Document dDO97N6rwwoqX8opk64mMGXR5

y R EC t i v t ~ DEC i u 1986 f HEYWOOD Z ' gtg ItXdde <4eu,, Hour /6> C^J-'V Q^t T Mt-tir-&> 4trt4$ Aho^/^^/w 'Xi^CC, sr?*r 7(j j j j if f t ucc 004862 Union Carbide ( Cowwunity & Ea? & Environaen ^,3- ^ron^iVecl M C,0. 39 Old Ridgebury Road Danbucy._CT_ >ar 21. 11998 8i^-^t TO: R. c. Hi K-4 V f< ECEI V E D CC: W. E. Ch*.~>. N. H. Gainaa H. L. Greenberg D. L. Haywood, E. K. Jensep*^ K. G. OttX^ DEC i 6 1986 D. UE8ESKIND SUBJECT: Vinvl Chlorida Epideaiolocy Study . E C E I V JAM OUT 2 2 198 \ G. OTT. P Dear Dick: Attached i a copy of the EPA raaponaa to our "PYI" submission n saptaabar 9. 1986 concarning the CMA-eponeored apidaaiology atudy f vinyl chlorida vorkera. Plaaaa note the aacond paragraph of page l of the EPA October 14. 1986 latter: "In view of EPA*a general intaraat in Corporate actiona that are taken on a voluntary basis In raaponaa to cheaical toxicity or expoeure inforaation. EPA raguaata that you deacribe the actiona that Union Carbide Corporation hae taken or plans to taka to notify workers and others about tha epideaiologic findings cited in the above referenced TSCA Section 8(e) subaission." Would you please prepare an appropriate response to this inquiry a that we can respond in a tiaely aanner. Thanks. Very truly yours. WCK:rl Attachaent 0085J N. C. Kuryla Secretary. 8RES ucc 004863 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D C. 204*0 OCT I 41966 mncton *o toxic sumtahcm CERTIFIED MAIL Mr. Cornelius C. Smith, Jr. Vice President Community and Employee Health, Safety and Environmental Protection Union Carbide Corporation 39 Old Ridgebury Road Danbury, CT 06817-0001 Dear Sir: With regard tot TSCA Section 8(e) submission ont vinyl Chloride Submitted by* Union Carbide Corporation Date submitted: September 9, 1986 EPA Document Control Number: 8EHQ-0986-0629______ EPA's Office of pesticides and Toxic Substances has completed a preliminary evaluation of the above referenced submission under Section 8(e), the substantial risk information reporting provi sion of the Toxic Substances Control Act (TSCA). The enclosed status report is the result of that preliminary evaluation but does not, however, necessarily represent EPA*s final conclusion on vinyl chloride. in view of EPA*s general interest in corporate actions that are taken on a voluntary basis in response to chemical toxicity r exposure information, EPA requests that you describe the actions that the Union Carbide Corporation has taken or plans to take t notify workers and others about the epidemiologic findings cited in the above referenced TSCA Section 8(e) submission. < RECElXtO ' *Et * > OCT 20^ \*4 I* ` f 21 1906 . &&KUBXU>' w, E. ucc 004864 In responding to this request for information, or in thervise communicating with EPA regarding this submission under Section 8(e), please refer to the EpA Document Control Number that has been assigned to the submission. As in the case of initial 8(e) submissions, all responses/correspondence will be placed in the public files unless confidentiality is claimed according to the procedures outlined in part x of EPA's TSCA Section 8(e) policy statement ("Statement of Interpretation and Enforcement policy; Notification of Substantial Risk" 43 FR 11110; March 16, 1978). Any confidentiality claims should be supported by submission of information as described in the enclosed item entitled "Support Information for Confidentiality Claims." All available informa tion requested by this letter should be transmitted to the EPA Document Control Officer at the address Delow within 20 working days of your receipt of this letter; any requested information or supplemental information that becomes available following your response to this EPA letter should be transmitted to the Agency immediately upon your company's receipt of such information. Document Control Officer (TS-79Q) (Attn; Section 8(e) Coordinator) Office of Toxic Substances U.S. Environmental Protection Agency 401 "M" street, S.w. Washington, D.C. 20460 Should you have any questions or comments prior to responding to the Agency's request for additional information, please contact Mr. David R. Williams of the Chemical Screening Branch/ECAD at (202)-382-3468. The Environmental Protection Agency looks forward to continu d cooperation with the Union Carbide Corporation in its ongoing efforts to evaluate and minimize the potential risks posed by chemical substances to health or the environment. Sincerely, Enclosures Chemical Screening Branch CSB/ECAD/OTS/OPTS (TS-778) .... / 0AT|:. OCT 14 1906 . Page 1 of 4 ~r SUBJICT: Status Report* 8EHQ-0986-0629 Aoproved A- MOM' James F. Darr, Section Headrf*"*9 Chemical Risk Identification Section/CSB TO. Frank D. Rover, Branch Chief Chemical Screening Branch/ECAD/OTS/OPTS Submission Description The union Carbide Corporation submitted a copy of draft final report entitled "Epidemiologic Study of vinyl Chloride workers." (According to Union Carbide, the study had been conducted for the Chemical Manufacturers Association (CMA).) The "Summary" section of the submitted report presented the following information with regard to the conduct and results of the performed epidemiologic study: "The cohort consisted of 10,173 men who had worked for at least one year in