Document 5bJrj9RRoyXBJrmLejYY0DwX5

1 ENVIRONMENTAL PROTECTION ACFNCY In the Matter of: : PUBLIC I'HARING ON : VINYL CHLORIDE : S: .1 3 !l ....................................................................... 3| X February 3, 1976 Room 3305 401 M Street, S.E. Washington, D. C. 1 ! 11 I 12 i r .13 j 14 ! I 15 | l 15 !*I 17 | 1 13 j 19 | 20 i t i 21 I The above-described hearing convened, pursuant to notice, at 9:00 o'clock a.m. BEFORE: RTCKARE DENNEY, Chairman JACX FARMER 4 SUSAN WYATT DR, JOHN KMELSON rm, WILLIAM MARCUS TUI. ROBERT McGAUGHY DR. ARNOLD KUZMACK 22 23 2-1 | 23 n____ AP00028066 TABLE OF CONTENTS W- I1TN" ESi S: Robert Strelow, Barry I. Castleman, Environmental Defense Fund Ralph L. Ilarding, Jr,, Society of the Plastics Industry. P. J, Gehring, Dow Chemical Harry Connors, Diamond Shamrock Raymond Shenk, Air Products and I Chemicals, Inc. ... PAiGEi 3 9 58 87 123 132 1 i i i I t^aporiinrf C-amyany- AP00028067 > -\ PROCEEDINGS 1 CHAIRMAN DENNEY; . Will the meeting please-come 4 5 i 6 7 S 9! t 10 11' 12 13 to order? Good morning, 1 am Dick Denney of the Office of General Counsel of the Environmental Protection Agency. I would ^ike to welcome you on behalf of Russell Train . our Administrator and thank you for your interest in this proceeding. Robert Strelow who is the Assistant Administrator for the Office of Air and Waste Management Programs will make a statement to start the hearing off. MR. STRELOW: Good morning. I will be responsible for recommending to the Administrator the final standard 14 I 15 15 which EPA should promulgate to regulate vinyl chloride . emissions to the air. - .... X would like to welcome you to this hearing to consider whether vinyl chloride is a hazardous air pollutant, 16 and if so, what standard should be adopted to limit its 19 emissions. 20 Most of EPA1s efforts to prevent air pollution 21 have focused on pollutants that are very widespread in our 22 environment and for which there is a substantial amount of 23 information. Por such pollutants, national ambient air 24 quality standards have been established. The public issues 25 ein, S.frtof/jm* .............. r AP00028068 4 associated with these pollutants are well known. They include such matters as use of stack ga3 scrubbers by 1i t : i utilities, auto emission standards and transportation control plans. FPA also has the authority under the Clean Air J Act to directly regulate the emissions of hazardous air " pollutants that are less generally pervasive but which may threaten health in localized concentrations'around emission sources. Vinyl chloride is this type of pollutant. j t It is a relatively new pollutant, its dangers have only - ' - - .-v-riV" very recently become known.' . ` For those reasons EPA has less of a data base with respect to vinyl chloride titan for some of the more widespread pollutants. Our limited information on s .. ,.'u" vinyl chloride is a matter of concern to EPA.` ' '* EPA was faced with a choice of either not regulating emissions of vinyl chloride until further 'information could be gathered or regulating vinyl chloride *now on the basis of the limited information available to us. We believe that vinyl chloride should be regulated now. ve do know that vinyl chloride is a carcinogen that has caused disease and death to workers exposed to relatively high levels of this chemical. We do not' know ' " the extent to which the lower levels that are present in the general environment around production facilities AP00028069 constitute a danger to health. However, because vinyl chloride is a carcinogen;, any level of exposure probably ! J j carries some risk. Carcinogens are believed to have latency periods l t| as long a3 20 years from initial exposure to the occurrence of the disease. Polyvinyl chloride production has only 'recently been undertaken on a large scale. Only about ten of the approximately 40 polyvinyl chloride plants are : 20 years old or older, and the oldest one is 40 years old. The first report of the risks of vinyl chloride i j' i was in 1974. These factors are relevant to why there is limited information available on the- effects of .vinyl chloride. These factors are also relevant to why EPA % believes it should take action now. ' v. However, in view of the information presently T available, EPA does not believe that it is appropriate at this time to set such & stringent standard that it would effectively ban all production of vinyl chloride, vinyl chloride has many important uses -in our society. There - are no present substitutes for some of these uses. The emission limitation that EPA is proposing to promulgate for vinyl chloride should reduce ambient levels to well below those levels at which cancer has been observed to be induced in animals and well below those levels to which occupational workers who contracted cancer '.Jit,*' c,,.,, iiartu I AP00028070 'are believed to hava been exposed. * I believe that participation by both environ 1 mentalists and industry at this'hearing should provide useful information to assist us in evaluating the approach which we have proposed for this pollutant. Prior to making my recommendation to the Administrator concerning a final regulation for vinyl chloride, I will review the hearing record as veil as the written comments received in response to EPA*s proposed regulations. * Thank you. . CIIAIRMAN DENNEY; Thank you, Roger. This hearing is intended to provide opportunity % * for interested persons to state their views or arguments, i ! or to provide information as to, first, whether vinyl ? chloride when emitted to ambient air may cause or contribute to irreversible or incapacitating illness? If so, second, what standards should be adopted to regulate such emissions of such a pollutant? The Administrator is required, under Section 132 of the Clean Air Act to establish air ouality standards at the level,which in his judgement, provides a margin of safety to protect the public, unless on the basis of information presented at this hearing he finds such pollutant is not a hazardous air pollutant. pant* | j AP00028071 7 Accordinglv, participants in the hearinc are 3 ! Ii '! i 5 ii i si 7 S 9 ID 11 12 13 14 ' is 16 17 ' 13 19 20 21 22 23: 24 2-5 requested to identify specifically the portions of their presentations, if any, which are directed to the issue of whether the pollutant in cruestion, vinyl chloride, is or is not a hazardous pollutant an defined in Section 112(a)(1) of the Act. Thare will be, I believe, five parties presentingtestimony at these hearings. Following each statement, the panelists, the people you see here, may ask questions of the witnesses. . Any questions that other participants, in this hearinq may have for a witness should be submitted to me in writing, and I will request the panelists to ask the questions.* Should we, in. the questioning of any witness, request additional material^or answers in writing,, we request it be submitted to EPA not later than February 23rd of this year. Additionally, all witnesses will be permitted to submit post-hearing comments to EPA if they wish. The comment period does not close until Feburary 23rd on the EPA proposed regulation, so, of course, any member of the public may submit written comments up until February 23rd. This hearing is an informal hearing, technical tnf (Taatm* party AP00028072 -9 rules of evidence will not apply-. Any motions or requests for rulings or procedural points should he directed to me. j I ' The panelists in this hearing, starting on my loft are first, Jack Farmer and Susan Wyatt from the Office of Air and Waste Management. Dr. John Knelson from i the Office of Research and Development. Dr. william Marcus 7! from the Office of Toxic Substances. Dr. Robert McGaughy 3 from the office of Research and Development and Dr. Arnold Kuznack from the office of Planning and Management. 10 The order of the presentations at the hearing 11' today are first, and I would like to go through the list 12 before anybody comes up, First, I would like EDF, the Environmental Defense. Fund to testify. .. 15 Second, will be the Society for the Plastics Industry. 17 Third will be Dow Chemical. 18 Fourth will be Diamond Shamrock. 19 ? Fifth will be Air Products. 20 I would like to begin now with the witness from 21 the Environmental Defense Fund who I understand is to be 22 Parry Castleman. 23 ' Would you cone forward, Barry, and sit in the 24 middle chair of the witness table on my right. Incidentally, before Barry starts to testify. Coo, AP00028073 9 we have received from some of those testifying, copies of their presentation. T-?e would suggest that you talk to the people who are giving the testimony if you would likes, additional copies. You can, of course, ultimately get copies from EPA, but we will have to reproduce them, so, if you want any copies now please talk to the people who are giving the testimony. Barry, are yoti ready? MR. CAETLEMAN: Yea. STATEMENT OP BARRY I. CASTLEMAN, ENVIRONMENTAL DEFENSE FUND._____________________________________________________ MR. CASTLEMAN:. Good morning. I am Barry Castleman, aconsultant to the.Environmental Defense Fund. FDF is a nonprofit public interest organization with a membership of some 40,000 scientists, lawyers and . citizens nationwide. Since its inception in 1967, EOF has been actively involved in actions aimed at reducing the involuntary exposure of the public to carcinogenic pesticides DDT and aldrin/dieldrin, are examples of EDF successes in halting widespread exposure of the public .to carcinogenic chemicals* Before we get to vinyl chloride, I would, like to talk about tho level of exposure of cancer in general. Cancer has reached epidemic proportions in the ? r/f/i a ^**,1 r*t n v AP00028074 United states. '"Tie rate of increase appears wore rapid 1 jthan either the rate of increase of population, or the rat of increase in the total death rate. Today, one in every four Americans contracts cancer during his lifetime, and two-thirds of these die from the disease. In 1973, there were over 600,000 new cases of cancer, and approximately 350,000 deaths. Cancer is a leading cause of premature death in the United States The economic impact of cancer is massive. The direct and indirect coats of cancer, including loss of earnings during illness and during the balance of. normal life expectancy, have been estimated at a total of $15 billion for 1971. Although less certainty exists on the role of most environmental contaminants in human cancer, than say, cigarette smoking, drugs and occupational airborne particles, a recent Presidential panel concluded that: "Cancer incitements by so far unrecognized chemicals combine to form a threat to health that may well be of at least the same general ' size as the three major threats just described [i,,e., cigarette smoking, alcohol abuse, and choice of dietary composition). These chemicals may be natural or synthetic.* Although most of the evidence for the effect IQtp'irUnQ Co, ompantf AP00028075 11 of environmental carcinogens on man has come with industrial exposure to high levels of these earcinocma, most cancer 4 experts agree that the low levels of carcinogens to which * I j 1 the general population ia exposed are responsible for the majority of human cancers. ] Although others would argue that the levels of these chemicals in the'environment are too small to be of significance to the general population, the scientific evidence simply does not support this viewpoint. For example, the chemical aflatoxin is known to c&uso cancer in man, and in experiments on trout, it was shown to produce liver, tumors when present in feed in concentrations as low as 400 parts per trillion? even at this low.level, its carcinogenic effect was_ enhanced by addition of various non-carcinogenic oils to the diet. Similarly, dieldrin, a chlorninated hydrocarbon pesticide now banned by EPA, still used in Frazil and other countries# has been found to be carcinogenic in the lowest concentrations tested, 100 parts per billion. Therefore,' lacking scientific evidence that a threshold existed for any chemical careInogen,the Ad Hoc Committee on the Evaluation of Low Levels of Environmental Chemical Carcinogens reporting to'the Surgeon General in 1970 concluded that? - **No level of exposure to a chemical carcinogen AP00028076 12 should be considered toxicolooicallv insignificant * for nan." i \ ) ! This report, though five years old, was cited in the EPA report for the Vinyl Chloride Regulations. It is with a recognition of these facts that I would like to address the proposed standard for emission of vinyl chloride into air. First, it is necessary to retrace both the t development of medical 3:nowledgo and EPA regulations with [ < I respect to vinyl chloride in order to appreciate the problexrfs raised by vinyl chloride and to establish plans for reacting to the next vinyl chloride* V7a all recognize that vinyl chloride is one of hundred^ - of widely used chemicals that were never pre-tested on laboratory animals for chronic toxicity - prior to being introduced commercially. Due to the long latency period for the induction of cancer and the fact that chemically induced diseases have received inadequate study, it would be most fortuitous if vinyl chloride*s longterm health dangers were unique. In May of 1974, an international conference was convened by the New York Academy of Sciences to review the health hazards posed by exposure to vinyl'chloride.. h This followed by four 'facnths the first announcement that angiosarcoma of the liver, an "extremely rare and always 1 dL. &......../* AP00028077 i1 nutagonic effects were also associated with exposure to 2 vinyl chloride. In the suinmer of 1974, Dr. Peter Infant/ 3 who is currently with the National institute for Occupa 4 tional Safety and Health, observed an excess rate of serious i 5 birth defects in residents in Ohio counties with plants 6 emitting vinyl chloride. 7 The central nervous system birth defects noted S commonly result in death during infancy. A more recent Ct report from Norway, though including a small number of W cases, also linked these same types of birth defects to 11 neighborhood exposure to vinyl chloride, while neither 12 of the above reports is conclusive, taken together they i V.i support the hypothesis that vinyl chloride air pollution U can produce central nervous system birth defeats. 15 Mutagenicity, as.-distinct from teratogenicity, 4 .. . * . a* ^ 1G was indicated in studies by Dr. F. dc?'erresl-of the 17 National Institute of Environmental Health Sciences, on 18 the effects of vinyl chloride on salmonella - liver microsome 19 systems. 20 In addition. Dr. Irving Selikofff, of the 21 Mount'Sinai School of Medicine reported data suggesting a 22 higher than normal rate of stillbirths and miscarriages among wives of vinyl chloride workers and a high incidence 23 \ 24 of abnormal chromosomes among, the workers .themselves. I 25 This was when EPA was starting to take action for same. *m* /?i?t*+r!irui AP00028078 J.3 This was in 1974 By August of 1974, EPA had sampled the air-' J around a dozen vinyl chloride and polyvinyl chloride plantsJ Grab samples contained up to 33 parts per million of vinyl chloride and 24-hour samples ran as high as one fi part per million. Thus, the cumulative exposure of the neighbors of these plants to vinyl chloride were.comparable to the present workplace standard for a 40-hour week. Yet, in a letter of reply to Dr. Albert Fritsch, Director of the Center for Science in the Public Interest and myself, the Administrator of the EPA, Mr. Train; alluded to this monitoring data on vinyl chloride by saying: "Following an assessment of this preliminary data, it was determined that there was no scientific evidence to indicate that vinyl chloride emissions pose an imminent hazard to people living near these plants." I was amazed at this. Fifty parts per million in test animals and 35 parts per million outside the plant, and this is not construed to be a hazard. This purports to have scientific merits. Are there any scientists on the panel who would like to explain the scientific merit? Z would be interested in hearing that later on. Usually occupational exposure standards are at 1A, t a ^onxpfint' j AP00028079 15 100 tines as high as the concentrations allowed by environnontal standards. This is just for a general workplace. In September, 1974, Mr, Train presented EPA's vinyl chloride Task Force Report, saying that available control technology could reduce vinyl chloride emissions ! I | l I | from polyvinyl chloride plants by 75 percent and from vinyl chloride monomer plants by 90 percent. However, five months later, Don Goodwin, Director of Emission Standards and Engineering Division, EPA, described the situation existing at that time as follows: ''Generally 'speaking, the industry is presently controlling the vinyl chloride emissions to the i extent that it is economical to do so. That is, the recovered vinyl chloride will pay for the control equipment that is installed. At this stage of our investigation, it is our opinion that neither the polyvinyl chloride nor the vinyl chloride jnonomer plants are presently controlled to the extent''that j available control technology will permit." The equipment had been installed at that time, and this equipment paid for itself in productivity. The EPA painstakingly compiled a best available techonology standard after observing the industry through 1974. Through almost all of 1975, the standard was examined < \ * * ^omnantt AP00028080 17 by people in the EPA. and other governmental agencies, by industry and possibly members of the public, this is an extremely lengthy review and I think it is very important to try to put retaliations out and somehow shorten this review process. Possibly have some of the review going on after a proposal is issued, or at' least, after a substance is declared to be hazardous. Now, another year ha? passed with industrial application of controls plodding along at the snail's pace dictated by the economics of product recovery that pays for itself. It is 1976, but we still do not have, any state or national emission standards, and much of the technology in use today resembles the best pastry in the bakery that they will lot you have for free* . . TIad EPA declared vinyl chloride a hazardous air pollutant in June of 1974,the final standards would have been due by June of 1975. The public would have been spared an additional year of unregulated emissions from the 59 largest sources of vinyl chloride air pollution in. the country, and the state of development of engineering controls would have been more advanced a year ago than it is today. Under the clean Air Act, the EPA had the authority to force the United-states vinyl plants to close until air pollution controls could be installed. Ttfhy did AP00028081 FPA not at least declare* vinyl chloride a hazardous air pollutant in 1974 so that the industry would have ! I j been required to install integrated systems for control j of emissions both inside and outside of these plants? Wo hope that F.rA will do its job better and faster for the next vinyl chloride, I don't think vinyl chloride is in any way . unique. X think a lot of chemicals have been intro duced the same way, and there arc others coming alpng j that may bo discovered to have the same hazards. Now we will get to the proposed standards. As has recognized, the major issue raised hy the setting of an emission standard for aoparent non- threshold pollutants,- such as vinyl chloride is, and that is EPA's term, how far exposure^ should be reduced to provide an ample margin of safety. That is the crux of this issue. What is the social acceptable risk, no you dare risk any level of exposure? EPA accepts the notion that operaticnrof * .