Document MJwqVMNGY0awZDqdr7m8Mz20M

7ENVIRONMENTAL CANCEH7-A'REPORT -TO THE 'PUBLIC October 12-13, 1977 Auditorium . School of Public Health,.. University of Texas Health Science Center Day I 9i00-9:15 Welcome Betty Anderson, President, League of Women Voters of Texas Brenda Gehan, President, League of Women Voters of Houston Dr. Marcus Key, School of Public Health Dr. Roy Gottesman, Tenneco Chemicals I. Introduction 9:15-10:00 AM 10:00-10:15 AM 10:15-10:25 AM John Veisberger, Ph.D., American Health Foundation. --Questions-- -Break- II. Test Procedure 10:25-10:50 AM Charles Shaw, M.D., M.D. Anderson Hospital and Tumor Institute, Carcinogenesis Center, Overview 10:50-11:15 AM 3. R. Brinkley, Ph.D., Eaylor College of Medicine, Cell Transformation 11:15-11:40 AM A. Clark Griffin, Fh.D., M.D. Anderson Hospital and Tumor Institute, Animal Studiea/Sta.ndard Assay 11:40-12:05 AM John J. Costanzi, M.D., Univ^tsity ..of Texas Medical Branch-Galveston, Early Detection in Man 12:05-12:20 FM --Questions-- 12:30-2:00 PM -Lunch- Commissioner R. David Pittle, Fh.D., U.S. Consumer Product Safety Commission, Consumer Product Safety with Special Attention to Products with Benzene 4 III. Statistics and Epidemiology 2:00-2:25 PM Patricia Buffier, Ph.D., University of Texas Medical Eranch- Galveston, Important Statistical Considerations and Problems in Evaluating Health Effects (emphasis on X 2:25-2:50 ?M Vinyl Chloride and Benzene) David P. Discher, M.D., San Jose Medical Clinic, Important Epidemiological Considerations and Problems in Evaluating Health Effects (emphasis on Vinyl Chloride and Benzene) 2:50-3:05 PM 3:05-3:15 PM --Questions-- -Break- IV. Cost 3enefit/Risk Assessment 3 * 15" 3 = 50 PM J. Gustave Speth, LL.B., Member , Council on Environmental Quality, An Overview from Government Perspective with Emphasis on Risk 3:50-4:05 PM --Questions-- -'*--4:05-4:30 PM Charles Barden, P.E., Immediate Past Director, Texas Air Control Board, State Government Perspective V 4:30-4:55 PM Tom Downs, Ph.D., School of Public Health, Industry Perspective 4:55-5:20 ?M John J. Sheehan, Legislative Director, United Steelworkers, Labor Perspective 5:20-5:30 PM --Questions-- DINNER FOR SPEAKERS, STEERING COMMITTEE see 2-1823 9i00-9:10 AM 9:10-9:40 AM /. .9:40-10:10 AM.. .. 10:10-10:25 AM 10:25-10:35 AM . ' Day-II - . \ ivjfv'.' /' V- Bill Stewart, P.E., M.S., -Director, Texas Air Control Board, Welcome "~ Carlo Tamburro, M.D., University,of Louisville School of Medicine, Health Effects of Vinyl'- Chloride ' Susan Wyatt, M.S.P.H., Environmental Engineer, ' ~"- U.S. Environmental Protection Agency, Control Status of Vinyl Chloride --Questions-- -Break- VI. Benzene, Present Findings Concerning Health Effects % :--- Donald Lassiter; Moderator 10:25-10:50 AM Joseph Wagoner, Asst, to the Secretary for 0SHA, Department of Labor, Government Overview, Control Status -2 10:50-11-25 AM Irving R. Tabershaw, M.D., Professor Emeritus, Occupational Medicine, University of California at Berkeley, Industry Perspective .. 11:25-11:55 AM Sylvia Krekel, Oil, Chemical, and Atomic Workers International Union, Labor Perspective 11:55"12:15 Noon --Questions-- -Lunch- VII. Delineation Present Regulatory Development-Process (Each speaker will cover the mandate of the present legislation', research data compilation ard. evaluation, regulation formation, risk assessment and cost/benefit components) 1:45-2:10 PM James R. Janis, Acting Director, Standard & Regulation Division, U.S. Environmental Protection Agency 2:10-2:35 PM Roger R. Wallis, Deputy Director, Standards and Regulations Texas Air Control Board 2:35-2:50 PM --Questions-- 2:50-3:00 PM -Rreak- VIII. Advocacy 3:00-3:20 PM 3:20-3:40 PM 3:40-4:00 PM 4:00-4:15 PM F&mela M. Giblin, Attorney, Advocacy Process in Regulation Development -3ecky Fossdal Moon, League of Women Voters, Citizens Views and Concerns with Regard to Regulatory Process Curtis W. Smith, Ph.D., GhtA*?man--of^Dens^ne, Shell --Questions-- ADJOURN The proceedings of this Conference -will be published by Texas Reports on Biology ard Medicine. see 2-1024 f r^- '--Roy T.. Gottesraan',- Ph.D*, Tenneco Chemicals, Inc. Current: -Director, Environment and Regulatory Affairs Department, Tenneco Chemicals, Inc; Responsible for a multi-faceted program involving evixonmental science, occupational medicine and health, Industrial hygiene, toxicology, product safety and regulatory affairs; senior member, American Chemical Society; member, Association of Research Directors; Fellow, American Institute of Chemists; Fellow, New York Academy of Science; member, Phi Beta Kappa. Previous: doctorate in Organic Chemistry, Rutgers. *5*. see 2-1825 John ;H. Weisburger ,-''Ph. D.