Document rkm9DGaXdJmpGj21yzvm3Ykq

A To. T. Grumbles Interoffice Communication From: Date: Subject: ffD. Penney July 12, 1993 IARC REEVALUATION OF ETHYLENE VISTA The review of ethylene by the International Agency for Research on Cancer (IARC) is not based on any studies showing ethylene produces cancer in animals or humans. In fact, the opposite is true; an animal carcinogenicity study of ethylene conducted as part of the National Toxicology Program was negative (i.e., no evidence of cancer). IARC's interest in reevaluating ethylene is based on the results of a metabolism study conducted in humans. This study found that when humans breathe ethylene, a small amount (=2%) is converted in the body to EO. The conversion of ethylene to EO has also been demonstrated in animals. It is the conversion to EO, an animal carcinogen, which has raised concerns about ethylene. Historically, IARC has not considered metabolism studies in its chemical reviews. However, IARC has recently been moving in this direction. Ethylene is amongst the first chemicals to be evaluated by IARC on this basis. As you know, CMA is considering the sponsorship of studies to investigate the risks of ethylene's conversion to EO. It is anticipated that these studies will show that the small amount of EO that gets produced from ethylene is not enough to cause cancer. CMA's plan is to have as much of this data available as possible in time for IARC's review. Dave Penney cc: V. Messick - Houston C5 O 70 > t H 8 H 0 Z 0 0 0 OM d c fcfeoKtLU Sty's* O'. ScArvdt t- f CHEMICAL MANUFACTURERS ASSOCIATION July 19, 1994 To: Phthalate Esters Panel/ERTG/TRTG Re: Swedish Ban of PVC David Cadogan has just sent me the English translation of the "Recycling Delegation's" review of PVC on Behalf of the Swedish Government. I will send you anything new as I receive it. As always, if you have any questions please do not hesitate to call me at (202) 887-1207. Marian K. Stanley Manager Phthalate Esters Panel 2501 M Street, NW. Washington, DC 20037 Telephone 202-887-1100 Fax 202-887-1237 4 frA Responsible Care' A Public Commitment A VRD 000 20 18886 ECRI EUROPEAN COUNCIL FOR PLASTICISERS & INTERMEDIATES A SECTOR GROUPCF SF0 DC/ab/471/940705.28 Addressees : Messrs. cc: Angaroni - Dorrler - Lafora Comas - Koch - Thompson - Schreyer - Muniz - Krubner - Langer Van Orden - Royer - Succi - Harris - Staley - De Lemos Pinto - Donnelly - Bruch - Kuhmann Losch - Moseley - Jansseune - Forslund - Leroy Solano - Lopez Quintanilla - McKendrick Moeschel - Vanden Burre - Deuvaert Technical Committee Members Toxicology Working Group Members Environment Working Group Members Brussels, 5 July 1994 Dear Colleague, THE "RECYCLING DELEGATION'S" REVIEW OF PVC ON BEHALF OF THE SWEDISH GOVERNMENT Please find attached an English translation of Chapters 15-17 of the above review together with a summary of events in Sweden since the report was issued. Neste and Hydro Plast have managed to extend the time for industry comments on the report until 15 November, 1994. In my meeting with Neste we discussed how we might gain the support of the plasticiser users and carry out some studies to enable a better response to the report. Neste, together with Hydro Plast and funding from the Swedish Government, will carry out measurements of the levels of phthalates in the environment at locations across Sweden. This should put the earlier, rather localised, hot spot measurements into perspective. We will ask ECETOC to carry out modelling of the Swedish environment to be used in conjunction with the analytical measurements. In addition, the ECPI Environmental Working Group should consider possible ways of measuring the actual loss of plasticisers from outdoor articles such as roofing sheet to refine our current "worst case" estimates. 1 would ask you all to consider the attached document carefully. It may seem an extreme Swedish situation at present but it could easily spread to the rest of Europe via the activities of the green lobby. I would be most grateful for your urgent comments on the proposed actions and suggestions for an action plan. Yours sincerely, O----- n tt r Annr aki Technical Coordinator ECPI YRD 0002018887 NESTE Chttmcali Re. Possible Swedish phase out of plastizised PVC. June 8,1994. A report was presented by the Swedish Recycling Delegation The recommendation to the Ministry of Environment and Energy is to limit the use of plastizised PVC and take steps to reach a complete phase out by year 2000. June 13 ,1994. A delegation from the Swedish Association of Chemical Industry and the Swedish Association of Industry had a meeting on the Ministry of Environment and Energy. The ministry informed that the proposal will be sent out to the parties for consideration shortly. The time for consideration was proposed to 2 months. The Industry protested and demanded that the time to respond should be extended to the year end. The Ministry asked for cooperation and constructive thinking from the Industry. In a separate meeting the Industry representatives discussed and agreed on how to organize the work to get a united response from the industry to the Ministry. June 27,1994. A delegation from the industrial parties had a meeting on the Ministry of Industry giving the view from the Industry on the work of the Delegation where the unfortunate mixture of political and factual statements in their report and press release has already caused disturbances in the market. Stressed the importance of allowing enough time for the industry to work out their comments on the proposal which will be sent out for consideration. The Deputy of the Ministry promised to involve himself in the process and to make contacts with the Ministry of Environment. Future Neste Oxo has following plans for the near future: Project to measure background concentrations of phthalates in aquatic environment like lake water, sediments and soil. The project is shared with Hydro Plast and is performed in cooperation with the Inspectorate of Chemicals and the Swedish Environmental Protection Agency. Involvement of customers Private talks with Presidents of customer companies and competitors Swedish affiliates. Made by President of Neste Oxo. NESTE Chemicals Meeting with Dr* Cadogan to get CEFIC:$ views and support. Meeting with customers business and technical representatives to explain Neste Oxo:s position to defend DEHP and why. Mobilize support from the customers. Contact with international competitors . GW 28.06.94 >1 5*3 <<<533533 CO oc GoeO PVC - a plan for the avoidance of environmental effects Chapters 15-17 > SOU 1994: "Kretsloppsdelegationens'' (The Recycling Delegation's) Review of PVC on behalf of the Government Translated by Martin Richards Underulsning och Ouersdttning 19th June 1994 page 1 0688102000 <R Ac P* 15 Overall Finding 15.1 Production of PVC raw materials There are three production methods for the production of chlorine. The two Swedish chlorine manufacturers which manufacture chlorine for the production of PVC use a method which has several recognised environmental problems. The manufacture of chlorine uses an amalgam method which is a mercury process. During the production of chlorine it is mostly the loss of mercury to the air and the consumption of energy which are, according to "Naturvirdsverket" (National Environmental Protection Board), are the most trying factors. Chlororganic compounds are also released. The use of mercury for chlorine production shall, according to Sweden's acceptance of an international agreement "Nordsjonkonferensen" (North Sea Conference), be phased out by the year 2010. The manufacturers have the prospect of using the amalgam method for a further 16 years. None of the manufacturers have, as yet, applied for a change-over to another method, nor has anything, other than testing, been carried out. The production of chlorine for the manufacture of PVC is not included in the reappraisal according to "MiljOskyddslagen" (The Environmental Protection Law) which is planned for PVC manufacture installations. The production of PVC raw materials is from chlorine gas and ethane via a production stage dichloroethane (EDC) and vinylchloride (VCM). The production of PVC raw materials takes place at one site in Sweden. Approximately 40 percent of their production of PVC raw materials is used within the country and the rest is exported. Of the Swedish consumption 60 percent is imported, mostly from Germany (30%), Norway (10%) and Finland (10%). Several of the light and heavy waste products are strongly contaminated with dioxins and other unwanted chlor-organic compounds. Hazardous waste in the form of dichloroethane and vinylchloride tar are produced during manufacture. The waste is either destroyed in the company's own waste disposal installation, stored or exported for combustion in a VCM factory in Holland. The release of Translated by Martin Richards Underuisnlng och ttuersbttning 19th dune 1994 page 2 VRD 0002018593 AA chlor-organic compounds to water beyond the waste water treatment plant to which the production site is connected , according to The National Environmental Protection Board, is not negligible and possible measures should be investigated further. Diffuse pollution in the form of chlor-organic compounds also occurs from production sites. Approximately 70 percent of all chlorine which is used in Sweden goes directly to dichloroethane production, which is a step in the production of PVC. Of the total amount of dichloroethane produced in Sweden half is used in the next stage in the production of PVC. In "'Kemikalieinpektionens'' (The Chemical Inspectorate) "SolnedgAngsprojekt" (Sunset Project) the chlorine compounds used or created during the production of PVC were studied. Noted among the chlorine compounds which are used in Sweden were the components related to PVC production together with previously regulated chlorine compounds, partly because they exist in large amounts and partly because they are associated with negative effects on health and the environment. A planned reappraisal (following the 10 year-rule) of the Swedish installations for the production of PVC raw materials, is expected to take place in the Autumn of 1994. The National Environmental Protection Board are now preparing the commission and believe that, within the framework according to the Environmental Protection Law, one can bring about the further measures for environmental protection which are necessary. The Recycling Delegation make their findings against the background that "Naturverkets" (The Department of the Environment) statement on environmental problems at die installation which produces PVC in Sweden is not conclusively significant for an overall judgement of PVC 15.2 Additives Additives are always added to PVC Which additives and which amounts depends on the required properties of the material. PVC always requires, however, the addition of stabilisers. Translated by Martin Richards Underulsnlng oeh tiuersttttnlng 19th June 1994 page 3 VRD 0002018392 15.2.1 Plasticisers To all flexible PVC, which in 1992 was more than half (52%) of the PVC - usage, plasticisers are added. Plasticisers in PVC leach out from the product over a period of time either during use, at landfills or from PVC buried in the ground, since they are not tightly bound to the polymer. The Chemical Inspectorate has, dining the Spring of 1994, within the framework of the plastic-additive project, carried out a risk assessment of plasticisers which are used in PVC. This it has shown that diesters (such as phthalates), triesters, phosphates and chloroparaffins are the plasticisers which are used for PVC The ) dominant group of plasticisers are phthalates. Diethylkexylpfrthalate (DEHP) stands for the largest part (60%) of the total usage of plasticisers and is at the same time the most researched in terms of health and environmental effects. DEHP is slowly degraded at low temperatures and especially under oxygenless conditions. DEHP can, therefore, accumulate in sediments. Studies carried out indicate, according to The Chemical Inspectorate, the risk for effects on sediment life forms and water-filtering organisms. DEHP can also bio-accumulate. Other plasticisers, such as DINP, DIDP, TOTM, TEHP may be less easily degraded than DEHP. There are indications that DINP, DIDP can be somewhat more poisonous than DEHP. DEHP is used as a plasticiser for, amongst other things, PVC products used for medical treatment such as PVC blood bags and PVC tubing. Exposure levels for people are, under certain medical treatments, near those levels which have shown to give effects in animal studies. ) Emissions of plasticisers from PVC products are to air and water. The largest source of emission from products to air are, according to Chemical Inspectorate, FVC-coated metal sheet at a level of approximately 300 ton per year and FVCcoated fabric of the order of 100 ton per year. Emissions to air from flooring and wallpaper amount to approximately 2-3 ton per year. The release to water during cleaning is approximately ten times larger than the release to air. Measurements of sludge from communal waste water treatment plants show DEHP in all samples. Overall it is calculated that 30 tons of DEHP end up in sludge every year. Translated by Martin Richards Underolsntny och QuersSttning 19th June 1994 page 4 0002018893 7C33 The annual precipitation from the air has been measured as 130 ton DEHP. There are too few studies about plasticiser content in leach water from landfills for any general conclusions about emissions from landfills to be drawn. According to a Government decision (prop. 1990/91:90, JoU:30, rskr. 1990/91:73) the use of phthalate shall be limited. The emission of the phthalate DEHP to the environment should, according to the Chemical Inspectorate, be reduced. Analysis of exposure shows that a large part of the emissions come from products and The Chemical Inspectorate's opinion is, therefore, that there should be an investigation into the possibility of reducing the use of DEHP in plastic. The Reyding Delegation believe that since phthalates are used almost exclusively in PVC, the reduction should take place in PVC products. Aside from phthalates other diesters and triesters and phosphates have plasticising properties. The documentation which exists today is insufficient according to the Chemical Inspectorate. The information which does exist suggests, according to the Chemical Inspectorate, that however a change from DEHP to one of the other plasticisers which were investigated would probably not give any significant risk reduction, if any reduction at all. Chloroparaffins shall be, according to a previous government decision (prop. 1990/91:90, JoUSO, reskr. 