Document Bv3KwRdkaZJeLn8196yQZOZ04

UNION CARBIDE CORPORATION CORPORATE PRODUCT SAFETY P. O. BOX t36i, south charleston, v*. VA. 25303 August 4, 1980 Dr. John Stafford Imperial Chemicals Industries, Plastics Division P. 0. Box No. 6 Bessemer Road Welwyn Garden City Hertfordshire AL71HD England Ltd. Dear John, Subject: Brain Tumors Union Carbide Corporation Texas City, Texas Knowing your great interest in the subject I am sending you the following items: 1. Clipping from The Washington Post dated July 24, 1980 on "Cancer Outbreak Found at Two Texas PI a-nts". 2. Alexander, Victor, M.D. ."Brain Cancer in Petro chemical Workers - A Case Series Report Draft VI" Occupational Safety and Health Administration, U. S. Dept, of Labor, Washington, D. C., May 1980. This draft report and UCC comments are for your information only. Table 5 showing recognized and suspect carcinogens at the plant is misleading. Acrylonitrile, dioxane, hydrazine and vinylidene chloride are over-emphasized and should not be viewed as universal factors at the plant. 3. Lasagna, L., "Statistics: A New Co-Carcino gen", The Sciences. May/June 1980. This has no bearing on the subject, but it might be interesting. Dr. J. Stafford -2- August 4, 1980 Chemical Regulation Reported dated July 18, 1980 "Citizen Petition Seeks Regulation, Cites Carcinogenicity of Plasticizer" We appear to have a developing furore on di 2 ethyl hexylphthalate and other vinyl plasticizers. If you have any news or data in the European area, please let us know. Very truly yours, RNWJr./rhw Enclosures cc: Dr. T. R. Torkleson R. N. Wheeler, Jr. Assistant Director Product Safety UCC 049374 Dtt: JUL24 1980 Cnmoiteti tiy Jana Raamuuan 202/328--*229- . , 1 Chemical Menutecanrs Association. 1825 Connaeticut Av,, n.w., Washington. O.C. 20009 ^TBB-VASHLICTO* POST Tl*nT.J*trU.im Cancer.Outbreak Found at 2 Texas Plants By VictorCohn. and Joanna /w--y thanwould maw ft&atf expo- m t Mix perdenier materiel or lo A svrious oufflreek. at brain* oiaur cation intbe plant" is involved, said has been discovered ia taro.Taw- pte Jtmw gaana -tor Dow. "That* la corhemicsl plants* .ante federal so- far to connect the- work- dais, tear they maj'find,* high tncl ; ylirato the- State --wt* - dcsea of brain cancer elsevrbwe te-i Deteom Eagle. bmmp at Warn tho hui industry that mafcta ehamfc Carbide's- Teiaar.Cliy plant. pnl cals teas efL -- Ah* At cancan tecMence any hr la a probe that started ta parly - higher Then-the, uetieoel average hat Ht-lxcdttar of tbw American-Jour^ .sal ef Industrial Medicine. which-will-.i enotepeteUsb the fine scientific report. ; -- teat: euthreakr. written by a group*... jfidite Ptt ilanodc-of OSHA.1 , *W1i-*Sbed'"dimW .tatow'btrw fwido^ : itf. said. Sheldmrw AXU-CIO dlactnr ef occupy- j cith and safety- There has ~ . MWj^dustrywide study of tt, just 187*. 39 brain-rumor cam -- M at the aw -yet been-proved hifhv then then fatal to ter--hart baca disco*- " ' htiliMt in the arc*, "if it is. we're pMr*is no syeterutic rpidcnuol- ogy yet of tho Americas work force." * arao ament recent and pan worker* '** as aaxtana as anybody, to tat to he sai& , , . - *J at a Sow Cbmical plant 4ft T. aw Wteete ed it.* hc-said. But he skid the feet that Dr. Euleh*^ port. Tax. Eighteen other faud cam "t'irba*-tho stady beian in tumed np at a Union Carbide planM***", teatlberropwsid thar the im u. cSe^T, . Binghem, OSHA director, "put gather' OSHA'r ftryt medical and to-.; seb i Taxer Cay-Tax. ** the evencr might be riarl chlorides entile team" meant' OSHA had A. veBttoonth*-iprnla.nwshirchlaisthethIfwckairttdooCttedd l,ttbelMSihd*fSrcunSMnlwSdwwitlhf,^thne g^llobla*,*' skilled teem to go tn the Union Car-''1 - bido-plaat early last year'and'Oegls to-t7 with plana thaAmafce or-process po- - h. the 'predominant ear being fotmd. study tbchrain tumorx.; . - _* ti ochesticals. Bat so far, federal lares- . ptrt deter of -the victims had no expo-' tisators bar* net been able in pin* *r enrrtevfeyt chteWcTthTNlOSH^r' pent a guilty cbemlcalMft, mare. smchertssdA^ re- 1 `Alexander-headed that first investi-'' gatiom which was tittered by a com- ' plaint |n late 1878 from a brain cancer i Ultely. . group of rteniteteorc HSt, Tony XrnochJ oftheOfl. Chemical victim, at Union Carbide. 4 ^ , ess--thougb then art several under and Atonic Workers Union said pre- : ' ~ Iranically,' that victim's cancer had l suspicion. _ Hminary* lepers frnn other studies 1 spread from another part of his body. The brain-cancer incidence among "found; bigber-than-normai rates of So bris` not cdfitially.'considered' one- workers ia the plants in the last 3b b*"rain and stomach rsncca among p- . of the victims,.; * -' ; . years is twice the normal level m the- frochealcal workers along the Ttaae.-.' general population. Dr. Richard Wax- Golf Coast and as a result the union wsiler Of the National Institute - eg . . end 'the. National Cancer Institute are- - Occupational Safes and Health studying the entire- industry- Evratn* GOOSE) said yesteday, . { tlly 60,000 workers will be checked, he All d the victim* are..mea..row | women wort ia the-plants. "Thera isl a. cancer epidemic among Investiceters from the two federal: t American workers and certainly tgeneiea involved--tbspartiaent's Occupational Labor Satety D*-and :1 among thnejd`pworkers we represnet," . Health Administration (OSSA) and Pstrochkaicals Involve' more than. the Department of Health and Human .30.000 workers la Texas alone and Services' MCSH--have not yet been bring in about S3 billion annually, ac sole to look ia detail at other plants, cording to state figures. The Eounoa - V let- it's taportmt* for workers" to ' speak.up. Waxweiler said. TI w* badal beard from that worker," be- niA. "w wouldn't have laown about* Un ion Carbide. W wouldn't have known ; about Dow or any at it*-' v . Woriting with Texas docton and health officials and with Unfoo Car- ` bid*--r company that has been "highly end unusually cooperative,,Alexander said^-Alexander found IB'_tamnn among. 8.000 poopie who had worked st the- Texas dty~siaat'iine* tboufb they have started some in*et- Chamber of Commere* reported last T8M. when the first victim died.. ligations. year that dr of every 10 pounds or They have reports, they saldL of pos gallons of U.S. petrochemical produc- . sible ccsccntratioBS of > brain tion come from tbe Texas- Gulf Coast, cancers in plants at Beaumont end . Dow's Fraepon plant, which covers + Port Arthur, Tex.; Charleston. W. V*.; 500 acres and employs 7.000 peisonx. is the biggest op* there. Louisville, and San Francisco. as well as one in Canada. "There's no reason to susoect ail pe trochemical plants." Wsxweiler said. But Dr. Victor Alexander of OSEa ; OSHA and XIOSH officials are : planning s joint conference on tbe problem, possibly ia October, involve log government industry and the-ad* entile and medical worlds; Tbe sltua- He'then investigated "a secood plant"--which be would. not namo-- 1 and found flv* brain tumor But two of these orarJe had also' worked at Union Carbide. - - Statisticians at tea famed MD. Anderson'Hospital and Tumor* Institutein Houston then combed their eompu* terlzed Texas death records for lists of bruin cancer victims and fheir work monls. taid there may be "five or six others" si least, sod J. William Uoyd. OSHA epidemiologist said. `There may be any number of chemical plants in volved.