Document empoawE67nYp01NgRnNDB4kyM

VOSC*H C, KCLLCA 'UOh| n, nccKMAN w>luam . onencsANi. wa. MALCOLM 0. KAIAtTMUl *r( v. BLACK rcaaM#c 9. v4*M jCMoaAmBBTOiilWLaC.Wc*..lMoA*B(B*i* . wicMACb a. mobboncmab. maBBm* xcnmum KAB* bob CVCNB *J*lOc6HrtteNNBl.. BDbIUbCB.M*tACcBKa91v* CHBISTlNE A MCACMCB SHIBLCT %. ruvi**4BO B A. B C BLAWBCBCC B. UAk**lN al m imm h bAc^Oca^as.ltawb-jabnactt MOT ASM1TTCO l* B.C. SCXChvUiM.A4a., MBBl.oLtAcN* OtOBoC #. MISKO BAC9CBICK J. DAY, J. MABCI E CKOKTCtN' MABCM 1C. C0WAH BATBICB J. auaa a. caAia tavtcmv MABK A BlCwCBa . KooxrtpbbmalwMiewAtk a. bckt CATHcaixc h. aoeMca BiCHAAt AJAArf Jtr*wcT a. kerb* AAl* ABNC MOKTCITB CLUOT BEULOS inAHNSKL OCNHAH* BUCAA C. AOA* MARK L m*OAA tow/M c. hsu(< law offices Keller and Heckman 1150 17'" STREET, K.W. SUITE 1000 WASHINGTON, D.C. SOOO (80S) 950-5000 August 28, 1989 teJCNTjrio STArr 8A*Cfc I OlJIUPt, Ba. . eAJ*ics v. aacoCM. bb. . aettBT K MaTkew*. b-. O. JAXN B. MCBBCBUAM. B. 4. ear uyrmBC rOLlV JU*Tlh C, BAwcvu r>, s. TCLCCOMMymCATIONt KHS'Mcca ChaAlC* r. TuaMca TCLOC TeLceoBica (cob toa-ra> CAtlC ADOBCBC -XeVMAM- waiTjt'a oiacer oui.NUB'tt* (202) 956--5641 VIA TELECOPIER Meredith M. scheck The vinyl Institute Wayne interchange Plaza 155 Route 46 West Wayne, New Jersey 07470 II Re: CARB Draft Report on Vinyl Chloride Dear Meredith: Enclosed is a cover letter and the executive summary from a preliminary draft report on vinyl chloride being prepared by. the California Air Resources Board (CARB) . Comments are requested by September 8, 1989. Since the deadline is fast approaching, we may wish to contact CARB and determine whether later filed comments will be accepted. The enclosure is all the materials that I have. I understand that Goodyear sent a copy of this to Goodrich, but I am not sure who at Goodrich received the materials. If the entire document is needed, you or I can obtain it from Ed Nowak at Goodyear (216-796-7417). Please let me know if I can be of any further assistance. Cordially yours, Enclosure cc: Ed Nowak Larry Thomas Robert w, Sherman Lewis R. Freeman, Jr. Peter L. de la Cruz VVY 000028837 AUG 2*1, 'S3 ,10:29 FROM GOODYEAR RSS RM 25B ATaH 0> CM<fOHy*____ AIR RESOURCES BOARD uci q irttET >.! lOX M15 SA^lAMtNTa CA PAGE.002 G*oro Qwtewf)iw Cnw> August. X, 198$ Dear Sir or Madam: Draft Re&ort-OJ -Vinyl. -Ch lo_r.ld& As you requested, enclosed for your review and comment is the preliminary draft report on vinyl chloride. Public review of this report includes two comment periods. The first comment period begins with the mailing of this report and you have until September 6, 1969 to submit your ] written comments to us The staffs of the Air Resources Board I (AR8) and Department of Health Services (OHS) will review and I respond to all the comments received. Your comments and our responses to them wilt be compiled in Part C of the report and where approp.riate, the report will.be revised. The revised report will be mailed out to you and other i members nf thp public for a second and final review. It will t include Parts A, 6 and C of the report as veil as an Executive j Summary which summarizes Parts A and 8. At this stage, the ARB and DH5 staff will only accept comments on the Executive Summary i and any revisions made to the draft report. A 20 day comment i period will be given for your review; comments received.and our . | responses will then be incorporated as an addendum to Part C | After reviewing all public comments, the ffnal draft report along with Part C will then be submitted to the Scientific Review Panel for its review. The Scientific Review Panel has requested that all public comments be directed to the AR8 during these two comment periods. Please note that, in accordance with this process, the ! Panel will not receive or consider any comments submitted | directly to it, or received by the ARB after the close of each comment period. VVV 000028888 ftUQ 2 i * 89 '10:29 FROM GOODYEAR RES RM 256 .k PAGE.003 .-2 August 2/ 2999 I.n.. o- 'rd-- e-W r f o*'r your c^omme"nts *tWo Wbe WcoWnII4siidwesri ecdv Vontl thhit i1s9 version of the report, they must be received by September 8, 4$f$ end submitted to: Mr* Robert 8arha, Chief Toxic Air Contaminant Identification Branch Air Resources Board Attn: Vinyl Chloride P. 0, Box 2815 Sacramento, CA $5812 If you have any questions concerning the report or the comment procedure, please contact Mr. Richard Corey of the Substance Evaluation Saction at (91$) 323-8543. Enelosures cc: Scientific Review Panel Peter 0. Venturing, Chief Stationary Source Division -AUG 2? 