1990/91:73) phased out by the end of the year 2000. The short-chained highly chlorinated chloroparaffins, should be eliminated by 1994 at the latest Highly chlorinated chloroparaffins are not used for PVC Shortchained chloroparaffins which are used in PVC are already being reduced. The Recycling Delegation believe that the use of phthalates and chloroparaffins should be reduced, respectively phased out. The Recycling Delegation note that the government have previously made such a decision. The information which does exist suggests, according to Chemical Inspectorate, that however a change from DEHP to one of the other plasticisers which were investigated would probably not give any significant risk reduction, if any reduction at all. 15^2 Stabilisers Stabilisers are added to all PVC to protect the material from decomposition, the largest group of stabilisers consists of lead compounds, the other stabiliser which are used for PVC are barium/zinc compounds, organic tin compounds and calcium/zinc compounds. Cadmium has previously been used as a stabiliser in Translated by Martin Richards Undermining och tiversbttnlng 19th lune 1994 page 5 * 68 9 101000 (jjM PVC but that use has now been prohibited in Sweden. Cadmium can, however, still exist in long-lived products which were produced before the prohibition, for example flooring. The use of lead shall be phased out mainly through voluntary measures according to a previous government decision and the use of organic tin compounds shall be restricted (prop. 1990/91:90, JoU:30, rskr. 1990/91:73). The environmentally harmful use of these organic tin compounds should be phased out as soon as possible. This decision applies to the overall use of these compounds, that is not only in connection with with PVC. The change-over to alternative stabilisers in PVC has, according to the Chemical Inspectorate, not yet been carried out on any great scale, neither for lead nor organic tin compounds. Other stabilisers which today are used for PVC have an unknown effect on the environment. The Recycling Delegation believe that the phasing out of lead and organic tin compounds in PVC should be intensified. 153 Recycling At present in Sweden there is no recycling of PVC products. However a certain amount of recycling does occur in connection with production and installation wastage. In other countries there is a certain re-use of material from PVC products such as pipes, profiles, bottles and flooring. The scale of this recycling is however small compared with the large amount of newly produced PVC product. According to the commission a decision is to be made whether it is, for certain long-life products, that it can be more advantageous to recycle the plastics than to replace the material In terms of volume, the amount of the long-lived PVC products which could be considered for recycling are pipes, flooring and cables. According to the Trade Organisation there is only a small amount of PVC piping available for recycling. The Fipelayers Organisation note further that it would be difficult to achieve the large collection level that is required to reach an economic basis for recycling. Technically there are no problems for the recycling of PVC from PVC-piping. No large amounts of waste PVC cable are available for recycling, according to Translated by Martin Richards Underulsnlng oeh Ouersattnlng 19th June 1994 page 6 VRD 0002018895 *3 information from involved industries. Approximately 10 500 ton per annum PVC flooring are put in landfills. 15.4 Combustion (Waste burning) PVC contains 57 percent chlorine. The presence of chlorine in combustible waste can create dioxins and other chlor-organic compounds as well as hydrogen chloride which is add producing and strongly corrosive. High levels of chlorine in waste make it difficult to stabilise the ash before storage. Chlorine in combustible waste can be dealt with with today's purification techniques, but it requires special corrosion resistant materia) in the combustion installations, extra cleaning stages, purification stages and treatment of the gases. With lower chlorine content in the combustible waste the investment costs are lower and the storage of ash from the dry neutralisation of the hydrochloric add in the gases should, according to The National Environmental Protection Board, not be required to its current extent For fluid neutralisation the chloride is released into the container and no costs for the treatment of ash arise. Chlorine in the waste which is burned today comes mainly from waste fat and PVC. The PVC-containing waste whch today is combusted originates mainly in households. Chlorine from PVC is judged by The National Environmental Protection Board to be responsible for between 35-50 percent of the chlorine content in the gases produced. In future the proportion of chlorine in waste which is due to PVC is antidpated to increase because half of the chlorine content is expected to be removed by, for example, composting or rotting, FVCs relevance for the chlorine content in the waste-gases will increase, everything else being the same. The combustible waste has a low energy content FVCs energy content is also low in comparison with the energy content of other thermoplastics. Metallic stabilisers in PVC are not broken down during combustion but remain as an environmental hazard in ash and slag. This covers also cadmium which can occur in older PVC products. Any great release of uncombusted phthalates (plasticisers) is judged by The Translated by Martin Richards Underlining och tiuersSttnlng 19th June 1994 page 7 Chemical Inspectorate not be relevant from the Swedish waste combustion installations. PVC's importance for the buildup of dioxins and other chlor-organic compounds during combustion is well discussed. Dioxin emissions from waste combustion installations have been greatly reduced during the past ten years through optimisation of the combustion process and better purification techniques. The improved cleaning techniques have, apart from lower dioxin levels released to the environment, also given lower levels of chlorophenols and chlorobenzenes, which, according to The National Environmental Protection Board is of importance since these to a lesser extent are trapped in the cleaning stage. Other dioxin release where PVC can be the source, are uncontrolled burning on landfills, illegal burning of cable and remelting of PVC-coated plating. The Recycling delegation note that for the waste which today, is burned, special cleaning stages are required to neutralise the hydrochloric add which is built up and reduce the release of chlor-organic compounds. The Recycling Delegation find that the burning of PVC, amongst other things, on the basis of its low energy content alone, can be regarded as a method of disposal. 