* Spokesmen for Dow end Union Car bide noted that the results so far are tion "is something, we didn't know about before." said Dr. Irving Sellkoff of Mount. Sinai Medical * Center inN'ewYnrh, This led the Investicaton to' the Dow plant, the site of 39 tumors among more than 30.000 workers tine* the early 1860s. Studies now are focus* Ing on company records to determine- where- the men. worked and whax inconclusive. "We see no common (y\o*) for internal use only V)CC mm felcrodne European LtierracaL Firms Jbxpect tyotits cDtmieiii they vrutpond to to thevest wnpltx. vMeh ntn 200 dlffer- To Fall Sharply in 1980 Due to Recession cot product*, including antifra . chlorine. U;tX ethylene. vinyl ehl*nde tod ether toduiutol chemical '7By Jonathan Srnrax OtherUJL chemical coactrns art also building blocks. And Jhn M. Gooes nutting teto senna difficulties. Prtux Worker* at Union Carbide'! plant had job* `alb over the place," Wax* weiler said. One of the tow eommotr denominators was that 13' pt the 1*\ viefims bed worked1 there more than* 13 yean.- * ; The Texas, plant studies.'- end the " stndlae of workers* background!, are tall cot complete* fedtrail'Investig*- '. ton said. . But "we strongly suspect? said AJ-* wander, that the-cans* of the tumor*. may bo not a single, chemtoai.bot."a ebemleal.proeeM'--exposure to hil or . some of the many steps that lead to a- single chemical product Or. her laid it* may be more than one presets in volving the 300 or so ebeaieali'tonn- no.-jy found- in a modnf ! cal factory. . . aw r/See-rMn ky tmu wall XTkcrt secas*L The rapid itnenehmeni to tot West Eu ropean chemical market vm cut deeply torn, profits, ti rtjer European producers this prafit could be down as much as 20% at Lar* Industries Ud. aad 5% to 10% at 90C ewnattonaj Ltd-, industry specialists say. rOne thteg is wt 1)10 will certainly be ynr* . * a wotsryear for tot chemical industry than The sales decline tou saited ahrupdy to un." saya Karl Wacsler. chairman of toe March has already spurred price cutang* by German Chrmiral Indusry am^ Qnttoental European companies. and plant emailmenra to the United Kingdom; where rbeodcal cracarna are even more severely Chemical production to Germany began to lag to Aptfl-and weakened further to May and Jishl hemes.. ML . With Europe's dropoff to Industrial pt to. 1M0. chemicals will almost cer tainly drop." declares Chris Burbridgt. an taecsaiMBt analyst at.Phillips-4 Drew, a All toe Mg tom German chemical compantos Hoachst AG. Bayer AG and. BASF AG-have ton allscud by toe downturn. bet are bmftant to forecast the effect a ` smeibroker. toe drag of a general budnees European chemical concerns are bong bun by wbstanflal Moekpfflng ton year a ad-vanct of expected price tooaaam. inroads into the market by agfrts- sjve aeBtog of lower-cost American Imports, HWttfti Seefelder.. chairman of BASF, says toat toe chemical industry's "economic pi expects wfO be toeeassogiy influenced by wid-wide political insecurity, which win hnntfr-ip worid trade, and by recessionary teodenties to toe UX" and the sales-intibiting impact of strong While sales lor toe German chemical cmiTiatos.tucb u tot British pounds ccoctras rm 20% to toe first quarter, toe Hurtng. too, art rising prices for neural rate cf tooiase dropped to 12% for the first gas aad ofl. The cnat of tuck raw materials hall aad wdl hirtocr decline to *% for the tor. Wesiero European chemical concerns full year. Deutsche Sank AG predicts. And mJD% to toe first quarter of this year aad the bank ama that now of the full-year to- % to toe pasru months. emse wifi be due o higher price*. The producers, moreover, are toting to- b Switaarland. a spokesman lor FI Hoff- creasng competition from Eastern Euro mam-Lafioche It Ca. says: "iafiadoa is toe pean chemical plants, many of which were mato prabiem. as prices can't be raised A/1 Ti-n*s l\Vi -- I- * ;Louisiana Waters Searched . brought tote producson to recent years with enough to compensate for wage increases tbh aid of Western capital. Mom European chemical concerns, how ever. art broadly diversified, and some- For Toxic-Chemical Drums areas ct their business, such as agricultural cherracals. drugs aad inorganic chemicals, , SHELL BEACH. La.. July B (AT) --' art bolding up. "The chemical crunch woat [The Coast Guard searched a Mississippi ; RiverwmtRwny near bsv today formore - -than 130 drums of haxardous rhettoralo wtocoe potasdal danger led to the -* > o( an outlet to the Gulf of Modco. j The drums west tots the watw tom . 'sight from the cargo ship-Testbaak aftn- the collided with the See Daniel, a Pana manian ore earner, the Coast Guard said. Nc Injuries were reported to the eoi- . iisjonaioetc; miles southeast of New Or- he overwhelming as to U74-7V* reasons ent toduscy specialist, referring to toe xiueeie five yen ago following toe quadra- pdng.af oil pnccs by members of toe OrgiBizadcn cf Pttraleum Exporung Countries. Industry - leaders expect toe nexr IX months to be toe most difficult, with a primp beginning to toe second half of 1M1 aad farther recovery to US2. "The current tectaiion. which is only now beginning to Europe- win last undl mid-lsSL" predica Obw-ona. V" A " GOVERNMENT regulations n banks to tail esstoraers more than they to know. NorthweKern Naflonai Ba Mbnaapolto sent easterners a tsoo booklet entitled "New EJecspnie 1 Missing from the- Teathank m O drnis ofhydrohromic add and a cargoship container bolding to drama of penta Jean Gandois. president of Rhene-PouJeoc SJU toe French chemical concent. In toe UJ the chemical-indusary slide Transfer Disclosure Notice." To test n ship, 100 of toe booklets contained an ; paragraph prantixtor no for the askla ehloraphesol. The hydrebrosaie add began in March, and results to April aad one has yet requested toe money. forms a poisoams. gas when It to m> May hare been "disastrous." says one in hined with water, tort the gas dissipates dustry specialist. The British companies quickly in open air, the Coast Guard nad. have been affected by plummeting indus trial production, which is expected to be down t% for the year, to contrast to a I* to 2% Increase to Conttoenal Europe: toe JUL241SS3 L .5. Accuses Chemical Maker saong pound which prices British products CHICAGO--The federal government wants to :c.d Monsanto Corp. liable for contaminating taka -Lcmgan by telling a toric chemical to a lakeside out of mme export markets, and higher prices for some raw materials than those paid by West German and French- compa- taker of boat motors. I Imperial Chemical Induscies t-d, the Clrtl ehargst sgafntt Monsanto ware added to a blgyst VX chemical company, is jjkely to STJ lawsuit against Outboard Harms Corp. sf Wank- end toe year with pretax prafit of iesa than ;sn. 111. The government says Monsanto continued . the equivalent cf fl.it billion, down more tiling poJyehlonnarad biphenyl to OMC even when - than 10% from last year, industry analysts imew the motor firm was discharging toe poilu- breast JCI. itself in oil producer, will ben ist into the water. efit from new North Sea Oil production, but CiT.piita by J:ne Rasmussen Chemical MarrufacturefS Association OMC has filed its own complaint against Men* l ' the gains wont be enough to ;ris*t cbemi- r.to. , I cal-eiriungs declines. Dur-ig toe lSTJ reces- ! sum, 1C preax profits fell 30%. . UCC I -1- DRAFT VI Brain Cancer In Petrochemical Workers - A Case Series Report Nineteen primary brain cancer deaths have been found among workers at one United States petrochemical plant. We believe this Is the largest single series of presumably occupationally-related brain cancers reported in the medical literature. In November, 1978, the Occupational Safety and Health Administration (OSHA), the Federal occupational health enforcement agency of the U.S. Department of Labor, received an employee complaint that work-related chemical exposures might have caused brain tumors In fellow workers as well as his own recently diagnosed brain cancer. . OSHA's Office In Houston, Texas