- Vice ; President, for' Research Americah7-Health':'%./- Foundation. Current:' ' Director, .Naylor Dana Institute for Disease " Prevention, AHF; Research Professor of Pathology, New York Medical. College; Research on the etiology of the major human cancers: in particular, cancers in the digestive tract, the, endocrine-related organs, and the respiratory tract; broad background in the area of chemical carcinogenesis, the mechanism of action ard metabolism of chemical carcinogens, the bioassay of chemical carcinogens, and the interrelationships between mutagenesis and carcinogenesis. INTRODUCTION--ENVIRONMENTAL CANCER-REPORT TO THE PUBLIC: Current data show that 80-9C$ of human cancers stem from environmental causes. The basis for this statement hinges on a consideration of l) changes in incidence of specific cancers such as cancer in the lung, breast, stomach, colon, and the like, with time; 2) the incidence of these cancers in various parts of the world; and 3) the changes in incidence when people move from one area to another. Historically, cancer was first related to environment in people exposed to specific products like soot or coal tar and, later, to chemicals, in an occupational setting. This demonstration has opened the field of environmental carcinogenesis. Thus, the public in general and even experts are under the impression that cancer in people is due to specific chemicals like those in the special case of occupational exposure. To provide perspective, we can state that occupational exposure in industrial societies accounts for l-5^ at most, of all -Qancer cases. Most of the human cancers, including those at the main sites, nam%iy^cancer lung (98,000 new case in 19?? - American Cancer Society data), stomach "(23,000 new cases in 197?), large cowel (101,000 new cases), pancreas (21,800 new cases), breast (89,000 new cases), prostate (57,000 new cases), ovary (17,000 new cases), and endometrium (27,000 new cases), in most instances, relate not to specific chemicals in the environment but to our lifestyle. People are aware that one aspect of our lifestyle, smoking of cigarettes, leads to lung cancer and, in fact, some other cancers such as larynx, esophagus, and oral cavity (together with excessive usage of alcohol beverages) arvi, in part, urinary bladder. People are not aware that the other major factor leading to disease stems from the diet. Cancer of the stomach has declined here but is high in Japan, Central and Latin America, and Eastern and Northern Europe and is ascribed to specific factors, in particular, the absence of foods containing Vitamin C on a year round basis. The other cancers mentioned stem, in part, from diets containing high fat levels such as those in the Estern world, ir. contrast to diets eaten in Japan, where cancer of the colon, breast, prostate, and ovary have far lower incidence than in the Vest. While much mere research is required to acquire full comprehension in this complicated field, it would seem that the public can help themselves in preventing or avoiding specific cancers by minor alterations in lifestyle. Thus, public action even at this time would prevent the major human avoidable cancers. see 1876 Charles R. Shaw, M.- D., Professor of;Biology,-University of.Texas M, D. Anderson Hospital. Chaired 'National Academy of Sciences Committee on Fublic Information. in the Prevention of Occupational ^ Cancer, 1975-1-977 Diplomate of the American Board of Psychiatry and Neurology. Member of the Environmental Mutagen Society. Also member of the American Society of Human Genetics. SCC 2-1927 ( ." >. B. R. Brinkley, Ph.D., Professor, Department of Cell. Biology, - Baylor . ' " College of Medicine. Previous: Professor and Director of Cell Biology, .V -;": The University of Texas Medical Branch-Galveston; Assistant and Associate Biologist, M.D. Anderson Hospital and Tumor Institute. TEST PROCEDURES--TUBULIN AND ACTIN IMMUNOFLUORESCENCE: AN ASSAY FOR CELL TRANSFORMATION IN VITRO: Cells transformed in vitro by either chemical or viral agents usually display a variety of distinct but dissociable properties, including alterations in shape, cell surface changes, loss of density-dependent growth control, loss of anchorage-dependent growth, and reduced serum requirements. In addition, increased mobility of cell surface receptors and redistribution of the receptors within the plane of the cell membrane has been described as a consistent property of many transformed cells Recent studies in our laboratory and elsewhere have identified specific alteration in cytoskeletal elements, including cytoplasmic microtubules (Mts) and microfilaments (Mfs), that may account for several of the previously mentioned tumor cell properties. Using monospecific antibodies made against 6S bovine brain tubulin as immunofluorescent probes, we have identified an extensive cytoplasmic microtubule complex (CMTC) in a variety of nontransforncc cells in vitro. The CMTC consists of a delicate network of fine fluorescent filaments that radiate out from a central focus within the cytoplasm (the centrosphere) toward the cell surface. These filaments, believed to be Individual microtubules, axe seen to terminate near the plasma membrane. This would be expected if they are associated with receptor complexes on the cell surface, as some studies have indicated^..Colcemid and other microtubule inhibitors reversibly abolish the CMTC. When transformed cells are examined by tubulin immunofluorescence staining, the