153 Landfills Altogether there are approximately 350 000 ton PVC products accumulated in landfills since the year 1965. During die same period approximately 200 000 ton PVC products have been burned in communal combustion installations. Approximately half of the deposited amount is plasticised PVC in the form of flexible film and coated PVC products. The amount of PVC piping and PVC cable in the ground is great and accumulates continuously. Overall an order of magnitude is calculated to 900 000 tons PVC piping and 390 000 ton PVC coated cable have been accumulated in the communes from the years 1965 -1992. Pipe has a lifetime of at least 100 years and according to the trade organisation, cable has a lifetime of 30 years. These Translated by Martin Richards llndenilsnlng och fiuersfittnlng 19th June 1994 page 8 VRD 0002018897 products have not yet to any great extent served their time. Every year approximately 10 000 PVC flooring and 3 000 tons PVC coated products are deposited in landfills. Approximately 3 000 tons PVC film and 5 0006 000 tons of other PVC products are calculated annually to end up at household waste dumps. PVC which is taken to these landfills is mostly plasticised PVC. The amount of research and investigation around PVC and its effects is great. However, information is lacking in certain important areas such as in which way decomposition takes place, which decomposition products are built up and the environmental influence from these. FVC's slow decomposition rate can in itself mean risks since a lot of PVC material is produced and spread in that time before the effects of any eventual decomposition products are noticed. This was noted in 1983 by Naturresurs och Milj6kommitt6n (Natural Resources and Environment Committee) (SOU 1983:56). Plasticisers migrate gradually out of the PVC products. Decomposition of the polymer results in a great accessibility also to the additives. Heavy metals in stabilisers come out into the environment. The additives in turn are degraded. The speed at which this happens and how much plasticiser and stabiliser are transmitted to the environment via leach water and to the air from existing landfills is unknown and neither are the effects on the environment. Those PVC products which remain in the environment after use will in the long term give rise to leaching of additives, for example lead, to the surroundings. The Recycling Delegation considers it appropriate to find out what happens to PVC polymers and additives in landfills and in the ground. The Delegation assumes that the involved sections of the Industry will carry out this investigation. The Recycling Delegation finds that those PVC products which today are in buildings and installations are a special problem, from the point of view of wastes, since these older PVC products can include larger amounts and more environmentally hazardous ingredients than todays' PVC. The Recycling Delegation considers that conventional landfills are an unsuitable Translated by Martin Richards llndervlsnlng och tiuersdttnlng 19th June 1994 page 9 8688 IB U 0 B QH method of disposal for older PVC waste which includes envirorunetally hazardous components. The Recycling Delegation's finding is that there should be an investigation into the special measures required for the waste which already exists and which includes PVC where information is to be found out about the decomposition processes' possible effects on the environment. I I Translated by Martin Richards lindenitsning ocb tiuersbttnlng 19th June 1994 page 19 VRD 0002018699 16 Means of Control 16.1 Producer Responsibility The government required The Recycling Delegation to analyse whether an overall producer responsibility for PVC and other chlorinated plastics should be introduced for short-lived and/or long lived products. The Recycling Delegation shall, according to its terms of reference, gradually suggest producer responsibility for new product groups. The Delegation's suggestion for product responsibility for tyres was delivered to the government in April 1994. The Delegation has in its continued work prioritised cars, electronics and building materials. PVC is used within all of these three areas and in especially high levels in the building sector. The use of PVC within die building and installations sector, covers 80 percent of the total use of PVC in the community, in total 80 000 tons of PVC raw materials per year. The repsonsibility of those who are defined as the producers include the physical and economic responsibility for the treatment of the products when they have served their time. The Recycling Delegation intend to suggest producer responsibility for among other product groups cars, electrical and electronic products and building materials. 16.2 Phasing Out One way of avoiding environmental effects from PVC is to phase out its use. Through a total prohibition of PVC covering import and export from a certain date, the continued environmental influence from the new PVC products could be avoided completely. Import restriction demands, however, partly that it is in accordance with current agreements and rules within political trade areas such as RES and GATT agreements, and partly that the import can be regulated. Translated by Martin Richards Undervisning och tiuersdttnlng 19th dune 1994 page 11 RD 0002618900 Information about exactly which imported products include PVC is, today, not complete. It would be difficult to effectively maintain a fair import restriction. A rapid phasing out of PVC does not give the opportunity for a successive change-over to alternative materials. According to the studies the Delegation have carried out a rapid phasing out of PVC is calculated to give high additional costs for the affected branches of industry. On the other hand if room is given for, among other things, development of good alternative materials to PVC then the additional costs can be lower. A phasing out through the active use of the substitution priciple can be effective in areas where alternatives exist or can be developed, which applies to a large section of the FVC-useage areas. Such a phasing out should cover imported products. For the most important areas of use it should be possible that via a step-by-step phasing out of the use of specified products should also cover imports. For certain production areas, for example, the import of consumer products with PVC, it can possibly be more difficult to achieve phasing out 16.3 Marking Marking is desirable to make it possibe to distinguish between different types of plastic Many companies already choose today to voluntarily mark their plastic products. Among those plastic products which are used by individual consumers, such as packaging and household items, the marking of, more than anything else, polyethylene products, has become the norm. For recycling and the disposal of waste, knowledge of the different product content is important There are problems today in the form of hydrochloric add development from PVC materials when recycling plastics and other thermoplastics. Marked products would make sorting easier. Marking would also give guidance for product choice and change of products. The system and standards for marking plastic has been developed in certain countries and discussed in the international standardisation context.. It is common that the marking of plastics is according to DIN standards. These standards include marking symbols for the most common thermoplastics Translated by Hartln Richards Undervlsnlng och tiuersbttnlng 19th June 1994 page 12 including