Document peZw9r3qbVjVeom6Dn1go5QXk

J!!J|||l|IIIIP|pi.iJll|Mii|iplWI|WlliMfWP"WWHWftll I I. |l MU..........HP npi ................ p i MANAGEMENT 1. mm r- ............ L|H HMMI't-- mqnmtwm *" ||4|mjiiii|i nnjfWmi^,.nWPi k--i;rur;i- .......................... ........... P................PH ................................................................ . A whaft happened r\ since VGM? Changes in the manufacturing procedure for VCM and PVC as well as the government action that spurred them have failed to dampen the demand for this plastic. But more importantly this may have set the future pattern for resins ^; ' j .- fc * + .. -fI j -- -* *1ins i ' *' j . v''itv^ i 'Jj va~ . S1'*r*i-- -', 4- Cl ..' ^P * -*F m- J| ^ .r w, ^ * V 1 - A. The vinyl chloride monomer (VCM) occupational health hazard has been brought under control to such an extent that workplace problems no, longer . exist, "ThMIf this problem created b rapic! change in the method of manufacturing polyvinyl chloride. However, the full impact will not be evident for another year or two when the industry comes into full compli ance with the recently issued EPA emission regulation. inhering-miracles were required almost overnight in order to meet the severe safety problem that almost shut down the PVC industry. As a result PVC with extremely low levels of residual vinyl chloride monomer (RVCM) is now produced which can be processed and used with safety. Interestingly though, PVC has been used safely for food packaging, building products, potable water transmission, medical applications, and in other markets for many years, so that it might be said that the cure had no short range implications. Most processors that purchase large quantities of PVC, such as the auto, appliance, electrical, and building industries, require resin that has no more than 5 parts per million (ppm) of residual RVCM, so that they will not be required to have "regulated" process ing areas. v ;- Technology currently used results in PVC that contains less than 10 ppm of RVCM while some companies are producing PVC with as little as 1 ppm or less. Practice indicates that resin with 10 ppm or less of RVCM will result in processing emissions below the 0.5 ppm OSHA "action level". This fact relieves the processors of monitoring and health check requirements. Health menace discovered In 1964 it was discovered that a bone problem developed in the hands of men who cleaned the reaction polymerizing vessels. The industry then initiated studies to determine what long term effect VCM might have on worker's health. The "hand problem" was eliminated through better working practices including the development of hydraulic reactor cleaners. It had been known that high levels of VCM could have intoxicating and even anesthetic effects. This led to re search that eventually provided the scientific basis for the various govern ment regulations of VCM. On January 23, 1974, B.F. Goodrich voluntarily reported to NIOSH (Na tional Institute for Occupational Safety & Health) and Kentucky state authori ties three cases of angiosarcoma of the liver, a rare cancer, that had fatally affected employees working in their Louisville PVC polymerizing plant. This resulted in an extensive search by the industry through old medical records for other cases which might have gone unnoticed. Ultimately it was determined that 48 deaths due to angiosarcoma had occured between 1961 and 1976, including 18 in the U.S. All the deceased had been exposed to high levels of VCM for long periods of time and death followed exposure by an average of 20 years. It was estimated that exposure had probably been over 250 ppm daily for at least several years. Most had been reactor cleaners, where the highest VCM concentration exist ed. Resin producers took immediate steps to reduce worker exposure to VCM and began to develop new technology. &*. .its * . , -s` i * jL V. >/ J e!1 ' - : <f ->LVr * 'iv*:'* : f "i OSHA action i* At the time of the B.F.G. announce- ment the Occupational Safety & Health Administration standard for VCM had n been 500 ppm maximum exposure. This standard was based on 1971 recommendations by the ACGlH 7 (American Conference of Government' tal & Industrial Hygienists). ' April 5,1974 OSHA set an emergency^lg! temporary , standard of less than 50 ppm. On May 10 they issued1 'a proposal for a "no detectable"//' * ::i*n exposure. Even though progress had been made in VCM containment, the industry did not believe that this level could be attained. On October 1, 1974 r OSHA adopted an exposure standard of 1 ppm on a time-weighted average for eight hours, with 5 ppm ceiling for 15 minutes. VAB.0001035404 . 