Medicine - Chemical Manufacturers Association N.I.E.H.S. see 1-1275  Name 166. Shepler, Thomas *y. i 167. Skalsky, Harry 168. Skory, Lyman 169. Soffiritti, Morando 170. Sorenson, W.R. 171. Stafford, John 172. Staura, J.F. 173. Sun, Hee-Sik 174. Suzuki, Y., Dr. 175. Swetonic, Matthew M. 176. Tamburro, Carlo H. 177. Tanaka, Hozumi 178. Tassignon 179. Thomas, Jean C. 180. Thomka, L.M. 181.'Torkelson, T.R. 182. Tsonges, Theordora A., Dr. 183. Westendorf, Bill 184. Wharton, F.D. 185. White, Faye 186. White,.George F., Jr. 187. Vainio,.Harri 188. Vianna, Nicholas, Dr. 189. Wagoner, Joseph K., Dr. Affiliation General Tire and Rubber --Reynolds Metals Co. Dow Chemical Co. N.I.E.H.S. Tenneco Chemicals, Inc. Imperial Chemical Industries, LTD. E.P.A. N.I.A.M.D.D. Mt. Sinai School of Medicine Hill and Knowlton, Inc. University of Louisville Kaneka America Corp. Solvay, Belgium Rhone Poulenc, France Dow Chemical Co. Dow Chemical Co. E.P.A. Monsanto Co. Continental Group, Inc. Government Research CorpReynolds Metals Co. Institute of Occupational Health, Finland N.Y. State Health Dept. E-D.F. see i~1276 Name 190. Wheeler, R.N. 191. White, Lowe 13 , D. 192. Yodeiken, Ralph 193. Young, Ronald 194. Zavon, Mitchell R. 195. Zimmerman, Jack E. 196. Zuk, Xrena Affiliation Union Carbide Corp. ASARCO, Inc. N. X.O.S.H. O. S.H.A. Hooker Chemical Co. Diamond Shamrock Co. Interdevelopment-, Inc sec i-l277