jobs involving exposure to vinyl chloride prior to January 1, 1973. These men were em ployed at 37 plants in the U.S. belonging to 17 com panies. Observation of the mortality experience of the cohort was extended to December 31, 1982. A total of 1536 cohort members were identified to have died. The observed mortality, by cause, was compared with the ex pected based on u.S. mortality rates, standardized for age, race and calendar time. Analyses by length of ex posure, latency, age at first exposure, calendar year of first exposure and type of products were performed. The [performed epidemiologic) study confirmed that the vinyl chloride workers [had] experienced significant mortality excesses in angiosarcoma (15 deaths), cancer of the liver and biliary tract (SMR 641), and cancer of the brain and other central nervous system (SMR 180). in addition, the study also found a significant mortality excess in emphysema (SMR 179). On the other hand, the study did not find any excess in either respiratory cancer or lymphatic and hematopoietic cancer." * NOTE: This status report Is the result of a preliminary evaluation of Information submitted to EPA pursuant to Section 3(e)* the substantial risk Information reporting provision of the Toxic Substances Control Act (TSCA). The statements made In this report should not be regarded as expressing final EPA policy or Intent with respect to the subject chemical(s). Any review of this status report should take Into account the fact that the report may be based on Incomplete Information. IM ,i i iacv. UCC 004866 i 8FHO-0986-0629 Page 2 of 4 in submitting this report to EPA, Union Carbide stated that "the information oh excess emphysema observed in [the] vinyl chloride workers is not reliably ascribed in the report to exposure to vinyl chloride because of: (1) potential problems involved in th cause of death coding for emphysema; (2) the manner in which the diagnosis of emphysema was made (clinically or pathologically; (3) the possible contribution of other factors such as smoking and geographical variation; and (4) the absence of precedents in experimental animals." In addition, union Carbide stated that the apparent excess of biliary tract cancer "may be explained by failure to diagnose angiosarcoma properly." Submission Evaluation The submitted epidemiological study continued the follow-up of 10,173 workers who were exposed to vinyl chloride for 1 year or more between 1942 (or on initiation of complete recordkeeping systems at the studied plant) and December 31, 1972. The vital status of 9200 members was characterized as of December 31, 1982. Within the period of the study, 1536 (16.7% of the cohort) died. When compared to the mortality experience of U.S. white males, this cohort had a statistically significant deficit in total mor tality. statistically significant increases in mortality were observed freu neoplasms of the liver and biliary tract (Standard Mortality Ratio (SMR)641.2; p<0.001; 37 observed), brain and central nervous system (SMk-180.2; p<0.05; 23 observed) as well as emphysema (SMR179.6; p<0.01; 41 observed). The excesses in liver and brain cancers have been reported in other epidemiological studies of vinyl chloride-exposed workers, while the excess in emphysema deaths appears to be the first of its kind. Liver cancers and angiosarcomas have been causally linked to vinyl chloride exposure and several studies have re ported significant excesses in brain cancer mortality. In this TSCA Section 8(e) submission, the liver and biliary cancer SMB's showed a highly significant increasing trend in analyses with in creasing length of exposure and with increasing latency since first exposure. Tnese trends appear also in the the analyses f the brain cancer deaths. By contrast, analyses of the emphysema deaths showed a decreasing trend with length of exposure with the SMR being statistically significantly elevated for workers with exposures of less than 10 years. The excess in emphysema deaths was limited to polyvinyl chloride manufacturing and to workers who were 35+ years of age when first exposed. The observed em physema excess was not associated with the year of first exposure or with latency since first exposure. The limitations of the reported study include the lack of control for confounding exposure such as smoking or other occupational agents. in addition, bias may have been introduced because the deaths were not histologically confirmed. It should be noted, however, that these particular limitations (and others listed by Union Carbide) are Insufficient to explain the observed excess in emphysema deaths. UCC 004867 / 8EHQ-0986-0629 Pag* 3 of 4 In conclusion, this epid miological study appears to hav* been conducted carefully and the results are presented in an unbiased fashion. The excesses in liver and brain cancers observed in the cohort could be used possibly to estimate low-level human cancer risks. The observed excess in emphysema deaths is a finding that deserves further attention. For example, an in-depth evaluation of the existing epidemiologic information on vinyl chloride could be conducted in order to determine the ability of previously per formed studies to detect emphysema excesses. Current Production and use A review of the production