CMTC is usually undetectable or greatly diminished. When microtubules are present, they appear as short, randomly oriented filaments. The striking differences in immunofluorescent patterns between normal and transformed cells have enabled us to correctly identify transformants in mixed cell populations containing both normal and malignant cells. Similar alterations are observed in the structure and distribution of cytoplasmic actin-containing microfibrils (Pollack et al., Proc. Nat. Acad. Sci. USA 72:99^-998, 1975)* Normal fibroblasts display numerous parallel bundles of actin filaments (stress fibers) whereas transformed cells have very few stress fibers. We propose that tubulin and actin Immunofluorescence patterns can be used in conjunction with other assays in short-term screening of chemical carcinogenesis.,. i 5CC 2-1828 v"... *''":* vA_. Clark Griffin, Ph.D., American Cancer Society Research. Professor -.ofBiocheaista^y. 'Current: Member, Biochemistry Department, M.D. ,Anderson Hospital and Tumor Institute; Research in carcinogenesis, protein : synthesis, nucleic -acids, mechanisms of cancer induction, and cancer prevention. Previous: Faculty, Biochemistry, Stanford University School of Medicine; Chairman, Biochemistry Department, Baylor University : - College of Medicine; Ph.D., University of-Wisconsin. TEST PROCEDURES--AHIMAL STUDIES: A brief historical account of the involvement of chemicals in the origin of tumors in man and animals will be.presented. With increasing indication that many chemicals may cause cancer in several animal species,the U.S. Public Health Service has compiled these findings into several volumes entitled: Survey of Compounds which have been Tested for Carcinogenic Activity. Fan tom related to the develojxnent of a standard test on assay procedure will be reviewed which will include: animal species, strain, age, sex, mode and dosage of test chemicals, time factor, pathological evaluations, data analysis, cost factor and final evaluations and* recommendations. Several animal model test systems will be reviewed and problems related to the testing for chemicals in the air, water and the environment will also be considered. <>S , . i- scc 2--1329 i John.' J.-Costanzi, M.D.Associate Professor.of Medicine,. Department .of O';-:;;'-..Internal Medicine,' The University of Texas Medical Branch-Galveston.':3- TEST PROCEDURES--SCREENING TESTS FOR CANCER: Unfortunately, there is no known test that will predict or detect very early cancer except the well-known"Pap smear for carcinoma of the cervix in women. In general, the best screening test available is a careful survey of high risk patients. Other tests which have ccme into widespread use over the past four to five years have included serum test for carcino-embryonic antigen, -alpha'fetoprotein determinations and various other immunoserological tests; Other screening tests, such as the Makari test, are currently being investigatOne of the known events with most patients with cancer is a depression of the immune system. It is therefore reasonable that if certain parameters of the immune system are depressed, this patient may be more prone to develop cancer. Many efforts are being examined along these lines. This discussion will encompass all of these points ard elaborate on tho best methods for screening patients at risk for developing cancer. R. David Pittle, Ph.D., Commissioner, U.S. Product Safety Commission. Current: Member, U.S. Product Safety Commission. Previous: Assistant Professor of Electrical Engineering and Public Affairs, Carnegie-Mellon University; President, Alliance for Consumer Protection; Member, Federal Executive Board Consumer Services Committee; Member, Consumer Advisory Committee, Pennsylvania Insurance Department; Member, Consumer Relations Panel, National Association of Homebuilders, Consumer. Federation of American, American Council on Consumer Interests, Consumer Siandards Committee of the American Society for Testing and Materials, and the American National Standards Institute. see 2-1830 Patricia A.'Buffler, Ph.D.r Assistant Professor of Epidemiology, ' The University;of.Texas Medical Branch-Calveston. Current: Assistant Professor, Xlniversity of Texas at Houston School of Public Health; Co-Investigator,' Development of a Model Cancer Control Program for Employees in the Chemical Industry; Member, Medical Advisory Panel, Texas Air Quality Control Board. Previous: Principal Investigator, Cenetic Risks of Yir.yl Chloride; Principal Investigator, Epidemiology of Primary Liver Cancer in Selected Texas Counties; Member, International Who's Who in Asian Studies, Sigma Xi, Galveston Chapter; Jbrticipant, documentary film, "Occupational Carcinogenesis." IMPORTANT STATISTICAL AND EPIDEMIOLOGICAL CONSIDERATIONS AND PR03LEMS IN EVALUATING HEALTH EFFECTS--Outline: I. Cancer increase - apparent vs. real increase effect of population changes (aging and growth of population II'. How much of cancer incidence is due to environmental factors? (60-9C^) - how these estimates derived known environmental etiologies evidence