2ft ^***- -*** n dairm Win* - mt- II- - . n' w" I t I ^ - at ir **n i Oecember 1976 / plastics world hi, ., - New continuous stripping column to remove VCM from PVC developed by B.F. Goodrich is being installed. Because these units are fast and efficient, they provide a lower "residence time" and heat history for the resin compared to batch stripping. The industry fifed a petition for judicial review of the standards. In January 1975, the court of appeals uph eld the OSHA standards, by contending that OSHA is not restricted to setting standards that are feasible with known technology. Because of the judicial proceedings, the imple mentation date for the standards was delayed until April 1, 1975. Meeting the new standards The industry's opposition to the "non-detectable" standard had been based on the then current technical impossibility of achieving this standard and on the impracticality of using air-line respirators. In the final regulation OSHA changed from "non-detectable" to a level of 1 ppm continuous to 5 time averaged peak ppm that brought the standard into the realm of technologi cal feasibility, although still difficult and costly to achieve. The introduction of a time weighted peak gave the industry a practical flexibility that was not available under the standard that had been proposed. By permitting the use of gas mask rather than air line respirators at levels below 25 ppm, OSHA eliminated a major compliance difficulty with the standards. Meeting the OSHA require ments has resulted in technological progress far beyond expectation, I rit /r* d* It should be emphasized that the hazards related to the manufacture of polyvinyl chloride involve the direct inhalation of unreacted vinyl chloride monomer gas by workers. There has never been evidence to indicate hazards to employees who handle or transport products fabricated from PVC resin. i- EPA and emissions The Environmental Protection Agen cy (EPA) established a vinyl chloride task force in February 1974 and on May 31, 1974, requested emission data from manufacturers under provisions of the Clean Air Act. On June 11, 1974 they announced that preliminary monitor ing test results showed "no scientific evidence to indicate that these emissions pose an imminent hazard to people living near these plants ..." EPA said nonetheless it would propose regulations with the coopera tion of the PVC industry to reduce VCM emissions by 75 to 90 percent of 1974 levels, even though only a few measurements above 1 ppm were recorded. On December 24, 1975, EPA pub lished the limitations on air emissions of vinyl chloride. The regulations require substantially reduced VCM emissions from PVC processing plants, which due to the sharply reduced RVCM in the resin is less of a problem *^ m an A V> f v- j *- 4. 4 -\ v : The science versus the politics of safety ".4;>":. sk-Aiflt'a >" p--sfj-S5:* '# + . :* headlines are so alarming, peYplexin^ancf; personal in their cations as those concerning When .discussing safety, rpart of the problem concerns de~ frnmg its meaning. An excellent dissertatii*o'- n on t.h7*is' :sub* j-ectft 1 *b_ y . -- ^ y* W.W- Lowrance of Harvard Univer- sity provides some logic: Safety is not measured. Risks are measured. Only when those risks are weighted on the balance of social values can safety be judged: a thing is safe if its risks are judged to be acceptable. ; . Measuring the probability and severity of harm is an empirical, scientific activity. - Judging the acceptability of -i: ____isX* '-'S'' - a normative, political activi- "ty.!* : - 1 - f iKt* Realizing that no pursuit can be absofu ree of risk is a matter of irfefutaBleifact ^ *4*.