Document NegKnGbnZoMGg37KQv37N486E

DEPARTMENT OF !-:iALTH, education, and welfare PUBLIC HEALTH SERVICE NATIONAL INSTITUTES OF HEALTH DCTHESOA. MARY', .ANfJ ?OQM April 5j 1976 Daniel S. Dixler, Ph.D, Kel1er and Heckman 1150 17th Street, N.W. Suite 1000 Washington, D.C. 20036 Dear Dr. Dixler: Thank you very much for your letter of March 9. I appre ciate your kind words regarding the talk I gave down at Research Triangle Park on March 2, and I am enclosing a copy of the talk in the form in which it will be published in Environmental Health Perspectives. After receiving your letter, I called NI0SH regarding fabrication plant angiosarcoma cases, and was informed that the NI0SH data presented as my Table 4 have not been withdrawn. You might wish to communicate further regard ing this matter with Dr. J. William Lloyd of NI0SH. Although I did not discuss "community" cases of angiosarcoma in my talk, I am grateful for the information on community cases you enclosed in your letter of March 9. Again, my thanks to you and Mr. Heckman for your help. Yours truly, xa \LyJv, V'\ y y.'M* Myra Karstadt, Ph.D. Consultant as i 02304 PVC :!! J; J ; i ] RPL ] CAT I OX'S AP'D PRODUCTION TRDNDS MYRA KARSTAD" MARCH 7} )W AS I 00023043 11J a nun v ) 1?/';. 7 P. Goodricd C!:c"iica] Company enounced that t ]! y; c v c a c i o. workers in a polyvinyl chloride (PVC) polymerization plant laid developed a rare cancer, any i o s a r c caret of the liver exposure to vinyl chloride was linked to d ev e 1 cun c n t of a at; 1 o s a r cona ol the liver by subsequent epide;:! j ol op i ca j studies. And m a ]. studies, several initiated before idee A JA Goodrich announcement, also link exposure to vinyl chlor .id e (VCM) with development of cancer. Regulations promulgated in the llJhitcd States of America (USA) since carl,, 1.074 have resulted in the lowering of VCf! concentrations in the atmosphere of PVC manufacturing plants, and decreased coneentratjons of YCM in PVC resin. Ihis has reduced the cancer risf of PVC production workers, workers in PVC fabrication plants and the ultimate consumers of f a b ric a t e d P VC pr o du c ts , Ve arc; now at a crucial stage as regards studies of the effects od_ plastics and plastics components on human health. Human exposure to massive doses of VCM, whether due to uncontrolled venting of PVC polymerization vessels or tire voluntary venting in a /nunc bathroom of an aerosolized VCM hair spray, is essentially over. The time lias come for study of possible health hazards posed by the complex plastic system called PVC. Why be concerned about PVC? A publ ic.a tion (1) states thn t : > {"Total world employment, in the YCM and PVC -producing -1- AS I 0023044 on p .1 o)' cu i n i n d u s t r j e which a: a PVC as, a basic element are ij];cly to tola] in i)\ million',-. Those who cone in contact with PVC every day in some torn or other probably make up about at leva St one-third of the 'human race." WW1i.ld L.- arc tine human health effects of PVC? There are several components of PVC mine]], on their own, could affect human health adversely:YCM, PVC dust considered ns a dust, additives of various sorts("additives" for our purposes includes stabilizers, colorants, flame retardants, plasticizers, fillers etc.) But one cannot consider the components of PVC solely as independently-acting potentially toxic agents. PVC is a complex chemical, system with 1 i 111 e-und er s tood interactions, both physical and chemical, among its components. Leaving aside the multi-component interaction problem for the time being, consider the individual components of PVC which may pose risk of harm to humans. YCM is already identified as a cancer-causing agent. Even given the .reductions of YCM in PVC resin, winch have been achieved by changes in both production and compounding procedures, some RVCM (residual vinyl chloride monomer) is still present in PVC In 1974 Rowe(2) estimated the average monomer concentration of PVC