for environmental causes of cancer (geographic comparisons III. What to measure? - , , , ... , what health effects are important? (premature death, morbidity, reproductive outcomes, effects on offspring-childhood^nalignancies) IV. Identifying health effects - three basic %pur.oaches used in epidemiologic studies - descriptive (cross-sectional or ecologic)--examples: chemical industry coutnies and cancel* what type of infounation obtained--interpretation limitations case-control (retrospective)--example: primary liver cancer in selected Texas counties what type of information obtained--interpretation limitations cohort or mortality followup studies (prospectives)-- example: mortality followup study of VCM exposed chohorts what type of Information obtained--interpretation limitations .David.P. "Discher,-;M.D.V Director, Department of Industrial and Environmental "--Medicine, San Jose' Medical Clinic. ' Current:' Specialist in occupational mediclnejResponsible for the development of health service programs for - industry: Research in occupational health problems. Gus Speth, LL.B., Member, Council on Environmental Quality, Co-founder and Staff Attorney, Natural Resources Defense Council. Previous: . Law Clerk, Justice Hugo L. Black, U.S. Supreme Court; Yale Law Journal; Rhodes Scholar; Author of numerous articles; Witness before Congressional Committees on environmental issues* Charles R. Barden, P.E. Current: Manager of Air Quality Control, Engineering Science, Inc.; Member, Texas Society of Professional Engineers, Texas Public Health Association, Air Pollution Control Association, American Industrial Hygiene Association. Previous: Executive Director, Texas Air Control Board. see 2-1832 A '/X: Thomas-D.:Doyns/ . ftv;I).~, Itofessor of ;-Biometry,: -Univ^rsity.of -Texas School .. of Public ; Healthl}^':-Curren't:>-''Adjunct /Professor of -Mathematical Sciences, Rice University^ Previous: '^Faculty, Biometry-Department, Case Western Rcscr University;.. Ph.D. from the`University of Michigan. . John J. Sheehan, United Steelworkers. United Steelworkers. Current: Legislative Director, * . v: Eill Stewart, P.E., Texas Ail* Control Board. Current: Executive Director, Texas Air Control Board. Previous: Texas State Department of Health: General Portland, Inc.; M.S., Environmental Health Engineering, University of Texas. see 2-1333 burro'.'-HeD..,v Professor -'of-Medicine," University of . Louisville School''-of .Medicine. -Cu^ent: .'Chief, Digestive Diseases and Nutrition : Vinyl Chloride Project; Member, International Association, for the Study of the Liver, American Association for . .rthe Study of Liver Disease, American Federation for Clinical Research, and -American Association of Human Genetics;' author of more than 4-0 -.publications and contributions to books. Previous: Professor of Medicine/Associate in Oncology/Associate in Pediatrics, University of Louisville. HEALTH EFFECTS OF VINYL CHLORIDE: Vinyl chloride has been used as an - . anesthetic agent as well as a basic chemical for plastics manufacturing. Vinyl chloride's previously unknown carcinogenic capability appears ..to be .. related to the body's ability to convert'it from a non-toxic or minimally toxic chemical to a toxic and, with prolonged exposure, cancer-forming agent. Early exposure in animals causes body cells to make adaptive changes which may prepare them for malignant transformation and which appear to precede evidence of morphological injury. Ihese findings appear to 0t.. occur before a low-grade chemical, injury occurs. Vinyl chloride chemical injury in man appears to follow the same pattern. Present clinical data in humans now demonstrate evidence of pre-cancer injury and cancer transformation of various types of cells in different organs of the body. Manifestations of pre-cancerous injury to organs other than the liver (such as the lung^ heart, spleen, brain, and lymphatic system) may also be occurring and require further investigation v. Early detection of these pre-cancerous chemical injuries requires a prospective on-going system of surveillance and the development of diagnostic methods which can identify specific caustic agents in the presence of non-specific injury. Such a systematic approach has been developed and is now in operation. Its initial achievements appear to be the foundation for future success in controlling the health effects of Industrial chemicals. see 2 - .1 e 3 4  Susan Wyatt, M.S.P.K., Environmental-Engineer. ./Current:.. .U.S. Environmental Protection Agency; development of 'standards for, atmospheric .emissions of ` i: vinyl chloride. . Previous: M.S.P.H. from the Environmental Sciences and Engineering Department, School of. Public Health/ University of North Carolina. .. CONTROL STATUS OF VINYL CHLORIDE: The EnyrionmenUl Protection Agency (EP.V) listed vinyl chloride as a hazardous air pollutant in December, 1975 and promulgated a national emission standard for it under the authority of section 112 of the Clean Air Act on October 21, 1976. On November 19, 1976. : the Environmental Defense Fund (EDF) petitioned