began an investigation of brain canc r mortality at the employee's worksite, a moderate-sized petrochemical production facility In Texas City, located In Galveston County south of Houston. Workers, family members and surviving relatives, union officials, local physicians and hospital staff, Texas state health officials and * company personnel were Interviewed. Four primary brain tumor deaths were discovered among former employees In this way. It is ironic that the worker who filed the original complaint with OSHA was found to have a metastatic carcinoma to the brain, and is not counted amonq the cases. The plant physician subsequently reviewed death infor-stion maintained by the medical department, primarily covering workers who died while employed and who by virtue of 15 years of company service were eligible for death benefits. Ten deaths from primary brain cancer were identified. These ten ucc 049378 00 NOT COPY OR OUOTE -2- DRAFT VI included the four previously found. OSHA then requested technical as sistance from the National Institute for Occupational Safety and Health (NIOSH), its companion research agency In the l/.S. Department of Health, Education, and Welfare. In February, 1979 OSHA, NIOSH, and the company established a collaborative study plan to Investigate the apparent excess of brain cancers. An his torical prospective cohort mortality study was begun to determine the Standardized Mortality Ratio (SMR) for brain cancer, and whether there exists any other unusual mortality pattern. Also included within the cohort study is a case-control study of all primary brain cancer cases to estab- lish whether a particular job or chemical exposure 'at the plant is asso--' dated with an excess risk of brain cancer. A reference neuropathology laboratory has agreed to examine autopsy and surgical pathology specimens to provide histologic confirmation of the cause of death. Each of these studies is well underway, and results are expected within a few months. An experimental case-finding technique was added to the study design to provide an early estimate of the extent of the problem. A computerassisted search was conducted of Texas Bureau of Vital Statistics data maintained by the M.D. Anderson Tumor Institute Department of Epidemio logy. Since company records showed that 99J of plant employees reside in Galveston, Harris and Brazoria counties, a list of all primary brain cancer deaths among males more than twenty years of age from 1950 through 1977 was obtained for these three counties. This list of 732 primary brain ucc 049379 KWJU.'JW TIM 11IIU DO NOT COPY OR qiJOTE -3- DRAFT VI cancer deaths was matched against company personnel files. Four additional confirmed cases resulted. Further investigation of company records re vealed two more cases. Three other employees became UT during the pre liminary period of the study. All cases were deceased^as of Narch, 1980. * The current total of 19 cases is the subject of this cast series report. v*r' Work history data for the 19 cases are provided in TAM* 1.- The average age at death for the cases was 52; the youngest died at age 30, and there were four deaths after age 60. Over half the deaths occurred between ages 50 and 59. The age distribution observed in this series does not differ significantly from that reported in other series. Total length of employment at the plant ranged from 1 month to slightly more than 35 years, with a median value of 20 years. Two cases had sh?rt exposure periods of 38 and 29 days respectively. Median length of employ ment excluding these two cases was 22 years. The interval from first employment to death, which provides an estimate of latency, varied from as few as 3 1/2 years to nearly 36 years, with a median of 24 years. The median values for exposure and latency period in this series are typical of those found for other tumor types In occupational cancer investigations and are consistent with a hypothesis of occupational etiology resulting from chvmical exposures. No particular trend or clustering by hire date among the cases has been . identified as compared to the general plant population. One case was uce 049380 DO NOT COPY OR QUOTE -4- DRAFT VI hired in Tate 1940 as part of a small plant start-up crew. Three more were hired in 1941 during the first year of plant operation, and the others at fairly regular intervals until the last group of four started work during 1953. The first death occurred in 1956, followed by five others during the 1960's. Twelve of the deaths occurred after 1970, three of them during the past year. No established pattern is evident from the observed years of death, but there is no evidence that the rate of appearance of cases is declining. The plant has a current workforce of slightly more than 2,200, including nearly 1,500 hourly and production employees. The average age is 44, and approximately 1,050 current employees have 25 or more"years of company service. Since the plant began operation in 1941, there have been a total of 8,850 employees. These include 6,802 white males, 884 black males, 1,083 white females, and 81 black females through December, 1979. The distribution by county of residence for current workers is provided in Table 2. The plant also engages a temporary independent contractor work force of 100-250 daily, mostly for construction jobs. Unfortunately, no employment records are available for this group. Demographic and cause of death data from the death certificates are pro vided in Table 3. All cases occurred among male employees, 18 whites and 1 black. The mortality rate for primary brain cancer in Texas among black males is about one-half that for white males.^ However, very little' can be said regarding the racial distribution of cases, since it appears ucc 049381 DO NOT COPY OR QUOTE -5- DRAFT VI that increased numbers of black employees`have been employed at the plant only in recent years. All but one of the cases were native-born Americans; the lone exception was Norwegian.^ The great majority of the cases were born In Texas, two were from Louisiana, and one each was from Massachusetts, New Mexico, and Oklahoma. None of the U.S, states of origin have a particularly high risk for brain cancer, compared to the U.S; national average. There is pre sently no information available about the age of the cases when they moved to Texas, or where else they may have lived. Sixteen of the cases were Galveston County residents_.at the time of death; the other three were from Harris County. The possibility of an environ mental etiology related to Galveston County was considered. County-wide data from the National Cancer Institute on the brain cancer mortality rates for Harris, Galveston, and Brazoria Counties from 1950-1969 are in the mid-range for Texas and U.S. national values as shown In Table 4. A survey * made by the Texas State Department of Health for 1977 showed that the Galveston County brain cancer crude mortality rate was 3.6/100,000. There is no evidence from these data that local environmental factors outside the plant am responsible for the apparent excess of brain cancer. To obtain an initial estimate of the brain cancer risk, brain cancer deaths among adult white males In Galveston County were analyzed using the list described previously. A total of 54 primary brain cancer deaths occurred in the county from 1962 through 1977. To establish a rough DO HOT COPY OR QUOTE -6- DRAFT VI comparison, information from the Health Services Administration on county population characteristics was used.^ In 1970 Galveston County was 68X white, and 62S of the population were between the ages of 14 and 64. A 1970 county population estimate was 170,000 of whom 49JC were males.