PVC. In the USA 32 States have passed laws about the marking of plastic bottles and containers. All thermoplasts shall be marked with symbols which, for the most part, look like the DIN standard. Translated bu Martin Richards Undermining och tiuersdttning 19th June 1994 page 1 VRD 0002016902 17 Plan for the avoidance of environmental effects from PVC and other chlorinated plastics The Government has, through its decision on 27th May 1993, given The Recycling Delegation the assignment to develop a plan for the avoidance of environmental effects from PVC and other chlorinated plastics. Those measures which The Recycling Delegation suggest cover only PVC. The use of other chlorinated plastics is so limited that they have been left aside. The Chemical Inspectorate should be commissioned to follow the development and use of the other chlorinated plastics. If their use should suddenly increase greatly, the Inspectorate should decide whether or not measures are required to prevent the eventual environmental effects from these products. The Recycling Delegation's proposals cover the use of PVC raw materials and PVC products which takes place in Sweden, which includes imported PVC. 17.1 Flexible PVC Of all the PVC products little more than half are flexible. Plasticisers gradually migrate from the flexible PVC products into the environment. The largest group of plasticisers are phthalates. Other plasticisers are diesteis, triesters and phosphates. The Recycling Delegation works from and has the same basis as the previous governmental decision that the use of phthalates and chloroparafflns should be reduced, repectively phased out. Against the background of risk assessments that have been made in terms of the effects on health and the environment the Recycling delegation believe that the use of those phthalates that today are used to soften PVC should be phased out. The information which exists suggests, according to the Chemical Inspectorate, that a change from DEHP to one of the other plasticisers which were investigated would probably not give any significant risk reduction, if any reduction at all. It is included in the producers and importers responsibility to show that an alternative is acceptable in terms of health and environment The Recycling Delegation believes that the use of todays flexible PVC should be phased out. With todays plasticisers are included phthalates, diesters, triesters Translated by Martin Richards llndervlsnlny oeh fiuersbttnlng 19th June 1994 page 14 VRD 0002018903 and phosphates. The Recycling Delegation believe that it is especially important to phase out, as soon as possible, todays flexible PVCs products which use large amounts of plasticisers or which emit large amounts of plasticisers. The change-over shall be initiated as soon as possible in the product areas where PVC can be exchanged for an alternative with better health or environmental properties, can take place with equivalent performance and without greater costs. The greatest single release of plastidsers to air in the area of usage takes place l ) from coated metal sheeting and coated fabric. It is therefore important that the phasing out of todays flexible PVC takes place soonest within those two groups. Also it is of great importance that the phasing out of flooring is carried out a soon as possible since flooring is the product group which today has the greatest use of plasticisers. PVC products which have a short life-time are to the greatest part, flexible. Within several product areas, such as offices and leisure, there are today alternative materials without the plasticisers and stabilisers which are used for PVC. For certain short-lived products for example medical packaging, a slightly longer change-over period is required. The Recycling Delegation find that the governmental aim of phasing out short lived PVC products through substitution can and should be followed as soon as possible. Consequently, in order to reduce the overall use of todays flexible PVC and its environmental effects, the phasing out shall be carried out as soon as possible for the flexible short-lived PVC products, PVC coated fabric, PVC coated metal TM sheeting and PVC flooring. Also for other flexible PVC products, the phasing-out should be initiated. 17.2 Stabilisers in PVC Stabilisers are added to all PVC The largest group of stabilisers is lead compounds, followed by barium/zinc compounds, organic tin compounds and calcium/zinc compounds. Translated by Martin Blcherds llnderulsnlng och fiuersdttnlng 19tl June 1994 page 15 The Recycling Delegation note that the use of lead according to a previous Government decision should be phased out and the most environmentally hazardous organic tin compounds should be phased out as soon as possible. The phasing out of lead and organic tin compounds in PVC has until now gone very slowly. The Recycling Delegation believe that the phasing out of these indicated stabilisers shall be carried out as soon as possible. It is unclear to what extent it is possible to replace these stabilisers with other alternatives. Knowledge about the environmental effects of alternatives is also inadequate. It is part of the producers and importers responsibility to show that an alternative is acceptable from an health and environmental viewpoint. 173 Elimination Large quantities of PVC are today accumulated in die community in products in landfills and large amounts are added yearly. The Recycling Delegation has noted that todays PVC products contain additives which can lead to environmental damage. Older products can also contain, for example/ cadmium, which, in this use, has been forbidden in Sweden. An important issue of avoiding environmental damage from PVC is how the PVC which already exists accumulated in the community shall be treated. The Recycling Delegation believe that conventional landfills are an unreasonable elimination method for the older PVC waste which contains hazardous components. The Recycling Delegation finds further that the conventional landfills are doubtful solutions for file expended newer PVC products with hazardous components. Plasticisers and stabilisers will be, in time, released and can be spread in the environment The effects are not kown. Neither is it investigated which biodegradation products can, in the long term, be formed from the polymers themselves. Translated by Martin Richards Underulsning och finerstfttntng 19th June 1994 page 16 VRD 00020 1890 5 A The Recycling Delegation believe that the appropriate sections of industry shall speedily carry out the biodegradation studies of PVC in accordance with the knowledge required for production and imports according to the law (1985:426) about chemical products. This work should include an investigation of the risks for die production of persistant toxic compounds through the biodegradation of PVC polymers and their additives in landfills and in the ground. The Recycling Delegation suggests that the National Environmental Protection Board shall be assigned to monitor this work. An interim report of how the work is developing and what results have come out should also be presented at the latest June 1st 1995. The National Environmental Protection Board shall also be ) assigned to assess the results