the United States Court of Appeals for review of the standard. On March 24, 1977, EDF and EPA. amoved-to dismiss the court proceedings in View of a settlement agreement requiring EPA to propose certain amendments to the standard. These amendments to the standard were proposed on June 2, 1977* Since that time EPA has received numerous and adverse comments from the industry on the proposal. The main issue involved is how carcinogens should be regulated under section 112 of the Clean Air Act. Section 112 of the Act'requires that emission standards be set "at the level which in the judgment of the Adminis trator provides an ample margin of safety to protect the public health from such hazardous air pollutants." This requirement appears to assume that each pollutant regulated will have a threshold level of effects below which no health effects will occur. It has not been possible to determine if there is a threshold level of effects for vinyl chloride and it is not certain that such a threshold may be determined in the near 'fibtjjre- :. In the absence of strong evidence to the contrary, then, the only level of vinyl chloride which would appear to be absolutely protective of health is zero, which may be achievable only by banning vinyl chloride emissions completely. That, in turn, would require closing the entire industry. EPA has decided that the costs of eliminating the industry are too high and has instead developed standards which require emission reduction to the lowest level achievable using technological means. .- .>\s.''rX-* . Donald. VLassiter,. Ph.D..,- Environmental .Health Associates. Current: 'i Development.pf. cancer control monographs -for NCI. Previous: Staff assignments with NIOSH ani OSHA; Represented the U.S. as member, U.N. Committee on Occupational Cancer; Initiated and directed Occupational Cancer Control Program for OSHA. *. Joseph Wagoner, S.D.Hyg., Special Assistant for occupational carcinogenesis in the Office of the Assistant Secretary of Labor, Occupational Safety and Health Administration (OSHA). Current: President, Society for Occupational and Environmental Health. Previous: Epidemiology Branch, National Cancer Institute; National Institute for Occupational Safety and Health; doctorate front the Harvard School of Public Health. scu 2-1836 -Irving R.-,-TabersStt~l;:^M;-D.'T-'Cdnsaitaht:.:-^CientV^rfi'EditorV^Joiirr^'^pf:^^Vi!y:''.-:-.-.Occupational Medicine ;.:Cor.sultant in .occupational' Bedlciae';:-i;>S:evi6uar`.l'" Professor, Occupational: Medicine, -University of-.California, Berkeley; : Service in. government, industry, insurance, and academia. ESNZEiE--FRCT2CTE0N FROM ADVERSE HEALTH EFFECTS OF BENZENE: 'Acute'' exposures to high levels of benzene produce central nervous'system symptoms. Chronic benzene poisoning, that is, exposure to low levels over along period of time, has a myelotoxic effect with a diminution in the red and white blood cells and platelets. In severe chronic exposures aplastic anemia may result, with death as the ultimate consequence. The issue from the regulatory standpoint is whether or not benzene will induce leukemia (cancer of the blood). CSKA's policy is to make a standard as low as possible .if a chemical is demonstrated to be a carcinogen. However, no clear-cut evidence exists to conclude that benzene in lower doses, by itself is leukeciogenic. This conclusion is based on three kinds of evidence: animal experimentation, ellaical experience, and epidemiologic studies.- The only conclusion permitted from, this evidence is that benzene may be considered a suspect leukemogen at high doses. 2ccperier.ce' to date demonstrates that the present standard of 10 ppm provides adequate protection for the worker from acute and chronic effects. Hence, CSKA's proposal to reduce this standard to 1 ppm is unjustified. However, CSKA's proposal to include monitoring provisions will afford a further measure of protection since benzere-indSted^effacts on the blood are reversible and wild provide data upon which re-evaluation of the standard can ce based in the future. SCC 2-1837 _ . Sylvia,Krekel, .-Oil,-Chemical, and-Atomic Workers International Union. '' Current: 'Occupational Health Specialist for OCAW;'Active in drive to gain a strict standard on benzene exposure. James R. Janis, Acting Director, Standards and Regulations Evaluation Division, U.S. Environmental Protection Agency. Current: Chairman, Regulation Development Work Group for OSHA, EPA, FDA, and Consumer Product Safety Commission. e,- Roger R. Wallis, Deputy Director for Standards and Regulations Program, Texas Air Control Board. Current: Member, National Governors Conference Clean Air Task Force, Air Pollution Control Association. Previous: Texas State Department of Health. see 2-1833 Pamela M. cibllh,-: Attorney-at-law. " Current: '/ AttorneyMcGinnis ;-> , Lochrldge and Kilgore; Member, 3oard of.Directors of State Bar- "1 - Environmental Law Section. Previous: Chief Counsel,-Texas' Air"Control Board; J.D., University of Texas Law School. Becky rossdal Moon, League of Women Voters. Current: Member, U.S. Environmental Protection Agency Advisory Committee for Toxic Substances; Member, League of Women Voters-sU-S....Environmental Quality Committee. Previous: Air Quality Chairman, '3fceaiie..;Of Women Voters of Houston; Member, Board of Directors, League o'f 'Sfo'men Voters of Houston; Chairman, Air Quality, League of Women Voters of Texas. C. W. Smith, Ph.D., 2S>:11 Oil Company. Current: Consultant, Health, Safety and Environment, Shell Oil Company. Previous: Worked with the trade associations developing reactions to OSHA standards, especially with the MCA on benzene; Represented the MCA in meetings with theEnvironmental Protection Agency to develop regulations under the Toxic Substances Control Act; doctorate in Organic Chemistry from the University of Illinois. UiCC 2-1839 SYNOPSIS Responsible industry as represented by the Manufacturing Chemists Association (MCA) accepts the need for regulation and is prepared to work with others in its development. For workable, cost-effective regulation, there needs to be effective interaction between the regulatory agency, industry, and the public. Examples are cited where these three groups have worked together, but at arm's .length, productively and where problems have developed when regulations are written without an understanding of the industry to be regulated. This need for input by industry is acute because there are very few people with industrial background in the agencies and because, in general, the agencies have inadequate technical strength. Mr. John Quarles, former Environmental Protection Agency (EPA) Assistant Administrator over the Toxic Substances Control Act (TOSCA), pointed out the need for greater technical strength in the Office of Toxic Substances (OTS) in his talk during the first public hearing on regulations under TOSCA. Mort Corn pointed out the same need in Occupational Safety J Health Adminis tration (OSHA) in his review at the end of his term as Administrator of OSHA. From personal experience, the author presents.the picture that we are faced with a tremendous task of testing and regu-lsiting..existing and new chemicals, and that industry is prepared to do whatever*Is reasonable to pro tect health and the environment. In particular, industry accepts the need for rational regulation and welcomes the opportunity to work with govern mental agencies and the public in its development. Furthermore, because industry has the knowledge of what is involved and will be responsible for implementing the testing and regulations, it has a unique contribution to make. By the.examples cited, he hopes to have convinced you that arm's-length cooperation has been productive and that to attempt to develop regulation without their effective participation results in waste motion. Summary? C,W. Smith, Consultant Health, Safety 4c Environment Shell Oil Company see 2-134 0 On October 7 Dr. Joseph Vagoner of OSHA, due to freeze on travel by the Department of Labor, informed us that he will not be able to attend-the Conference. . Dr,. Peter F. Infante of HIOSH has .agreed to attend in his place for the October 13 presentation. Day II, Section VI--1035 am. -Peter F. Infante, D.D.S,--Dr. Public Health in Epidemiology from the . University of Michigan School of Public Health. Currentt Epidemiologist engaged in research with Industry-wide Studies Branch HIOSH Cincinnati Ohio, -s* 770709(1) APf/JDftfAOS-JQ 7H MJ90ML fl&SS90fi 9JAAWRD9 ' -TOR V9/OL (HlDR9d. - - ; - '' The nn.iJ-Ona.L Qjr.iAA.Lon AlandandA. fon. vinyl. chlonlde pnomuJ-Qalcd Ln Ocdoben. A . .. of 1979 evolved fjxotn candy and. open dlACJUAAlonA. 6e.Ltvc.Qji 7/1f LAc pul)he and. LnduA.iA.ip ' *" ~ ...---------------- ~ Toldoiulng. pnomudgaLt.o/i{\of. I he. 09/61 Alandcud. of / pond. pen. nu-Ueon to - pn.oLc.cJ. wod-enn. fnom vlnyd cJ1Lj0AL.dc. and aflxm. exJcnALue dLA.cjiAAJ.onA. uLth LnduAdA.11 and. olhr.n/lf 7A pncxluccd five ncponlA ^ sedating. Lo pnonpecdlve vinyl cJiLoALdc oLji <'.ua,LU:y alajda/dn.. DunLng. evoLu.fL.oa of. l/\cA.e AcponOi, 7/1 of.fcA.cd InduAtny . and uf.hcjtA oppoAjjirLL y Lo JLacmjia cud co/rmoil on. the nepondA.. . ToHoning. fundhen. LnLojiAj.vc. a indy and LnlcjxacJJon. tvi.ih technical people f/iom Irdwilny and. olhcn. t.nlvncA fed pajtJJ.cAf 7/1 pnopuAyd a a /ajitlaj.d fan vLntjL chlonlde cmLAALonA rvt- 0O J7 59537).. Open, puOLj.c Ac.ctnLjiQA u.'CAc then Acid. QLcoaJjj. an open pnoecAA wan followed Ln oaaLvjju}. ad fixe. ex.lAfJ.tig /liastdajulj "fcjCe'-tlO' l^dt uxia cofXAiduAcdtlc. dj-Apuic oa io l/u\ need ancl juA.LLfLca.lLon fon. -djfa DLff.cjiA.JiQ. yLcwa. uLtJln gov ejxnmc.nl clLao wcjlc cxpn.eAA.ed and avaJLdah Le Lo /Me pubh.c. Ton example, Lji a, Ic.Upa. lo ?