* vinyl chloride plants has increased the risk of cancer among plant neighbors, and that the risk is roughly pro-* portlonal to the level of emissions. The calculations contained in the Quantitative Risk Assessment report by Dr. Arnold Kuzmack and Dr. Robert C,oai netnn AP00028082 f'cGaughy indicate that current Levels of air pollutton cause one to 20 eases o? cancer per year among vinyl chloride and polyvinyl chloride plant neighbors. With j ^ ] 95 percent emission reduction/ the linear model predicts less than one casa of cancer per year. However^ since there are factors in the EPA risk calculations that tend to underestimate the risk as veil as over-estimate it, I think it is important to emphasize that we have to put a firm upper limit on what tho risk is. V?e have to know that there aro not going to be much more than so many cases that are going to occur, v given the risk of exposure. For example, the estimates are based aololy on post-natal exposure, and possible exposure of..the fetus through transplacental transfer is not considered. Likewise, t the possible synergistic effects between vinyl chloride and other toxic materials to which ve are exposed has not been evaluated. The animal inhalation tests upon which the risk estimates are based were tests with rats exposed to vinyl chloride in an otherwise chemically restricted -environment. In contrast /-.people are subjected to many other chemical exposures, such as to polychlorinated biphenyls, PCB's. Half of the United States population is believed to have accumulated one to three parts per a v> . s* AP00028083 20 million of: `PCP'ft in thoir fatty tissues. These compounds i i aretsimilar to DDT and other chlorinated pesticides, Their metabolism activates specific liver enzyme systems, t enabling the liver to more readily metabolize such chemicals as vinyl chloride. j Apparently it is the metabolite in vir.yl chloride; and not vinyl chloride itself.. The body, in the course of digesting and metabolizing it causes cancer and so the PCD'a might make us more susceptible to cancer from a given dose of vinyl chloride than otherwise would be predicted. Using the EPA figures, we can calculate the lifetime cancer risk for near neighbors of vinyl chloride emission soifrces, having qualified the SPA* risk model that tests have been done. Our estimates assume an annual average value of 323 parts per billions for vinyl chloride concentration near a single, average polyvinyl chloride plant? a 40 year period-at-risk? and EPA*s figures of risk equal to 0.15 cases of all types of cancer, 0.071'cases of liver angiosarcoma per million people per year per parts per billion of continuous exposure. The 40-year period of risk assumes all exposures is post-natal, and can account for a lifetime, near- continuous residence within one-half mile of the plant. Of course, a number of people live near more than U, P, ifnr/rM ft e, m* mu # i AP00028084 i 21 one vinyl chloride emitting plant. Fully 46,000 currently live within one-half mile of at least one . -i polyvinyl plant, according to an American Public Health l Association survey conducted for EPA. We thus calculate the lifetime cancer risk for near neighbors to be about 1/500 at 1974 emission levels. With a 95 percent reduction in emissions, this risk would be expected to be reduced to 1/10,000. The present risk would be something in between. .............. . According to Dr. Marvin Sehneiderman, National Cancer Institute statistician who raised some hard questions about a socially acceptable risk at the New York Academy's vinyl chloride conference in 1974, "When people talk about l j levels they 'can live with,* they must be reminded that these could be levels that other people might die from." I think what we are raising here is who is sotting standards and who is taking the risk, and how can we get the people who are taking the risk into the standard setting process? i j I would suggest that hearings be held in Houston, for one thing, and possibly in other places which are large sources of vinyl chloride, so people who are taking the risk can be apprised to the extent possible,* so. that they " know what the risk is, and what we don't know about the risk. I think they may have some input as to whether it j A- j. .. k AP00028085 23 acceptable risks must be approached in terms of a benefit/ 1t j riskvcalculation. In our view, Congress did. not intend -' EPA to regulate hazardous air pollutants with merely the | best available technolgy. Technology is in its infancy ! i which may or may not provide the statutorily required "ample! i margin of safety. ** Nor did Congress expect EPA summarily to. close down entire industries emitting hazardous pollutants without regard to the value to society of the products of such industries. Thus, if a socially acceptable risk is to be determined, it must be justified by the social importance^ that is, the benefits to society of the article whose production entails that risk. This view is supported by the recommendation, of the National Academy of Sciences in its recent study enti tled, Decision Making for Regulating Chemicals in the Environment, that in cases such-as vinyl chloride: "Once the Government has made a reasonable case that the challenged use of an existing chemical- created an excessive hazard to human health or to the environment, the burden of producing evidence should shift to the proponent of use, who must then make an appropriate * showing that continued use is desirable." . In formulating the proposed standard, however, EPA appears to have lost sight of the predominant purpose u rttrta n n AP00028087 7A of Section 112 of the Clean Air Act, which, is to protect public health against hazardous air pollution emissions. i i j After deciding to perform a benefit/risk calcu lation which, by definition, takes economic factors into consideration, EPA appears to have accepted at face value the industry's projection of the economic impact of a zero emission level. Thus, EPA reaches the wholly economically- based conclusion that "setting zero emission limits would he neither desirable nor necessary." EPA alleges that, "the purpose of the proposed standard is to minimize risk to public health by establish ing an emission standard which will reduce emissions to the level attainable with best available control systems." j But*, the economic evidence offered in support of the standard clearly indicates that no serious evaluation of the desirability of continuing all existing uses of vinyl chloride was made, and an estimated annual growth rate of ten percent in the industry was apparently accepted without question. Certainly, any valid attempt to determine "socially acceptable risk" vouldhave to take the foregoing factors into consideration. EPA assumes that a worst case economic impact - would, be experienced under a more strinqent standard, and that the proposed standard will minimize risks to health. y?__ . Y*.________ AP00028088 Neither of these assumptions is well supported i.n the Standard Support Docraertt. i | in the first place, the standard Support Document includes a table of uses of polyvinyl chloride, about 97 percent of the vinyl chloride produced in the United States is used to make polyvinyl chloride, the table lists pounds consumed for each use, and re-narks on substitutes available for each, EPA acfcnow- j * ledges that substitutes exist for "approximately 85 percent j by weight" of present polyvinyl chloride uses, it is . clear too, that there must be substitutes for some of tiie : uses listed as having none. Obviously, one of these is PVC's for credit cards, and I can't imagine that this country would have . any shortage of credit cards if PVC was banned. ' ; Substitutes have a way of coming into existence cruickly, as was the case when widely used asbestos insulatior was banned by EPA. It is noteworthy that EPA lists credit cards as one of the fastest-growing markets for PVC, with an annual growth of 19 percent per year and 1974 consumption of 22 million pouds, 10 million kilograms. ;; In addition to EPA*s table of PVC product uses ''" r* ... and replacements, an industry-sponsored report lists several pages of products made from polyvinyl chloride dispersion resins. These resins are most difficult to strip of residual e nrtintf c<. ompnntf AP00028089 1 26 vinyl chloride monomer,, and appear to be -the most polluting polyvinyl chloride resins to manufacture. Only one product is listed as having "no known substitute," a paste used for highway bridge surface repair I am not familiar with, this product, but it may be an example of a product the manufacture cf which might be justified in terms of what good it does for society, and apparently it is not a substitutable product. On the other hand, it might turn out to be substitutable. At first i-i'4nce, apparent cost of substitutes for PVC prod\icts appears to be an increased cost for the product's users. But this cost must now be measured against previously unrecognized and patently unacceptable trosts to workers and to community health and safety* ' >-* . >-'- : - Although the eonsumer/taxpayer pays some of the costs of a disabled or deformed victim of vinyl chloride toxicity recruires extensive treatment and hospitalization, these costs are not perceived as added costs for consuming vinyl plastics. More important, these costs are never assessed in full to the companies that make vinyl chloride and ' ' polyvinyl chloride, and to the extent that, these costs are not internalized, society in general and some of us much more than others, subsidizes these industriesand AP00028090 27 i o l] other hazardous industries . | \ 7s it than reasonable to accept tha toll of ore- ^ ventabie disease that is associated with providing society 1 . with polyvinyl chloride graden hose, disposable diapers, i 5 ladies fashion boots, traffic ''safety" cones, mats, toys 6 and foamed-back football fields? '7 We acknowledge that seme substitutes for polyvinyl chloride have received little study and may be hazardous M il to produce. Other substitutes, such as asbestos cement 10 pipe, which is not the only substitute available`for-PVC 11 . 'pipe are known to be hazardous to manufacture. In many : .... 12 cases, however, substitutes are available which are safer 13 to make and use than PVC, H15 ` If,' in fact, such a vast number of actual and potential substitutes for PVC are available, why will IS imposition of a more stringent emission standard necessarily 17 have such a devastating economic impact? 18 With respect to health risks, it is clear that *, 19 a 95 percent reduction of vinyl chloride emissions should 20 reduce the risk of adverse health effects. Whether this 21 reduction .will, in fact, minimize health risks, especially 22 in the context of an industry whose every product, and whose 23 ten; percent annual rate of growth EPA seems to have 21 accepted as necessary and desirable, is a wholly separate andj 25 unanswered question. to /? AP00028091 28 We believe that Section 112 requires more protection of public health the." tho proposed standard ^ will provide, especially in view of the evidence that PVC products also cause adverse health effects which have not yet been mentioned. Clearly, the 6,500 workers in vinyl chloride and polyvinyl chloride polymerization plants and about 350,000 works in PVC fabrication plants take substantial j f risks from exposure to vinyl chloride. Dut there are others, too, including 75,000 to 1000,000 meat wrappers, many of whom are exposed to fumes from cutting PVC vrrapping with a hot wire. The fumes, mostly hydrogen chloride, have caused i a new disease called "meat cutter's asthma". In addition, a study just published by theDirector of the Washington, D. C. police and firemen's clinic, ascribes severe respiratory damage and possible coronary damage to inhalation of fumes from burning PVC plastic articles. These are hazards not only to firemen, but, of course, to people trapped in buildings that catch fire. Over the past six years, 191 D,, c. firemen were injured and one was killed by hydrogen chloride gas produced by tho combustion of PVC. One of tho authors.^ of the article. Dr. Victor Each, said that plastic fumes today outdo smoke as a fir danger. The potential danger ;* ' ____ AP00028092 2 IItl <* 5 6 7 !) 10 11 12 1? 14 15 IS 17 13 19 00 21 22 23 24 T:~t j 29 j from fumes released by burning plastic furnishings, wiring ! and glothing present a special fire hazard to most of j us in homesmd places we work. Finally, a new study about to be released by the National Institute for Occupational Safety and Health, shows an increased rate of miscarriages among wives of workmen exposed to vinyl chloride. The control group, which had a rate one half or one third as high, consisted of the wives of rubber workers. This indicates that one of the prime substitutes for PVC is less of a mutagenic threat than vinyl chloride.. The many disbenefits of VC production continue to require a vast expenditure of government resources. EPA will have to devote substantial resources to-enforcing a national emissions standard. Air monitoring and engin eering appraisals are needed for expanding the regulations to cover additional sources of vc air pollution, sludge disposal sites, PVC fabrication plants, ethylene amine plants and others. EPA's Office of Solid Waste Management meanwhile grapples with the problem of dealing with a mount ing volume of PVC trash. The United States Department of Agriculture is also concerned about VC air pollution. Livestock ? graze near some -.-sources of VC emissions, .and VC may accumulate in the fat of these animals, we understand * ^porlintj Cr otnpatttf AP00028093 I 30 > i oi 6 7 S Ai i 11 13 tn H IS 1G 17 13 19 20 21 22 23 24 25 that. EPA has been in contact with the Department of Agriculture and the Food and Drug Administration on this matter and that studies are in progress. I would be very interested in knowing, if you could tell me, what the update situation is about what we know about vinyl chloride and livestock* . The Food and Drug Administration last September proposed to ban all rigid PVC plastic food-contact articles, and announced at that time that it was considering a ban on PVC pipe for supplying drinking water. Vinyl Chloride was banned as a propellant in aerosol products by EPA, . FDA and the Consumer Product Safety Commission, The last of these agencies then had to defend its actions in court when manufacturers sued* I think It is getting to be a major part of tha,, Government rule-making function to defend its rules in court against a challenge* we challenge you in courts sometimes too, but we don't have the resources to do it as often as we would like. CKAIP.MAN DENNEY: Your challenges have not been all together ineffective, I might add. MR. CASTLEMANt The U. S. Department of Labor1 has, like EPA, had to commit a major share of its scant resources to developing and enforcing a standard to protect ^Arrni jQtp&Un<f AP00028094 i 31 1 |i i)lj 2 i| workers from vinyl chloride. Additional resources ; were necessary to defend the workplace standard all the way | 3 -;j it X j| to the supremo Court. Industry unsuccessfully challenged the part per million limit for 8-hour average exposure as 5 j unjustifiably stringent and technologically infeasible. Ii $. But the burden imposed by vinyl chloride is not 1 borne by the government's understaffed regulatory agencies 3j Cj ;j Ju IQ alone. Research programs of the National Institute for Occupational Safety and Health and the National Institute of Environmental Health Sciences have been likewise affected \l Major studies will be going on for years to try and map 12 16 | the extent of the problem and seek solutions. la there any way we can.diagnose angiosarcoma 1 14 1$ j Ifi I before a fatal tumor develops. We would like to find out just what this vinyl chloride problem is. Mostof our health research agencies are critically 17 15 tI 19 j I 20 -I 22 23 24 short of the funds and people necessary to keep up with urgent research needs in areas long recognized. The appearance of vinyl chloride on the scene thus diverts major resources from other essential research and regulatory programs, with the result that the public pays with a lot of tax dollars and an unknown amount of prolonged danger from exposure to other toxic substances. A3 the foregoing disucssion indicates, there is much evidence which would support imposition of a more f^Cfreriinq C?*>tn;>-*nu AP00028095 1 ii 3 i! r. 1 ii i : i ( 7\ i o ii > i 10 I nI ii 12 ! 13 i i t 11 15 16 17 18 19 20 21 22 23 2-1 25 stringent; emission standard for VC. This would include zero emissions for substitutable uses of PVC plastics, and incentives for developing substitutes for currently non-substitutable uses. Not only is the alleged economic impact of a stricter standard greatly overstated., but the basis for concluding that application of the best available technology to reduce emissions will provide the ample margin of safety required by Section 112 is speculative at best. We emphasize that best available technology is not synonymous with an ample margin of safety. Ifv ample in this case must be defined in terms of a socially acceptable risk, we urge EPA to redetermine that risk by giving greater weight to the very real health costs involved, and by making a more objective assessment of the potential economic impact which is likely to occur given the availability of substitutes for PVC. The statute requires no less. 1 1 I j Ke would like to talk a little bit about engineering comments, most of which we will submit in the next three \ weeks In Baltimore they were making a rocket fuel as most of you know, which used dimethyl nitrosamlne as an intermediate. Dimethyl nitrosamlne is one of the family of carcinogens which is very much exploited. It ,1 V? AP00028096 1P 2 !| 11 ii i> !l 6. .7 10 li in 13 i 14 15 16 17 IS 19 20 i 21 22 23 24 _o 33 has carcinogens, mutagens, just about every animal specie that^has ever been tested -- And, yet, we don't know \ \ | what these things do to man. As we know vinvl chloride will cause cancer ** j ., .i in man, and when it was discovered that there-were nitrcsamines the ambient air in Baltimore, the air pollution officials in theCity of Baltimore, brought enough pressure on the plant to force its closing. This plant manufacturers a rocket fuel for the airports, which the Air Force describes as a critical national security airport. At the time the Air Force maintained there was - ao substitute route for making this hydrogen fuel. : Now that this plant is going to be closed because people in Baltimore just don't like the idea of taking the risks of this kind. It is one part per billion, as long as they! can find any of then, they were advised this was an acceptable risk. This is apparently a pretty essential product and the Air Force spent $12 million to renovate the plant t and to install the best available control technology. Now the National Cancer Institute is going to study another way of making rocket fuel which /has come along which doesn't use dimethyl nitrosamines* We will send in detailed engineering comments on the proposed standard in the next three weeks. Obviously A &.Z9______ _ AP00028097 I it will he necessary to see that plants emitting vinyl chloride are stringently controlled, as the phasing out of these vinyl products takes place. Some of the topics wo will address are, the use of enorqv-efficient incineration to minimize VC emissions from oxychlorinatien vents at ethylene dichloride/ VC plants; the : use of scrubbers on such incineration systems to control air emissions of hydrogen chloride: monitorinq and record keening; elimination of relief valve discharges to the ambient air; the need to develop information on sources not included in the proposed standards; and the need for a formal commitment to review the standard one year after promulgation, in the light of information not available in time for the current rulemaking. That concludes what I have to say. CHATRJttN DENNKY: Thank you very much. Before X ask if any of the -- The purpose of this hearing is to get information from those who testify and not to debate the standard. This is also not the forum which EPA will use to respond to any eritisisns or questions or comments -on our standards. We will have to do that next year with our final rulemaking, and we will do so. With that in mind, I would like to start and find out if any of the panelists hero havo any questions. .A"'r/M* n-. n'Grtjt.nQ ;*nn<> AP00028098 J9.dk, do you? MR. PARMER! no, x do not. CHAIRMAN DENNEY: Susan? I 35 ! i i ; i j I J MS. WATT: Yes, I do. Mr. Caotleman is correct, there are some substitutes for many of the PVC products, but unfortunately a lot of these don't have some of the more desirable characteristics of PVC. For example wood and rubber used in the construc tion industry, I am concerned that industry will probably, develop other substitutes besides these, and I wanted to ask Mr. Castlcman if he knows of any existing mechanism by which we can assure these substitutes developed are not worse' than vinyl chloride itself? ' ' MR. CASTLEMANi Well, you can set up several v i ] i j j classes of substitutes. You can set up substitutes which are obviously safe, much safer to produce, and which are I | relatively readily available. I would think, for example, the use of aluminum for credit cards. There are lots of things you can see that can be substituted that are available. Maybe cast iron for polyvinyl chloride pipe# and then there are the ' classes of products which we are not too sure of, but it now appears, for example, that at least the rubber workers that we used as a control group for the vinyl workers, have picric rttrltne AP00028099 1 36 1i S` 7 '5. 