^ Thus, the white male population of employment age at risk during 1952-1977 was somewhat less than 38,000; the plant white male population was about 1,800 or about 5% of the county total. Yet during this period, 11 of 54 brain tumor deaths among county residents occurred in plant employees, nearly 20% of the total. This suggests an approximate plant-wide risk of about four-fold. The underlying causes of death as recorded on the death certificates are listed in Table 2. Nine cases of glioblastoma multiforme were recorded directly on the certificate. Further investigation of hospital and physi cians' records provided evidence that there were six additional cases of glioblastoma multiforme among the total of 19. According to these records one case also was reported to be a metastatic lesion to the cerebellum. Preliminary medical evidence thus suggests that 81< (15/19) of the tumors were glioblastomas. Because this type of tumor usually accounts for 40-55X of deaths in reported brain cancer series, this would indicate an excess of ql'.oblavtoma multi forme among these cases. The difficulty of precise neuropathological diagnosis for brain cancer is recognized, and the pathology review is expected to better define this observation. Th plant is a diversified petrochemical manufacturing `facility with a late number of major product lines, including ethylene, butadiene, naphtha. ucc 049383 DO NOT COI'Y OK QUOTE -7- DRAFT VI ethylene dichloride, diethyl sulfate, glycols, e ehydes, acetates, alcohols, amines, organic acids, and plastics and resins (polyethylene, vinyl chloridevinyl acetate copolymers, phenol-formaldehyde resin). Review of the plant's chemical Inventory reveals the presence of at least 11 recognized or suspect carcinogens in significant quantities as raw materials, reaction by-products, or manufactured compounds. These are shown In Table 5. Careful preliminary examination of the work histories of affected employees does not yet estab lish any common job title, department code, or chemical exposure. Eight of the men were chemical operators in production departments but they were spread throughout the plant, and worked on different chemical processes. Six others were maintenance workers who may have had the^ opportunity for plant wide exposures over the years. Two worked in the chemical shipping depart ment as weighmasters with likely multiple exposures. Five worked in various construction trades. Work histories on the cases are limited to employment by the company with two exceptions. Case 1 was a salaried employee at a nearby petrochemical plant from 1948-1964, and Case 6 worked as a pipefitter from 1952-1974 in the same plant. No information about other potential chemical exposures is presently available. The detailed examination of work histories in the case-control study offers the best opportunity to establish a connection between a particular chemical exposure or type of work and an excess risk of brain cancer. A detailed literature search for compounds inducing brain cancer has identi fied 26 different chemicals from experimental animal studies as shown in * Table 6. Review of available epidemiological studies provided in Table 7 * tjCC 049334 offers several Intriguing clues, but little solid documentation for occupa tional ly-related brain tumors, except in the case of vinyl chloride. Recent mortality studies of oil refinery workers in Canada f*^and petrochemical workers in Texas ^^suggest the possibility of an excess brain cancer risk among these groups, although as yet no specific causative agent has been identified. A comparison of experimental studies, epidemiological data, and the plant chemical inventory shows that vinyl chloride, acrylonitrile, and diethyl sulfate are possible suspect agents for inducing brain cancer in these workers. On the basis of prior knowledge from human and animal studies, and its presence in the work environment under poorly controlled circumstances in the past, vinyl chloride must be the first compound considered. However, to date, examination of the work histories of the 19 cases does not support a significant positive association with vinyl chloride exposure, and other agents must be carefully evaluated. The information available indicates that this number of brain tumors is excessive in a population of this size, and that the tumors are likely to be occupationally-related. There is no good evidence to implicate non plant, general environmental factors. A very careful and thorough investi gation of this situation must be made, since a previously unsuspected chemical exposure may be responsible for this striking appearance of brain cancers in a single petrochemical plant. I ucc IK 8 3 85 REFERENCES Drift VI 1. Fan KJ, Kovl J, Earle KM. The ethnic distribution of primary ce: -al nervous system tumors: AFIP, 1958 to 1970. J Neuropathol Exp Neu -1. 1977; 36: 41-49. 2. Schoenberg BS, Christine BW, Uhisnant JP. The descriptive epidemiology of primary intracranial neoplasms: the Connecticut experience. Am <3 Epidemiol. 1976; 104: 499-510. 3. Choi NW, Schuman LM, Gullen WH. Epidemiology of primary central nervous system neoplasms. Am J Epidemiol. 1970; 91: 238-259. 4. Mason TJ, McKay FW. U.S. cancer mortality by county, 1950-1969. Bethesda, Md.: National Cancer Institute, 1974. (DHEU publication no. [NIHJ 74-615). 5. The Texas Department of Health and the University of Texas System Cancer Center M.D. Anderson Hospital and Tumor Institute. Impact of cancer on Texas, 1978: 99. 6. U.S. Bureau of the Census. County and city data book, 1972 (A statistical abstract supplement). Washington, D.C.: U.S. Government Printing Office, 1973: 450. 7. Zinmerman HM. Brain tumors: their incidence and classification in man and their experimental production. Ann NY Acad Sci. 1969;*159: 337-359. 6. Percy AK, Elvebaek LR, Okazaki H, Kurland LT. Neoplasms of the central nervous system. Neurology. 1972; 22: 40-48. 9. Tabershaw IR, Gaffey WR. Mortality study of workers in the manufacture of vinyl chloride and its polymers. 00M. 1974; 16: 09-518. 10. Waxweiler RJ, Stringer W, Wagoner OK, Oones 0. Neoplastic risk among workers exposed to vinyl chloride. Ann NY Acad Sci. 1976; 271: 40-48. 11. Theriault G, Goulet L. A mortality study of oil refinery workers. . 00M. 1979; 21: 367-370. 12. Thomas TL, DeCoufle P, Moure-Eraso R. Mortality among workers enployed in petroleum reflnino and petrochemical plants. 00M. 1980; 22: 97-103. 13. Vasquez L. Gliomas in a rat fed with 2-acetyl-aminofluorene. Nature. 1945; 156: 296-297. 14. Maltoni C, Cillberti A, DiMaio V: Carcinogenicity bioassays on rats of acrylonitrile administered by inhalation and by ingestion. Med Lav. 1977; 68: 401-411. * ucc 049386 DRAFT VI 44. Mon sort RR, Peters DM. Proportional mortality among vinyl chloride workers. Lancet. 1974; 2: 397-39S. 45. Byren D, Engholm G, Englund A, Westerholm P. Mortality and cancer morbidity In a group of Swedish VCM and PVC production workers. Environ Health Perspect. 