1 *83 10:30 FROM GOODYEAR RSS RM 25S PRELIMINARY CRAFT TECHNICAL SUPPORT DOCUMENT PART A PUBLIC EXPOSURE TO* SOURCES. AMD EMISSIONS OF VWL CHLORIDE IK CALIFORNIA REPORT TO THE AIR RESOURCES BOARD OK YIKYL CHLORIDE PAGE,004 FrifteioaA Author. Richard Corey CgntrlfcLUflq^uthgrs Tom Parker Chris Nguyen Paul Allen Steve Hui Reviewed and Approved by: Joan Oenton, Manager Substance Evaluation Section Robert Barham, Chief Toiic Air Contaminant Identification Branch Peter 0. Yenturini, Chief Stationary Source Division July 1589 WV 000028890 RUG 2-1 *89 10:30 FROM GOODYEAR RES RM 25 l PAGE.005 unhr i r. imopucnoN Part A of this report is an evaluation of vinyl chloride's uses, emission sources# ambient and Indoor air concentrations, and population exposure in California. Also included are discussions of the physical properties-and atmospheric persistence of vinyl chloride. California Health and Safety Code Section 3965-5 states that substances listed by the U.S. Environmental Protection Agency (EPA) as hazardous air pollutants (Section HZ of the Clean Air Act) shall be identified as toxic air contaminants (TACs) by the Air Resources Board (AfcS). Therefore, because the EPA has listed vinyl chloride as a hazardous air pollutant, the AR3 is directed by statute to identify vinyl chloride as a TAC. The AR8 is the state agency responsible for the Identification of TACs in their non-pestlcldal uses. .The California Health and Safety Code Section 39555 defines a TAC as "an4 air pollutant vhich may cause or contribute to an Increase in mortality or an increase in serious illness, or vhich may pose a present- or potential hazard to human health.* The findings of the Part A report are considered vith the health effects findings (Part B report) of the department of Health Services (DH$) to determine if a compound should be identified as a TAC by the ARB. In 1978, the ARB adopted an ambient air quality standard for vinyl chloride of 10 ppb for a E4-hour average. The standard represented the limit of detection for vinyl chloride at the time it was adopted. Yinyl chloride is an extremely volatile compound that is primarily used for the production of polyvinyl chloride (PYC). PVC is fabricated for use in several products of vhich many are used by the A-l vvv 0 0002QS91 i 'AUQ '09.10*30 FROM GOODYEAR RES RM 256 * PAGE.636 j construction industry. In California, the Identified sources of vinyl chloride emissions ere landfills, PYC production and fabrication facilities, and sewage treatment plants. Available information indicates that landfills are the largest source category of vinyl chloride emissions in California. Yinyl chloride has been measured in the ambient air near hazardous waste and municipal waste landfills. Numerous studies have documented the presence of vinyl chloride in the landfill gas of these and ether landfills, and have shown that vinyl chloride can be formed In landfills where chlorinated organic compounds have been disposed. Therefore, because disposal of such chlorinated compounds is prevalent, the staff reconrands that ail landfills (hazardous and municipal) in the state be regarded as potential vinyl chloride emission sources. In this, report, ambient monitoring data and meteorological data are used with an atmospheric dispersion model to estimate population exposure to vinyl chloride near two California landfills. The modeling results show that people living near these landfills are exposed to elevated levels of vinyl chloride. The results also imply that people residing near other landfills in the state may be exposed to elevated levels of vinyl chloride. In addition to estimating ambient air exposure, this report also evaluates indoor air exposure to vinyl chloride. Based On limited monitoring data, indoor air exposure to vinyl chloride is probably not significant for the majority of the population. However, for people residing near landfills, inhalation of indoor air may represent the most significant source of vinyl chjoride exposure. This Is because vinyl chloride can migrate underground from landfills and accumulate in nearby structures. The concentrations of vinyl chloride measured in