1 3 10 u 12 13 i 14 15 16 17 13 ID 20 21 22 23 24 less of a mutagenic.risk* We can verify that they have less of a carcinogenic risk, and of course, the same would apply for neighbors of tho plants. So, I think you can set up several classes of products, the ones you know that have safe substitutes that are relatively readily available, and those where substitues are a little harder to bring into existence, and then there are those where substitutes are questionable in terms, highly questionable, or not very highly question able, in terms of manufacturing them. And, timetables can be established for accomplishing all of these in an attempt to minimize economic dislocations. We are in a position where, I think, we have hope s j for ourselves, by depending upon over 4 million tons a year for PVC Plastics. Wo keep digging ourselves into this' 1.`. yw. and we will get ourselves into a ten billion a year'dependency on the stuff, or we can look for a way to get around this. It is not a real dependency, an apparent dependency..' In terms of health it ia very real, CHAIRMAN DENNEY: Dr. Knelson, do you have any questions. DR. KENLSON: Yes; I-have several questions. I would like to ask Mr. Castleman, in your introductory comments you mentioned that cancer has reached epidemic proportions in the country. To me this implies f AP00028100 J7 1 2 4 I there has been a changing experience in neoplastic disease i occurrence/ probably specific neoplastic disease. i i Can you comment on this, your data/ to substantiate this? MR. CA5JTU??'*AN: Wo saw a brief rise of five percent, but now that seems to be less than a five percent 7 rise in the subsequent data. We saw a small jog in the increase of cancer in the country, and it is this hard to appraise that 10 at this time. There are increasing levels of cancer 11 ! of certain typos. There is occupational, there is lower 12 i! intestinal tract cancer which seems to be a matter of **S i *1 changing diet. il DR.. 30JELS0N: Vou were relating the change in ls neoplastic disease experience of cancer incidence in the IS country. I think the general industrialization process 17 in the United states. Therefore, we would expect a long 18 term, very definite trend, relatable'tp this change in IP industrialization. 20 Would you like to comment on that? 21 MR. CASTLEMANr Certainly. The use of pesticides, 22 the wide use of pesticides like chlorinated compounds, 23 ' X , ^ have been banned because they cause cancer. . It started 24 about 20,30,40 years ago, but really took off after World 25 War II. I think we now are only beginning to see the y^Jcrnc $?fnorlin~ ^ AP00028101 30 ' !i , 1' * il > i! b 7 3! ii IVI 10 11 ` 32 i-3 14 15 10 17 13 13 20 21 22 23 24 incidence of disease that has been produced by introducing these chemicals as haphazardly as we can, and scaling up our production. DR. KNELSONt X think it is a very good comment. X would like to ask another specific cruestion. Did you say that you feel cancer is the leading cause of premature death, or a leading cause? MR, CASTLEMAN: I can't think of any larger cause of premature death, but, of course -- DR. KNELSON: Can you tell us how you define, premature? ", t :: - . MR. CASTMiMI: If you have a bunch of asbestos workers, let's say, and X am sure some of them smoke, and a lot of them get lung cancer. One out of five. But, still the risk of getting cancer, even for those who smoke is about ten times as high as it would be for smoking alone. That means one out of ten who get lung cancer are dieing before their time, that is for smoking, that < is a premature death. DR. KNEI.SON: You mentioned the concept of no permissible level:of certain environmental factors. Would you like to comment on what you mean by a permissible level? MR. CASTX.EMAN: Well, we ore talking about setting \jh,,.of>rftnn *. .Aitt ner r-u I AP00028102 i i 30 \i a zero emission standard of the manufacture of substitutable | uses,. For other uses, uses which like the highway paste, j may have some great value to society and which may not 1 be substitutable with other materials, there may be some 5 social acceptable risk for the manufacture of these things, 6 But, again, I emphasize these people who aro taking 7 them should be told what is going on, and asked if it is S an acceptable risk. j a In the City of Baltimore, if you take o in a 10 million as a figure to consider as an acceptable risk, u George Ferrary had to.think about -- He is in a city of is ! 13 one million people in Baltimore -- and he had to think of whether one in a million was an acceptable risk in terms U : of losing one `off the residents of that city. 15 16 17 when you think of it in those terms, maybe it is a little bit less acceptable versus when you think about your chances are one in a million, which are pretty good IS odds. 19 20 21 22 `23 24 25 When you are making a decision as a public health official, you are making it from the other side.. DR. KENLSON: We are talking about acceptable risks. These are cogent comments, but I would like you to comment more on your concept of zero 'remissions or no . permissible level. , How do you determine what is zero emission? This AP00028103 I is ft function of technology. You cannot say 2ero emission -- 'I 3 l` St i! * MR. CASTLEMANs X knot-?, and you can't say zero risk as long as there are going to be emissions of things like vinyl chloride* DR, KNELSON: I wonder if you vould redefine your 6 i concept a little bit? What non-zero levels would you think 7 are permissible, since zero is a concept, perhaps, but it is not attainable. As I say, the amount of any particular constituent 10 in the atmosphere is a function of technology to measure. 11 MR. CASTLEKAN: X am not talking about a zero 12 emission level. I am talking about zero, which would be 1-3 accomplished by a phasing out of the industry to the extent 14 we can do it and as fas t as we can do it. 15 Zero emissions in the past have also been described 13 or zero exposure, has often been described as measured 17 by soma instrument such as a part per million. 13 We are not talking about that kind of zero. 19 DR. KNELSONt One final question. You mention 20 the observation of chromosomal abnormality in plant workers. 1 Would you give us your impression of the relevance 22 of this kind of finding? 23' MR, CASTLEMA2?: Well, in light of the increased 23 rates of miscarriages that were observed in the wives of 25 these workers, which is in a report which will be published O4'f j*t.* r* r* Z\9 Mfujtr*. v AP00028104 & ll this week, something that Infante is working on now, I think I you have a very strong reason to suspect that this material is a mutagent.that causes genetic damage to persons who are exposed, and that this translates itself. DR. KNELSONj Is it correct to assume then that you are equating the chromosomal aberrations with a mutagenic ergo, future teratogenic effect? HR* CASTLEMAN: Not necessarily. That is usually a test for carcinogicity, T realize. I thought you were talking about the fact that the workers seem to have more than their share of chromosome breaks, which was observed byhiological tests, more of a carcinogistic test. DR. ICNELSON: What I was trying to get frem you i is your concept of the relevance of these chromosomal aberrations, and the relevance.of this occuring to the other kinds of occurrences.that you mentioned, such as increased screening systems. I would like to have you comment on the relation ships betwoen these bioindicators. X think the relationship is a good one for discussion. One that must be scruitinized. MR. CASTLEMANr I would prefer to send in comments i on that later on, because the people who are most expert .. in that are not here today.- CHAIRMAN DFKNKY: Dr. Marcus, do you have any questions? ^4c /)( AP00028105 42 i DR. MATjCUS j Do you know of any evidence of the increased ri3k in the general population, other than the studies that have been done in work? MR* CA5T3VEMAN j Aside from the fact that there were apparently two neighborhood cases with no known o occupational orposure, no I' donJt. - .7 DR. MARCUS: I would like to say that EPA investigated very carefully those cases, and we consulted .i with our expert doctor, Hans Topper of Mount Sinai, and lU it was his expert opinion that these people did have 11 angiosarcoma.' that was of a different type then that caused 12 ft by vinyl chloride monomer, and I must say, to date we ! .5 do not have any evidence that angiosarcoma has been n m produced by vinyl chloride monomer in -the general population 15 MR. CASTLEMAN: X think it is important to ' 16 realize that only about one-fourth of the present PVC 17 plants were operating 20 years ago. The latency of this 18 disease is 20 years or more, and of these ten plants, 19 at least one-fourth of the present level of plants, which Sn is about ten, the total production rate is one-tenth of the 21 rate it is today. The population nay also have been thinner 22 around the plants than it is today. ' 23 So, if you look at the present situation in terms 24 of how many people lived near the plants of a certain 25 size, it bears little resemblance to the situation 20 r.a C<o. ntfni fuf AP00028106 43 t years ago* ) , The mortality experience that we observe today started 20 years aqo. I don't think the absence of l cases is any proof of anything. Wouldn't you agree v/ith 6 a? 7 !i :i <3 11 10 11 12 i/j -14" 15 15 17 13 39 50 21 22 23 2) 25 that? DR. MARCUS: In general I would say that is a very cogent comment. The only thing here is that vinyl chloride happens to offer us a unique opportunity to see an extremely rare cancer, which we can say is maybe due to the substance in question, rather than, an increased rate of cancer, which is a very difficult thing to assess.. That is why I say, I was hoping somebody would have some information about VCM induced angiosarcoma in . the general public, because we have not been able to find it'as yet. MR. CASTZJ3MAN: I talk to the came people you do. CHAIRMAN DENNEYi Dr. McGaughy. DR. MC GAUGIIYt I just have one short question. We are interested in getting as accurate a picture as we can as to 'what the risk is to the population due to vinyl chloride exposure. You mentioned there were two or three factors that we have not considered. Mainly the carcinogicity of vinyl chloride and other chemicals and the transplancental effects that might caused to expectant mothers, i polling e. AP00028107 44 I 1 , I would appreciate, in your eventual comments, 2 if yqu could tell us, if you can, what there studies are. Just inform us as to what risk these effects would have. We have been trying to get evidence on this, and we have had a very hard time getting a realistic estimate of what these effects are. So, if you could provide that, we would be very grateful. o ;i i 10 11 12 1A si li 15 IE 17 18 19 20 21 22 23 24 25 MR. CASTLEMAN: X wish X could, X can provide you certain information between the activity of EVC's in the body and vinyl chlorides, but I think ray point was, it is very difficult to make these kinds of quantitative estimates, and there are certain factors which -- It is just impossible to know the size of when you make these calculations.* So, you have to qualify the calculations by sayinq that. ..................... DR. MC OAUGHY; We would appreciate, at least your viewpoint on the uncertainties about this, CHAIRMAN DENNEY: DrKusmacfc. DR. KU2MACK: I have a few questions, somewhere along those lines. You state that the estimates of one to 20 cases do not give a firm limit of the risk, which I certainly agree with. Elsewhere in this statement you suggest that it could be, of course, ten times higher than that. That gives Jl AP00028108 I 45 me none problems, It scans to me at some point if the risk was sufficiently greater than what we are estimating we would see a lot of cases of angiosarcoma around the plants, even taking into the account the lower production i j ! levels in the past. 6 Do you have any idea as to what -- At what 7 increased level you would expect to bo able to demonstrate H the cases around the plant? 9 ITT?. CASTLEMAN: No, I don't. r didn't give that I lu much thought into calculating this. I just took the I j 11 figure of one chance in a thousand just to measure the 12 possible uncertainty if we are going to be apprising people <3 in tho plants what their risk is. 14 DR.'KUZMACX: You mentioned the one in 500 chance 15 of getting cancer for a near neighbor. Considering the 15 1; 17 is !| chance of getting cancer is something on the order of one out of five, do you believe that an increase from one out of five, to one out of 500 is a sort of increase that, 19 in fact, concerns people, that people will change where they 20 live as a result of that? 21 kr,, CASTLEMANs If you are putting it to them 22 that they are taking one chance of five hundred of dying 23 before their time, it is not just what they die of but 2-1 when they die. 25 DR. KUZMACKi There seems to be some conflicting AP00028I09 46 t 1! U 2j evidence as to how people evaluate these risks. MR. CASTLEMAN: I think the public has certain 3 i i 1 i? rO !I ,i ,1 '! difficulties comprehending hazards they can't see. DR. KUJSMACJCt Your alternative recommendation is that certain uses of vinyl chloride be phased out over a time period as substitutes are available and can be evaluated. KR. CASTLEMANs Yes. r..f Ii! i 10 f DR. KtiSMACK*. Do you believe that Section 112 gives EPA that authority? 11.! V' ' MR. CASTLEMAN:' Yes. \ ; ^ 12 5 ij DR. KUZMACKs I think it would be desirable, if in your written comments, you go into a detail on that, 14 . v- is.; MR. .CASTLEMAN r We can certainly provide that. . DR. KEELSON* I neglected to ask you one technical 16 i 17 question. I was kind of shocked about 33 parts per million. 13 Could you give us the average tine, the circumstances 19 surrounding the reflection of that sample. 20 KR. CASTLEMAHs 1 believe that was a one hour 21 sample. If you check the Task Force report, you can see 22 what reasoning there was. I think that was a sample for 23 '^one hour average in time. 21 . CHAIRMAN DENNEY: Mr. Farmer, I believe you 25 have a question? puny AP00028110 47 Mil. FARJCER: Yes'. ! Mr. Castlenan, X just want to wake sure I j understood what you were basically reccrnmending. I under stand what you are basically recommending is what we should do is wore or lcs3 assess the products and uses and determine whether the substitutes would have less of an- environmental ! . impact than vinyl chloride. And, if ve determined that the alternates, like aluminum instead of PVC for credit cards have less of 10 an environmental impact# we should ban further use, their 11 use# and the ones we do determine are socially acceptable# 12 and there is no substitute# then the type of standard S3 ii wg have proposed would be applicable for the production 14. of polyvinyl phloride for those kind of end products; is -15 ; that right? 10 MR. CASTLEHAN: That is pretty much it. It is 17 not just environmental impact, we are also talking about IS health as well. IS MR. FARMER: what factors would you recommend we 20 consider in evaluating the environmental impact of the 21 substitutes as compared to the environmental impact of 22 polyvinyl chloride? 23 MR. CASTLEMAN; Primarily# you are concerned with 2-1 the air pollution hazards? 25 MR. FARMER: We would be concerned with all factors, Jfc,*' $eporliny Company I AP000281f1 48 2 i i| 4 5 6 7 3i U 10 11 12 23 14 15 . 18 17 13 19 20 21 22 2.3 24 25 and -that was what I was after. 1 ?**,. CASTLEMAN: Some of the factors you micht consider -- Would you consider air nollution to be something that cor.es from the combustion of these things, because if you do, you vxould maybe be concerned with the health hazards, the final end uses. . It is not a simple appraisal to make. I would really like to sit down with you sometime and work out a little better what we think , what, kinds of criteria should be established. What we are looking for in ways of eliminating this kind of risk people have been running, living next to these plants, and perhaps taking a cancer risk. CHAIRMAN, DENNEYs I would like to ask a couple " ` of questions. * One is, I would like to expand a little bit on what Mr. Fanner asked -you and you were just talking about. It seems to me if we have learned anything from the environmental movement, any dislocations are apt .to have unforseeable prohibitions or unforseeable effects. To the extent you are suggesting we actually go down and devote agency resources to making each polyvinyl application, and then to evaluate the possible adverse environmental and other consequences of each of those, I am not quite snore how we would do that. C?'aynpantf AP00028112 A9 If you are suggesting, and this is going to be my question, are you suggesting we simply, for'instance, if we had it your way, should we ban this starting a year from now? The reason I ask this, is the central concern I have, if we say within a year, whatever time thing you want to talk about, immediately switch over and say from ' now on no more polyvinyl chloride-.pipes, credit cards, insulation and so on, and various other uses, is it your opinion if you had to make that judgement now that we would be clearly better off, or we could Iks better off, , .N * "* or you think there is some reasonable way we could conduct studies, and all of these things to Insure that we don't end up with a worse problem than we have now? MR.'CASTFLMAN* I think you would be definitely better off* I -think you can, again, establish classes of products for which the decision is a lot easier than others. Where you have some difficulty deciding whether the substitute is really something you would want to go with, then you could call for more information from the industry by way of the usual announcements and rulemaking procedures. CHAIRMAN PENNEY: I am somewhat doubtful that we can do that particularly, because we are constantly learning new things as with vinyl chloride as vre had anticipated when we started out. AP00028113 1 50 1 2 ^ ji 1 i 6 MR, CASTLEMAN: > lot of the substitutes are going to be the same thing over and over acrain. Once you make the decision you have got a pretty good idea. When you see the same substitute coming un it can be applied. I don't think the job is as awesome as it might 6 look at first. 7 CHAIRMAN PENNEY: For instance, in vinyl chloride, b they are saying now one of the problems in regulating it 0i 10 11 is that we do have limited information, that there is a 20 year latency in the period of cancer, that the oldest plants are 40 years old and most of them are less than 12 20 years old, so we are just now finding out the hazards 1 V* of it. We do have some kind of idea of what those hazards 14 are. we do have some idea, certainly not a firm upper 15 ' - limitra^otitthe cancers we are talking about and what" some 16 of the impacts are. 17 I am wondering about the wisdom of saying we 15 know there are some hazards, we think we are controlling 19 them rather tightly right now, and we could possibly 20 21 22 - rachet then down even more in the future, at this time, sometime. Is it not possibly wiser from an environmental 23 point of view to consider that, to take the evil we.know 24 now, to figure out how much to cut it down now, before 25 we immediately cut it out wholesale in the environment and Company AP00028114 51 1 2 3f i 4I 5 . AO 7 5 3 10 11 12 IS 14; 15 15 17 18 19 0 21 22 23 24 25 perhaps wait another 20 years to find out they are even more hazardous than the vinyl chloride? * - ....... Mil. CASTLEMAN: Your point is well taken. There are obviously going to be some materials you want to be careful about in not bringing it into use. But, I think with a lot of these other things, many of them we have had.- longer experience than we have had with vinyl chloride, and we have a fairly good idea of what the health impacts are. chairman DENNEY? Is there any lower level of . . risk at which it would not suggest that idea that vinyl chloride should be banned? I mean, considering first off we would have to go through this process of finding sub stitute products -- And, the obvious dislocations and hardships to workers Is there any level of risk, one ... risk of cancer In 100 in the United States, is there any level of risk which you would not consider a wise risk? The ultimate banning of vinyl chloride. MB. CASTLEMAN: T*e do understand that there is a risk in everything, and we are not asking you to eliminate risks. We are just askinet you to choose among the risks that are Available. I do not think we can speak to an exact number.' I point out again that Dr. Schneiderman said, that one in a million was about as much risk as you should take for _s$eni r $<port< nn ?, tom n tf AP00028115 i i 52 1 2 ! an existing product in wide use. Near neighbors of vinyl chloride plants are taking, as near as I can guess', one A5 s 6..; .7 a in 10,000, which is substantially greater. That is cancor. We are now talking about these other effects on the unborn. If there was an advocate for the unborn who came to these hearings, I aia sure he would tell you to ban vinyl chloride. ^ CHAIRMAN DENNEYs why don't we start with Dr. Kuzmack and work our way back, 10 DR. KUZMACKj Just to follow up on the line n of questioning, I see a practical problem-.with this approach 12 in that a particular monomer plant does not'produce for a 13 'l i 14" particular use. It just produces the stuff and ships it to' fabricators''which moans wo cannot eliminate a particular' v IS IS use by setting a limitation on a plant. - We think it would be stretching it legally to 17 say that Section 112 standard would consist of banning 13 use of PVC in credit cards and and have you. Your reaction 18 to that? 20 MR. CASTLEKAN: You are not an attorney and neither 21 am I. Why don't we let the attorneys handle that question? 