resin to be approximately 1000 ppm. As shown in Table 1, RVCM concentrations of 100 ppm or less for suspension resins before compounding in July 1975 were not unusual by April 1975. An advertisement(3) run/by a major manufacturer of PVC stated that general purpose PVC homopolymers and blending resins were being produced with a maximum of 10 ppm, and usually less than 5 ppm, RVOL AS I 0002304 Tables ], 2 and 3, taken fr on1 the United States linvironmcnta I Protection Agency (fl'A) pubi icat i on ''Standard S u p p o r t a ii d 'n i r o n in c r t a 1 I in p act S t a t e m e n t: Inn i s s i o n St a n d a r d for Vinyl Gin or idc" (4) give some idea of the present RVCM in several PYC resins. In particular, note company R in table 1, 8 6,8% of .suspension resin production is said to be at 0-50 ppm RVCM(with a fool noted qualification that "some values arc speculative until improved stripping is installed".) Note also that for company A, 60% of whose resin had a RVCM concentrati of 2000-4000 ppm in April 1975, with the remaining 40% at 4 000- 6000 ppmV'al] suspension resins (were) to be reduced to less than 400 ppm RVCM by 7/75", Health problems which may be associated with RVCM in finished PVC resin are of importance to workers and consumers. The residual VCM in the old high-residue PVC evidently posed problems for workers in fabrication plants. Data collected by the United States National Institute for Occupational Safety and Health(NT OSH) indicate that several angiosarcoma cases were identified in fabrication plant workers in this country and abroad (Table 4) (5). NIOSH data (Table 5) (6) presented in late 1974 indicated that breathing zone samples in fabrication plants turned up 1 eahiv_cly iow concentrations of VCM-cvcn at a time when RVCM concentrations were high compared to today's values. Hven at that time, as Wagoner put it;"60% of the ASI 00023046 samples were .less than 1 ppm", (7). 1 ppm is the maximum exposure level (8 It our time weighted average) currently permitted by the United States Occupational Safety and Health -3- Administrntj or ( ASHA) s i tori arc: ,/Ary; i n quoting VAngooor (8) : "1 think it [the occurrence of at'losarcoioi of the liver in fabrication pin :11 work e r s - au t ho r As - no t e) po in t s t o the possihility of low love] exposure being obviously very hazardous 1 (8). A recent coni C study (9) prepared for NIOSH reported on fabricating plant ACM concentretions in 1975. The VCM concentration;;, as shorn in Table 6, are, in a number of cases, very lov(lcss than 0,01 ppm, the limit of detection). However, certain v;ork stations had values which exceeded the 1 ppm 8 hour time-weighted average currently permitted by OSHA. How low must you go before RVCM ceases to represent a hazard? A "no-offeet" level for VCM carcinogenesis has not been found to date;cancer has been found in all groups of animals tested with non-zero concentrations of inhaled VCM. Just how low are the VCM concentrations in fabrication plants now? Publication of monitoring data would be useful, for analysis of possible risks of harm to health. A fabricated PVC product category with wide consumer exposure is PVC automobile upholstery, rooftops and interior fittings. The HPA lias a contract study in progress entitled "Sampling of Automobile Interiors for Vinyl- Chloride Monomer". (10) . According to Headley (! 1 ) , who is working on the F.PA contract study, of 7 cars in which 30-60 minute grab samples were taken in 1975 under varying heat and sunlight conditions, one reading was 1.2 ppm VCM, one 0.4 ppm and the remaining five less than 0.05 ppm (the detection limit). The car with the highest A AS I 00023047 reading was sampled ere -eon th after assembJy-under the following temperature conditions: ambient. 