homes located near landfills have been reported to be several times greater than the corresponding ambient concentrations. j 1 j | j 1 j i | VVV 000028892 t .AUG 21 '89 10:31 FROM GOODYEAR RES RM 256 J? A* PASS00? Prepared by: California Department of Health Services Principal Editor: Norsaa Cravit2, Ph.D., KPH, Staff Toxicologist Reviewed by: Ceorge V. Alexeeff, Fh.D. Michael J. Lipaett, Douglas N. Cox, Ph.D. (California Public Health Foundation) Based in part on vork subnittted by: Carla C, Christensen and C. Tucker Heines, Biological and Enritonoental Chemistry Department, SRI International, 333 Ravenswood Avenue, Menlo Park, California 96025, Under Contract 85-8$67$ (045A) and by: Deborah Crady, M.D., K.P.H. School of Medicine, University of California, San Francisco, and Allan S&ith, tf,D, PH.D. University of California, .Berkeley VVV 000028893 eg 10:31 PROM GOODYEAR RES RM 25S PAGE.008 DrCAr i Executive Sumaary Vinyl chloride Is a short-chain halogenated hydrocarbon, used predominantly in the manufacture of polyvinyl chloride and various packaging and construction products. Vinyl chloride has very lev degree of acute toxieiey, with cvo-hovr inhalation U>5^ values ranging froa 27,419 ppa in nice to 236,215 ppm in rabbits and guinea pigs. Exposure to high concentrations can lead to narcosis, cardiovascular and respiratory irregularity, convulsions, cyanosis and death. Several husan deaths have baen attributed to occupational . exposure to very high levels of vinyl chloride, Autopsies of these patients revealed congestion of the liver, spleen and kidneys. Acute toxicity synptoas are thought to occur above 100 ppa. Chronic exposure of workers to vinyl chloride has been shown to lead to "vinyl chloride disease", characterized by occupational acro-osteolysi*, vasospesa of the hands similar to Raynaud's syndrom, dermatitis, circulatory and central nervous eyetan alterations, throsboeyeopenla, splenomegaly and changes in liver function. Eight symptoms commonly reported by workers exposed to vinyl chloride (including dirtiness, headaches and nausea) were observed even at dose levels be lev $0 ppa. Vinyl chloride has been shown to induce cancer In animals in utero^ but has not been shown to cause any other reproductive or 1*1 WV 000028894 0UG. 2*1' *69 10132 FROM GOODYEAR RES RM 256 ft PAGE.009 developmental effects in rats, mice and rabbits. Epidemiologic studies of families of vinyl chloride workers or communities having vinyl chloride processing facilities suggested the possibility of j aa increased incidence of birth defects and spontaneous abortions among people at risk; hovever, subsequent reviews of these studies have concluded that there is__ Inadequate -evidence_^eo, link environmeptal qr___agfiqrnal___exposure to vinyl chloride_wjth blrsfr defects or- spontaneous abortlons__ln humans. The noncareinogenic effects occur at concentrations near or above 10 ppa, which is greater than four orders of magnitude above possible general cablent levels in California (0.5 ppb). The noncarcinogenie effects also occur at concentrations greater chan 3 orders of magnitude above the highest concentrations measured near landfills <10 ppb). Consequently, SHS--staff do. not--expect nonearcinogenic adverse health effects to occur fronL_acute_oc chronic exposures to vlnvl, chloride _ln ambient air. IbS___International Agency for Research on Cancer flARO. _the United States SovironaenraL. Protection__ AEftne*__ (EEAl-arvd the California gepArtraent of Health Services ^CDHSl have identified vlnvl chloride as a chemical for -which thare__ la sufficient evidence, of carc_itto4cnicitv ^in_be^hn,hunianjy__ftPd experimental animals . Chronic inhalation and. oral exposures of rats, nice and hamsters co vinyl chloride have been associated with an increased incidence of malignant and benign tumors at several sites including the liver, lung, mammary gland and the nervous system. In humans, 1-2 VVV 000028895 aUS '89 10*32 FROM GOODYEftR RES Rtl 256 pflse.eia epidemiological studies of occupationally exposed workers have linked vinyl chloride exposure to development of a rare cancer* liver angiosarcoma, and have suggested a relationship between exposure and lung and brain cancers. Although pharmacokinetic studies in humans exposed to vinyl chloride are rare, limited evidence Indicates that, following Inhalation of lev