22." 23 DR. KUZMACK> You also talk about an emission standard for sewer, and that is a problem. - 24 MR. CASTLEMAN: This is more of a legal Question. 25 I am not an attorney, I don't think I can give you the most f^rrorisnQ (^onpjinu AP00028116 11 U 1 a 53 qualified answer that the Environmental Defense Fund could offer you on it. V ) ! { i 3 CHAIRMAN'DENNEY: Dr. MeGaughy? A DR. MC GAUGHY: No questions. 5 CHAIRMAN DENNEY: Dr. Marcus? 6 DR. MARCOS: Mr. Castlem&n,'I would like you to 7 tell me what your scientific qualifications are so that I may be aware of them? MR. CASTDEMANt I ara a chemical engineer, and 10 11 12 13 . 14 15' IS 17 13 13 20 21 22 23 24 25 I also have a Master*s degree In environmental engineering which I got -- I qot a air pollution fellowship from HEW,-" and I worked in air pollution control in the State of Maryland, and I have also worked as a process engineer in the.-chemical industry for a number of years. ... - r ., DR* MARCUS: I would likejto make a couple> just kind of factual remarks, about'the polyvinyl chloride. Over the past year industry in their response to our activities has reduced, tothe best of ray knowledge, the amount of unroacted vinyl chloride monomer which we know to be the problem. Not vinyl chloride per se, frm something in the order of 4,000 parts per million, from the latest reports^! have received, to below 100 parts per million, and for most parts below 50 parts per million. MR. CASTLFMAN: This is not the dispersion rate for the others. AP00028117 1 2 lii 0 1 DR, MARCUS: The fact that dispersion resins has been brought up is interesting, we have initiated a study to determine whether there were, in fact, any dangers to the general public in products from which are made, using dispersion resins. 6j And, to date, we have found to look at a large number of : products, and are only able to find a very little amount 8 in parts per billion in one unusual circumstance. It is our best opinion now that while dispersion 10 resins would seem to be the most likely place to find a 11 problem, we indeed investigated and found none, 12 Secondly, I would like to address the area of 18 fire. The industry itself looked at it a while back and. 14 actually conducted experiments, as I recall, with animals is using various* proportions ofVvlnyl chloride, wood and other is things you might find in a fire. And, came to the con 17 clusion that while vinyl chloride perhaps offers some 18 danger in a fire, by far the greatest amount the fireman 10 finds in a home or in a business so to speak is due to 20 carbon monoxide that comes from incomplete combustion of 21 wood and wood products in that area. 22 While you make a large point of it in your presenta 23 tion, I feel I would like you to give us, if you could, 24 a little more information on how you reach that conclusion? MR. CA8TLEMAN: Well, I was speaking a little bit s$cm c ssppoorrtliinnag Ct pnr tt AP00028118 55 with on of the authors of the article on the District of Columbia Firemen, and I think it would be best if X sent you a copy of that article. f_t ?ii; 6 This doctor is a surgeon. Tie found vinyl chloride eombustien products to be very dangerous. Whether he means more dangerous than carbon monoxide, X would assume, because 7 X am assuming, that is true. ' 5 CHAIRMAN DENNEY4 Dr. Knelson. ft ! DR. KNELSON: An unrelated point I wanted to 10 respond to. You made the comment that you felt if there11 was an advocate in the room for the unborn he would 12 certainly advise the banning of vinyl chloride production VS in the country. Is that correct? 14 MR. 'CASTLEMANr Yes# it is a correct quote, yes. 15 DR. KNELSON: It so happens X am a pediatrician, 13 and X specialise in diseases of the newborn, and it also 17 happens that I have looked very closely into the entire 15 vinyl chloride issue with real concern, and cannot, as 13 an advocate -- I believe I am an advocate for children -- 20 and certainly for the unborn child, cannot advise the 21 Administrator today to ban vinyl chloride in the country 22 based on what Xknow. 23 r CHAIRMAN DENNEYt If there are no further 24 questions? One more question. Dr. Marcus. DR. MARCUS: we have gone round and round about AP00028I19 I 56 j i 1 i i substitute testing. My office in EPA, the office of Toxic 2 Substances, is faced with this problem; 'should toxic 3 substances control legislation bo passed? j | 1 41 J* I might say, it is not a simple question,' it j 51 ji is a very difficult one to answer, and answer both candidly fi and correctly, 7 I would like to say that from the point of e; i. o !i 10 11 view of what.we know now, and that is far more than what we know of other substitutes that might be proposed, I think that vinyl chloride is easier to live with than something that might do a better job, but then wa don't 12 really have the same information or history of exposure. ** And, to say that it is easy to test substitutes might be u correct, but to suggest that we so test everything that 15 ' might be used to rule out things like, cancer and other 16 " morbidity problems, is not a very inexpensive project. j 17 Since we know what is going on with vinyl chloride IS I don't think one would like to suggest that we stop 19 an industry in which there are 3,000,000 employees 20 directly or indirectly involved and try something new. 21 MR. CASTLE!IAN: if you mean indirect employees 22 which constitute most of those employees, you are talking , 23 ' about people who, say, put plastics on automobiles, X 21 don't think we are going to stop making automobiles, or that those people are going to be laid off. ------------ AP00028120 57 ObviouoXy substitutes will come into existence and we can get a pretty good idea of the time it would take for substitutes to come into existence. i I j poses. Vinyl Chloride is remarkable in the hazards it It is recognized by the fact that EPA has declared I 1 only four hazards air pollutants since the Clean Air Act was passed. There are a whole lot of things going around that are as bad as vinyl chloride in the context of thinkinc about substitution. That is a point to make. CHAIRMAN DENNEYi 'I would'like to thank you, . . , Mr. Castleman. I would like to take about'a*15 minute ' break here, in order not to violate the anti-trust laws. I understand another network wants to set up. I don't know where they are from. I think they are from Nebraska from the logo. we will meet back here. We will start again at 20 minutes.to 11. (Short recess taken) CHAIRMAN DENNEYS I think we will start up now. If anyone in the hall is interested in coming in,now is the time to do it. The next witness is Mr. Ralph Harding of the . Society of the Plastics Industry, and I would appreciate it if the gentlemen accompanying Mr. Harding, or Mr, i Harding himself, will introduce the people accompanying him AP00028121 i i\ 3 <; i 4I i 5j 6 7 5! ji I> io | 11" 12 ! .i 14 IS 16 i 17 IS 19 30 21 22 23 24 25 58 and sitting with him at the witness table. | , Is everyone ready to go? All right, Mr. Harding, j would you please lead off and introduce the people with you. STATEMENT DP RALPH L. HARDING, JR., PRESIDENT OF THE SOCIETY OF TUP PLASTICS INDUSTRY MR. HARDING: Thank you; Mr. Denney. Laides and gentlemen, I am Ralph Harding, Presi dent of the Society of the Plastics Industry, SPI. I am accompanied by Mr. Albet J. Beveridge of the firm of j Ruekelshaus, Beveridge, Fairbanks and Diamond, our special counsel, and Mr. Robert w. Laundrie of General Tire Company, Chairman of our Technical Committee. On behalf of the Society I will comment on EPA*s proposed Vinyl Chloride Air Emissions Standard. Specifically, I will describe how the Vinyl Chloride and Polyvinyl Chloride Producers Group of SPI intend to respond to the proposed Standard; our reaction to the Standard; and in the industry's position on methodology used by EPA in developing the Standard. Let me summarise our position right now. We will do our best to meet the standard. Vie do want to urge the making of constructive changes in the proposal and will do, so in our written comments to be filed on February 23. SPI is the trade association for the plastics i industry. Our 1200 member companies and 52 operating units AP00028122 include producers of plastics raw materials, resins, I modifiers, adjuvants, machinery and mold builders; and the Society also includes processors and eovertors of the resins into end products. We estimate that SPI membership represents 95 percent of the plastics materials and machinery produced in the U.S.A and about 75 percent of domestic processing volume. The.Society's concern with polyvinyl chloride 5 begins with the manufacture of vinyl chloride monomer, WCM, and carries forward through its polymerization into polyvinyl chloride, PVC, and the various conversions process* to its multitude of end uses and ultimately to its recycling or disposal* In 1975, total pasties production is estimated"; at 22.1 billion pounds of which polyvinyl chloride accounts, for 3.7 billion pounds. In the United States there are 17 vinyl chloride monomer producing plants and 41 polymerization plants. Twenty-two companies represent- fi ing over 99 percent of VCM and PVC capacity are active members of SPI's VCM and PVC Producers Group. Polyvinyl chloride is the second most widely used plastics porduct in the United States. It is a solid, produced by several different polymerization processes. The sold source of PVC is vinyl chloride monomer, a gaseous chemical derived from petroleum or natural gas and chlorine. **+ nu I AP00028123 60 Although I know the panel fully understands this, I think there are some in the room that need it clearly understood that VCM is a gas and PVC is the solid. The plastic derived therefrom. PVC is used in a vast array of industrial and consumer products. While there may be substitutes for many of PVC's end uses, in some areas, such as blood bags and surgical/medical tubing, polyvinyl chloride is irdispensable. The availability of PVC has made possible the advancement and development techniques which are essential to medern blood technology and the treatment of kidney disease. The belting industry has stated that there is .no acceptable substitute for conveyor beltirg*Ui<i* from PVC, which would affect industries that range from coal raining to grain and processed food handling. in other areas, PVC has become vitally important; for example, in packaginguses and commercial and industrial wire and cable insulation. PVC's resistance to fire, water and solvents as well as its own chemical inertness have made it invaluable. As to other uses of PVC, it is uncertain whether substitutes are available; more critically, do we not know l the time necessary for their development and whether? they possess the same valuable characteristics as PVC? fQtporling ^onparty AP00028124 61 l 1 j! 2I 3i 4 Moreover, It is unknown whether potential substitutes way themselves nose a threat to public health. Originally it was cur hope to be able to provide detailed comments on the proposed Standard and the 6 j! 7 8 3 10 11 12 } accompanying Standard Support and Environmental Impact Statement, The Scientific Technical Assessment Report on Vinyl Chloride and Polyvinyl Chloride and the Quantitative Risk Assessment for Community Exposure to vinyl Chloride, The proposed Standard was not published until December 24, 1975, and the supporting documentation was not available to us in time to circulate prior to the week o January 5, 1976, Only then were our VCM/PVC producers in a position to begin analyzing EPA's material, 14. In-addition. The Quantitative Risk Assessment 15 Document is a new document which we were unaware EPA was XS preparing and it requires substantial time and expertise 17 to offer informed comment. 13 Therefore, because of the timing of this hearing, 19 my comments will necessarily be general. We plan to submit 20 extensive written comments on the technical, legal, 21 health and economic aspects of the -croposed Standard 22 before the February deadline. 23 Major areas of concern appear to bei One, 24 inclusion of small research and development facilities within 25 ^4em $ceppto*rrttitnnqp C\^<ompantf AP00028125 i 1 the Standard. Two, certain reporting and recordkeeping j rearu^remenfcs, and three, especially, the absence of existing technology to strip some dispersion resins to the level proposed in the Standard. i j i j In addition, some member companies are planning j to submit their own detailed comments on issues raised by the Standard and the supporting documents. As I stated at the outset, our VCM/PVC producers will do their best to meet the stringent requirements of the proposed United States Environmental Protection Agency i T Standard for vinyl chloride. As estimated by the Administrator, this will entail a cost of about $200 million with an annual operating cost of $70 million. Our preliminary analysis indicates that these. Estimates are j \ i low. Although the costs are great/ our industry as a matter of principle is dedicated to assuring that the public health will not bo jeopardized by the manufacture of vinyl chloride monomer or polyvinyl chloride resin. One aspect of the proposed standard deserves special comment at this point. EPA chose to regulate vinyl chloride under Section 112 of the Clean Air Act. This action requires emission ^st?.ndards for hazardous air pollutants to be set at levels which in the judgment cf the / Administrator provide an ample margin of safety to protect public health. Despite the fact that no demonstrable health f?tpr>rfinq c<.<-/*pan y AP00028126 \ risk to the public who live in the vicinity of our plants has been shown, the Administrator i3 of the opinion that a safe level cannot now be conclusively determined. j Under these circumstances EPA has a number of choices including deferring action until it has more facts; banning the substance; or requiring the installation of control t.ec)uiology to reduce vinyl chloride emissions with or without reference to cost, we commend the Agency for considering costs, although wo believe that it has not adequately weighed them against the actual benefits likely to be achieved in protecting the public health. In considering whether to ban vinyl chloride, epa was faced'With a substance that Is apparently a human carcinogen at high occupational exposure levels which existed in some plants prior to the imposition of the OSJIA Standard, and a carcinogen at lower exposure levels in test animals, but which has no demonstrable health effect at the extremely low levels found in the ambient air. In addition, polyvinyl chloride has many beneficial uses and its production and further use in various applications involves over two million jobs. Given the absence of knowledge of any adverse health effects of vinyl chloride at the very low levels found around the manufacturing facilities, EPA decided that a total ban fS.ef'or'inrf C >!'</// AP00028127 64 2-' I 3i 4! ft 6 7 would represent a cost to society that could not ho justified. EPA's decision to utilize a control technology alternative involves a further consideration of cost. The Agency has taken costs into account in setting the proposed Standard only when "costs appear to be grossly disproportionate to the emission reduction achieved.** *! j oI to I ! 11 ! FlPA rejected a `'fine balancing of costs against benefits*' in setting a best available control technology standard. As we have stated, at this point ve believe that 12 .in view of the lack of any demonstrable health risk at IS the extremely low levels of vinyl chloride in the ambient 14 air, the Agency should*have undertaken-a-more careful ` 15 16 II 17 13 balancing of the costs of each specific control requirement against the emission reductions likely to be achieved.' We urge EPA to attempt this balance before promulgating a final regulation in this case. We also m I believe EPA should apply the same methodology in the 20 future when regulating substances posing problems similar' 21 to vinyl chloride. 22 We want to support the proposed Standard and we 23 will offer a number of constructive suggestions regarding -S 21 the Standard itsolf, the Standard Support and Environmental 25 Impact Statement, the Scientific Tehcnical Assessment .4,.! * R.pnffino c,* p?ti AP00028128 Report, and the Quantitative Risk Assessment for Community Exposure to Viny Chloride. Our initial review of these documents dis closes what appear to be errors, inaccuracies and unjusti fied conclusions which should be corrected before the Stand ard is finally promulgated. These problems will be addressed in our written submissions and in those of the individual companies. The proposed Standard becomes effective 90 days after promulgation. A. waiver of up to two years to comply can be granted by the Administrator. In light of the lead time necessary to develop additional technology,, to order new equipment and to have it installed and demonstrated, same companies will undoubtedly require this ' additional time in which to comply with the proposed sta SRI also takes this opportunity to commend the Agency for adopting an approach which allowed an open exchange of information between the technical people of the Agency, the industry and other interested parties. This approach to developing a standard which involves complex technology is sound and we encourage its use in the future* We also' encourage the Agency's utilization of a quantitlative risk assessment analysis in determining the appropriate Standard. Even though we have major difficulties AP00028129 in this instance with the published document, the underlying concept is worthwhile. The Administrator of EPA has discretion under the Clean Air Act to determine which chemicals he believes may be hazardous to the public health. Fie admits his uncertainty* about the potential environmental threat posedby vinyl chloride and concedes that there is no demonstrable health risk to the people vho live near vinyl chloride or polyvinyl chloride plants. To fill in the gaps of our health effects knowledgs we believe he has an obligation to establish a procedure whereby the Agency cam gather additional information. We strongly urge the U. S. Environmental Protection Agency to provide -leadership in implementing a thorough, coordinated joint labor-management-citizen and government research program to give clearer answers to continued questions about the health effects of vinyl chloride including whether there is a safe "threshold* level for vinyl chloride in the atmosphere. The problems associated with suspected carcinogens with no established thresholds are simply too important for each affected group to pursue its own limited goals and to have the medical facts clouded by emotional claims. There are important studies which we understand have been undertakn by Dow Chemical Company which Dr. Perry J. Gehring AP00028130 I 67 3 will describe in some detail and we are hopeful that these 2 and similar efforts can be continued and encouraged by the Government. i 4 The industry"has participated in preliminary 5 steps to establish a comprehensive, coordinated research ; t 6 program. Frankly, we had hoped the Agency's response to 7 obvious research needs would have been more aggressive and 8 we hope that it will adopt the recommendation of the j Office of Air Quality Planning and Standards and the Office of Air and Waste Management on September 30, 1974, to 11 "initiate a research program to develop more definitive 12 data on the human health effects of evinyl chloride in 13 the general population and on ambient air concentrations 14 of vinyl chloride,"* 15 Thank you for affording the Society this opportunity IS to appear. n CHAIRMAN DENNEY: Thank you, Mr. Harding. is Jack, do you have any guestions? 29 MR.