16^.1 , interior air of car t>0^C, , seat surface 66^C. No attempt was made to follow any decrease in off-gassing of RVCM over time. Given ibe number of individuals exposed to "new car atmospheres" and cars or other motor vehicles generally, some further data on the KVCM content of PVC auto fittings might be useful, Even if risk to consumers from KVCM in PVC seat covers is lowi what, is the risk of narm to persons voiking in automobile factories? A recent stud)' try Infante et al(12) is especially interesting. The data collected by Infante and his coworkers have been interpreted to suggest that VCM may exert, a mutagenic effect on sperm cells of PVC production workers, leading to an increase in fetal deaths among*prognancioof workers' wives. Infante's findings arc not surprising in light of the demonstration by CXcQ-hfO.o ^ c,L ,' (13) of chromosome aberrations in PVC production workers and the finding by Amos (Id) that VCM is mutagenic in a Salmono]1 a test system, -5- AS1 00023048 The ."c. j ! i g 0, vim'.i nai'oiolnl c upholstery and oilier vinyl fabric 'a o ; ], <-;-;i>rg- in ''vidcnily , in large part "woman's work1, even mven the "rHi -cor'poncirc nature oil the PVC in auto fittings ; t ii g! i i.. b e i n t o r c s t .i n g io determine the incidence of ' nw m j 1; j r \ lbs .aiid birth delects in offspring among womens v-myj. muo uphol s > e i y v;oi lasj s. b'hat happens to 'PVC on pyrolysis? There seems to be some disagreement as to whether VCki is Li berated (15 J oi whether the principal) health tin'eat from burning PVC is caused by evolution of 11CHK0 Pas there been a definitive demonstration that YCM is not evolved during pyrolysis of PVC.' that about d c p o 1 y m c r i 2 a t i o n or aging? in sunlight? in heat? PVC ux mo'-n'T ; '" has " bee' Raynaud ' s syrhm ::'o/or oupa t ioenJ linked both to dermatitis and (16a) . acr ou s t co'ly s i s . /Dermatitis could be attribu table io several of the additives in PVC, or possibly to Wiki pScLl, A catalogue of resin components which have caused shin s e n s i 11. o a 11 on re a c L i o n s wou 1 o b c u s c f u 1 ________ One of the. important us consumer uses of PVC is in food packaging. Regulations(17) recently proposed by the United States Food and Drug Administration(PDA) deal with PVC food packaging. Although 4o FOf| industry data (18) have been presontecj/which indicate migration of VCM from PVC as below .->() ppM'.be "j nwost dcteci able" lev;-.) established by the FDA proposal ,c chaJJenges(19) have been raised to permitting use of PVC food wrap if there ,i a 6- ASI 00023049 dll / K \ y, )', c a a... ', i , , r , , a < t ' i * t Th " :: e 1: . < r abor' PYC f o o d wrap noints up what may be the salie n t c, a, a i a c t e r i. s t t c o f PVC co tnsidcted as a source of re s i dua 1 VCM die:-: con ;ai:i ad in PVC h as now joined the rani Its of other car cl a og on i c a u bat a sees w b. o s e prcsc)ice in trace amount s the amcan tr Ire t C d O rly by th ,',!fC\ u'< mT. s o f de t c c tio n-in the IJS food s upp I)' :i s i o r bidden by the D elancy Clause, an am en dm cn t: t 0 the t J n i t a d S t a t c s Po od , Drug and Cosmetic Act. T3 i a c c 1 a u 5 O i' o a d s in pertine nt p art: 1:, , ,]io add it iv v- shall be deemed to be safe if it is found to induee cancer v:hen ingested by nan or animal, or if it is found, if ter ter. ts which are appropriate for the evaluation or the safety of food additives, to induce cancer in man or animal... (20). FDA's attempt to set a non-zero tolerance for VCM in food wrap has been challenged as illegal due to conflict with the Delaney Clause (21) ,, 'it may be that final promulgation of a proposal setting a non-zero tolerance for RVCM in food wrap will be challenged in the courts. Efforts to reduce VCM residual in PYC have come a long way in just over two years. The industry lias demonstrated its ability to reduce VCM levels in PYC production plants from hundreds or thousands of ppm to a love] close to or at the OSJ1A 5 ho.), TbA of i ppm, AS I 00023050 Since chemical reactions rarely go to completion and arc usually reversible, will it ever be possible to produce a PVC resin