range (includes importation volumes) statistics for vinyl chloride (CAS No. 75-01-4), which is listed in the initial TSCA Chemical Substance inventory, has shown that between 3.8 and 10 billion pounds of this chemical were reported as manufactured and/or imported in 1977. This production range information does not include any manufacturing/importation data claimed as TSCA Confidential Business information (TSCA CBI) by the person(s) reporting for the initial TSCA Inventory, nor does it include any information that would compromise TSCA CBI. All information reported for the initial TSCA Inventory, including the production range information, is subject to the limitations that are contained in the TSCA Inventory Reporting Regulations (40 CFR 710). According to Chemical & Engineering News (June 9, 1986 issue), U.S. production ol vinyl chloride was 6.09 billion pounds and 7.78 billion pounds in 1934 and 1985, respectively. According to secondary literature sources, applications of vinyl chloride include the chemical1s use in the production of poly vinyl chloride, as a refrigerant, and as a plastics adhesive. Comments/Recommendations In its Section 8(e) submission, union carbide stated that any questions concerning the submitted report should be addressed to the Chemical Manufacturers Association. It should be noted that the Office of Toxic Substances (OTS) has received several Section 8(e) and "For Your Information" (FYI) notices on vinyl chloride. It should be noted also that several EPA Program offices (e.g.. Office of Air and Radiation (OAR)) have evaluated or are currrently evaluating available toxicologic and exposure data on vinyl chloride. a) In view of EFA's general interest in corporate actions taken on a voluntary basis in response to toxicologic or exposure data, the Chemical screening Branch (C8B/ECAD) will request Onion carbide to describe the actions the company has taken or plans to take to notify workers or others about the reported epidemiologic findings. UCC 004868 K 8EHQ-0986-0629 Pag 4 of 4 b) The Chemical Screening Branch will review tha reported information in greater detail in order to determine the need for further OTS assessment of vinyl chloride. c) The Chemical Screening Branch will send copies of this status report to OSHA, NIOSH, CPSC, FDA* NTP, OStfER/EPA, OW/EPA, OAR/EPA, ORD/EPA and OPP/OPTS/EPA. Copies of this report will be sent also to the TSCA Assistance Office (TAO/OTS) for further distribution. f f ucc 004869 V SUPPORT INFORMATION FOR CONFIDENTIALITY CLAIMS The Environmental Pr taction Agency (EFA) has be n receiving many requests f r access to n tices submitted to EPA under Section 8(e) TSCA. Accordingly, EFA must make a final confidentiality determination concerning the treat ment of the information in your submission, in order to make that determination, EFA needs further information from you. Under EFA's regulations on the treatment of informa tion claimed as confidential in 40 CFR Fart 2 (41 FEDERAL REGISTER 36902, September 1, 1976), you have an opportunity to submit comments to substantiate your claim of confidenti ality. To comply with these requirements, you must indicate which portions of your submission are claimed as confiden tial. Be specific as to page, paragraph, or sentence as appropriate. For those portions that you identify as confidential, you must address the following questions. In answering the questions, be as specific as possible, give examples if necessary, and connect the specific answers to the specific claimed portions. 1. For how long a period do you desire confidential treatment? May EFA disclose this Information after a certain date or after the occurrence of a specific event? 2. What measures have you taken to guard against undesired disclosure of this information to others? 3. To what extent have you disclosed this information to others, and what precautions have you taken in connection with the disclosures to protect against further disclosure? 4. Have there been any confidentiality determinations made by EFA, other federal agencies, or courts in connection with this information? If so, please enclose copies. 5. Do you assert that disclosure of this Information would be likely to result in substanital harm to your competitive position? If so, what are those harmful effects, and why should they be regarded as substantial? feet is the causal relationship between the disclosure and the harmful effects? 6. Do you assert that this information was voluntarily submitted as defined in 40 CFR 2.201(1)? If so, would the disclosure of this Information tend to lessen the avail ability to the Government of similar Information in the future? fey? i* lo making your claims of confidentiality and providing responses to the above questions, you should keep in mind that under section 14(b) of TSCA, "data from health and safety studies" are not entitled to confidential treatment, except to the extent that disclosure of such data would reveal either the portion of a mixture comprised of any of the chemical substances in the mixture or the processes used in manufacturing or processing a chemical substance or mixture. Any claim of confidentiality for data from health and safety studies that goes beyond these two types will be denied. ucc 004870