-FARMER? I would just like to urge SPI in 20 submitting their detailed information, that they address the 21 guestion of the substitute that Mr. Castleman brought up 22 earlier. " 23 I think this is an area we have not had a very 0,1 good handle on, and there have been a lot of discussions 25 about that. So, any information, as detailed as possible on ivrpartin5 -ontftftny AP00028131 68 11 2| i 3t 4 5 G 7' 8 ) ) 9! ! substitutes and possible problems, or other information, about Substitutes for PVC, I think will be helpful to us. MR, HARDING: This is putting us in a somewhat difficult position since X do represent all plastics, and I .would like to think my interest is balanced. ............. On what criteria do you want the question of substitution considered, and what specifically do you ask us in this connection? u 12 13 14 | 15 16 ! V~. MR. FARMER: I would not limit the substitute r . * * ^. list to merely plastics., Ne are talking about material - . ^ ; besides plastics, and X appreciate your position in terms of representing all plastics industry, but I think it would l>e very helpful to us to address the substitute- question. If we knew more about the uses of PVC's and then 17 19 19 20 21 22 23 24 ' 25 the possible substitutes for PVC in all these end use applications. HR. HARDING t If you accept the promise that there is always a substitute for everything, where do we go? There is a substitute for everything including m'e *T --' and thee, sir. MR. FARMER: X have been hearing there are some uses for PVC for which there are some substitutes. CHAIRMAN DENNEY: Me and thee may not have some of the adverse environmental effects. C^Btnon/Mj AP00028132 ,[ 1 2 3i * !l li - !! n G 7 S n 10 n 12 U t! 14' 15 15 17 13 19 20 21 22 23 24 Ms. Wyatt, do you have any comment? MS. WYATTt You mentioned the costs that would be incurred because of the Standard. Could you tell me about what percentage of those costs will be incurred because of the OSHA standards? MR. HARDING: No, I cannot. I think it is a premature number at this point. Nor have we attempted as an industry association to do more than help the companies supply you with information on that score directly. I think that they are interrelated. I do not think they are ready yet to be able to ascribe which costs to which standard, and there are other standards. The Food and Drug matter coming up relative to the monomer content in the product which is involved here. MS. WYATT: I was wondering, did they not have conveyor belts before PVC waa produced? MR. HARDING: Yes, I believe they did, but I think it was demonstrated its particular worthiness in this application. Sure, they had metal conveyor belts, and yet it has many desirable characteristics that are needed by the people who make use of conveyor belts. CHAIRMAN DENNEY: Dr. Knolson? DR. KNELSON: Thank you. I have several questions 1 would like to pose. AP00028133 70 1i 2i i, 3 :! !' i I r> I i f 6 The first fundamental one, What is your criteria establishing the carcinogenic property of a compound? I an prompted to ask the question by your comment in your presentation here concerning the "apparent carcinogenicity" of VC monomers? MR, HARDING: I think our position on this 7 subject will become more clear to you when you hear what S Dr. Gehrincr ha-s to say. 9 DR. KlJELSOtl: Do you have any further response 10 to that question? 11 12 ! 13 14 _ MR. HARDING: At this point I think no, because his comments will bear directly upon some aspects of that. DR. KNELSON: All right, I get to ask the question'again* 15 ie . i? is j i is j MR- HARDING* Perry will be happy to answer it. DR. KNELSON: On page, two you talk about the indispensibility of PVC in the blood transfusion technology, blood bag, surgical/medical tubing and so forth. I ant not exactly ancient, but there was a time 20 we did not use this polyvinyl chloride for these things. 21 I I would like to have you elaborate on this. 22 MR. HARDING: Par be it for me to tell a doctor 23 how it works, but I think that in the matter of transfusing, 24 the use of this particular type of tubing is made far safer and far more effective, and in the case of blood bags. ^perltna c<</mpnnu AP00028134 ii ii 1 2 H ti 4 5 6 7 S fj 10 11 12 35 I 14 15 IS 17 18 13 20 21 22 23; 24 25 the whole blood bag system is built around the use of thee plastics - DR. KNELSON: X know. The glass bottle industry w3 built around the availability of glass. X don't think that is the issues. What is so /.special about this particular material? ?4R. HARD TNG t I think that you have a tremendous added factor of safety. DK. KNELSON: What are these factors? MR. HARDING: For one thing, the blood bags don't break when you drop them, and I think that, again, indispensibility is always a relative matter. DR. KNELSON: What is Tygon? MR. HARDING: It is a form of PVC,ft DR. KNELSON: Teflon certainly is not? MR. HARDTNG: No, teflon is not. DR. KNELSON: What are the -- You talk the kidney disease treatment that is dependent upon PVC for tho artificial dialysis machines we are using, what are these membranes made out of? HR. HARDING: I will have to file an answer to that question. , DR. FNELSON: I don't think they are made out of PVC. The first ones were made out of cellophane. MR. KARDING: . PVC has certain characteristics ji.nt f*+tporfir\t) arnpantt " AP00028135 1 i l 1j 0i 2] i1 i 3i 5 i i! 0 i 6 7 >i ii 0: i 10 u 12 { >? 14 15 16 17 18 19 20 21 22 23 . 2-1 25 72 that are considered for these types of applications. DR* KNELSON? On page eight you say the ! Administrator admits his uncertainty about the potential and environmental threat posed by vinyl chloride. I would like to comment on that. Re always have a certain level of uncertainty. We always wish we had better data for any regulatory decisions made. But, I believe the translation of this could be, admitting doesn't uncertainty/mean' admitting no problem exists, and I do not believe that is the interpretation, or that interpre- 'tation can be applied, .` I. HARDING: It admits there" is an uncertainty. I think. This is why v?e go on to say seme of the things that follow, -- . 1 DR. KNELSONi I think we could probably preface every comment we make about regulatory decisions of the . agency with the statement there is some uncertainty. MR. HARDTNC: This whole point made here would support what follows concerning the needs. DR. XNELSON: As a research administrator I heartily endorse your recommendation. CHAIRMAN DENNEYS Dr. Marcus. DR. MARCUS: I find it interesting you find there is no demonstrable health risk to the people who live near vinyl chloride or polyvinyl chloride plants AP00028I36 Now, that is not such a very pat statement if one listens to Drs. Wagner and infante who seem to imply that in Plaineville, Ohio -- And, we have found recently in the first week of December, I think it was, in Norway, that there was an increased level ofhirth defects of women who live within two to five miles of vinyl chloride monomer plants. The nature of these birth defects was central nervous system. The thing I find, as the vinyl chloride coordina tor for the Agency particularly interesting wa3 that the''birth defects were of the same type a$$ those found . . . here in the United States as was found in Norway. I also find that three times the expected level here in the United States -- Two times the expected level in Norway, is not being able to say a non-demonstrable health effect. I would also ask the guestlon, why does industry leave it to Government to do these kinds of studies? Why hasn't industry taken the lead and looked in the environment? why must the Office of Toxic Substances conduct these kinds of things in the community? I feel it is part of the industrial responsibility to look around the communities they work with and go about and see if there is any problem, because we are now involved in a rather expensive and difficult decision to srfcm r /^sportin') ompanij AP00028137 5 :i 7 $ $ -11 Uj 13 I 1*1 I 15 16 17 j 18 ! 19 20 21 22 23 21 74 look at communities in which vinyl chloride monomer exposure would be the greatest. Secondly, to define the population at risk and to, thirdly, look carefully at medical help to determine i whether thore : has been any morbidity, I don't think tfto only reason one regulates is that people will get cancer or are dying in the streets. I would hope that you could answer why industry has not, at least you,have not looked at this? MR, HARDING* I would be glad to take first -- ' I think there are four questions there, \ ... I don't have, myself, the knowledge to comment on the Norway study, I believe you have some -- A report by CDC on the studies in Ohio where they concluded differently from Dr. Infante. X believe there is also another study that is being referred to, which Is not yet published, and we have not had the privilege of seeing it as some other people have apparently, relative to a study jointly conducted by industry, labor, government* S to further investigate the area that Infante talks about.' Again, by hearsay, I understand that report does not come up with very alarming information, but I think this is an area where both the record of this hearing and the situation needs to have further information. With regard to the studies you are referring to. rrftnn *> i ti AP00028138 1j l 2 li l; i i! 4 5 6 7 8 n !i li 10 -11 12 1.3 14 15 In 17 13 19 20 21 .22 23 24 25 75 let me just partly remind you, sir, that it was the industry supported research that discovered the problem in the first place. Furthermore, we have proposed and there is discussion underway, we have proposed that there be joint industry-government-labor-public studies. We are not asking the Government to pay for all'cf it. We are being, very, sort of, if you will, restrained in promoting this. We want this work to co ahead and we would rather not have it be anything but joint, a joint sponsorship. In today*s climate, if' industry were to pro- ' pose and finance and announce these studies unilaterally, today's climate stakes it likely that the findings would not be accepted, and we think the subject is too important for a discussion of methodology, and indeed, the facts covered by this study, there will always be a discussion of interpretation. But, we think`it is much more important that we get on with the work. He aren't asking the Government to do it all. We are asking the Government to help see it is brought about. DR. MARCUS: Do you recall when you were first informed about the Maltoni studies, and we were first ` informed of the dates, to your knowledge? MR. HARDING: This whole timetable, this whole AP00028139 chronology has been rehashed and rehashed and rehashed# in and out of the press. Are you asking we when X was first informed? DR. MARCUS: Mo, when Maltoni first informed industry and industry first informed epa? MR. EARDING: Maltoni, as I recall, first.' announced that he had some rats with tumors and X hope X will be allowed to eorreet this becauso I am doing this from memory rather than notes. But, it was in the spring I believe of 1972. Is \that right, 1972? A VOICE* Three'; MR. HARDING: Three, all right. Ho, a study at a seminar in Italy when a number of people from both I industry and 'Government' were `present. That-was the first announcement of the subject, and nobody really took *" ' it too seriously,at1 that time. It was just a preliminary finding. I am trying to work back. X think it had to be in the spring of 1972. But, In any case, this study had been going on. It is the kind of study, as you well know, where preliminary findings are not particularly valuable. It is just to carry it forward. He was*not originally going to announce anything until about 1975 on this study. DR. MARCUS: T would like to say-something in cm vanij AP00028140 1 i! 2j 3 `l 5 6 7 3 H 10 n 12 13 14 15 16 ! 17 IS 19 20 21 22 J 23 24 25 77 defense of industry which is kind of an unusual position. But, it is not the position of the United States Government\ a priority to eliminate data conclusions or studies done by industry because they are done by industries. I might compliment Dr. Oehring's studies, they are very well done. We accept that data, and in part most of the conclusions, the same is true of Haskall Laboratories and otherpLacas, because done'by industry does not make it unacceptable to the United States Government. We have now a plan in our office in which we have engaged the industry, the society for the industry v * ** and Government, and State Governments, to look at the particular problems, so we can work together. My*question Is why, when industry found out there was a possible problem, didn't they initiate this kind . of study. And, I hope in the future should something else come along that we will not have to go through the bureau cratic process to do that. It just takes us too long. MR. HARDING: The industry did'announce it. The industry did start it. Almost all the work on vinyl; chloride has been financed and sponsored by industry. Hindsight makes it very clear a lot of things could have- happened sooner. But, in terms of what was found out and done about it, we moved pretty fast, and we have not really tried to hide the subject either. ft C- t AP00028141 Dn. MARCUSs I never meant to imply that. MR. HARDING: I know that. I think we tend to agree. I think we are reaching the same point that more data, more understanding is needed, and wo are hopeful this can be done on a cooperative, joint-basis. DR. MC GAUGHEYr I would'.like to follow up on this last point you made. In your conclusion you mentioned that several research studies on the health effects on the populaton of vinyl chloride are needed, and I am wondering First of all, I would he very anxious'to see detailed ; statements of just what studies you think should be done. . . Secondly;,' I was wondering whether or not you think r-- I would like to get your ideas on whother you think these studies are necessary before we promulgate the regulations. In other words, how long do you think we should wait to get these studies, or do you think our current information is adequate to set the standards? MR. HARDXNGs I do not think it is our intention to put these studies in front of the promulgation of the regulations. DR. MC GAtJGHEYt You do not see these as effecting MR. HARDIMG: I think it is a matter of getting more and better information, so we all understand -the A & ,. S> ' AP00028142 WU i I methodological problems in trying to answer & question like, that, and how would you propose going about it? i J MR. HARDING! Again, I think thi3 is what this group is attempting to study, find in today*s time with the measuring techniques available, and the vaguaries of the kinds of data that are being developed, we are never going to get the finite absolute answer, but we should get a little closer. TvTe are talking about methodology and wo are talking about more studies along these lines. Dr. Gehring is going to talk about this, t--* ' Again, with the protocol, and the priorities, '' ' if you will, a matter of joint development so that we can in effect study your data versus our data. Not between Government and industry, and get on with knowing more. "/ DR. KDZMACK: Your feeling then, the study on j the metabolism of the substance in the body is one of * j the main sources of shedding light on tho threshold quastior? MR. HARDING: I do, but perhaps others are going to add that there ard other studies that are equally valuable. DR.KUZMACK: I think one of-the. problems we run Into in this sort of thing is that you start testing .- animals at very low levels. It requires thousands and thousands of animals to really got anything, and it is e.Ctnpatty AP00028143 31 1 really questionable about the feasibility of that sort of ! 2 thing. . 3 MR. HARDING: I agree. j >' i 5 6 7 8 3 i 10 11 12 CHAIRMAN DENNEY; Are there any other questions? Dr. Knclson. DR. KNELSON; We have been talking about joint 1 research by industry and Government agencies aid Government institutions, either conducted jointly or shared. There is coming into existence in Research Park, North Carolina,some research. Is SPI becoming involved . with this? MR.HARDING: '\Tf ,>rA . AM'1, * *.V X think all the members of that ^ company are members of our organization and there is Ut li&son already established. We will not be, per so, a 15 - sponsor, but through our joint membership there will be IS 17 | I w! ii 19 a close relationship, keeping in mind that most of-our concerns are involving the plastics industry beyond -when the material becomes ready for shipment. There ere other segments of the chemical industry 20 which have concerns primarily back into the chemical 21 process. So, yes, there is going to be -- 22 There are high hopes in our whole industry about 23 the value that lies ahead from the kind of work that will . 21 be done by the Chemical Institute, the Institute of Toxicology 25 DR. KNELSON: You say that although the costs are {Company AP00028144 great, the industry as a natter of principle, is dedicated ' to health of the population end that it not be jeopardized by polyvinyl chloride or polyvinyl chloride resin. X am sure you would make the sane statement with regard to any of the products, not just PVC; is that correct? .. MR. HARDING: Sure. DR. KNELSON: Would you care to comment on your Society's position vis-a-vis pending toxic substance - legistlation? j MR. HARDINGs X am not an expert on this subject; having been otherwise involved, but I would say that the plastics industry recognizes a need for some control being exercised in this area. At the same time, we recognise a balancing need not to stifle the introduction and development of new materials. That some of the control being proposed are extremely arduous and we think unnecessary. So, we are looking for a more modern approach to this. CHAIRMAN DENNEY: Dr. Marcus? DR. MARCUS: Would you please identify the areas . of 776 which you feel are far too restrictive? MR. HARDING: May I comment in writing to you on this,; please? * ............. __ ............................ IQtporiitty Company - AP00028145 I .. .. 1i *1 2 w0 i HR. BEVERIDGE: May I say this is far beyond the ' bounds of these particular hearings. Dr. Denney. 1 The question was asked which particular portions of 4 i 51 i the toxic ' substances bill Hr. Harding finds too restrictive^ and may I address a procedural motion, if you will , to you 6 - / to say it Is far outside the bounds of this particular 7 hearing# ... S MR. DENNEY: Yes. ' "*# 9 MR. BEVERIDGE: And, if va want to respond, we 19 will respond to it in writing. , : 11- MR. DENNEY: .You do not have to respond to that. 12 Your views were solicited, but you are not bound to respond ^ 13 to that. If you care to submit it, you may. - .14 .. -i 5' * *5 DR. MARpuS: I would like to explain why I asked that question. It seems to me you have had a particular 16 exposure to what can happen, should a chemical be introduced 17 and then there be a very unfortunate set of circumstances 13 set into motion. 19 I was hoping to benefit by your experience with 20 your response. I will be looking forward to your written: 21 response. 22 MR. HARDING: Acknowledged. 23. .... - CHAIRMAN DENNEY: I have one question. It is . .. r> a< a tough question I think, but I would like to hear your 25 response to it. ...... - . .. AP00028146 3 ii 4 ! .i i?hy should a porson who does not bear the direct or even indirect benefits from an activity have to suffer ; i j any risk from an activity? i MR. HARDING; That gets right to the heart of f> the whole thing, doesn't it? 6 CHAIRMAN DENNEYi t think it does. I would* 7 ' like to hear your response. g MR. HARDING: Say it again, please. 9 CHAIRMAN DEWEY: Why does person who does not 10 derive benefit from an activity be subjected to any risk- U from that activity?* Specifically, someone who lives near ; 12 a vinyl chloride plant who may be subjected to a relatively 13 low risk, have to ' bear any risk, if he does not benefit 14 in any Vay fife that plant? ' l ^ v 15" MR. HARDING$ We are< not in a position in industry 1G today to make sure that those risk9 'are kept at the minimum. 17 But, I think that Individual has to recognise a part of 13 a society beyond the community in which he lives. 19 This cuts ' into the whole question of how we 20 deal with clean air and clean water and the substances that Z j. are injected therein. 22 I don't think you can justify undue exposure and 23 there is a need to clean up and to protect people, but 21 I thin): the approach the agency is taking in vinyl chloride \ 25 is to minimize the risk, take it to the 95 percent below ^4cm ompant AP00028147 3i I 5 6 7 a u 10 11 12 13 14 15 IS 17 IS 19 20 21 22 23 24 25 what it vas, and to decide that this is a socially acceptable risk. -) % t I think we are engaged in that kind of discussion whether we realize it or not, all day, every day, in everything w do, including watching our children walk off to school. CHAIRMAN DENNEY: Let me say r agree. It is a very central Question that enters into all of our activities I want to emphasize I do not think it is unique to vinyl chloride. I just wanted to get.your reaction to it. I might have one further question ..;` If no one else has any further questions, thank you, Mr. Harding, I appreciate it and the gentlemen with you. * . -V t . ,: ~ ***** v , Will the^geritlemen from Dow Chemical please come . forward? Hopefully there will be no technical difficulties, but there are some technical complications. Some slides were planned to be shown directly behind us, on us, or under us. I am not sure what happened. We possibly should start to see if x*e can get them up here, before the Dow people start their presentation, and then we will know whether we are going to have problems. . .;i* - Mould someone please project one slide up? Can the panel members move out of the way? Is that relatively ^*$r*n.