completely free of residua) VCM' and incapable of breaking down to release VCM? The stumbling block for the continued health and growth of the PYC industry may well prove -7- be no t the tore C l U O J ,, (,"'l ` r X \ c c! oi y, 0 f; of VCM and li i gh p o t e n t i a 1 i' r\ \ 0-' -.rev for the few, bu ,1u ,' 1\ o tl i r e a t o f low dose s of VCM ;) ] f) out non- re ; j s); of r p ' > c c y for tlic man)'. "hc pro, mice of PVCM X ]; PVC r c p r c s c nts a pot cn t i a 1 ) i h h 0 >' a re! f Or Die Jar go iiu mber of humans exposed t 0 resin or c co ; mroCly, iV; i slice! or a st i c go o d s . 'Die cu sty natur e of PVC resin in ay re.-, .'resent a health hazard for persons with aa n o' c.upa t. i one i. exposure to PVC, Vi lie re could PVC dust represent a significant hazard? :a polymerization plant, work nations which could be dusty include dr vine and hag giro areas, storage rooms or silos where PVC resin is held for shipment, mixing areas in compounding er.i/cw fabr ten hi on facilities, and bughouses or cyclones ;i), p)' o due 13. o i`i or fa hr i c a t i on facilities. If the dusty o |,o, i- a .i on r arc no: completely Isolated from the remainder of- ho -p i : k'j u i. -i: i o n o t f a b r i c a t i o n f a c i1 it)7, dust hazards could be pres col throughout the plant,, how dueiy do PVC plants get? Two photographs (Figure ;i end figure 2) (?//.') taken in 197k in a large PVC polymerization facility in the US may be of interest., The first of the two pictures glees a genera) idea of the powdery coating on the equipment in the bagging area. `Die second is a picture of the floor of the plant-note the depth of the h . as indicated by the footprint r.. PVC dust concern in atjon data are not readily .1 v, i i 1 a b "l o ; a t least, the author had difficulty obtaining such {'into from labcn , government, academic and industry sources. It -8AS I 00023051 v,ou J b !>c very b j u) iu. . hose ; a teres lcc! i n prob] ons of dust caused (i is ease or industry, 3abor or government to take men suv ci'.icnt s o L pvg dust in the workplace and make them pub! 5c. Particle sizes within the respirable particle range have been noted in a US PYC polyme rination plant(23). (This was not the same plant as the one in which the photograpns displayed as Figures 1 and 2 were taken A number of clinical studies have demonstrated pulmonary abnormalities in PVC production and fabrication v;oxkcrs^(24 ) . Abno .malities have ranged from decreased pulmonary function,ps measured by i-'EV, to pulmonary fibrosis. Given the data currently available, work is needed to separate the effects on the lung and respiratory system of YCM from those of PYC dust. Experimental studies associate pulmonary * fibrosis with exposure of animals to PVC dust. In a recent paper from Italy, Prong in et nl(2S) performed a series of studies with a simple tbasic plan-place guinea pigs or rats in cages in the bagging area of a PVC polymerization plant and observe the.effects on the animals' lungs. These animal experiments were inspired by a clinical report of PVC-j.nduccd pneumoconiosis. (26) . The Prongin group, after microscopic cxminntion of tissues of the animals under study, concluded that they had demonstrated a pn cuii'.oc on io t i c reaction, brought on hv PVC dust. Experiments -)- AS I 00023052 reported as "in progress'1 as of i a t c 1 97 ( vcr e d cs igncd to determine vhc ther the pulmon ry fibrosis vas reversible on cessation of exposure to PYC Data on reversibility of pulmonary and respirator)' effects of PVC exposure should also be obtained for- human populations. Work is needed to determine whether VCM exposure heightens pulmonary response to PVC dust or whether, conversely, PYC dust may convey low levels of VCM or additives to the <m.