1976; 17: 167-170. uoc 049387 Table 1 WORK HISTORY OATA FOR 19 PRIMARY BRAIN CANCER CASES IN A TEXAS PETROCHEMICAL PLANT 0te of Case Hire _ Date of Death Length of Age at Employment Death {vears-months) -1 <2 "3 -4 .5 -6 *7 '8 -9 10 -11 -12 -13 14 -IS 16 -17 -18 -19 12/16/40 05/18/41 07/29/41 11/30/41 07/09/44 09/18/44 09/19/46 M/26/46 01/12/48 09/21/48 03/02/49 01/25/50 10/19/50 10/23/50 09/19/51 04/27/53 03/17/53 0C//1/53 10/30/53 05/15/64 02/19/66 05/18/76 12/13/65 10/28/79 05/21/74 03/07/79 03/22/73 01/26/71 07/02/75 06/05/71 01/13/68 05/14/74 02/18/80 01/08/74 10/03/56 04/05/62 05/05/71 12/21/78 51 56 66 55 59 55 55 63 53 49 61 66 59 57 52 33 30 44 49 3-6 24-8 31-8 20-4 35-0 0-1 32-3 26-6 1-2 2-1 22-3 16-7 17-1 28-10 22-3 0-1 : 8-7 17-3 24-8 Job Title Department Operator Operator Foreman Operator Bollermaker Operator Laborer/Oiler Operator Painter Pipefitter Operator Equip. Operator Operator Operator Machinist Machinist Welghmaster Operator Ueighmaster Production Production Maintenance Production Structural Shop Production Maintenance Production Maintenance Maintenance Production Maintenance Energy Systems Production Machine Shop Maintenance Shipping Production Shipping o 049388 DRAFT VI 15. Druckrey H. Specific carcinogenic and teratooenic effects of 'indirect' alkylating methyl and ethyl compounds, and their dependency on stages ofontogenfc developments. Xenpbiotica. 1973; 3: 271-303. 16. Zulch KJ, Mennel HD. Recent results in new models of transplacental carcinogenesis in rats. In: Tomatis L, Mohr U, Davis W, eds. Trans placental carcinogenesis. Lyon: IARC, 1973: 29-44. 17. Takizawa S, Nishihara H. Induction of tumors in the brain, kidney, and other extra-mammary gland organs by a continuous oral administra tion of N*nitrosobutylurea in Wistar/Furth rats. Gann. 1971; 62: 495-503. 18. Hirono I, Laqueur GL, Spatz M: Tumor induction in Fischer and Osborne-Mendel rats by a single administration of cycasin. ONCI. 1978; 40: 1003-1010. 19. Druckrey H, Kruse H, Preussmann R, Ivankovic S, Landschutz C. Cancerogene alkylierende substanzen III. alkyl-halogenide,-sulfate,sulfonate und ringgespannte heterocyclen. Z Krebsforsch. 1970; 74: 241. 21. Schoental R. Carcinogenic action <jf elaiomycin in rats. Nature. 1969;'221: 765-766. 22. Swann PF, Magee PN. Induction of rat kidney tumours by ethyl methane sulphonate and nervous tissue tumours by methyl methane-sulphonate and ethyl methanesulphonate. Nature. 1969; 223: 947-949. 23. Ivankovic S. Experimental prenatal carcinogenesis. In: Tomatis L, Mohr U, Davis W, eds. Transplacental carcinogenesis* Lyon: IARC, 1973: 92-99. 24. Magee PN. Mechanisms of transplacental carcinogenesis by nitroso compounds. In: Tomatis L, Mohr U, Davis W, eds. Transplacental carcinogenesis. Lyon: IARC, 1973: 143-148. 25. Alexandrov VA. [Transplacental blastomogenic action of N-nitroso methylurea on rat offspring']* Vopr Onkol. 1969; 15: 55-61. 26. Napalkov NP. Some general considerations on the problem of transpla cental carcinogenesis. In: Tomatis L, Mohr U, Davis, W, eds. Trans placental carcinogenesis. Lyon: IARC, 1973: 1-13. 27. inland B, Finkelstein M, Weisburger EK, Rice JM, Weisburger JH. Carcinogenicity of industrial chemicals propylene imine and propane sultone. Nature. 1971; 230: 460-461. ucc 049389 DRAFT VI 28. Schoental R, Cavanagh JB. Brain and spinal cord tumors in rats treated with pyrrolizidine alkaloids. JNCI. 1972; 49: 655-671. 29. > ltoni C. Predictive value of carcinogenesis bioassays. Ann NY Acad S.i. 1976; 271: 431-443. 30. Milham S. Cancer mortality patterns associated with exposure to metals. Ann NY Acad Sci. 1976; 271: 243-249. 31. Clemmesen J. Are anticonvulsants oncogenic? Lancet. 1974; 1: 705-707. 32. Clemmesen J, Hjalqrim-Jensen S. On the absence of carcinogenicity to man of phenobarbltal. Acta Pathol Microbiol Scand (Suppl). 1977; 261: 38-50. 33. Gold E, Gordis L, Tonascia J, Szklo M. Increased risk of brain tumors in children exposed to barbiturates. JNCI. 1978; 61: 1031-1034. 34. Brooks VH. Geographic clustering of brain tumors in Kentucky. Cancer. 1972; 30: 923-926. 35. Creaoan ET, Fraumenl JF. Deaths from brain tumors In eastern Kentucky 1950-69. JNCI. 1973; 51: 1717-1718. 36. Trouillas P, Menaud G, DeThe G, Aimard G Oeylc M. Etude epidemiologique des tumeurs primitives du nevraxe dans la reqion Rhone-Alpes. Rev Neurol. 1975; 131: 691-708. 37. Cantor KP, Hoover R, Mason TJ, McCabe, LJ. Associations of cancer mortality with halomethanes in drinking water. JNCI. 1978; 61: 979-985. 38. Cooper VC. Cancer mortality patterns In the lead Industry. Ann NY Acad Sci. 1976; 271: 250-259. 39. DeCoufle P. Further analysis of cancer mortality patterns among workers exposed to cutting oil mists. JNCI. 1978; 61: 1025-1030. 40 Kancuso TF, Ciocco A and El-Attar AA. An Epidemiological approach to the rubber industry. JOM. 1968; 10: 213-232. 41. KcMichael AJ, Spirtas R, Kupper LL. An epidemioloqic study of mortality within a cohort of rubber workers, 1964-72. JOM. 1974; 16: 458-464. 42. Monson RRf Fine, LJ. Cancer mortality and morbidity among rubber workers. JNCI. 1978; 61: 1047-1053. 43. Schuman LM, Choi NW, Gullen WH. Relationship of central nervous system neoplasms to toxoplasma gondii infection. Am J Public Health. 1967; 57: 848-856. UCC 04S390 Table 2. CURRENT PLANT WORKFORCE BY COUNTY OF RESIDENCE County of Residence Galveston Harris Brazoria Other Total Type of Employee Hourly Salaried 1,389 44 41 7 1,481 609 110 15 4 738 Source: Data provided by company Total 1,998 154 56 11 2,219 Percent 90.0 6.9 2.5 0.5 100.0 Table 3. MATH CERTIFICATE DATA FOR 19 PRIMARY BRAIN CANCER CASES IN A TEXAS PETROCHEMICAL PLANT Race/ Cause of Death Case Sex Residence Place of Birth Death Certificate Medical Records 1 1tf 6a1veston Texas Carcinoma of Brain Glioblastoma (Ml)* 2 VM Galveston Missouri Malignant Brain Tumor Meningioma (A) 3 W, Harris Texas i VH Galveston Texas Brain Tumor Glioblastoma (A) Brain Tumor-Meningioma Meningioma (MR) 5 hil Galveston Louisiana Glioblastoma Glioblastoma (SP) 6 HI Galveston Texas Brain Tumor-Glial IV No Records Available 7 BH Galveston Texas Glioblastoma Glioblastoma (MR) a tii Galveston Texas Glioblastoma Glioblastoma (SP) 9 VM Galveston Massachusetts Cerebellar Tumor Metastatic Cerebellar Tumor (SP) 10 Ml Harris Texas Astrocytoma Astrocytoma-Grade I (SP) 11 W Galveston Texas Malignant Glioma Glioblastoma (MR) 12 w. Galveston New Mexico Glioblastoma Glioblastoma (A) 13 Mi Galveston Norway Glioblastoma Glioblastoma (SP) 1U V* Galveston Texas 15 VH Galveston Texas 16 hH Harris Texas 17 LM Galveston Louisiana 16 U4 Galveston Texas 19 W1 Galveston Texas Glioma-Grade III Glioblastoma Glioblastoma .Brain Tumor Malignant Glioma Brain Tumor Astrocytoma-Grade IV (MR) Glioblastoma (A) No Records Available Glioblastoma (A) Glioblastoma SP) Glioblastoma A) Oata from company records, death certificate not available Source: MR-Medlcal Records; A-Autopsy; SP-Surglcal Pathology CCDJ Table 4. BRAIN AND OTHER CNS CANCER MORTALITY, 1950-1969: AVERAGE ANNUAL AGE ADJUSTED RATES PER 100,000 Location White Male White Female Black Male Black Female United States 4.4 2.9 2.3 1.5 Texas 4.3 2.9 1.9 1.5 Galveston County 4.5 2.9 2.5 2.1 Harris County 4.5 3.6 2.0 1.9 Brazoria County 3.1 3.9 1.2* 1.5 Based on one case The ranqe of U.S. rates for males for counties with >10 deaths from 1950-1969 were 3.1-5.4 (white) and 1.3-3.9 (black). The range of Texas rates for.white males for counties with >deaths from 1950-1969 was 2.3-10.8. Source: U.S. Cancer Mortality by County, 1950-1969, National Cancer Institute, DHEW Pub. No. (NIH) 74-615, Bethesda, Maryland, 1974 ucc 049393 Table S. RECOGNIZED AND SUSPECT CARCINOGENS IN A TEXAS PETROCHEMICAL PLANT Acrylonitrile Benzene Diethyl sulfate Dioxane Ethylene dichloride Hydrazine - Isopropyl Oils * Trichloroethane Trichloroethylene Vinyl chloride -Vinylidene chloride Table 6. EXPERIMENTAL BRAIN CARCINOGENS 2- Acetyl aminofluorene (13) Acrylonitrile (14) l-Aryl-3,3-Dialkyltriazenes (15) Azoethane* (16) Azoxyethane* (16) Azoxymethane (15) Butylnitrosourea (17) Cycasin (18) 1,2-Diethylhydrazine (15) Diethylnitrosamine* (15) Diethyl Sulfate* (19) Dimethylbenzanthracene* (20) Dimethyl Sulfate* (19) Elaiomycin (21) Ethyl methanesulphonate (22) Ethylnitrosobiuret* (16) Ethylnitrosourea* (23) 1-Methyl-2-Benzyl-Hydrazine* (15) Methyl methanesulphonate (24) Methylnitrosourea* (25) Methylnitrosourethane (intraplacental) Procarbazine* (23) Propane Sultone (27) Propylene Imine (27) Pyrrolizidine Alkaloids (28) Vinyl Chloride (29) Transplacental carcinogenesis ucc 049395 Table 7. EPIDEMIOLOGICAL STUDIES: aUES TO HUMAN BRAIN CANCER ETIOLOGY Aluminum Workers (30) Anti-Convulsant Use (31,32,33) Farm/Rural Residents (3) Geographic Clustering Kentucky (34,35), Rhone Valley (36) Halomethanes in Drinking Water (37) Lead Smelter Workers (38) Machinists (39) Oil Refinery Workers <11) Petrochemical Workers (12) Rubber Workers (40,41,42) Toxoplasmosis (43) Vinyl Chloride Workers (9,10,44,45) ucc 043396 Ml tftI 1 M KAl I I v A l t %| Al I ^IN'. Ill PARTMI NT UNION CARBIDE. CORPORATION *#*** *yi niii 4 Ni * *>#*. f* t u*) ` CORPORATE EriDEHIOLOCY Victor Alexander,M.D., Chief Medical Advisor, OSHA, Rood N3656 U.5.Department of Labor, Occupational Safety & Health Administration, Washington,D.C. 20210 21ct May 1980 Dear Doctor Alexander, Re: "Brain Cancer in Petrochemical Workers - A Case Series Report" DRAFT VI Speaking on behalf of my Corporation and those staff expressly involved in this investigation, in collaboration with your Administration and N10SH, I wish to express our appreciation for this opportunity to review the above cited draft paper, prior to your submitting it for publication. We do have a few comments and suggestions to make, which we hope may be helpful in enhancing the accuracy and clarity of the paper. I shall handle them on a line by line basis: Page 1 - first sentence. We feel it is not strictly true that nineteen primary brain cancer deaths have been found, but rather eighteen, one having turned out to be a metastatic cerebellar tumor (Case No.9) as you comment in the text, and in Table 3. We appreciate that this case was classified as "cerebellar tumor" on the Death Certificate, and in some aspects this paper describes a Death Certificate Study. Would it not be better to give the nus&er as eighteen and add, In parentheses ( nineteen as originally certified )7 Page 1 - third and second lines from bottom: we suggest: "...primarily covering workers who died while employed and also those who by virtue of 15 years...." Page 3 - lines 12 and 13 - we suggest:"TWo cases had short periods of employment, 38 and 29 days respectively." Page 3 - lines 17 through 20 - we feel that this is a weak argument, almost a nonsequltur: long latency periods between onset or death and postulated causal * exposures are equally consistent with non-occupational cancer, surely. Page 4 - line 5 - In fact thirteen of the deaths have occurred since 1970 ( the last one recorded to date in February of this year ). ucc 049397 -2- I'agi* 5 - Second complete paragraph - We (eel that the conclusion in the final sentence f this paragraph nay be unwarranted at this tine, brain cancer Mortality rates for the relevant three counties have been reviewed only through 1969 and 13 of our 18 deaths have occurred since 1970. It is our impression from talking with Dr. Patricio Buffler of the University of Texas Health Science Center at Houston t In the past decade brain cancer Mortality rates for that general glon May well have ellnbad steeply, either with or relative to national races. Pages 5 6 6 - Paragraph eoBnenclng on Page 5 and ending on Page 6 - We all have real problems with this method of estimation. The statewnt that the plant white male population at risk, which contributed 11 of 54 brain tumor deaths for the county, during 1962-1977, was 1800 or 5Z of the county total, appears to refer to a static plant population. However, many more than 1,600 would have "passed through" the plant and have been at risk of dying over that 16 year period. It is true that there would hove been some ln-nlgratl n and out-migration to and from the county over such a period too, but such dynamic population effeet would be proportionately much less in a population the sire of a county, than in the population of a single industrial plant. We do not have any argument with the resulting estimate of an apparent four-fold relatl risk for the plant population, which is consistent with our crude PMR estimat based on the. total deaths recorded at the plant since 1941, but rather with the valldldty of the method by which it was reached. Page 6 - last two lines and first 3 lines of Page 7 - this list of major product lines is on historically comprehensive one which does sot reflect the sltuatl at any point in time: we suggest: "...a large number of major product lines, which over the years have Included ethylene, butadiene.etc............" Page 7 - lines 15 - 17 - Cases 1 and 6 refer, we believe, to workers whose employme we shared with Monsanto. In view of the fact that you have Informed us that Monsanto in Texas City has also shown an excess of brain cancer cases above expectation, and that Cose 6 worked with us for only 38 days in 1944, then for 22 years for Monsanto, ve feel that it is rather biased HOT to discuss this aspect of Case 6, who probably "belongs" in the other plant's cohort, just as you have awarded Case 1 to Union Carbide 1 Page 7 - lines 17-18 - "Ho Information about other potential chemical exposures is presently available". Dr. Clenn points out that previous work histories recot on our pre-employment medical forms on many of our cases were provided to OSb K10SH. s Page 8 - line 8 - and Table 5 - We feel that undue and misleading prominence has been given to acrylonitrile. This known human carcinogen has never been on our plant site, even as an on-stream intermediate. That it appeared on ur exhaustive inventory at all is purely by virtue of the fact that it has been transhipped at our Ocean Terminal which Is some miles from the Plant Site. Only a very snail number of Texas City employees would have had any potentia! at all for exposure to this compound, and that extremely remote. A general comment: as this is a preliminary paper, explaining theneed for the joii agency and corporate study of the problem, we find the failure tomention the appa ently parallel problem at two other petrochemical plants in the general area rathe prejudicial. ucc 049398 - 3- We hope that these comments and su^uestlons have been helpful and that It will be possible for you to implement most of them with minimal modification of your paper. Once again we thank you for this timely opportunity for us to review and consent upon the paper. Dr. Clenn and I also wish to thank you for the courtesy of the offer of co-authorship of the paper, an offer which however we wish to respectfully decline. All of ua at Union Carbide look forward to ongoing cooperation with your Administration and NXOSK in trying to shed more light on this heretofore quite baffling problem through the timely completion of the agreed studies. Yours sincere H.H.D.Utldjian.M.D., Associate Corporate Medical Director for Epidemiolo e.c. to Dr. Susan C. Austin, Corporate Epidemiologist Dr. Thomas A. Lincoln, Corporate Medical Director Dr. Dave Clenn, Divisional Medical Director, Texas/Gulf Coast Mr. Damon Engle, Plant Manager, Texas City Mr. Jackson B. Browning, Corporate Director of Health,Safety * " 'ronmental blind copy to John Whittlesey,Esq., Law Dept., for info UCC 049399 We hope that these comments and tuKiifitionx have been helpful and that 1L vil] be possible for you to implement most of then with minimal modification of y ur paper. Once stain vs thank you for this tlmtly opportunity for us to review d consent upon tbs paper. Or. Clean and X also wish to thank you for the courtesy of the offer of eo-authorshlp of the paper, an offer which however we wish to respectfully decline. All of us at Union Carbide look forward to ongoing cooperation with