* $vr*orftn ^ AP00028148 96 ;! clear? would people rather have more lights? Are you -^.satisfied with this? w Before ve begin I would like to ask, first off, approximately how much time do you anticipate you will need to give your testimony, leaving questions aside? HR. GEHRING: One-half hour. CHAIRMAN DENNEY: All right, one-half hour for Dow, and it is ray understanding and I hope People here will correct me if I am wrong, that Air Products and Diamond 10 Shamrock are planning to appear, but very briefly, a total' 11 of five or ten minutes, is that incorrect? - v., 12 A VOICE: That is correct as to Air Products. U CHAIRMAN DENNEY; How about Diamond Shamfcock? 14 A VOICE: Also correct. - 15 16 17 13 ii 19 CHAIRMAN DENNEY: What we will try to do then .is _ try to complete the hearings this morning. We should be done at 12:30 at the latest, but we will try to wrap it up this morning. The witness for Dow, I. believe is Dr. Gehring. 20 DR. GEHRING: Yes. 21 CHAIRMAN DENNEY: Would you please introduce the .22 gentlemen with you, not on the panel. Dr. Marcus wears 23 many coats. 24 STATEMENT OF P, J. GEHRING DOW CHEMICAL, USA. 25 ' f'sejjorfing dmp<ilAj^ AP00028149 87 I' 4} I\ 9 10 I i i11 12 I 18 14 15 16 17 18 19 20 21 22 23 21 DR. GEHRIKGt First of all, I an Dr, Gehring, and I am the Director of the Toxicology Research Laboratory of Dow Chemical. On my left is Mr. Paul Hill who is an employee with the Dow Chemical Company. I assume I do not have to introduce Dr. Marcus. CHAIRMAN DENNEY: He shouldn't be taking a job with industry. DR. GEHRING: Z have a slight cold, so if I sun not talking loud enough raise your hand and I will try to conform to your desires. The purpose of my testimony is to inform you of studies being conducted in the Toxicology Research Labora tory of the Dow Chemical Company on the fate of vinyl chloride in the body arid how the results of these studies relate to assessing the potential hazard of low level exposures, to vinyl chloride. These studies have been supported in part by the Manufacturing Chemists; Association as well as The Dow Chemical Company. The studies I will describe are referred to technically as the Pharmacokinetics of vinyl Chloride. Pharmacokinetics is the study of the dynamic process involved in the absorption, distribution, metabolism and elimination of chemicals from the body. Toxicity, including carcinogenesis, is caused by the presence of a specified amount of a chemical or yn ntf AP00028150 , ii 1 ii 7 Si c 10 11 12 }S 14 15 IS 17 is i 19 20 21 22 23 24 25 an its degradation product in tissues and colls? and subse quently reversible or irreversible reactions of these materials with cellular tissue components. In essence, toxicity is a measurement of what selected doeses of a chemical or its degradation product do to the cell, a tissue or the body. Pharmacokinetics quantitates the presence of the chemical or its degradation product In the cell, a tissue or the body. Knowledge and consideration of both are inextricably associated in i utilising the results of toxicity evaluation of high doses.;* to predict the hazard of low doses* To illustrate further my point. Slide 1 shows a typical cose response curve for the percent of individuals in triangles in a population responding adversely in some manner to selected doses of a chemical. The sigmoid curve represents a response of a population described by a normal or Gaussian distribution. These adverse responses are discernible over only a range of doses represented by the solid line because the investigator is limited by the number of individuals he can include in such a study. It should be emphasised that in theory the tails of the sigmoid curve nevor reach zero on the low dose side and never 100 percent on the high dose side? that is, the curve approaches zero and 100 percent asymtotically* ^c/n# (^nmpa.tu AP00028151 89 1J 2!> * ). - t! `2 i! [ 5i The adverse effect, cancer as well as other untow ard- effects, will occur in theory no natter how low the dose if the population is sufficiently large. However, for most adverse effects, experience leads us to conclude that there is a dose^fcelov which-adverse effects will not 6 occur; that is there is a threshold, because drinking two 7 v one-fifths of alcohol over a short period of time would kil] S some people, we do not conclude that one drop of alcohol S will kill some. 10 This is another effect X would point out, that , l i alcohol is also responsible for the production of liver ' 12 cancer. 13 A simplistic scenario is that for a faster runner 14 to pass a slower one, he needs to traverse ono-half the .13 distance between ,the two, then one-half that distance and lfi so m? one mathematical theory suggests the faster runner 17 can never pass the slower. 15 However, definitive observation leads us to 19 reject that simulation. Unfortunately, such definitive 20 observations V. :'nonexistent for carcinogenicity and X believe 21 will remain so for a long time. 22 Tn the case of carcinogenicity, stochastic, 23 guess work by definition, statistical projects are made from 24 the range of over which an increased incidence of 25 cancer can bo perceived to predict what percent of individual's ^cm< /?crtarlinn - AP00028152 90 may respond at lower doses. The a priori assumption for 2 li reading such projections is that the chemical is handled i j the same by tho body as the dose decreases. If the dynamics 4 for the fate of the chemical change, such extrapolation is 5 not valid. Conceptually/, it is not surprising that the toxicity, including carcinogenicity of a chemical is 8 expressed only after the detoxification process of the body 9 are overwhelmed. In such cases, the response of the 10 population may be more accurately described by the other two U dash lines in the lower left-hand corner. r' 12 That is, you do get a bending off of the predicted 13 dose response. 14; Having provided the above background, I will.proceed 15 to describe the results of studies which show that the.,!.', 18 dynamics of the fate of vinyl chloride in the body change 17 with dose and exposure levels. Inltally, the motivation for. 18 these studies was results of Maltoni which suggested < 19 stroncrly that the Incidence of cancer in rats exposed to 20 50 parts per million was less than that predicted from 21 exposures to levels ranging from 250 parts per million 22 to 10,000 parts per million. 23 I would.also like to indicate that this has also 24 been a particular research development of ours. 25 In the initial studies, we exposed four rats mpttna AP00028153 ?< these studies, it was concluded that vinvl chlorite monomer is metabolized or " "" !>! decrraded -- re a dil.v7. at low concentretiorvs . --^ and that the primary pathway fog degradation is swarded at ? concentrations exceeding 220 parts ner million. 0 Another objective means of demonstrating that 6 the pathway for the metabolism or degradation of chemicals 7 may be overwhelmed is to administer potential inhibitors 3 of its metabolism. j) The next slide, slide A, shows that the adminis 10 tration of 5ml/3cg 95 percent ethanol inhibits profoundly n the metabolism: of vinyl chloride monomer by rats exposed to 12 an initial concentration of 50 parts per million ethanol is but not of rats exposed to approximately 1,000 parts per 14 % million. '" . 15 In other words, hero we have an inhibitor vjhieh 18 has a profound effect on ono pathway and a less dramatic 17 effect on another pathway. IS In other studies, we found that SKF-525A inhibited 19 by approximately 20 percent the metabolism of VCH by rats 20 exposed to initial concentrations of approximately 1,000 21 parts per million, but caused no inhibition in rats exposed 22 to initial concentrations of.leas than 100 parts per million. 23 Again, indicating there is a divergence of pathways, 24 two differnt pathways involved. The results of these studies led to the conclusion patty AP00028154 ;! that VCM must be metabolized by at least tvo different I; pathways. The primary pathway for metabolism is overwhelmed j! as the exposure concentration is increased until at ccnccntralj |i tion exceeding 220 parts per million, the secondary pathway :i predominates. Slide 5 illustrations my point. It is in somewhat a more simplistic fashion. In this slide is shown a barrel with two slits in it and the amount of material coming into :j the barrel increased as you go from A to n to C to D, and 10 of course, at some point it is just dripping in. The one 11 slit will handle the elimination of the material, but if you .. 12 j increase this to very large levels the capacity of this 1* ; slit is overwhelmed and it begins to flow out of the other M slit in the barrel. 15 So, hascially, we *.ar! interested in what is the IS relationship of these two slits to the toxicity and perhaps 17 carcinogenicity of vinyl chloride. 18 In Subsequent studies, wo were fortunate to have 19 radioactively tagged Carbon 14 to follow the fate of VCM. 20 This facilitated greatly following the disposition of the 21 11 administered VCM. 22 Slide 6 shows the percent of C-14 activity 23 eliminated via various routes following different single-oral 2-1 doses of VCM in corn oil to rats. The C014 activity expired 25 i 14 14 consisted of eo, and C-VCM. 4 The C-14 activity found in urine, feces and carcass and tissues represents nonvolatile -/lem* fcfr no+fttty C^urtpnntf AP00028155 $4 .etabolits of vcm. The key itcn to notice in this slide is that the ;i _&ose is increased from 0.(75 and 0.X0 mg/kg to ?0 and 100 fi ,mg/k<r, the percent exoired as VCM increases markedlv while j| the 1other parameters, particularly urinary excretion of the C-14 !> 1 'activity, correspondingly decrease-. , Again, this demonstrates that tho primary route for the elimination of vinyl chloride from the body is i! <dose depending; that is, the primary route is overwhelmed 10 \ jand more begins to spill out via other routes, the upper slit n jin the barrel. ! 12 " "" ' |. jj 12 Since urinarv and pulmonarv excretion of vinyl )chloride was dramatically altered as the doso increased from i|. M pne to 100 mg/kg> the question is raised whether these processes 15 elimination may be a function of dose. This question ts -an be examined via elucidating the rates of elimination. 1? Slide 7 shows a plot of the logarithm of the 13 i!'C-14 activity eliminated via the urine as a function of 19 jtime. Since the slopes or rates of elimination are Unchanged, 20 L must be concluded that urinary excretion of nonvolatile* - 21 metabolites of VCM is unaltered by dose. 22 Slide 3 shows similarly the expiration of vinyl 23 chloride per se follovfn<f-s;ariodv doses.1: Elimination follow 24 ing 0.05 or one ng/kg occurred in accordance with a first-orderj 4|rate of mono-exponential process. j}'*.. %.vorlin/t AP00028I56 j! ii 1 '! I 2 ii ll I When 100 mg/kg yas given the elimination was biexponontial. The rates or t 1/2 time for elimination are indicated in the figure? those correspond to those reported for blood by Withcy, the Candian rood and Drug. oi These results are indicative of a material which is bound reversibly to some site in the body having a finite capacity. As the dose increases, the availability of these o !| binding sites decreases and the chemical is free to find ij its wav to other sites as well or to be eliminated. 10 S Thus, it may be concluded that the expiration of vinyl, n t2~ chloride monomer foilwing differnt doses indicates that the pulmonary excretion of vinyl chloride monomer is not J3 : 14 * i1 i 15 j I' IS a rate limiting step. Even more important, the data indicate that the state in vhich vinyl chloride monomer exists' in the body changes with dose. " Slide 9 summarizes the dose-dependent excretion 17 of vinyl chloride via urinary excretion, solid linev and 1H pulmonary elimination, broken line. 19 The area demarcated by the rectangle represents 20 that range of doses over which distributive or metabolic ai saturation occurs. It is noteworthy that in ongoing 22 carcinogenicity studies, Maltoni has reported an angiosarcoma 23 j of the thymus in a rat give 50 mg/kg per day and one of the 21 ! liver in a rat given 16.6 mg/3cg per day. No tumors have, as yet, occurred in rats given 3.3 mgAg per day. Company AP00028157 u !i !| >i . ,j Although the data collected from studies in rats 2, jj given oral doses of vinyl chloride elucidate tho dose- ! < ! 'j A :! , :i ' j! dependent fate of vinyl chloride, these hearings are'-. mere concerned with, inhalation exposure. Slide 10 depicts the fate of C-i4 vinyl chloride in rats exposed forsix to ten hours or 1,000 parts per .million, immediately following the exposure, the rats were placed in cages providing for collection of C-I4 aofcivity in the expired air, feces and urine over the 10 ; '( U! subsequent 72 hours as can be seen. As in the experiments in which oral doses were given, the presents of 0-^14 activity-- 12 | 13 * I I 14 j 15 | expired as VCM increased as the exposure increased.. Also to be noted in this slide is that the percent of. Crl4 activity found in the tissues and carcass increases -slightly as the exposure is increased from ten to 1,000 ! parts per million, although not statistically significant, 17 if you look at carcass and tissues, you can see the percent IS !i increase from 13.8 'to 13,48 percent. I would not request that anyone attach a great 20 ] deal of significance to this, except this is a rather 21 remarkable finding, because a much larger fraction of the 22 vinyl chloride was expired as vinyl chloride per ae.23 So it is not normalized for the actual amounta 24 This may mean that a larger fraction is being 25 bound to the macromolecules of tissues. This aspect is being ^Aetnt f^rporliny AP00028158 97 1 il 2 ii l Investigate currently since such reactivity may explain carcinogenesis. H. 'J 4 i! 5 ii The two subsequent slides Bhow the elimination of C-14 nonvolatile metabolites in the urine and vinyl chloride monomer per se in the expired air. This is the elimination 8 in the urine. You can see again these processes go on 7 about the same rate regardless of exposure, and this is the expiration of vinyl chloride in the air. Again, these results support the conclusions of IU. previous studies, one, that the fate of vinyl chloride 11 monomers changes with dose and, two, that this occurs because 12 the primary pathway for the metabolism of vinyl chloride 13 monomer is saturated at high doses or exposures. 14 TN Since the metabolism of vinyl.chloride monomer 15 appears to occur via, at least, two saturable pathways, ig ; 17! 18 i ! a considerable effort has been made to elucidate the metabolites of viny chloride. Already it has been demonstrated that a measurable 20 i ?.l amount of vinyl chloride was metabolised to the end-product of mammalian metabolism, that is, carbon dioxide. Using high pressure liquid chromatography, three 22 major metabolites have been isolated from urine. Two of 23 the three have been identified by gas chromatograohy-raass 24 spectroscopy. These are shown in Slide 13. 25 Metabolite A is N-aeetyl-S (2 hydroxyethyl) AP00028159 cysteine. Metabolite B is thiodiglycolic acid. Together 92 i i these metabolites comprise 50 to 60 percent of the * 1; radioactivity found in urine. Both of these metabolites i *1 are likely formed from the compound shown at the bottom, 5 2-hydroxyethyIcysteine. 6 .. At one point in time, it appeared that the third 7 major, metabolite in urine, comprising about 30 percent $ of the radioactivity, was this compound, shown at the bottom. {> Even though some analytical comparisons between the IQ isolated metabolite and. 2-hydroxyethylcysteine favored this 11 conclusion, others failed to establish identity. 12 Another way of saying this is that we conducted 12 one to many experiments. M The finding of these metabolites of vinyl chloride 15 in. the urine indicates that vinyl chloridetnoncaner- is 18 transformed in the body to a reactive intermediate metabolite. 17 Thi3 reactive metabolite is detoxified by reaction with IS ; >,! glutathione, a tripeptide containing glutamic acid and glycine as well as cysteine. 20 Subsequently,the glutamic acid and glycine moieties 21 ! of the tripeptide are cleaved and the cysteine conjugate 22 of the reactive metabolite of vinyl chloride is either 23 acetylated or further oxidized and excreted as the 21 \ aforementioned '.metabolites. 25 Before leaving the subject of metabolism, it is -Mem* jQeporiitty Company AP00028160 99 important to state that the metabolites of VCM were not changed either qualitatively or quantitatively as the dose i; ;; or exposure level was increased. j: Since evidence has beenvpresented showing that there are at least two pathways for the metabolism of 6 vlny cloride monomer, this indicates that both pathways 7 produce reactive metabolites leading to the same end 3 products. Our initial work and subsequently that ? of others, end X refer to that in the document by Kappus 10 et al, 1975; Dolt et al, 1975 and Barbin et al, 1974r which U indicates that one pathway involves oxidation of vinyl 12 chloride monomer by nicrosomal enzymes to chlorothylene 15 oxide. The other pathway, yet to be identified, is, we 14 'feel, the primary pathway at low doses or exposure levels; 15 it is blocked by administration of ethanol and is very likely IS i! located in the soluble fraction of the cell. 17 I Reactive intermediates produced by the latter IS pathway are less likely to induce toxicity or cancer because 13 | critical macromolecules-protein, DMA, rna -- are less 20 proximate to the site of their formation. This concept 21 j| however, I concede is speculation at this time. 22 Now, I want to return to a subject which is 23 less speculative. As I indicated previously, the reactive 24 metabolites of vinyl chloride monomer are detoxified by 25 reaction with gluthathione. This is very important because AP00028161 100 \l 1}{ it has been demonstrated that when high doses of some 2 'j chemicals, for example fcromobenzene and acetaminophen are .[ given the glutathione is used up at a faster rate than it can be produced bv conjuaation with the reactive intermediatesJ As the level of glutathione in the liver is I i l> ! progressively depleted, the reactive metabolites react with 7 macromolecules such as protein, DNA, RNA, loading to' * 8 if toxicity, Gillette, 1974a and 1974 b, two articles. Generally, it is accepted that at least one mechanism for chemical 10 carcinogenesis occurs via such reactions. n To assess the effect exposures to vinyl chloride 12 may have on hepatic glutathione levels, rates were exposed 13 to concentration of 10, 50, 150, 250, 1,000 or 2,000 parts 14 per million for durations of one to seven hours. The results 15 are shown in Slide 14, IS ! Exposure to 150, 250, 1,000 or 2,000 parts per million 17 l -vinyl chloride monomer caused a progressiva depression of )c . the hepatic nonprotoin sulfhydryl' content,* the hepatic i 19 ! nonprotein sulfhydrvl content is primarily glutathione. SC SI Exposure to 50 parts.per million for seven hours 4 produced a small and inconsistent depression. Theri was 22 a considerable variability because we shoved the number 23 of rats in this concentration and some shoved it and some 3*1 didn't. i. 25 | No depression was observed in rats exposed to ten C.DMIiilny AP00028162 parts per million vinyl chloride monomer. These -----------s results indicate there is a measurable biological threshold for the depression of hepatic glutathione-: levels induced J by exposures to vinyl chloride. Unequivocal depression? afe produced by concentrations exceeding 50 parts per million, while expsoure to 50 parts per million seem to be a transi tion zone and exposure to ten parts per million causes no depression. Kow do* these results relate to the carinogenicity "of vinyl chloride? In the studies f.Maltoni and Lafemine, 1975, the reported incidence of angiosarcoma of the liver in rats exposed four hours a dayr five days a week to 2,500 or 6,000 parts per million was 2? percent* The incidence in rats exposed'to 500 and 250 parts per million wer.e, respectively, 12 and seven percent. Reference to the figure indicates that the depression of the hepatic non protein sulfhydryl content observed after four hours of exposure coincides with the increased incidence off r*giosarcoma. In the study of Maltoni and Lefemine, 1975, an incidence off two percent agiosarcoma of the liver . occurred in rats exposed to 50 parts per million vinyl chloride monomer. As I indicated previously exposure to 30 parts per million for seven hours caused a small and inconsistent depression off the hepatic nonprotein sulfhydryl ^/Jcnxo j^taorflnO ttanif AP00028163 ! IV * - 1! content. I also indicated that this exposure appeared to bo in the transition zone of the threshold for this bio 1 i! i i! logical effect. In a recent publication by Maltoni, Ambio, Volume 5, 1975, not only the incidences of angiosarcomas of 6i i i _i ' Ii * i i *. 