- Because?ju.J Ift-,W- .v there are degrees of ` there ^are"consequently de- grees of safety. Science contrib utes to the public-political decision b ut it does not rep resent the com plete basis Tor the decision. It provldes. probabiIities(^nd conse quences of events, not their value to' people. Safety its .relative to . and can change with time and can therefore be judged differently at different times. Knowledge of risks evolves from ekpeTfence and has personal and social standards of acceptabil ity; these also change. So that steering a course to industrial and consumer safety requires the prop er blend of science and politics. Government officials have been notoriously reluctant to give vocal support to the use of "risk benefit analysis** in making any public health decision. This makes the recent comments of outgoing FDA ad m inistrator Alex an de r Schm idt all that more'significant, " 5' , We build .highways, we build bridgestCwi build buildings, know- mg full what the statistical in doing those things. So it is not reasonable to believe tha^use*of chem icafs fn our sbcietv- can be * * - m.. ' ^ PVC since VCM Typical Toxicology Study SafeguardsAbandon Adopt Spociol New Plastic Material Industrial Use (Non-food contact) Adopt Special Safeguards Abandon Toxic Froc*d With Uu Proceed With Uit No-Effect level Animal Carcinogen I Proceed With Ua* ] No-Effect Level lh years)Chronic Studies (2 Abandon Abandon Toxicological Tests Acute Subacute * Sub-chraoK * Special Irving S. Shapiro, Board Chairman of DuPont, states. "If we cannot make a product without adverse health and safety effects, we are just not going to make that product, no Adequate Dale fin adequate Data matter how profitable it might be..." This block Literature j Search } diagram shows the DuPont approach used in developing Start mi Point new non-food contact plastics. carcinogen, government biostatisti cians calculated that from 1964 to 1974 there should have been 10 excess deaths from angiosarcoma among people living within five miles of VCM and PVC resin plants in the U.S. The survey showed, in fact there were no excess deaths from angiosarcoma among th is group. This led to the conclusion that "This survey has produced no evidence that living around vinyl chloride plants is a risk factor in the occurrence of liver angiosarcoma". In addition, at the EPA public hearing. Dr. William Marcus of EPA's office of toxic substances, stated that there is no evidence "that angiosar coma has been produced by vinyl chloride monomer in the general population". EPA action On October 21, 1976 the new EPA emissions standard was issued to eliminate the possibility of future problems. It affects about 60 PVC, VCM and ethylene dichloride plants. The order states that any VCM emissions from equipment preceding and including the stripper is limited to 10 ppm, this includes stripping process water. Compliance or request for a waiver must be registered with EPA in 90 days. The granting of waivers by EPA to a maximum of 2 years require detailed time schedules showing engineering and equipment improvements taken to meet the standards. It will be difficult lo meet the 90 day period. Lack of technology as well as unavailability of cS alh :_ . i. V. A healthy industry j* Due to the versatility and capa Goodyear at 250 MM lb will add 50 bility of the PVC industry in solving MM lb more next year; Stauffer at its VCM problems, its future looks 350 MM lb will add 80 MM lb more stronger now than in the past. next year; Robintech at 250 MM lb There are now 21 PVC and 11 VCM adds 50 MM lb next year and 200 ^ tfV -.r ' : . p' " (including Diamond Shamrock to MM lb in 1979; Shintech currently be on stream in a year) producers. at 220 MM lb will add 110 MM lb 'v 'i ' r, 1r , f'. , J. I A mild VCM shortage could occur next year. Tenneco will have 700 at the end of 1977 but hew facilities MM'Jbs by ,1978 when 190 MM lb coming on stream in 1978 will are added. Union Carbide, with its f1 r \ *11 * make it a short one. i T i * T 400 v MM Ibs/yr! is also making -t f- 'i'. r .t c- Strong demand for. PVC is lead changes.,; ; 'j iK ing to plant expansions!: Air Prod * Add in 500 MM lb for Borden, 200 j.. 'i ucts at 200 MM Ib/year will add 120 MM lb for Certain-Teed, 180 MM SI * lb "i-, "V . . I. L MM lb next year; Conoco' for Ethyl, 180 MM lb for General *j;f* ive Tire, 220 MM lb for Georgia- a total of 560 MM.jb. Diamond Shamrock has a 5?0 MlvTIb. capaci ty in PVC, but the big story is their entry into VCM with 1-billion Ib/yr capacity coming on stream in 1978. Firestone will add 200 MM lb PVC Pacific, 1100 MM lb for Goodrich, 180 MM lb for Hooker, 120 MM lb for Pantasote, 150 MM lb for Rico: So PVC total for now is about 6.4 billion Ib/yr and will add 1.26 B lb in 1978 and another 0.6 B lb for in 1978 to give them 600 MM Ib/yr. 1979. equipment indicate that some opera tions could take up to 2 years to comply. The new controls are estimated by the government to cost the industry $200 million for equipment plus as much