- "<' -C lungs\ Possiblc enhancement of dust effects by other chemicals in the work atmosphere, and/or the additives in the PVC resin should also be investigated. PVC dust could also be swallowed. Volkheimer (27) has found that PVC particles can be "persorbed" from tire intestine into the lymph or blood systems. The effect of locally high concentrations of PVC particles carrying minute amounts of potentially teachable RVCM or additives merits investigation, especially as concerns contact with lung or liver tissue. The possibility of PVC dust serving as a skin irritant should be explored., PVC dust could serve as an efficient means for bringing a sensitizing compound into contact with the skin. The suggestive nature of the clinical and experimental data available at this time supports reduction of PVC dust levels in polymerization, compounding and fabrication facilities. The OSHA standard(28) does not include PVC dust protection or reduction regulations, although such regulations were recommended by NI0S1!(29), ASI Ooo23053 -10- finally, the question of additives. (o 'Die final i ublc (Table ) lists several major categories of VC add i ti ves color ant s , fibrous reinforcements, flame tetardants, n3 asticizers and stabilizers. (30). Based on experimental and/or clinical data, questions are in order as to Idic safety of representatives of each of these chemical classes /J v/ for instance. Ames (31') has recently re;) or ted that a certain flame retardant compound used in children's sleepwear Is highly mutagenic in a S a .1 m o n c 11 a test system. Compounds exhibiting mutagenic activity in this bacterial test system are likely to be carcinogens as well. "Chat about the toxicity of flame retardants used in PVC plastics? .. In September 1972, NTBUS held a conference on phthalic acid esters .,(32). that is the current thinking of regulators and researchers regarding the safety of these chemicals? There is considerable documentation of toxic effects of certain organotin compounds. (34) . The biocidal,, activity of organotin compounds, several of which arc being used as pesticides at present, should cause concern about possible effects of organotin plastics additives on human health. Possibility of complex interactions among PVC plastics components and between the components and living systems should be emphasized. Most probably, very little is known about these interactions. ASI 00023054 Since last Pall, the author lias been working, as a consultant to AIPIIS, on a project designed to identify chemicals which should be studied for possible adverse health effects -11- for humans, Because of its wide population exposure due to enormous production volume and broad spectrum of uses, and health problems a.:1 reads associated with YCM and PVC dust and certain additive.', PVC seems a likely caiditiatc lor further investigation. .given the current state of scientific knowledge-at least ss regards data available for public scrutiny-producers and fabricators of PVC cannot assure the public that PVC plastics are safe for huma n u s e, Therefore, interested scientists the world over, whether working for industry, government or labor unions, or engaged in research at universities, should make a concerted effort to collect and analyze such data as are available at present on possible risks of harm to human health attributable to PVC. Scientists should identify research which should be carried out to determine whether or not the family of PVC plastics is safe for general use, and seek the necessary funding to carry out whatever studies are needed, 12- ASI 00023055 Tabic 4-6 APR I! 975 STATUS OF S.