/t dated Munch 9, 1976} the deputy. RaaLaIojxJ. Sc.rjicJany fan nvlnonmesilal /IffajAA, DepeudmenJ, Qojrmcjic.c staled Ln c.omrv'j'.lJ tiQ on U\e 7t` A. djoifl. etwLjx.on,nc.ntal L/npacL a In IcmcnlTT^ - *7" ' lLal lhe. need fon aucJx a(nlngciti acuLncmc.nLa. conlaL.ncd Ln lAc a lad omen l have not been juAU-fled" . iohen the ncnudlji of availed)h. atudLeA have been cxajnLncdt LL La. opponent that no concAcic uJvcaac human effccJji outAide the plant bounduny can be on. lave been n.eluded Lo pn.eA.cnt ejnuiAdonA of vinyl cJxlonJde' l.hoA<L La iw evidence lo nuppon.1 that Lhene La. a A.uhnlcuxiLad nlid*. and ijtad nevene lldr.cAA an. dent A will oacti/i oniony. populadLonA Ln ojiccla adjoining, vinyl cJxlonJjde plajitAU.. DeAplle Lite dlafiude oa lo Act^uLncd Adnlngcnep a wonlaible Adandand nan evolved uJu.cJx uctn coaI effective Ln acvcaoL ncApcc.Ln. DenplLe the dlnputc, 9nduA.Ln.y pledged Lo meet lAin LeeIv^lj)g.y~Atn.etcJiLng. Alajdxutd going, no fan. oa. Lo wxg.enf.ly commit AubAtunJL.aJ. capl.lJu.1 aid. pejtAonncl Lo the ipiih Ln the lndcACAd of ocdlLns). on wid.h the..job of dc.CAfpiAlng cm. LAAlonA. I I see 2-1842 tearCL* 5unpniAung.ljy} tJiiAjppen and intenactive pnoce^A^trivolying. aJJL ponticA at. Lnt.cjin.Ai. uxjla f.oUo<iied Ln only aLx. monUxA by pnopoAed amendmentA w/xich: . UJOA.C. advanced. be.fonc mcaAuncA ncjjuined by the cxjA.LLny A Landand have, bn.cn fully Lmplamented on thein effectiv eneAA mcoAuned, .. wane not. juA.iL.fL.cd by any new toxicologic oa. medical, evidence Ahowing. need fan. clxange, . oju> notcon! effective., ^ _ . exr.Jj.taed open pant-. ccpatcon by. aJLL pajiilen at. IntenjeAi dunlng. thein evolution. 9n advancing the exLji.iL.ng. nlandnnd, fVA calculated Uni. the expoAune of the. b. 6 million people Jiving, within a 5 mile nadiuA of Vfil and TVQ pJanin -would be decAxtajicd fnom tj pantn pen billion in aln to Icaa than 2 paniji pen billcon, By \june of (975j (T^ hud completed cxJ.enAj.ve Aunveyn of vinyl- chlojiide coneenJjuj.iL.orxA in din Aunnotudlnq. thnee dlffenent plant complexes, JlndlngA wene that ccnccnijvuLLonA be.ybnd only {000 melenA cv.ejuzg.cd Icaa than S puntA *s? pcji billion. Jhiji. iixLA mono, than a yean bc.fone the AiandalSl-wctA' pnomulgatedl Anound. Shell Qhcmi.cal Qompany*a Sonco plaidoLji conccnlnationi beyond 1000 mcJcjiA avcJtng.cd only (.j? pemin pen billion/ ninety pvncejxt of the meoAunczncnJA wane below /.6 panto, pen billion, 9i La opponent fnotn .thin data that LevcIa wane below thoAC. contcjnplal.ed by (J*A befone imy>lemnnloJlon of the coninoh ncquined by the Aijuvlund. forvUdenijug. thin, it would- Accm unc.onAcU.onab le to pnopoAe tighten Ada/viandi without a showing, of. need befone the exlntlng aiordand uxla fully " Implemented and 11a effectiveneAA nic.OA.uned, 9n a memo to the AdminLAtnctox dated Play 2J, (977s the AAAiniant AJ/ninin Ota ton fox TicAC.cuich and development commented "She amendjnrnt aLoJpa the effecin of nedtuU.ng totat vinyl chlo/ude emiAJiionA La Jcaa. than one penceni, ///0/u\ banin fon thene colcjjJjxllonA La unclean and xhould be atide explicit, 9 9f. thin Atatemcnt La txue^ the net benefit of thin, amendment in aucntlonab le, n see 2-1343  < ?.cvjiL . AejjiJat.oAy {Woe egdlngA. o/i vi.rx.yL c1LojujI<l conthaAt' vividly Uih ' -;" the. exJ.c.nALvc, open ojuj' LntejuL.cli.ve. pnocejiA followed ijr deyeloping the. Atandand. Aw e/ni /?, 177A, fpl fi toil cl Petition. fon Re.vi.eur of the Standard. 3he S79 - ansi into compajii.en filed moti on*, to InJeAvene Oecemben. 7> !77&. SuApAlAlngly 7A oppoA.ecl ijo/i.c. noullne motiona. to ait mvcnc. cm a matted. of night. 3he. count appnuve.d. the, i./rteyive/ltion*. (]cuuicl'uj lSs!777- Starling eanly. Ln $CVlUOA.IJ. 1^77, ~ begu.n. private nogolxa.1a. om ux.th DJ to dlApone of the 7ell (Lon. foe Review. Jh<iA.c negoiiatu.onn excluded a11. olhen {xla.Iaca dcxipLte tie count appnx/vcd motlorxA t.o i.ntojivqj\c. ancl acpented ncyaentA (o he Lnc.Liu.lcfi. Jhc cloAed- negoilailonA continued ilmough truA lebnuany am! rruled cn cl fonmal agA.ec/nent beitueen. 7A and ~ fJLJ. Jhe count dtA/mnned the pAoce.cdj.ngA between j)9, 7A and S79 cla an LntcA.- venon. flancl 2h} 1377 without .$79 having paAil.clpaJ.ed dcAplt.e. Ha count appnoved Aighi. to do ao.. 9nenedj'h ly, [7A abcuuluner. It,1 obligation, to publicly defend^ jjJrjsdta- pAo/nulgai.ed .Aiirjtdu.-td on cut expedient to Act tic. with D3. Aoacja/cjl, 7/1 agnjeedl In the. Actllc/neni to inconpona!c explicit pnlval.ely ne.gottjjJ.ed tcnmA Ln. amcnd/nentA t.o be [tn<jpo \ed no Late*, 1Jan cJune. /; (7779he. AcJjJ.cjnc.nt pAOvlded clLao that If f/.ruci ac/j.on by. 7/1 defronted ax.yrl.ficum!ly fnom. tie. IcnmAfAeJ^out, D3 nen.enye.d tie night to pett_tlon the. count fun nevu cur of that. acJLon, 9n effect UJj with 7A!a ConcMAAaJV'.e.f pnomalgaled. fVwpoAed amc/dmcnlA to a publicly developed AtandoAxl yeJ t.o be. fjxJlxg. implx-mejJ.ed umJJujuI pQ.nlLcLpa.tlon. by. the. affected public and InduAtny ux.tloul a nhouM-ng. of nee<l. AIao Inmcd-i-blc (iM tie tirjpancnt lucli of involvement of the Armi-Atont Adjru.runijuzton and AdinlutixitnuJoA i.n ao Lr/xporJant an Laauc befoAc. the Acttlcmcnl had b een qqae.cd. A memo fnotn the. Qffl.ee. of nf)AcemcnJ to the. AdmLnlalAnion dai.ed flay (3, 1777 conlai.nA the. uAto/utdlrg fln.\L panagnaph: l,bejzauAe. tie Age/tcy Alla (jjA.ej.tdy been corrmLtt.ed to tie AubfecJ 7nopOAcd Ame/ubnc/iIa by a count aLLpulaJ.Lon. Ln the foAm of a ""`joint floiion to IKahIaa"1' the. peJULo/i fon acvLoju of thin. Agency*a pAxjnuilyalLo/i of the National mLA*Lon SijundaAxL fon. Vinyl fhloruf/e ({f)J i'. 