as $70 million/yr in operating costs. The FDA and monomer migration PVC packaging being supplied to end product manufacturers in 1976 contains little or no measurable residual monomer. There is therefore no liklihood of VCM getting into the diet from PVC food packaging materi als. These virtually monomer-free PVC resins were developed more than three years ago, when the issue of RVCM migration from packaging into the contained substance first came to light. This was prior to the discovery of any link between VCM and cancer in humans. Schenley Distillers, Inc. previously reported to the Treasury Department's Bureau of Alcohol, Tobacco and Firearms (BATF) the presence of RVCM in distilled alcoholic beverages, such as vodka and gin, packed in experi mental PVC bottle. Levels up to 20 ppm in vodka and 25 ppm in gin were found. Regulation of the safety and purity of alcoholic beverages is normally handled by BATF although legally the Food, Drug and Cosmetic Act, administered by the Food & Drug Administration (FDA) also has applica bility to "alcoholic foods". As a result, the U.S. Department of the Treasury withdrew its provisional approval for the use of PVC plastic bottles for distilled alcoholic beverag es and FDA took under study the question of vinyl migration from food packaging. SP1 subsequently supplied data to FDA which indicated that small amounts of vinyl chloride could migrate to non-alcoholic foods from the "old formula" (i.e. high RVCM) PVC bottles then in production. But because the FDA proposal on food additive use of PVC was nearly two years in coming, pressure on the FDA from consumer groups and Congress men began to build. These groups contended that zero migration could be the only safe level because there exists no such thing as a "safe dosage" of a carciaogen. On July 1, 1975, the Health Research Croup, a Ralph Nader affiliate peti tioned FDA to ban completely ail PVC December 1976 / plastics world IILLIHIPUUIIlMI. mrmaPT*mnip it a- . Tt im m- Pmunnim^HIHiii T *>< *** fWi M> ill I JiHP1IHiMi|ii>jih>- Win!*- -- trr< iMiipm<imniihPWinwM*mnMi>n iiiininimuiwfiwwiwi^wi * *!* < mu.Mm flUIIMlitlimilF'flllim IIJIMMFII1 n.lfHPTTI1<- .:i::...lP^. KJ1U ii|^*n!nilR<B iiiipmp^iin) fV,.r 4 p '-Hi ** ---# .11 m iiwntf p>*h -- -y* 't----------- *. - - -.4*-. ^lif-u.+wl 4 f^::n !' f ,.. . JI .. ............. 1*V' | ,. *lM ' 'fi-1'?; 4,7 l-fc'i iP ' r . ,:7. i % ::'p -i : : * 1 A1 5j.'; Jii.. /" /: j1 t *' *il,: i ii i, i ' ;T ' k ,' "+ ! III*! e1 iJ * i*/'ii ?h! * 1J9." :!l objectives in pWlaorsldtics PVC since VCM A action to research data missing in older studies. Who does what? Although no master plan has been formally adopted, several industry associations appear to have staked out certain areas for action. SPI is concerned with the manufacturing and fabricating of plastics and any danger these activities pose to its employees and the consumers. However, toxicity emphasis is on the monomers because there is little danger that polymerized plastics, due to thei high molecular weight might be toxic. Any toxicity would come from residual monomers as was the case with PVC. MCA is primarily concerned with basic chemicals and what occurs during the production of monomers before they are polymerized. They worked on the VCM problem and now are also deeply involved in styrene, acrylonitrile, and other monomers. CUT plans to study t asic chemicals of afl types this induces the chemical precursors of monomers. For example, Cl I r starts off with ethylene and toluene, MCA takes the next step of studying VCM and styrene monomers and SPI is concerned with PVC and PS polymers. This includes residual monomer < s well as break down into monomc rs due to faulty processing. Testing facilities , Chemical testing facilities in U.S. and world wide are being strained to the limit with the massive workload, not only from plastics and chemicals but also metals, papers and food. Fortunately a number of fully qualified facilities are operated by U.S. chemical companies, such as Dow Chemical and DuPont. Monsanto is now completing a large complex. NIOSH reports that 47 toxicology labs (industrial and private) currently function in the U.S. CUT plans to establish their own laboratory. In the mean time, like most government agencies (National Cancer Institute, NIOSH, etc.) work is contracted to private labs. FDA is also in the process of building a large lab. University lab's are active but need sponsorship