>1.' .'Jl ;s in:. STRIPPING V Company Number of Suspension Resin Grades % of Suspension Resin Production R VCM (ppm) A- 60 2000-4000 40 4000-COCO B -- 100 2000-5000 c 5 Graces 100 <400 DE 13 Grades ttr 15 Grades 30 20 86.8 5.4 3.8 3.2 .8 100 400 500-700 0-50^ 100 500 1000 4000 ' <400 G 4 Homopol.ymer 6 1500 14 -2500 4 Copolymer 80 100 16 300 84 400 H 4 Grades I- 100' 38 9 26 5 15 8 2000-10,000 400 600 800 1800 3600 4000 --^Based on data from responses to 3/31/75 section 114 request. --^All suspension resins to be reduced to <400 ppm R VCM by 7/75. ^Some values are speculative until improved stripping is installed. AS I 00023056 bus pens i on i<esu: s ASTK-' Cell Class GPT-26250 GP 2-1 6340 6 P 3"-13340 GP4-1 `0840 GP6_-1 5343 GpT-14443 GP2-14443 GP3-15433 GP5-15433 GP6-15433 Copolymers Cl 1-8500 Cl T-3500 U/a Prop 3 13 33 24 0 1 1 5 9 1 1 p(Vi vc;i into sir inner (40-60) x 103 3 (4G-C0j X 10 Avg. pnni VC 14 out of stripper (dry basis) t 3 >050 2,050 (50-70) x 103 (60-90) x 103 1 ,200 i ,050 (90-1201 x 103 950 (80-100) x 103 (80-100) x 103 (80-100) x 103 600-- 550 5 00 1 (90-110) x 103 (100-140) x 103 450 450 Avg. ppm out of dryer1 308 162 104 95 82 25 16 21 15 18 Emission f actor kci VCM/ 100 kn PVC 0.27 0.18 0.09 0.09 0.08 0.06 0.06 0.05 0.05 0.05 (40-60) x 103 (90-110) x 103 2,100 1 ,000 280 95 0.18 0.09' --^ASTM cell cl ass is standard definition of resin, -- Based on 1imi ted data (Less than three samnles). ASTM-D-1755 This company plans to 'install secondary strippers to further reduce the residual vinyl chloride content shown above by increasing the stripping temperature to as high as 85C (185F) and the residence time to one hour. 4.12.1 ,8 Company The values below were obtained by conventional steam strinping at the conditions shown. Values are for 1973 and 1974. AS I 00023057 V- Cl -. I u L .. - 4 . . K . - .... t Table 4-5. APRIL 1975 STATUS OF DISPERSION RESIN STRIPPING WITH PROJECTION OF FUTUR CAPAS III:IES- Plant Current RVCM^ After Stripper (ppm) In Product * Projected RVCM (ppm) After Stripper Time to Implement Controls Needed to Meet Projected Levels A 30,000 1-3 20,000 B 50,000 5 10,000 c 20,000 5-15 4000-6000 D 1 SCO-4000 i E 15,000 1-10 6000 -f 1!-C1Oh F 13,000-18,000 10 4500 500-1000 i G 2000-10,000 25 2000 ] 400 j H 14,000-18,000 . 5-30 1200 < I 2000 <1 6 months 6 months 48 months 12-18 months 30 months 42 months 30 months 43 months 30 months - From responses to March 31, 1975, section 114 request 2/ -- RVCM = Residual Vinyl Chloride Monomer AS I 0 0 0 2 3 0 5 8 TABLE 4 XIOSH Sop cumber 12, IS 7. TA3LE II REPORTED CASES OF AEG 10SARCOMA. OF THE LIVER ALONG NON-POLYMERIZATION WORKERS EXPOSED TO VINYL CHLORIDE 1Mr* r*"v t '-p --i \f Ouo.\ CASE ;n/ Fed. Rep . Gerrcany Fed. Rep . Gentony Great Britain Italy Sweden Er.ited States United States 03* 07* 02* Ci 02* 14 15* BIRTH DATE 07-16-30 05-09-36 G9-0S-I4 Co-15-34 11-27-11 00-00-13 0C-00-25 1st VC or PVC EXPOSURE. DX ANCIG' SARCOMA AGE AT DX 06-09-52 C0-00-60 CO-CO-46 00-00-65 00-00-45 08-18-38 00-00-00 03-00-73 00-00-74 ' 02-C0-70 04-19-71 05-15-72 06-00-73 07-00-72 43 38 55 36 61 60 47 YRS 1st EXP TO DX 21 14 24 6 27 36 00 TOT YRS EXP 14 03 Tj 23 00' 00 LATE OF DEATH 10-10-73 12-16-74 12-30-70 0 ~~ i 6 * / _i 03-16-72 07-03-73 02-15-73 Note * * j ^ y; N ere Note Notee v 6 Note Note 1 ,To:e 3 Not a 4 Note 5 Note 6 Pour ins ?VC oil mixture on to fabric ba ses Production of ?VC seeks Product ion of Vinyl Chloride Machine operator covering electrical wire with PVC plastic insulation Accountant at plant reeking PVC fabric Leading pesticide cans with VC propellant Note ? Note 8 Note S' -Angiosarcoma involving liver, lur.g, and pericardium. .Although difficult to deter: site seems to be pericardium. Diagnosis: Sarcoma (possibly ''angiosarcoma'1) , liver. Possibility of generalised the reticuloendothelial cell system cannot be ruled out. Assistant Factory Chemist ormarY AS I 0 0 0 2 3 0 5 9 - indicates- microscopically conrimad anvLcsarccna of the liver. 00 Indicates unknown data,, yjvvAfM cr v;v, ccm^ataa:;:*^ m ?'<z F A r': C A n CM FACILITY ' Ccfi:cr.lMt^ns Tjpt o! r1 ^r.l film (r:-)I:''s.it'.i0'vis 10 ................... p^t Inr^<L3'(O(SncjW)i):y^CcOU'p'<j3l';.ir,? ...................................................... ;3-e samples....... ............. (!>,' Ann *a-.:'*s ......... ...... ........................ (C) SwJiCf i"pies,,............................................... invjn V i r>; u m 1? < o <j :;o <.3 <10 <.! 35 <. 1 S40 <. 