from die biodegradation studies and if necessary suggest measures, including time-frames for these measures, whose aim is to reduce the environmental impact of FVC in landfills and in the ground. When PVC is burned the majority of the plasticisers are made harmless while the heavy metals from the stabilisers are collected in the ash and slag. The chlorine content of the waste which is burned involves risks for dioxin build up. Due to the chlorine content of the waste special cleaning stages for the smoke and corrosion-resistant equipment in combustion installations are required. The Recycling Delegation believe that all FVC waste which contains environmentally hazardous components shall be managed of in an environmentally acceptable way. The Recycling Delegation suggest that the National Environmental Protection ) Board be assigned to investigate what final treatment is the most appropriate from an environmental point of view and to suggest suitable measures so that a negative influence from PVC in waste shall be avoided. Special landfills of PVCcontaining waste shall be considered. The development of information at an international level should be carefully followed. 17.4 Recyding of Material The older PVC products, accumulated in the community represent a larger Translated by Martin Menards tlndervlsnlny octi fiuersdttning 19th June Y 994 page 17 VRD 0002018906 A amount of hazardous material than the newer PVC products. Older PVC products can also include cadmium. It is the Recycling Delegation's opinion that recycling of PVC using todays technology cannot be recommended. It is, according to the Recycling Delegation's understanding therefore that it is not suitable to initiate recycling of PVC at all on any great scale before it is known what eventual influence on the environment can occur through recycling of PVC It is the responsibility of those who want to start recycling to show that recycling does not give unacceptable environmental effects. The Environment Protection Department ought to study the information and judge the suitability from an environmental point of view. The Environment Protection Department should follow the international development of understanding within this area. 17.5 Producer Responsibility The Recycling Delegation intend to propose producer responsibility for amongst other product groups cars, electrical, electronic and building materials. The largest part of the PVC which is used today will thereby be covered by producer responsibility for separate product areas. In the formation of producer responsibility are included the proposals and measures for the avoidance of environmental influence from PVC, which have been introduced here. The Recycling Delegation believe that producer responsibility normally shall be expressed in product groups and that therefore it is not appropriate to initiate producer responsibility for the material PVC. 17.6 Marking The Recycling Delegation suggest that all PVC products and other chlorinated plastics be marked to ease sorting for recycling of other thermoplasts and the treatment of waste. Marking gives also important information about plastics, that is for both companies and consumers. Marking can also make it easy to introduce product responsibility and change over of PVC material, marking shall at first be voluntary. The affected Trade Organisations have an important role in Translated by Martin Richards Underuisnlny och fiuersdttnlng 19th Jana 1994 page 18 i A (,) ^ this. The Recycling Delegation propose that The Chemical Inspectorate be assigned to monitor the work with marking, which is voluntary and if this does not take place to consider compulsory measures. 17.7 Phasing Out The Delegation has judged the environmental influence of PVC in all aspects from the production of chlorine to waste. The Recycling Delegation suggest that today's flexible FVC and rigid PVC with environmentally hazardous additives be phased out as soon as possible. Within certain product areas the replacement of PVC has taken place or is taking place. The Recycling Delegation has noticed that within many product areas there are alternatives which already can replace PVC or can become alternatives after a certain period of change-over. For certain products there is today difficulty in replacing PVC, which can be due either to prohibitive international standards, todays machinery or demands for specific material properties. The Recycling Delegation find that many technical problems can be solved and that FVC can be replaced within several areas of use. If time for the change-over is given. The Recycling Delegation's investigation shows that the extra costs involved for the affected areas of industry will be significantly lower if sufficient time is given for the change-over and for material development The Recycling Delegation have, amongst other things, for this reason, chosen a successive phasing out which should however be initiated immediately and carried out quickly for the specified areas. The Recycling Delegation suggest that the Chemical Inspectorate be given the assignment to pursue and follow up the phasing out of todays flexible PVC, as well as the phasing out of rigid FVC with environmentally hazardous additives, in such a way that the phasing out can be carried out by the year 2000. In the assignment should be included the follow up of the introduction of new additives. It zests with the producers and importers to produce the environmental effect data which will be referred to. The Recycling Delegation should, further, yearly report to the government how the phasing out is Translated by Martin Ricbards Undervisning och fiuersRttnlng Itth June 1994 page 19 [ 0 6810 0 0 0 QUA progressing and whether compulsory measures should be brought in. The Recycling Delegation should follow the international development and pursue the issues of the phasing but of this health and environmentally damaging PVC within the framework of the international chemical cooperation. Translated by Martin Mcbards OodervlsnUig act) fiuersattoing 19tti Jvae 1994 page 21 VR1) 0002 01 8 909 COMMITTEES I6H0Z000 GH To: Interoffice Communication From: Date: Sutyect: Distribution D. Penney, Corp. R & D March 1, 1994 VIS1A International Agency for Research on Cancer Classification ofEthylene Oxide The working committee of the International Agency for Research on Cancer (IARC) has recommended upgrading ethylene oxide to "carcinogenic to humans". IARC had previously classified ethylene oxide as "possibly carcinogenic to humans". This is the first time IARC has determined a substance to be a human carcinogen based on human genetic data without clear evidence in human cancer studies. It will be several months before an IARC monograph, which fully describes the rationale for LARC's decision, is published. For years the industry has treated ethylene oxide as a possible human carcinogen and has successfully adopted stringent measures to protect both employees and the environment. Consequently, IARC's upgrading of the classification of ethylene oxide is not expected to have any significant regulatory impact on its manufacturing or use. The attached questions/answers document was developed by the Chemical Manufacturer's Association's ethylene oxide toxicology task group to answer some questions about IARC's action. Please note that this document is for our use only and should not be distributed outside of Vista at this time. If you have any additional questions, please give me a call (512-331-2468). Distribution: Austin: R. Bauer, M. Cox, C. Hammond, J. Heinze, K. Kinsley, R. Martin, J. Roheim LCCP: K. Fogg, J. Friend, N. Tower Houston: T. Grumbles, T. Huffman, P. Jemigan, B. Larsen, J. Ledvina, T. O'brien, J. Stokes, M. Reynolds, W. Vogel JAN-14-1900 09:59 P.003/005 A VRD 000 2018911 ETHYLENE OXIDE QUESTIQNS/ANSWERS 1) Are there any recent studies that provide evidence that EO is a human carcinogen? No. In fact, the additional scientific evidence from numerous recently completed human studies, while not definitive, lessens concerns raised by the early animal and Swedish human studies. 