your Administration and NIOSH In trying to shed more light, on this heretofore quite baffling problem through the timely completion of the agreed studies. H.M.D.Utldjlan,M.D., Associate Corporate Medical Director for Epidemiol) c.c. to Dr. Susan C. Austin, Corporate Epidemiologist Dr. Thomas A. Lincoln, Corporate Medical Director Dr. Dave Glenn, Divisional Medical Director, Texas/Culf Coast Mr. Damon Engle, Plant Manager, Texas City Mr. Jackson B. Browning, Corporate Director of Health,Safet: . ronmental blind copy to John Whittlesey,Esq., Law Dept., for info. ucc 049400 Reader's Guide Continued irom page 29 exceed 18 percent. But what is not said is that the data also permit one to assert that AS usage could easily be associated with a 16 percent reduc tion in risk. These are the confidence limits oi the best estimate, which is that there is neither more nor less risk. The report justifies its use of many, many statistical comparisons by as serting that all of the spotted associa tions in subgroups were specified as possible pnor to the study. It also adds, to the credit of the authors, that "the positive associations seen here in [may] represent merely chance , variations in subgroups of a study which, overall, fails to demonstrate an association between AS use and bladder cancer." I suspect that many neutral observers will opt for the lat ter possibility. For instance, of the 42 P values given for AS associated risks (and there is no way to tell how many others were computed but not de scribed) only 11 are statistically signif icant with one-tailed tests, and five of these fall by the wayside if one prefers two-tailed tests. Place your bets, friends. In fairness to the report, it must ! be said that these (and some other) sources of error and bias are at least mentioned. But the press release and the media coverage ignore these ca- 'eats, and thus represent journalism that is at best sloppy and at worst dishonest. The statisticians involved have thus become allies of those waging a holy war against AS. Saccharin and cyclamates seem to be such weak carcinogens that it requi'es a horde of statistician-epidemiologists, plus SI.5 million of public monies, to keep the carcinogenic pot boiling. Meanwhile, the Canadians have re canted, muttered "mea culpa" (not very loudly), and exonerated cycla mates because "there is not a shred of evidence" of the carcinogenicity which once seemed to demand regu latory action. Miguel Cervantes, let thy shade rest in peace. Don Quixote is alive andvsell. > thf srifvri c m-wiunf mo UCC 049*401 Current Report Polychlorinated Biphanyla ARKANSAS. TEXAS TEST BURNS SUCCESSFUL; INCINERATOR APPROVAL WEIGHED BY REGION Approval of two incineration facilities to burn polychlorinated biphenyls commercially appears imminent. Environmental Protection Agency officials in Region VI, Dallas, are performing final evaluations of the results of test burns conducted last fall at PCB incineration facilities in Deer Park, Tex., and Eldorado, Ark. Agency officials at EPA headquarters in Washington, D.C., already have reviewed the data from the test burns and said regional officials have the authority to approve or disap prove the facilities' permit requests as they see fit, agency officials told Chemical Regulation Reporter July 17. Approval of either incinerator by the region would make it the first site approved for commercial destruction of PCBs. The effective date of several clauses of PCB rules promulgated under the Toxic Substances Control Act and PCB regulations recently proposed by the Department of Agriculture and the Food and Drug Administration hinges on approval of commercial incineration facilities for PCBs. Roger Meecham, a spokesman for EPA Region VI, said, however, officials there were not ready to announce a deci sion on the incinerators. - The Deer Park facility is operated by Rollins Environmen tal Services, while the Eldorado incinerator is operated by Engineering Systems Company (ENSCO). According to agency hazardous waste officials in Dallas, the agency is under pressure from the two facilities and from industries storing PCBs to approve the incinerators. Community groups, however, have protested the incinera tion plan and were assured by the agency that every precau tion would be taken in evaluating the test bum results. "We still see a few anomalies we want to review," an EPA regional official said, adding that the agency was being supercautious because of the controversial nature of the decision. Even if the incinerators were approved, the approval would be "tentative" until the public in the affected areas had a chance to comment and until the agency addressed "each comment very carefully," the official added. He would not estimate when the agency may announce its decision. EPA officials in Washington, however, said they believed the decision was imminent 99 Percent Efficiency According to agency headquarters officials, both test bums achieved well in excess of 99 percent efficiency and emitted no PCBs into the ambient air. Gas chromatograph studies of the emissions showed that both incinerators were well within the PCB rule limit of 99 percent destruction efficiency for commercial incineration facilities, the officials noted. Regional officials in April had asked for more data on the ENSCO test bum (Current Report, April 25, p. 92). The con sultant on the project had supplied only summaries rather than the chromatograpb strips themselves, regional'officials said. Evaluation data on the Deer Park bum. however, included the strips so there was no need to ask for further raw data on the Rollins test bum. they added. Because community concern about the safety of the in cinerators is high, regional officials have promised to an nounce their tentative decision on the incineratoi , to schedule at least a 30-day comment period, and to hold pub lic hearings before granting final operating approval. Should the region decide to approve the incinerators, the hearing and comment process would require at least 60 days, the regional officials said (October 26, 1979, p. 1292; January 11, p. 1588). Phthalates CITIZEN'S PETITION SEEKS REGULATION. CITES CARCINOGENICITY OF PLASTICIZER A former Environmental Protection Agency employee July 10 petitioned the agency to take regulatory action against a widely used plasticizer, saying the agency knows the substance causes cancer and poses a risk to humans. The petition, filed by William Myers, Arlington, Va., said di-ethylhexyl-phthalate (DEHP) should be declared a hazardous stubstance under Section 4(f) of the Toxic Sub stances Control Act A chemical may be designated as a 4(f) substance if it is a carcinogen, mutagen, or teratogen which poses "significant risk of serious or widespread harm." After such a designation, the agency must move to regulate the 4(f) chemical within 180 days using provisions of Section 5,6, or 7 of TSCA. On the other hand, if the agency decides the risk is not unreasonable, it must publish that fin ding in the Federal Register. Myers filed the petition under Section 21 of TSCA which allows citizens to demand that the agency take regulatory actions, including actions against specific substances. The Act requires the agency either to grant or deny the petition within 90 days. Test Results Accepted According to Myers' petition, the agency received and con curred with the results of a study done by the National Cancer Institute, which found di-ethylhexyl-phthalate to be a potential carcinogen. That concurrence was reflected in the agency's action to block manufacture of six related phthalates submitted for premanufacture review, Myers said. "That [NCI] study apparently satisfied ... the agency as to its validity in showing di-ethylhexyl-phthalate to be a car cinogen," Myers wrote in his petition. Shortly after receiving the NCI study on DEHP, Myers said, the agency initiated its first regulatory action under Section 5(e) of TSCA to require further testing of six related phthalates then undergoing premanufacture review (Current Report, April 25, p. 91). The firm two weeks later dropped its manufacturing plans saying the ensuing publicity could jeopardize its confiden tiality claim, the tests would cost about 94 million, and it did not know of the NCI study on the analogues (May 16, p. 155). According to Myers' petition, the agency believed such plasticizers posed a risk or it "would not have moved against the production" of the new substances under Section 5(e). Myers noted that about a billion pounds of DEHP is produced in the United States each year. The substance is 7-18-BO Copyright 1980 by The Bureau ol National Affair*. Inc. 01 a 7973 10-100 SO ucc 049402 . 