1 FAein 3 1.2 IS <1 2 ff PJC3'if3lr>rtC>tf1 25 in 10.21 171 16-20 10; 17 AS I 000230fiO ADDITIVES colorants fibrous reinforcements asbestos flame retardants plasticizers phthalic acid esters stabilizers organotin compounds AS I 00023063 References 1. Levi nsS'ii, u, : i ny ; C h 1 or i dg : a cace study of the new occupational health hazard. International Chemical Federation, Geneva, Swi tzerl and , 19 74 s 15, how ;o ester, t,s 5. To; r:eco 'AY or ins have YCM down for a 10 count.,.down to 10 parts per mill ionfaeverti event) , Tie 'fail Street Journal, July 9, 1975, 4. line advertisement states (in part): . . "At Tenneco, we've developed a unique new production teclmology tnat allows us to produce our general purpose Pid nomopolymcr, olending and cwsp.^rsion resins with no more than 10 parts per million of VGn(vinyl cnloiiec mic tvTiical YCM content of these homopolymer and blending .r.e...s.vin"1'" less" than 5 marts nor million and under 3 parts for our dispersion^ resin And, wc are producing our flexible compounds at non-detectable(less tn,-n 1 pom) levels. "This is a 981 to 991 reduction from what was once the typical oractice ox tine inaustry for residual YCM." j. EPA-450/2-75-009, U.S. Environmental Protection Agency, Office of Air and Waste management, Office of Air Quality Planning and Standards, Research Triangle Park, North Carolina (October 1975). 5. The U.S, N10SH has been maintaining a register of VCM-related angio sarcoma cases; this is one of the continuing series of tabulations published by the agency. 6. Vinyl Chloride, Hearing before the Subcommittee on Environment of the Committee on Commerce, United States Senate, August 21, 1974, Serial No. 93-110, U.S. Government Printing Office, Washington, D.C. 1974, 51. 7. 6, above, 50. 7a. Standard for Exposure to Vinyl Chloride, Occupational Safety and Health Administration, Department of Labor, 39 Fed. Reg. 35890 (October 4, 1974). 8. 6, ibid. 9. Barnhart, W. L., Toney, C.R., and J. B. Devlin: Environmental/Industrial Hygiene Surveys of Vinyl Chloride Monomer Manufacturing Operations and Operations where Polyvinyl Chloride and Copolymers of Polyvinyl Chloride are Processed, Contract No. CDC-99-74-50, U.S. Department of Health, Education and Welfare, Public Health Service, Center for Disease Control, National Institute for Occupational Safety and Health (August 1975). 10. Feairheller, W. R., Cheng, J. T., and R. J. McCormick: Sampling of Automobile Interiors for Viny Chloride Monomer, EPA Contract No. 68-02-1404, Task 1, Cost and Performance Report, 1 June 1975 to 30 June 1975, Environmental Protection Agency, Research Triangle Park, North Carolina. 11. Personal communication, February 23, 1976. AS! 00023064 . n fan fo, P.F . , '-.'a goner, J.K.. Me Michael, A.J., Waxv/ei 1 or, R.J. and P Falk: Go no tic Ru> ks of Vinyl Chloride, Lancet (in press). h Ducaiman, A. , Hi rscnorn, K. and I. J. Selikoff: Vinyl Chloride exposure and human ch romosome aberrations , 31 Mutation Res. 163 (1975). McCann, J.. Choi, E., Yamasaki E. and B. M, Ames: Detection of carcinogens as mu bacons in the SrMmono ij a/mi croscme test: Assay of 300 chemicals, 72 Proc. Mat. Acad. Sci. USAS 135 ( 1 975). coetoner, c.A., Bail, G.L and B. Weiss, Combustion Products from the Incineration of Plastics, ERA Grant Mo. EP-00386, Program Element No. 1D2053, EPA-670/2-73-049, 25, 26 (July 1373). See, for instance, Dyer, R.F. and Y.iMEsch, Polyvinyl Chloride Toxicity in Fires, 235 J.A.K.A. 393 (1976); Hornblower, M.; Plastic Fumes In sidious, The Washington Post, December 11, 1975, AS. See, generally, 1 above; 246 Ann. N.Y. Acad. Sci. (Proceedings of International Workshop on Vinyl Chloride, May 1974), (1975). Department of Health, Education and Welfare, Food and Drug Administration: Vinyl Chloride polymers in contact with food, Notice of Proposed Rule making, 40 Fed. Reg. 40529 (September 3, 1975). Heckman, J., counsel (Washington, D.C.), Society of the Plastics Industry, Inc.: Submission for the Record in FDA Docket No. 75-N-0190; Vinyl Chloride Polymers in Contact with Food; Notice of Proposed Rulemaking, 40 Fed. Reg. 40529, September 3, 1975 (December 19, 1975). Johnson, A. and S. Wolfe, Health Research Group, Washington, D.C.: mission for the record in proposed FDA regulation Vinyl Chloride Polymers in contact with food (December 19, 1975). Sub 2.1 USC s 348(c)(3)(a). 