to finance the very expensive chronic or life time animal studies, usually several years in duration. NIOSH estimates a shortage of 50,000 professionals exist in the area of occupational and product safety. They add that there are only 850 profession al toxicologists and the American College of Veterinary Pathology lists only 300 pathologist members. Ability to pay In light of great public, political and media interest in the subject of carcinogens, the problem of limited resources is very real. The testing needed to provide the basis for competent judgements about the hazards of materials used iSextensive and a large amount of money is required. To determine the carcinogenic effects from long term, low-level exposure requires that each testing program take at least 2 to 4 years and millions of dollars to complete, In a short time the total bill could add up to billions. Umi/wf m In all probability the life-line to financially supporting the toxicology tests will be through industry associa tions. Death of PVC Somewhat like Mark Twain, the reports of the death of PVC have been greatly exaggerated. Cost has gone up, but not significantly. And despite afl the damaging publicity its growth is healthy, possibly maintaining 12% annual growth for the next 3-4 years. The usual cost increases of energy raw materials, etc. have affected PVC, but no more than for other resins, 'is ' metal, paper, and other materials. y. *. *; m - m" ^^ *" *i Safety costs per pound should only : ** - involve parts of a penny, in fact, in the * ** r\ '\ J -f short run production costs could be lowered due to the changes in - ,J r manufacturing technology. : * ,-r. In the meantime yearly production capacity for VCM and PVC has been 'T-'i-i considerably increased. A VCM short age could occur late 1977 to early 1978 * " r. before almost another 2 1/2 billion lbs ^ - . comes on stream, at which time we'll have a 7 billion lb capacity in U.S. Total impact Even though the chemical industry as been producing and handling large 'J' amounts of many toxic chemicals with comparative safety for years, the case history of VCM has put the "fear of Cod" in the hearts of the plastic/ chemical industry. The U.S. plastics industry vitally understands health- related hazards and is determined to do everything in its power to be sure that it does not sustain another urprise like VCM. D.V. Rosat Industry pipe standard PS fr: ? f .: ` . : -' '-jr.". - ' \ . ' : Potable PVC water pipe and. fittings do not pose a health risk for possible future regulations. In the September 1975 FDA pro- water pipe under their Standard 14 ... :. 4 4. * , jv tr ..jul.'. -jfc'.'O : , r x- y-vC. ..*.-.-i-' , NSF approves pipe based on rawr based on extensive research cont w posals;-,data were requested on ~ -- ------ ----- -- ' t ducted by the industry sfrice 1974. PVC pipe although no regulation 1 The amount of time,? cost, and on its use was proposed-: Considpi^ reviewing"'.''th^f^ifuation^' scientific expertise dedicated to able data were supplied in the SPIiii NSF in August 1976 developed its the program is impressive.But also: ^ impressive .is. PVC pipe consump?'f*.t1y^' t8h0e0-FpageEDecSembAer 19^75 .reMport to^; f. stestitansd esvatalunatfiolan^rdapjjp^r^oaacghr^to^if; -H4r- tion, which pot Id groW to 1.3 In February --1-9--7--6-;--a- joint`.^>#t-! 1977,: If adopted, ..... oresen*, % billion lb this year and; to 2 1/2 (Plastics ^institute of SPI) and Uni--. 'twill put a. pj>M$ billion lb in 1980. ; B e 11*/'*** P fast i c Pipe Association VCM in.PVC pipe. Wilimit;% d' J* H\. 4 When water passes through any groups was set up to look into the there is no detectab!eftextracti6n: - pipe (steel, coated steel, cement- VCM extraction question and to NSF will use a test method devel asbestos, plastics, etc.) there is a possibility of some leaching out or establish a standard for self- r- ;: _ .'+.- regulation oped by the PPI committee on VCM that is accurate to 2 ppb (parts per material extraction from the pipe; .r. . This group made its findings b ii I i ohj.; Th is t e st shou Id allay. the wall. So when tie VCM problem available to NSF (National Sanita fears of those who felt .that we J '+. * developed, pipe and resin produc tion Foundation) which has been might experience 'another liquor ers initiated studies to obtain data checking and certifying all potable bottle fiasco. ;v.;": o. r > : y 32 f VAB.0001035408 December 1976 / plastics world