3nai.nf f. A. I). (. No. jC~2(dtjJ the. cln.cuJ.aJLon ot thin j>achage fan concunAcncc. at thlA point atjpcjjnSi. to be. o/Ju. a pnjj foAma. cxcacJac. J/iLa ""^oLnJ Action //// ukiA aJgnet! by ft/uuAel cud filed flc.L'id 21f 1777/ wijlout fonmaj nevi-cw cuul c.onctvoienrc. at the. A.aaLaIanj AdmLnln LaoJoa Ley HI " ldt_L 2-1944 to the NationalWiId 1ic Federation and to the National Association of Manufacturers on March 25,'1977, for example, the Administrator stated: "During my tenure as Administrator, I intend to <lo all in my power to improve the performance of this agency. I want the agency's work to be marked by balance and judgment, scrupulous credibility, thorough assessment, and tough but fair enforcement. Our decisions may not always please everyone, but no one will be able to *;ay that we are arbitrary; that we discourage diversity of opinion; and that we do not do our homework." <Pp. 1-2.) - _____ In that same speech, he also referred specifically to the chemical industry, and to EPA`s tasks in regulating certain types' of chemicals. "The 'fact that evidence exists that a particular chemical may cauag .harm is not -- in and of itself -- sufficient to warrant a total ban. In the complex technological society in which we live, judgments on risks and benefits must be carefully made. It is essential that EPA approach this regulatory task with objectivity and openness and with scrupulous- regard for the facts. " (P.8.) EPA's Deputy Administrator, in'her remarks to the Chamber of Commerce of the United States on May 3, 13?7 pledged that EPA would enibcace "the following s implc procedures": "First, we will sincerely take a long, hard look at every potential regulatory move and ask. ourselves whether it is really needed. Second, if wc conclude that it is, we will do our best to write it in clear and concise English. Third, we will see to it that public participa tion and involvement take place from the very start of the regulatory development process. No surprises. Fourth, we will consider economic and social impacts. Fifth, we wi*ll favor economic approaches whenever these would seem to work as well or better tla.ui regulatory approaches.* \ id nn S 2-1 Available time and the interests of this audience probably make it inadvisable for me to discuss all. of the proposed amendments to the vinyl chloride standard. Our position is that, despite projections and speculations to the contrary' by KPA and others, the public was and is not at risk to exposure to vinyl chloride by operatory conditions prevailing at plants even before implementation of the existing standard. No adverse human health effects in communities adjacent to such operations have been found which arc \ related in any concrete way to vinyl chloride exposure. There is solid evidence which has been disregarded by regulators and others to show that there is a no-effect level applicable to vinyl chloride ai.r concentrations and that concentrations to which the public may bo exposed arc several thousand times lower than these concentrations. There arc, however, at least three provisions of the proposed amendments that you may wish to know about. (1) It is pro|X>sed that an ultimate goal of zero emissions he established. This is neither possible nor necessary. Since there is a limitation to society's resources, it makes no sense to spend these resources where there is no established need and when there are other problems hogging attention where spending of resources would bring great benefits. (2) It is proposed that no new source of vinyl chloride be constructed within 8 kilometers of an existing source, unless emissions of the existing source are reduced so there is no net increase in total emissions. This is an extraordinarily costly projxasal having anti-competitive effects as well. Costs of increased capacity will be sizeable, debottlenecking expansions at existing facilities which have been so helpful in past to keep American Industry' competitive in world markets may be excluded. There will be a tendency to see 2-1846 ... 2- - overbuild new capacity .to avoid future restraints and smaller companies will be comparatively disadvantaged. Emission/air concentration modeling studies have shown this proposal would cause but a 0.1 part per billion change in air concentrations within the 8 kilometer circle. Considering the public is not now at risk, such a proposal simply is not responsible. (3) It is proposed that new plants and, after three years, existing plants limit vinyl chloride concentrations in vents to S ppm rather than 10 as required by the existing standard. It is not reasonable to expect that plant systems designed to perform to the 10 ppm limit can be expected to perform to the lower limit with equal reliability. Therefore, this proposal would require further expenditures which arc not reasonable considering EPA themselves have stated this "will have the effect of reducing one percent." total-tcmissions by less than ___ ________ I tt*. see 2-1847