'i the liver were given but also the latency periods for their development were provided. The latency periods were 4, 70, 78, 81 and 79 weeks in rats exposed to 10,000, 6,000, 2,500, 500 and 250 parts per million respectively. 20 . So, you can see, they are pretty much the same. n The latency period was the sane regardless of exposure 13 i i Mi level. However,, in rats exposed to 50 parts per million, the latency period was 135 weeks. Indeed, tumors were t IS iii IT i i i 2S ; ! 10 i i 20 i discovered in these aged rats when they were killed at the end of the study. Since the tumors in the former croups of rats were discovered 'as they died spontaneously, the discrepancy is even greater than the values indicate. the latencies for the development of other types ___ of tumors showed the same discrepancies. Consideration of- 21 these results leads me to conclude that in rats exposure to 22 50 parts per million vinyl chloride monomer four hours a 23 day is in the threshold transition rone for not only/', 21 hepatic nonrrotein free sulfhydryl depression but for tumor 25 induction as well. tuff C. AP00028I64 103 In summarizing the studies on the pharmacokinetics and metabolism of vinyl chloride, the data indicate that the fate of vinyl chloride in rats is a dose-dependent 1 ii 5 i! il 1 I ! .'7 | s! i 0 process following either single oral administration and after inhalation exposure. More importantly, it appears from the data available that a correlation exists batween doses of vinyl chloride monomer that cause tumors and thosethat saturate metabolic or detoxifying pathways. The primary detoxification pathway for vinyl 10 chloride which appears saturable at high dose levels,, :n- -involves conjugation of its reactive metabolites with. . 12 i [ .33 I nonprotoin sufhydryl groups. Therefore, it `seems reasonable to postulate that as the nonrurotein sulfhydryl groups are 14 depleted, ractive metabolites may be free to react- With 15 other-macromolecules DMA, TINA* Protein, lipids, resuting 13 in toxicity and carcinogencity. 17 Recent reports have demonstrated that*in the presence 16 19 i of fortified microsomal enzyme preparationsreactive metabolites of vinyl chloride momercter are produced which covalently *20 bind to rate liver microsomes protein sulfyhydryl groups, 21 SNA and adenosine of DMA. 22- Inclusion of.glutathione in the system will 23 decrease or 'preclude these reactions depending on the 24 concentration. It is highly significant that exposure to 25 ten parts per million vinyl chloride for seven hours caused & Mftnntf AP00028165 1i no depression of hepatic nonprotein sulfhvdryl content. 104 ; i i , This indicates that there is a threshold of exposure 4i * in rats where the ability to replace sylfhydryl croups is not overwhelemed and physiologic defense mechanisms remain fully operative. Furthermore, this suggests that thresholds exist for toxic effects which are expressed 8 ii with greater intensity as this protective mechanism is depressed. Studies currently in progress are designed to characterize the macromolecular binding of vinyl chloride \0 ' monomer to protein and Nucleic acids following exposure 11 to various concentrations of 14 C-vinyl chloride mesnower. 12 Finally, I want to reemphasize strongly that stochastic, !? statistical^projactions utilizing data collected from 14 rats exposed to concentrations exceeding 100 parts per 15 million arc invalid for predicting the hazard of lower 15 levels exposures. Such projections violate the a priori 17 assumption that the dynamics governing the fate of the 13 compound are unaltered. 19 Our pharmacokinetic studies on the fate of 20 vinyl chloride monomer show .that the dynamics for its 21 . dispostion change as the dose or exposure level is increased. 22 Also demonstrated was a threshold for the depression of 23 hepatic glutathione. 24 Finally, the discrepancy between the latent 25 period for tumor development in rats exposed to 50 part3 $*porlinq Company AP00028166 i! =I per million vinyl chloride and the latent periods for those'exposed to higher levels indicates a threshold for O i! tumor development exists. Thank you. CHAIRMAN DENNEY; Thank-you. I was saying many -6 | i 7 ii si of the same things to my wife this morning. '(Laughter) CHAIRMAN DENNEY: Hava you any emostions of u Dr. Gehrino? 10 Mr. Farmer/ do you have any questions?- ix MR. FARMERS- No.'. - /' / -.*\ 12 13 I CHAIRMAN DENNEY; Ms. Wyatt? MS. WYATT; No. 14 CHAIRMAN DENNEY: Dr. Knelson. 15 DR. KNELSONs. Were you the one that I get to 18 j i 17 1 ask what the criteria for carcinogens are? . DR. GHERINO: I guess I am the one you are going *.8 to ask that of. I'd I think these are under much debate, as you know. 20 I feel that X have very little -- Well, the criteria are 21 whether an agent administered to an animal or an individual 22 will cause cancer, simply that is it. 23 Now, that defines, for me at least, the potential 24 to produce cancer with that particular given dose. That 25 to AP00028167 106 1 does not Indicate that lover doses vrill have the same 2 i sort of activity. ;i ii - ! DR. KNELSON:_ That is a very simplistic definition i !! of carcinogenises. So, let's get into the meat of it 5 very quickly, and in the interest of time I will ask 6 a few pointed questions. 7 You made a great -- Admitted a lot of the varying S latent period with varying do3es in these studies. At the lowest level it took a long time, a long latent level. 10 At the higher dosage there wasn't much latent period. 11 Did-that surprise you? r V 12 ; DR. tiSKRXNGs No, it does not. 13 What did surprise me though, there- is something 1-1 that did surprise we, and X. tried to point that out and 75 X~will reemphasise it again. IB The fact that the dose levelsof 200, 3,500, 6,000, 17 10,000 and- sc on had latent periods which were identical. :3 t There would be .no differences in the latency periods, . 19 whereas this one was cmite different. So, that really 20 indicates to me at least, that the mechanism is changing 21 dramatically, and to make projections to me, one should 22 utilize -- One cannot throw out the high dose data. You 23 should use all of the data, 'and X think one of the most 24 valuable projections at this point in time is using that 25 " r data and finding out what the deviation at the lower levels jlcmt f^epartintf Comprint* AP00028I68 107 \ moans. 2 DR. KHELEOff: All right. Now, at the low dose level there is a long latent period. What were the tumors 1 that were discovered in the mice? S DR. HERRING? These were rats. 6 DR. KNELSOW: The rodents. . When they died finally, 7 and wore autopsied? 3 DR. GEHRlNGt One had an angiosarcoma of the liver, \1 and one had an ephoblastoma (Ph.) 10 V' .jV.' . DR. XNELSONs Do you think that tumors that 11 occur spontaneously in an experimental animal, when that 13 spontaneous occurrence is speeded up, doec that constitute is in other words) earlier induction of an otherwise spontaneously 14 occurring tumor? Does this constitute carcinogenlses? 15 DR. GRHRIRG: That one is a very difficult one to Id. answer obviously, because you could be potentiating the 17 effects, latent effects, of viruses in laboratory animals. IS DR. KNELSON; 1 am just asking you whether you 19 think that is a valid test for carcinogenises? 20 DR. GEHRING? Yes, I think it is something for 21 you to look at, definitely. 22 DR. KNELSON: You would just as soon put off getting 23 V- - /. *'*'* T. a tumor, wouldn't you? 1 24 DR. GEKRINC3? Yes, of course, but again, X emphasize 25 that in the case of rodents, and I think this has very AP00028169 109 little to do -- I an not questioning the angiosarcoma production in these rodents, or the fact that it was produced fay vinyl chloride, but to keep the issue open, X -think the speeding up of tumors -- For example, let me point this 5' i 6j out. If you reduce the dietary intake of rodents you tremendously delay by one-third, you tremendously delay, 7 i 'the reduction of spontaneous tumors induction. 8j I r. ' Poof* this tell us we eat. too much and ought to reduce our dietary intake by one-third? 10 DR. KNELSONs I assume the controlled and VC 11 - dose rats had the same diet? . v 12 DR. GEHEXNfit I am not questioning the data that n have been gathered in this study* I am ,just 3aying -- 14-; i I was responding to your qeustion of what I feel. 15 :- DR. KNELSON: Do you think transformation of a \ IP benign tumor into a malignant tumor is related to an 17 ! -environmental fact constitutes oarcihog^nisea?' IS DR. HEHRING: I would say yes. 19 CHAIRMAN DENNEY: Dr. Marcus. 20 DR.*' MARCUSr ` A very interesting paper. 21 I would like to ask just a few simple questions. 22 do you think that exposure of animals to 24 hours a day, 23 seven days a week, would change what you see in terras of 2'J glutathione content in the liver -- Let's say the vinyl 20 chloride? j i^cporiinQ ?ompnnU AP00028170 DR. GEHRING? 7hat is a very difficult question - to answer* I do not, from the data, we have, for example, you can see that seven hours exposure at the one dose level ten parts per million, did not preclude replacement of the glutathione level, I assume the time sequence there is one that is a very difficult one -- Well, it is not difficult to estimate, we just haven't done it* DR. MARCUS: Do you think that -- j DR. SERRING: It changes spontaneously incidentally. You are looking at a running target so to speak. -V'*- ' ' DR. MARCUS? What animals were exposed to vinyl chloride, lot's say, and not fed, starved, would they have a higher induction rate of tumors than those who are well fed? DR. GEHRISTO: I would expect yes. If what I feel is the case, that glutathione is the detoxifying, the length of detoxification, that not feeding the individual . j j i or lowering the glutathione content by various means would increase susceptibility.' DR, MARCUS: So, vinyl chloride monomer at low doses made the animals somewhat sick, and they do not eat, and their susceptibility increases? DR. GEHRING: I would say that would be the case, but when you say low doses, I would like to have that pnrtu AP00028171 I quantitated. *-V ii I) DU. MARCUS: Below 50 parts per million, for argu- li ii ments sake. DR. GF.JTRING: I would question whether that dose level makes them sick. > DR. MARCUS: T was' getting to the human case in 7 which you have a person who might he more than just a g moderate drinker of alcohol. Would that have any effect t; on the glutathione content level? 10 DR. GEIIRING:. I believe it would. 11 DR. MARCUS: Would that person then be at a,greater \2 risk than you and 1? DR. GEtTRIKG: I believe that is the case. 14 In fact. Dr. Selikoff -- 1 certainly fall into that 15 category ---- but at any rata. Dr. Selikoff has publicly said IS that there appears to be an increased level of angiosarcoma 17 in people who imbibe more than the normal population. IS DR. MARCUS: I think that study has not been 1? published, .but Dills is involved. 20 DR. GEHRING: He made the statement publicly. 21 But, again, those were high level exposures. They \ 22 were not these exposures that we are talking about, or 23 addressingour attention to. . *4 DR. MARCUS: What I am trying to point out specifically, 25 j studies of this nature are important, but I would like to know (^nwunnw AP00028172 II 111 1 :| '-s what you think aboxit exposing animals, let's say, in uteral, suppose somebody lives near a vinyl chloride ol'ant and there is one part per million of vinyl chloride in the air, \ ; or maybe less, or more maybe, and the lady is pregnant and the child crows up in that atmosphere. Do you think i> he is a greater risk than an exposed child? 7 DR. GEBRING: I do not think he is. That is the 8 answer to your question, I don't think that he is. i.j DR. MARCH?t 1 do not remember what the glutathione V<j content in the liver was -- n V . m<i . * r * .DR* GEHRXNGt X think there is more to it than that. 12' You are assuming the metabolic capacity of the mother to Vi handle this material is not predominating. Right now we ii do not have data on the transplanqental transfer of vinyl. ' / * * * * \: 15 . chloride. . * -- '" 15 Whether any gets there? I am sure some does, a 17 few molecules. But, how much this is? \8 One thing I have not related here, but it. is known 12 we have conducted in our laboratories studies on the -- 20 in rodents again -- actually rabbits, rats and mice on vinyl 21 chloride. The effect on the embryo and fetal development, 22 and those will bo reported and submitted to you, but there 23 were no effects. . 21 . Now, insofar as carcinogicity, t believe Dr. Maltoni 25 has some studies and the results are not completed at this "time. " *1-- ^omttetny .............. AP00028173 << 1 ! DR. MARCUS: X am trying to gat at the difficult question of 24-hour exposure. Has Dow done any studies in the carcinogenic area below the 50 parts per million A ft ;i over the two years that Maltoni is talking about? DR. GEHRINC: The answer is no. 6 DR. MARCUS: Can you tell us why he did not initiate 7 that? . ' 8j \ n 'I DR. fJEHRIMG? T can tell you why we didn't. We had other materials in the chambers at the time. It was i& ii. a matter of assessing priorities for a particular material. * . i . ' More importantly, ve did not know what studies 12 i] i, .&..>. I)! i to initiate. We wantod to get some parameters to decide studies that would give us answers. To just pile in a bunch of animals at just less than 50 parts per million, 15- would be an absolute exercise in futility. ! ID You cannot do it statistically unless you understand 1? what the basics are that are going to allow you to interpret 13 such data when you get it. It is a moot point. 19 Wo really do not have -- X hive some ideas now what 20 types of studies could be instituted to provide that 21 final link to cancer, but that has only been gleaned 22 through what we have done. 23 DR. MARCUS s That was precisely what I was trying 1M to get at. Now that we have this kind of information, when 25 do vou think using that particular design -- when do you ompani/ AP00028174 |i \\ expect it to be controlled? \ 113 i \ i DR, GEARING: This is again a guesstimation, I grant you. If our data are correct I feel that none -would be seen at ten, and I may be wrong, 5 ;! DR. MARCUS: I just found it interesting, the i question I am trying to ask you is Maltoni only went down to 50, and I don't know why. DR. GEKRING: He has subsequently gone down more, because in retrospect he would have loved to have gone J 10 down lower. / U DR. KNELSON: One think I have to say, don't forget 13 | It 13 || about the big number problem. We keep talking about the dose rates and the latency periods, and we are talking about U risk rates of one in a million. So, we have got to use 15 !l 1* !} extrapolations, unless you are prepared to set megamillions experiments. 17 j i DR. GEARING: I am not suggesting that at all. IS >i i 19 1 I 20 DR. KNELSON: T want to inject this note of caution into the discussion here, because we put ten rats in a cage at ten parts per million for their lifetime, and you ! i don't see any angiosarcoma. You and I know it does not 22 mean -- 23 DR. GEARING: Absolutely. May I respond to that 21 one thing. 23 Unfortunately, neglected in assessing the risk of P, ir/i i AP00028175 I 114 \ \ M vinyl chloride to workers is the feet that, 1 believe, in * i every ^case of angiosarcoma there were other signs or ii other disease states present. ! We have also, in our studies at Dow which have been published, have examined the liver function of workers 6 and found that one of the most sensitive parameters was the 7. clearance and an aggression analysis v,<as done on this. K X think the animal studies have been, in Maltoni's case, X feel leave that point unanswered, what was the state; 11 12 I I of the animal otherwise? Was there other concurrent or _ concommitant disease states? This is tremendously valuable in estimating risks of a particular disease, that is, 14 15 H 17 15 .19 20 i 21 22 23 2-1 25 cancer, and I don't know where it lies right now. Does it represent the most sensitive parameter oar does it fall to the right of the dosage required to cause other disease states? DR. KNEZ.SON: Are you saying that you think vinyl chloride monomor is related to a variety of tumors, a variety of nooplasir.s, not just cancer of the liver? DR. GERRINGi I think your document will show that.' DR. KNfFLSON* And, other diseases in addition? j j t I DR. GEHRING: As you well know, scleroderma, juvenile sclerosis, DR. KNELSON: I want that in the record. Do you think that cancer is a multi-factorial disease ing Co \party AP00028176 115 1 or do you think it is a single bullet, single target? n OR. GEHRING: I think it is multi-factorial. 3 DR, KNELSONt So, you must place chemical carcino-- t gentses along with all of the other factors that may be f related to the induction of cancer in people? 6 DR. GEHRING; Yes. 7 CRATRJWT DENNEY: I would like to request Dr. Marcus 3 and other people who have cmestions, because of the time, g if possible to try to keep them to a minimum, or to 10 request that the answer be submitted in writing. ` . 'll X also think the issues are highly technical. S3 We don.*t have a simultaneous.-translator* X have just 13 learned angiosarcoma and I am still practicing carcinagicifty, M -so.I think the technical answers will have to be answered,, 15 but in writing. is DR. MARCUS? One short question, non-technical. 17 In your report you mentioned there were two pathways. IS Is it your professional opinion that one pathway shuts off 13 and turns on, or do they operate simultaneously? 20 DR. GEHRING: I think the lower pathway, and the 21 primary pathway for metabolism, we feel is in the -soluablo 22 portion of the cell* We do not feel at this time it is 23 related to microsomal metabolism, and this one predominates vo. .V at lower exposure levels, whereas, we know and it is 25 better established that the microsomal oxidation of vinyl ' A tO , . /> AP00028177 J i 1 chloride, very likely the chlorethylene oxide is another J pathway. Thin one appears to be much lower, and when j you say "shuts off, obviously there are always going to I j 4 ! be a few molecules that get through, j i 5 | Enzymes, even though one is much faster than the j I i 6 other, the other enzyme is still going to get a few molecules I i: through. So, when you say complete shut down, that is 3 ! O' vt i 10 a different thing than I am implying by a threshhold. I am implying great changes in rate, and in the degree of importance o that particular enzyme, j ! ! 11 . 15 CHAIRMAN DENNEY t Dr. MtSGaughy. . DR. MC CAFKTHY: I have a cuestion about your ] i 14 attitude towards these studies as they relate to what is standard. . .. 35 f" '- There are several chemicals which have been known : 16 ' M i7 ; to be protected by glutathione in the body, and probably there are other chemicals that do not act by that mechanism, 13 i although I cannot reel -off a list of them and which 39 category. 20 Suppose, I do not know what the situation is at 21 Dow, but suppose you were responsible for the health of the 22 Dow workers, and suppose you were screening a bunch of 23 substances. If you found a substance that reacts like' '- "\ 24 this where glutathione acts a3 a protection, if you were 25 ! confronted with a substance like this, would you feel much ,t t/y yy AP00028I78 117 !| 1 jj ,'i 2 'tI, safer in recommending exposure to the vorV.ors than with ! i - another substance that did not show this protecting mechanism? In other words, how does this relate to your occupational standards? I was wondering how you would trans-j 3 ! fer this break ''point into metabolic conversion at 220 parts Ho ;i 7- i 1I 3! `A ;ia i! JO I] per million? I v/onder if you can transfer that into any kind of standards for the workers? DR, GETTRITWt The metabolic break point irt one case, I said it was above 100 from the pharmacokinetics analysis. 11 Prom the standpoint of the glutathione levels, somewhere' 1 12 around 50. io How do you transform this to your workers? That M-. ;is very difficult. One of the difficulties, I think, and T.S .. ; one of the things that has not been considered adequately 18 is that the people, at least, appear to be less susceptible 17 18 -jj 19 I 20 | i i 21 j ! 22 than do some of the rodents species to vinyl chloride, and there could be much argument on this, hut, for example, exposure to mice to 500 parts per million of vinyl chloride causes death in a considerable fraction of them. So, if, obviously, rodents are not responding, mice in this case are not responding as people do to vinyl . 