19, above. Photographs, taken in unidentified PVC polymerization plant, provided by Mr) Steven Wodka, Oil, Chemical and Atomic Workers International Union, Citizen-Legislative Department, Washington, D.C. Personal communication, William J. Nicholson, Mt. Sinai School of Medicine, February 18, 1976. See, for instance, Lilis, R. , Anderson, H., Nicholson, W.J., Daum, S., i'-ischbein, A.S. and I. J. Selikoff: Prevalence of Disease among Vinyl Chloride and Polyvinyl Chloride Workers, 246 Ann.' N.Y. Acad. Sci. 22 (1975); Miller, A., Teirstein, A.S., Chuang, M. and I. J. Selikoff; Changes in Pulmonary Function in Workers Exposed to Vinyl Chloride and Polyvinyl Chloride, 246 Ann. N.Y. Acad. Sci. 42(1975); Wegman, D.; ASI 00023065 Comments in discussion, 246 Ann. N.Y. Acad, Sci. 20(1975). 25. i-rongia, LA, Spinazaola, A, and A. Bucarolli; Lesioni pulmonari s penmen ..all da i na I aziono nrolungata cl 1 polveri di PVC in ambit. etc i cl V '0'' 321(1976) (title translation provicod . , , -l ` ft < ital lung damage from prolonged in- halation of airborne DVC dust. 26. Szende, B., Lapis, A., Nemes, A. and. A. Pinter: Pneumoconiosis caused ay the inhalation of PVC dust, 61 Med. Lavor 433(1970). Czlora_ According to Miller' ot al ., (24, above, at 51): "...If exposure to vinyl chloride and/or PVC is causally related to air flow impair ment, we do not know which substance is more pathogenic. The fi ne dust of tiro polymer might be more likely to'concentrate in and damage the small Air,ways. This dust, end other small respirable particles, perhaps from tobacco smoke, may also serve as carriers for molecules of a monomer gas to settle in these airways." 2/ Volkneimer, G.: hematogenous dissemination of ingested polyvinyl chloride particles, 246 Ann. LAY. Acad. Sci. 1 64(1 975). 28. LAS. Department of Labor, Occupational Safety and Health Administra tion. Standard for exposure to Vinyl Chloride, 39 Fed. Reg. 35890 (October 4, 1974). 2S. For the NIOSH recommendations, see 1, above. To date, neither the US OSHA nor the US EPA has taken any specific steps to reduce PVC dust considered as dust. Dust reduction and pro tection was recommended to the OSHA by NIOSH, EPA on p. 49-of its standard support document '(4, above) states: "With regard to the potential problem of polyvinyl chloride particulate as a possible cause of pneuuinoconiosis, NIOSH is currently involved in e xperimental studies on the effects of the particulate in animals. The extent of public exposure (as opposed to occupational exposure) to ambient concentrations of the particulate is unknown at this time. Ambient measurements of polyvinyl chloride particulate have not been mode by EPA in the vicinity of industrial sources because no technology is currently available for separating polyvinyl chloride particulate fro;:; total suspended particulate. As data become available from NIOSH and other sources on the health effects of polyvinyl chloride particulate, EPA may find that it is necessary to reevaluate the need to propose standards for polyvinyl chloride particulate." AS I 00023066 50. See, ye:neral 1 / 3 {_; . 5 OCif; pood. A. A. : Audi tiVC'S Bnyinceriny T, 23 (:[972) 31, Hnviren non :al ri.it fen SC fund, de Pi lion pu rsu Consumer Pr OuUCt G ifcty CoITiOli ssiion to comme.ncc issuance oi ^ con C 1 nor pro duct safety rule, 7 (; 32, b;t"o: :aps o G tA t' roe tin;;-, -ire printed m v` ' ..`>0 , , c: j. i o: i . Gu 54, Pinos, V> T, Airynnot.in '(impounds . Indus trial applications and biological i vesti cation, bnvirounental Health Perspectives 61 (1973). AS I 00023067