388 CHEMICAL REGULATION REPORTER used in a wide variety of consumer and commercial goods (See related story, p. 399.). "This volume, and this exposure should be cause for some concern," Myers wrote. "However, knowing the Office of Pesticides and Toxic Substances as I do, I think their management could probably use a little help in acting." Clarification Sought Myers, who left the staff of EPA Assistant Administrator Steven Jellinek about three months ago, also asked the agen cy for an explanation of its position on "me too" chemicals. The "me too" issue involves agency policy on handling chemicals already in production and use when a premanufacture notification review or new tests show that related substances or analogues pose a risk to humans or the environment. Although the agency has no clear policy on handling such substances after they are on the market, it said in a May policy memorandum that substances known to be carcinogens before January 1979 would not be subject to action under Section 4(f) of TSCA. An agency staff member told Chemical Regulation Reporter July 17 that a policy for handling "me too" chemicals is being drafted. He conceded that Myers' petition and his earlier one demanding that the agency declare benzene a 4(f) chemical (June 6, p. 227) were spur ring the agency to act more quickly to develop a policy on "me too" chemicals. Policy Quoitions Involved According to the staff member, Myers' filing of the two petitions raises several policy issues and legal questions which must be resolved before responding to the petitions. "We need to have a consistent approach rather than deal haphazardly" with each "me too" or 4(f) chemical, he said. Among the issues involved is determining what Congress intended when it gave the agency 180 days to initiate regulatory action on a 4(f) chemical, he noted. It is clear that Congress, in passing TSCA, did no{ intend to make Sec tion 4(f) a type of chemical Delaney Cause, he said. The Delaney Clause of the Food, Drug, and Cosmetic Act requires the banning of any food additive which is shown to cause cancer in humans or laboratory animals. The clause does not allow the agency to gauge risk or exposure. According to the staff member, EPA in responding to Myers' petitions must decide the criteria for declaring a chemical a 4(f) substance. The agency must decide what kind of information is needed and what kind of certainty it must have of "serious and widespread" harm before making a 4(f) declaration, he noted. The agency also is faced with deciding the appropriate dis position for 4(f) substances, he said. Although the Act gives EPA authority to regulate a 4(f) substance under Section 5, 6. or 7 of TSCA, those sections give the agency many alter native means of regulation, be noted. The agency also must develop a policy on handling chemicals when a "new unreasonable risk" is discovered, be said. This "whole question of what you do with 'me too' chemicals has been one of the most difficult questions we're facing as we review" premanufacture notifications, he add ed. Current plans are for the agency to draft a comprehensive policy on the handling of "me too' chemicals and 4(f) sub stances within the 90 day time limit which began to run when the benzene petition was filed June 3. The staff member explained, however, that because of the complexity of the issues involved, no reply is likely until close to the September deadline. Pesticides EPA MAKING PROGRESS. HOPES TO PUBLISH FOUR REGISTRATION STANDARDS. JOHNSON SAYS The Environmental Protection Agency hopes to publish four pesticide registration standards this summer, accord ing to the agency's deputy assistant administrator for pesticide programs, Edwin Johnson. Speaking at a July 9 meeting of the State FIFRA Issues Research and Evaluation Group, Johnson said progress is being made on developing a final model standard, but the for mat may change following comments on a prototype stan dard issued in January (Current Report, January 18, p. SI). The method by which EPA will determine use clusters for chemicals also will be published shortly, he said. The use cluster approach would not include all uses because of different application rates and dosages, Johnson said, but added the approach would cover existing uses and would put a product in the cluster which deals with its major uses. According to Johnson, the agency will not concern Itself with nitrosamines unless a product has more than one part per million, in which case a rebuttable presumption against registration review will be triggered. As for classifying products by regulation, he said his office is looking at fumigants to see if they should be handled this way or through the RPAR process. On the early call-in of data program, Johnson said EPA would accept test date not done according to agency protocols if they provide all necessary answers. The agency has a problem with data developed before the registration standard was worked up because EPA does not know where the data fit in, he said. The Office of Pesticide Programs is trying to carry out a group tolerance program, Johnson said, but is having dif ficulty grouping by botanical families when types within the species may retain pesticide residues at different rates. - - State Primacy Terrell Hunt, of the agency's Pesticides and Toxic Substances Enforcement Division, July 10 gave SFIREG a status report on the major elements of the state primacy program. Regulations setting up procedures for rescinding a state's primary enforcement responsibility for pesticide use violations are scheduled to be published by mid August, Hunt said. Final state grant regulations, which include primacyrelated reporting requirements, will be promulgated in late August, he said. Reporting regulations which apply the above requirements to states which received primacy without having a grant will be proposed in October or November, Hunt said. A policy statement interpreting the major items in Sec tions 26 and 27 of the Federal Insecticide, Fungicide and Rodenticide Act will be proposed in September, Hunt said. Some of items to be covered in the statement, he said, will be procedures for referring allegations of misuse to states hav ing primacy, criteria for granting and rescinding primacy, and emergency conditions to which EPA can immediately respond. According to Hunt the area of most controversy to be ad dressed by the policy statement will be the meaning of the term "commence appropriate enforcement action." This term refers to the 30-day period within which a state must act on a violation or have EPA assume enforcement respon sibility. 7-18-80 Chemical Regulation Reporter OMS.7S7Z/IO/SMM ucc 049403