2) What have animal (toxicology) studies shown regarding EO human carcinogenicity? EO has been shown to cause cancer in laboratory animals. The evidence has been used to conclude that this chemical is possibly a human carcinogen. 3) What have human (epidemiology) studies shown regarding ethylene oxide carcinogenicity? A detailed assessment of all the humsn studies related to whether ethylene oxide is a carcinogen has recently been published in the scientific literature. Nearly 30,000 ethylene oxide workers from five countries were included in the 11 studies considered in this evaluation. The evidence indicate that ethylene oxide does not cause an increase of cancer overall or brain, stomach or pancreatic cancers, which were seen in some animal and isolated human studies. The findings with respect to leukemia and non-Hodgkin's lymphoma are less definitive. While the majority of evidence does not indicate that ethylene oxide causes these cancers, there are some suggestive trends, and longer follow up of ethylene oxide workers is needed to better clarify these relationships. 4) For what reasons did IARC upgrade EO to "carcinogenic to humans"? Historically, IARC required clear evidence of increased cancer risk in humans in order to classify an agent into Category 1, "carcinogenic to humans". This is the first time IARC has determined a substance to be a human carcinogen based upon human genetic data without clear evidence in human cancer epidemiology studies. 5) What is the health significance of the genetic effects seen in workers exposed to ethylene oxide? We really aren't sure. The current view is that the genetic effects which have been demonstrated in humans are indicators of exposure rather than predictors of specific toxicological endpoints. Ethylene oxide is known to react with genetic material JfiN-14-1900 09!59 P.004/005 ZT6HBZBBB ASA (DNA) to form adducts. DNA adducts are naturally formed and repaired in all living organisms. Although some genetic effects have been associated with an increase in cancer incidence in some populations, there is no information concerning the specific events which lead to tumor formation from ethylene oxide exposure in animals. 6) What impact will the upgrading to "carcinogenic to humans" have on ethylene oxide manufacturers? For years the industry has treated ethylene oxide as a possible human carcinogon and has successfully adopted stringent measures to protect both employees and the environment. These measures will continue to be employed. 7) How much ethylene oxide is produced in the United States? About 7 billion pounds per year. 8) What is ethylene oxide used for? Most of ethylene oxide produced is consumed by converting it to other important chemicals, such as ethylene glycol And ethylene oxide derivatives. Ethylene oxide derivatives Include polyethylene glycol, glycol ethers, ethanolamines, and surfactants. It is also an extremely effective antimicrobial used in the cold sterilization of beat-sensitive medical devices and culinary apices. 9) Who is exposed to EO? Is it mainly industrial exposures or is the average person also exposed? Under the OSHA Ethylene Oxide Rule, workers are exposed to one part per million parts of air (ppm) or less averaged over an eight hour work day. OSHA has determined that this level of exposure protects workers from carcinogenic hazards. Residents in communities adjacent to facilities which make or use ethylene oxide are exposed to far less than are workers. Another possible exposure is natural formation of ethylene oxide in the human body. 10) Are there alternative materials available if EO use is banned? For most applications there are no feasible substitutes. 11) What are the hazards associated with ethylene oxide? For over 50 years, It has been known that ethylene oxide is extremely flammable and Its vapor could violently explode. Because of ethylene oxide's reactive nature, industry began its own test program to investigate the toxicity of ethylene oxide. JAN-14-1900 10:00 P.005/005 It was found in animal testing that exposure by inhalation resulted in adverse effects in reproduction studies aod also produced tumors in studies where animals were exposed for a lifetime. Consequently, promoting the safe handling of ethylene oxide has been a major effort of the industry for many years. 12) What is the OSHA standard for worker exposure to ethylene oxide? The OSHA standard is designed to protect workers from possible reproductive and cancer hazards. The OSHA rule limits worker exposure to an eight-hour time-weighted average of 1 part per million parts of air (ppm). There is also an excursion limit (similar to a STEL) of 5 ppm for 15 minutes. 15) What are the future plans for research on ethylene oxide? The Ethylene Oxide Industry Council (EOIC) continues to sponsor relevant health effects studies on ethylene oxide and has committed significant resources to this effort. TOTAL P.005 CHEMICAL MANUFACTURERS ASSOCIATION n April 19, 1994 To: EOIC & all Task Groups Re: EO Q&A Sheet Enclosed is a copy of the ethylene oxide question and answer sheet for your information/use in response to IARC's decision to bump EO up to "Carcinogenic to humans". Questions if 5 and if 13 are new. Please replace this with the old Q&A sheet. As always, refer all media requests to Tom Gilroy of CMA at (202) 887-1100. Robert R. Romano, Ph.D Associate Director, CHEMSTAR Manager, EOIC 501 M Street. NW, Washington. DC 20037 Telephone 202-867-1100 Fax 202-887-1237 LSI Responsible Care* t| g APubUcGoimitmant VRD 0802018915 A ETHYLENE OXIDE QUESTIONS/ANSWERS 1) Are there any recent studies that provide evidence that EO is a human carcinogen? No. In fact, the additional scientific evidence from numerous recently completed human studies, while not definitive, lessens concerns raised by the early animal and Swedish human studies. 2) What have animal (toxicology) studies shown regarding EO human carcinogenicity? EO has been shown to cause cancer in laboratory animals. The evidence has been used to conclude that this chemical is possibly a human carcinogen. 