23 chloride, where we would have discovered that.500 parts per 24 i. 25 i! million has an untoward effect a long time ago. When you say, what does it mean to me, I certainly would not recommend $Ctne f^etiariinq AP00028179 l t: ** ! that a major detoxification mechanism, glutathione, X 118 i ii ! would -certainly not recommend that exposures exceed those necessary to deplete this should be incurred. nut, how you translate that from rat to mouse and finally and ultimately to the one of importance, man, is a difficult procedure, and each and every chemical is different. DR. MCGAUGHY: Suppose you had a chemical -- Would you feel the workers would be more endangered to that chemical --- )*: 11 DR. GEHRING? It is very difficult. 1 Are ybu.talking 12 |i 13 about the same effect -- I an having difficulty with the meaning of your question. H; IS 16 ! IT 13 19 20 21 ? 22 23 V In this particular case, glutathione apparently lays around in the body and is there to pick off materials.' Things that can alkalanate DNA, that can alkalanate. protein can alkalanate RNA, and it is almost like an immune mechanism. If you get an excessive amount of alkaline materials formed, it picks it up. This can be both natural and synthetic type materials. U ^ *i .... Now, not all alkalanate materials go through the - reaction with glutathione predominantly. Some of then, ' -s 21 for example, apoxidos, apoxides of aromatic compounds, tho 25 primary pathway might be by an apoxide on apoxidies, so4It a io .. s* AP00028180 119 cyoes entirely in a different, direction. Z do not really know how to answer your question using the vinyl chloride examples by saying all chemicals fall in that area. They do not. They do not metabolise that way* DR. MC GAUGHY: We had not known about your study 7 demonstrating change in the metabolic mechanism. s DR, GEHRING: It is interesting, because it was given at the New York Acadamy of Science almost a year and 10' a-half ago, and.it has been published in at least two t u journals. 12 DR. MC GAITGRY: It is easy to make a linear projection 13 and if this mechanism you have come up with is valid for If: human exposure, then perhaps you overestimated it?. 15 But, I would just like to know what your attitude 15 ! is towards rink* 17 DR. GEHRING: Toward risk, I think you have to 13 get the best hard data you have available and put this in 19 a pot and then you go over on the other side of it, and you 20 say, well, for example, if alchemist comes into me at the 21 'Dow Chemical Company and says, I have Product x here, not 22 product,'but a new chemical, I don't know what the heck' 23 it is going to do, I don't know what it is used for, what 24 is an acceptable measure of exposure. Well, if there is 25 no no benefit whatsoever, there'is/acceptable measure of exposure AP00028181 i The question you arc asking i3, you have put rhe il I hard data m and really what you have to ascertain in when is the break iruthat tremendous increasa of costs for control going to occur* That is the area that you axe really dealing with in the assessment. DR. MC CAUGHYs Fine; 7 CHAIRMAN DENNEY: Dr. Kuzmaek. 3! 1 #I DR, KU3MACK* I just have a few ouestions. I A3 I understood from your response to Dr. Marcus 10 ! when you talk about a threshhold, you do not mean a level 11 below zero vher*i..5*?n6gicity .can .opeur>'butv just that, 12 the rate of occurrence would be a lot less? U DR. GEHRING; Well, biological processes do not .14 stop, they go on, and you don't have an abrupt situation. 15 The thing that.does happen, however, is as I 16 jj indicated before, that the relative importance changes 17 ji tremendously, so when they begin to ba much lower in 1$ ! importance then you get a change.* 1? For example, in Maltoni's study where the latency c,0 period dramatically changed, something happened. They n are different populations, and so the way I interpret that, 22 at least at this point in time, is that Maltoni's data 23 Itself indicates there is something going on to change that 2-5 latency period. 25 It makes it extremely longer, and, in fact, those Jt* m, ' Company AP00028182 1 ;i animals, like x said, were extremely aged rats, and Albert ii . . f, Altshuler has also looked at this. So, there is a threshhold !j So, even if wa lived hundreds and thousands of years, t suspect under those cases that the one molecule approach might be more appropriate. DR. XUZMACK: Or if you had hundreds and millions of people exposed. DP.. GEITRING: As long as you take into account | that the threshhold is a change in rate and you cannot make statistical projections when you have definitive evidence 11 showing that the incidence at those levels apply, to low$. 12 levels. 13 DR. XUZMACK: What is the nature of the evidence 14- ' that suggests it is the upper pathway or the higher'dust ri. .13 pathway that involves the carcinogenics? - : 18 DR. GEHRING: Well, one, you have Maltoni13 data 17 which correlates pretty well. Two, is the production of 1.5 chlorethyleno oxide above the upper pathway. At least' -- 19 some people have felt this gives the right type of reaction. 20 Those are the primary evidence. That doesn't 21 mean to say -- And, of course, the incidence the .correlation -32 is beautiful between the predominance of the upper pathway 23 and the incidence of disease. " 24 DR. KUZHACK: What experiments would you suggest that 25 would confirm or disprove the hypothises that below this AP00028183 ) I .22 1 level ycu,. would expect -- 2 . DR. GF.KR.INf?: I don't believe in mega-animal :i experiments. Right now the types o'f studies we are involved 4 in is to determine what the macromoleeular binding of the 5 reacting metabolites is, and whether this changes with dose* f> Unfortunately, vinyl chloride, it isn't -- 7 particularly when you get up to the upper pathway -- it S isn't all that metabolised that fast, so the amount of :'j radioactivity you can actually use- is somewhat limited* 10 But, we are pursuing that aspect. u We are pursuing another aspect to delineate not 12 only the microsomal metabolism of this material, or the inn> extra microsome, and we think that is quite important, If because this istbe one we feel is most likely by ethanol* 15 It is also located in the area of the cell which allows 16 more detoxification. 17 Nov, the ultimate thing to do is to tie this in 13 with carclnogicity. You will never do this in an absolute, 19 direct fashion* 20 We look at it as links in a chain. First we saw 21 the two differences in pathways, the subsequent aspect was, 22 let's look at the detoxifying systems and find out if it is 23 depleted, and this also accords you another aspect. It 21 shows you that accrualation has occurred. 25 Then the next one is the macromoleeular binding f^tportinj doKpaiuf AP00028184 1 and finally, the real last link that I feel is feasible, I feel, would bo to administer both materials which augment' and those which inhibit selectively those pathways and find out whether or not you increase the incidence of cancer above the background of controls, a It is still indirect, but X do not think we will 7 ever do better than that in our lifetime, 8 CHAIRMAN DENNEY; All right, I would like to go r on then to the next witness, I thank you very much. Dr. 10 Gehring, for appearing. a "'v- DR. GEHRING; Thank you. - 12 CHAIRMAN DENNEY; Diamond Shamrock is the next witness, Mr. Connors, I believe, U' y , I believe you are Mr. Connors of Diamond Shamrock, is would you please introduce yourself, w STATEMENT OP HARRY CONNORS, DIAMOND SHAMROCK CORPORATION 17 MR. CONNORS; Yes, ray name is Harry Connors. I ara 13 Vice ..president of the Industrial and Plastics Cnit of 19 Diamond Shamrock Corporation. 20 Diamond Shamrock is a major producer of PVC 21 resins at plants in Delaware city and Deer Park, Texas. 22 We employ over 500 people --** Excuse me, may .1 interrupt to 23 say that Mr. Robert Rill, senior counsel in our Law Department 2-1 is with me. 25 We employ over 500 persons in our PVC plants and <?o.,, pnn i/ AP00028185 -\ 1 li probably sanawhere over 600 people, Diamond employees are directly or indirectly supported by the PVC business. In addition, a subsidiary is engaged in fabricating PVC -t -| ' :| 5 !i products, and we have recently announced our intention to build a vinyl chloride monomer plant. You can see that Diamon Shamrock's involvement with, and interest in vinyl chloride monomer is substantial and i significant. The capital cost to Diamond to bring its "i ;i- PVC plants into compliance with the OSHA standard on vinyl '! 10 j` chloride and the anticipated EPA and FDA requirements 11 i 12 ! iIl' 13' ji ii I 14 - on VCM and PVC will exceed $15 million. This does Hot. include the cost.of water treatment facilities in our pvc plants nor added cost for our proposed VCM plant. We are a member of SPI and we support tho.SPi .s . IX5 ! 15 ; position stated by Mr., Harding earlier this morning, "but would like to emphasize to things further. 17 i 13 ! is! First, we are naturally very concerned with the Administrator's designation of vinyl chloride as a hazardous* air pollutant. ' Cff course, we realize that'the statutory 20 framework within which he proposed to act requires that such 21 designation precede any further regulatory action. 22 Nevertheless, it is our opinion that no evidence 23 has yet been produced which demonstrates that vinyl chloride M in the concentrations found in the ambient air, has, in fact, 25 caused any kind of injury. ^Acmq oorft*** AP00028186 1^3 * What has h<>an established tc that vir.yl chloride " i! i3 hazardous to workers exposed reulsriy to very high 5 ; concentrations over a period of many years. That evidence, i si i together with inoonc.lusive animal test data, provides the ij 11 ! basis for the Administrator *s conclusion that a risk to tho ;f f> j general public may exist.' The distinction is an important 7-i' ' ' .... 1 I one, since the regulatory measures proposed will" result in . ) " -| significant economic impact. ' ; Secondly, the Agency has rejected a fine balancing of costs against benefits, choosing instead to require that II the best available technology be employed to reduce vinyl ]2 chloride emissions. The difference may be substantial. O while exact costs cannot now bo established, it is 14- generally agreed, I think,' that compliance with tho proposed 13. regulations will cost-, at least $200,000,000, estimated by ! \\ tho Agency, plus the additional expenditure of at least -] $70,000,000 annually. And, we think also it: will probably b e more. This additional expenditure, has to reduce the 20 i ability of our industry to attract capital, unless we can |0.1 increase our prices in the neighborhood of ten percent, i 22 1 which is clearly inflationary. 23 while the Agency clearly has the duty to protect 24 the public, aqainst known hazards, it has mother duty to the public as well. We believe -that, even when dealing with a Jlcm*.* rfintf jttrritf AP00028187 9 126 known ha2arcl, tho Agency hub a responsibility to engage in that v,sry fine ba.lnnci.ru7 which It:, has here rejected. Certainly, when tho subject ci such regulation has not boon j j ! established to be a hazard, oven Greater care is warranted. j In conclusion, let no say that Diamond Shamrock j expects to maintain its plants In compliance with all b^ | Government regulations and, assuming our ability to aisa .7 prices, we will bo able to provide the capital necessary to 8i maintain our PVC plants in operation if this proposed 9 standard is finally adopted. 19 Furthermore,( because of the Agency*s commendable . . 11 procedure of making'drafts of their proposals available for 12 i:'. study and comment before publication, we can even now advise that, technically, the standard, for the most part is feasible 14 for our plants. 15 We deplore, however, the inflationary effect and \3 17 the waste that v/ill be. involved in a .significant .portion of 1-3 these huge expenditures for little discernible benefit. 1 Q We also cannot agree that it is correct to label vinyl chloride as a hazardous air pollutant in the concentrations 20 found in the ambient air surrounding VCM or PVCplants. *l\ We will be submitting detailed written comments 22 of a sumalementary nature on the proposed standard and 23 supporting documents which time did not permit us to have 2', 25 i prepared for this hearing. -.'`riTi'n * AP00028188 > Thank you, 127 } i \ DR, KNELSON: Just for my own instruction, you mentioned a. cost of $16 million for your implementation j j of the requirements. What fraction of the total capital expend- tures of your company'does that represent? i 1 MR. CONNOR; Ch?-the total capital expenditures1- . 7!' of our company# of course# this would be expended over vo ; a couple of years. It would be lit the five to ten percent * 'I ;! range. ;o |j DR, KNELSON: Five to ten percent. Over what : I a il period of time x*ould.that $16 million be amortized?' ia MR. CONNOR; It would be amortized in- general, <3 ii over a tv/o yoar period. i-t DR. KNEI.SON} In other words, you have to reinstall IS this step every ten years? is MR. COtlNOR; Yes. As a matter of fact, on the 1? average that is probably too long a period. Some of the facilities to which we will be adding this equipment, probably will not have a life of ten years. They have 20 already been in operation for ten'years, so ten years would 21 be*an exaggeration, I think, on the average. 22 DR. KNEbSON: You mentioned the inflationary 23' pressure of something like ten percent. By that you moan 24 the price of the resin will be increased by ten percent 25 as a result of this capital outlay? picnic Kfcporlin'j Comp,,nannti#, AP00028189 > i i :! * I MR. CONNOR: It vi.ll 1>3 necessary to do so in order to continue in business. DR. KNELSONt Most of us don't buy PVC resin by-products. Could you give ma an example of how the ten percent increase in the raw material would increase the 8 price of the product, to the end-user, the consumer is 7 really interested in? How much v/ould it influence the H i! cost of the phonograph record? MR. CONNOR: A phonograph reco.td is largely PVC 10 resins, so that it would, increase the raw material cost 11 of the resin the full ten percent. 12 What that would translate into in the sellinqr 13 !i *i price, I cannot tell you. . ,. ' Obviously a smaller percentage. V. . .. DR. KNELSON: A'much dialler percentage? 15 MR. CONNOR: Yes. IS DR. KNELSON: If it cost me $4.98 now, it might n cost me a couple of more cents. That is what I would have iS to pay for the assurance of this benefit? 19 MR. CONNOR: However, there are other products 20 that would be greater. Such things that do not have a high 21 input of let's say art, as your phonograph record has. 22 CHAIRMAN DENNEY: Dr.HarCUS. 23 DR. MARCUS: In your costing have you figgured 24 ; i in how much money you would be saving by recovering 25 ! distributing operations? A....... W. - /*............... AP00028190 1 MR. CC'TN'OR: Wo would obviouslv gain some return. But, the return is negative. Tn other words, wo aro spending more to recover a pound of monomer than is the value of that noncmer. That ' 1 doesn't mean the recovery material doesn't have a value, '> 6I 7! 9! i H but we spend more to get it than it is worth. Even if we project the cost by increasing the energy costs. DR. KC GAUGHYr What would your net figure be? MR. CONNOR: For $70 million, I would have to U) : i u! i 12 ! i - , ` 1,1 ; i 14 1 .i 15 j 18 | reserve a positive comment on that? I will have to check that. I think it is probably before the value of the recovery .monomer. DR. MC GADGHYs One point of clarification. The $16 million*what fraction of that is due to ERA, and. what fraction is duo to the OSHA requirements? _ , _ .. MR. CONNOR: Those things are hard to separate. lT i, But, I will make an honest effort. We think that something il 13 ;l more than half of that, but less than three-quarters would 19 be required for EPA. 20 DR. MC GAUGHY: Thank you. 21 CHAIRMAN PENNEY: I have one question. 22 I asked Mr. Harding how the industry can justify 23 imposing any risk on somebody who does not derive benefit 24 from an activity. You suggested, and ve have problems with 25 j that question, I think in general it seems it is being done AP00028191 1V 13Q <1 J i! i! 2P 3 ii i 'J I indeed promulgates regulations. But, I am concerned about your suggestion -- X am wondering about your suggestion that we do a more finally tuned benefit cost analysis, whioh is by no means a novel suggestion. I! 7 "I . -i }! Ji 10 n 12 lO H15 IS 17 i i 10 ! 20 21 22 23 2! I am simply wondering how we do that. It is one thing to say at some point it doesn't really warrant for instance, quadrupling the cost of utility power to reduce one common, coal to use an example, at some point there is a gross disproportion, For instance, if you could in some way quantify a health effect to be worth $100 to the person who has it in lost wages, pain or whatever, `would you then say an industry should not spend more than $101 to protect that * is person, and if it/$99, that person is lucky, ana if it is $101 it is too bad for him. There is no reason to make Industry spend more than his benefit. I am wondering if you have a suggestion. If you have an involved response to that, I would appreciate it in writing, but if you have a quick answer on how we would go about conducting such a balancing? MR. CONNOR? I am very afraid I do not have a quick or an involved answer. What you are referring to, I think, fundamentally, is we feel with an unproven risk, an unproven hazard, that M.-~. /?,,............ AP00028192 131 X one must proceed cautiously. 2 vre agree with the necessity for looking at. the problem for controlling major abuses, but whether one co^t | JJJ of going from reducing, let us say, just as an example, the ambient air concentration from two parts per million to j ?J 6 one part per million, in view of the available data on hazards, b *7 a nd, in fact, tho preponderance of data which would indicate S that the hazard was not excessive, it is probably ridiculous. o That does not mean that one doesn't continue iO to watch developments, and if data develops at a later 11. ^djate,* additional concern on health hazards would be worth 12 while. I`4 CHAIRMAN DENNEY: . What you are suggesting is not that we do a fine tune cost benefit, but rather we H 13 over estimated the health risk considerably. ]'" X ask this, because I have yet to find anybody 17 who has really been able to come up with a really"helpful, IS so-called fine tune benefit balance. We have talked to 19 a lot of people and we have been in litigation with a lot 20 of people who have suggested, we ought to do more. MR. CONNOR* We could make some specific suggestions 21 22 on specific technical points in our written submission. 23 DR. MARCUSx One simple question. If there is a proven health hazard . in some 2-1 25 particular chemical you do manufacture, how would you go ^trorftnqq Com|*oAji AP00028193 1 s?! 2 i! 11 S i A\ 132 about identifying- the people who are harried by it? MR. COTJNOR: X think X should defer to my Ire:?.! representative. X don't think you can answer that broadly. Again, I think that a oroduct that vinyl chloride i is of benefit to society and that, therefore, all members o of society are benefiting from it whether or not they happen 7 work in a PVC plant or not, because it is reducing their r* o !i cost-of-living, or increasing their standard of living. 3 ji 10 ! How, whether they should have correcting indemni fication I think it*s very moot, and.this would be true 11 1 of any chemical unless there was gross negligence involved, 12 i Gross and willful negligence. That is another matter. 12 *' CHAIRMAN DENNEY: Thank you very much. H Our next witness is Air Products, and I believe 15 you are Mr. Shenk. IS Mr. Shenk is the last person asked to testify. 17 Mr. Shenk, would you please introduce yourself? 13 STATEMENT OF RAYMOND SHENK, ATTORNEY 19 ATR PRODUCTS AND CHEMICALS, INC. 20 MR. SHENK: My name is Raymond Shenk, and X am - 31 an attorney representing Air Products and Chemicals, incorpor 22 ated . 23 Although we had asked for time at this hearing to 24 present our oral testimony on the propriety of fche Agency's 25 action in designating vinyl chloride a health hazard, we ortlr AP00028194 F* i* 133 have determined that the short interval hetveen publication of the proposed standard and this hearing is insufficient for -us to make a thorough analysis of the voluminous documents issued by EPA in supnort of its action affecting vinyl chloride. Accordingly, we have determined not to present any oral testimony at this hearing. We vill devote our energies to the preparation of detailed written comments which wo will be submitting to the Agency later this month. 10 Thank you. u CHAIRMAN DENNEY: Thank you.' 12 I will simply assume there are no questions. I Thank you all very much for participating in It hearing. We appreciate having you. IS (Whereupon, at 12:45 p.m. the hearing was. 13 concluded) 17 - l* '19 20 :U 22 23 'M rift ana AP00028195