levels of vinyl chloride <3 to 24 ppm), up to 71% (with a mean value of 4%) of the given dose may be absorbed. Vinyl chloride absorption appears to depend on its metabolism, which is a dose-dependent, saturable process. Due to saturation of the enzyme systems responsible for the metabolism of vinyl chloride (cytochrome P-450 and * alcohol dehydrogenase), exposure to concentrations above approximately 250 ppm will not necessarily lead to an increasing Incidence of tumor development. Metabolism of vinyl chloride leads to formation of chloroethylene oxide and chloroacetaldehyde, tvo reactive intermediates which undergo covalent binding to cellular aacromoleeules and are thought'to be responsible for the toxic effects of vinyl chloride. These and other metabolites may be further metabolised and excreted in the urine. Unaecabolised vinyl chloride is eliminated primarily In exhaled air. Vinyl chloride,.ls mutagenic in both prokaryotic and eukaryotic test systems, with significantly greater genotoxicity seen after metabolic activation. DHS staff__hava found--no., eyl^"g eareirtOEcnifl threshold level___and /because___vinyl chloride. .lie. 1*3 VVV 000028a96 BUS 21 '89 10:33 FROM GOODYERR RES RM 2SS 4. PftGE.811 \ C I: gucagenic. thg staff recoTmenda that vinvl,-chloride b* eor^ldarod -jj as r.oc having.a threshold for carcinogenicity^ . Several animal carcinogenicity and human epidemiological studies of occupationally exposed workers have been analyzed for risk assessment purposes. Although actual exposure levels are nor known, exposure estimates have been used to evaluate the Vaxveiler at al. (1975) study of vinyl chloride workers., Based on these eeeifiates, DHS staff has calculated that a lifetime exposure to 0.48S ppb night result in an incremental Individual cancer risk of 1 x I0*6(assutting liver, brain and lung cancer are all related to l 4 vinyl chloride exposure). This yields a risk estimate of 2.1 x iO"/ppb. In the case that only liver cancer Is assumed to be linked to exposure, a lifetime exposure to 1.0 ppb say be expected to result In a risk of 1.0 x 10 Due to inadequate exposure data, follow-up time and ocher methodological* problems, DRS staff suggest that the human risk estimates be used only for eosparaclve purposes. Evaluation of animal experiments by the linearized multistage model yields a range of human risks spanning from 1.6.x 5 g 10 /ppb to 3.9 x 10 /ppb, with most estimating a risk of between ,4 -5 10 and 10 /ppb. Evaluation of animal tumorlgeniclty data * indicates chat vinyl chloride's carcinogenic potency Is dependent on sex, tumor site and age of exposure. Taking these factors into account, D3S staff believe that the human risk estimates are consisttmc vlth those obtained for laboratory animals. The staff i of DHS recommends that the animal data be used to evaluate the risks resulting from vinyl chloride exposure. C9nya0uent.lv. the \ i .* 1*4 VVV 000028897 ^ AUG 2 g9 10133 FROM GOODYEAR RES RM 256 * :ik.t PAGE.012 DR,'.. raftgt--&f--risk*__ estimated--fxaa--STialyfCS----fef_ animal attidUt a-nri recommended by _fiflS, .far. regulatory .tt.urBaj.ee lie between 3 4 y lft!*/p?b and lf8_s lP"3/pph. Vinyl chloride has not been detected In the ambient air o California <liait of detection - 0.5 ppb) except at certain "hot spots". Air Resources Board (AR3) staff has aotxitercd vinyl chloride emissions froa the BKK hazardous vaste site in Vest Covina and the Oil landfill in Monterey Bark. Estimates of peak exposure concentrations for eaxl&ally exposed receptors range froa 2 to 10 ppb at the BXX landfill and from 0.6 to 9 ppb at the Oil site. Air Resources Board staff has estimated that between 17.000 and 111,000 individuals say be exposed to 1 ppb at the BKX site. A. lifetime exposure of 131*000 residents to 1 ppb would be associated vitb an upper bound estimate of 0.5 to 236 excess cancer cases. The calculations represent the upper range of plausible excess cancer risk: the actual risk,, which cannot be calculated, nay be insignificant. Based on the finding of vinyl chloride-induced carcinogenicity and the results of the risk assessment, SW3 staff finds__ thae vinvl chloride is an.1ajj? ttotlutant Vhioh nsv causa or contribute.- to, an___Increase In mortality or an increase in serious Ulr.e.gs,___or Which may pose_*^nrfeaepe or_Botential hazard to huasn hSA.lsh: VW 000028898