3) What have human (epidemiology) studies shown regarding ethylene oxide carcinogenicity? A detailed assessment of all the human studies related to whether ethylene oxide is a carcinogen has recently been published in the scientific literature. Nearly 30,000 ethylene oxide workers from five countries were included in the 11 studies considered in this evaluation. The evidence indicate that ethylene oxide does not cause an increase of cancer overall or brain, stomach or pancreatic cancers, which were seen in some animal and isolated human studies. The findings with respect to leukemia and non-Hodgkin's lymphoma are less definitive. While the majority of evidence does not indicate that ethylene oxide causes these cancers, there are some suggestive trends, and longer follow up of ethylene oxide workers is needed to better clarify these relationships. 4) For what reasons did IARC upgrade EO to "carcinogenic to humans"? Historically, IARC required clear evidence of increased cancer risk in humans in order to classify an agent into Category 1, "carcinogenic to humans". This is the first time IARC has determined a substance to be a human carcinogen based upon human genetic data without clear evidence in human cancer epidemiology studies. 5) Does EOIC agree with classification of EO as Category 1? No. EOIC does not believe that it is appropriate to classify EO as Category 1, given that in the case of EO, there is no systematic relationship between measured genetic endpoints and development of malignant disease in the extensive animal studies that have been conducted. Genotoxicity data of uncertain VRO 0002018916 A relevance to humans was used to upgrade EO to Category 1, in the absence of direct evidence of human cancer risks. 6) What is the health significance of the genetic effects seen in workers exposed to ethylene oxide? We really aren't sure. The current view is that the genetic effects which have been demonstrated in humans are indicators of exposure rather than predictors of specific toxicological endpoints. Ethylene oxide is known to react with genetic material (DNA) to form adducts. DNA adducts are naturally formed and repaired in all living organisms. Although some genetic effects have been associated with an increase in cancer incidence in some populations, there is no information concerning the specific events which lead to tumor formation from ethylene oxide exposure in animals. 7) What impact will the upgrading to "carcinogenic to humans" have on ethylene oxide manufacturers? For years the industry has treated ethylene oxide as a possible human carcinogen and has successfully adopted stringent measures to protect both employees and the environment. These measures will continue to be employed. 8) How much ethylene oxide is produced in the United States? About 7 billion pounds per year. 9) What is ethylene oxide used for? Most of ethylene oxide produced is consumed by converting it to other important chemicals, such as ethylene glycol and ethylene oxide derivatives. Ethylene oxide derivatives include polyethylene glycol, glycol ethers, ethanolamines, and surfactants. It is also an extremely effective antimicrobial used in the cold sterilization of heat-sensitive medical devices and culinary spices. 10) Who is exposed to EO? Is it mainly industrial exposures or is the average person also exposed? Under the OSHA Ethylene Oxide Rule, workers are exposed to one part per million parts of air (ppm) or less averaged over an eight hour work day. OSHA has determined that this level of exposure protects workers from carcinogenic hazards. Residents in communities adjacent to facilities which make or use ethylene oxide are exposed to far less than are workers. Another possible exposure is natural formation of ethylene oxide in the human body. VRD 0002018917 A 11) Are there alternative materials available in place of EO? For most applications there are no feasible substitutes. 12) What are the hazards associated with ethylene oxide? For over-50 years, it has been known that ethylene oxide is extremely flammable and its vapor could violently explode. Because of ethylene oxide's reactive nature, industry began its own test program to investigate the toxicity of ethylene oxide. It was found in animal testing that exposure by inhalation resulted in adverse effects in reproduction studies and also produced tumors in studies where animals were exposed for a lifetime. Consequently, promoting the safe handling of ethylene oxide has been a major effort of the industry for many years. 13) Does the proposed reclassification indicate that IARC has concluded that daily EO exposures pose a significant cancer risk? No, IARC assesses hazard. It does not make a risk evaluation which would require that exposure levels be considered. 14) What is the OSHA standard for worker exposure to ethylene oxide? The OSHA standard is designed to protect workers from possible reproductive and cancer hazards. The OSHA rule limits worker exposure to an eight-hour time-weighted average of 1 part per million parts of air (ppm). There is also an excursion limit (similar to a STEL) of 5 ppm for 15 minutes. 15) What are the future plans for research on ethylene oxide? The Ethylene Oxide Industry Council (EOIC) continues to sponsor relevant health effects studies on ethylene oxide and has committed significant resources to this effort. VRD 000202 3 915 CHLORINE COORDINATING COUNCIl/CMA) VRD 000291&919 , J. z& iP CHEMICAL MANUFACTURERS ASSOCIATION August 23, 1994 . ^ Ju pc ^K?1 Cf** A To: EOIC Voting Members EOIC Environmental Task Group EOIC Safety Task Group EOIC Toxicology Task Group EOIC Medical Epidemiology Task Group 7v^ j, -^T Re: September 13, 1994 Meeting Cancelled In discussion with Ron Van Mynen it was decided to postpone the EOIC meeting scheduled for September 13, 1994. We believe that we can get everything accomplished at our next meeting scheduled for December 6, 1994 (1-4 pm) in Washington, DC. Listed below for your information is an update for each of the task groups. Safety Task Group: The EO Propagation study contracted at the Southwest Research Institute in San Antonio, Texas is progressing slower than expected. SwRI is pulling together the test apparatus with 2n pipe being tested Sept.- Oct., and 12" pipe being tested late Oct.-Nov. Task Group members will have an opportunity to witness one or both types of field tests. The group will meet again in New Orleans on October 17, 1994. Environmental Task Group: The group is evaluating the final liAP's rule for EO compliance issues. Medical Epidemiology and Toxicology Task Groups: On 8/17/94 the group met with CUT and received a semi-annual update on EO research. On 8/18-19 an EO Risk Assessment Workshop was held at CUT, with EPA, OSHA, academia, and industry reps. The workshop members will break-up into small work groups and resolve several EO risk assessment issues. The tox task group will meet again on October 18 in Washington, DC. Industrial Hygiene Task Group: An article for publication on our protective clothing research is being prepared. An EO draft exposure 9 survey is also being prepared for ultimate distribution to all members. Please call me at (202) 887-1198 if there is anything I can do for you. Sincerely yours, /I# ^6*^7?, /^o*-*-*--* Robert R, Romano, Ph.D Associate Director, CHEMSTAR Manager, EOIC 2501 M Street, NW, Washington, DC 20037 Telephone 202*887-1100 Fax 202-887-1237 Responsible Care A PublicCommitment VRO 0002010920 C7> O A VRD 0002018921 ya i ; V *= f/ ^`Cf ^ iSu ^ u> MJ 0 *\ -iLK 6 V Lakes Xr , *'*' /now ! 1 O -f.4 fV | I / C A's e< Ia., ve is betlfe it thi* -, u n jnally, uiu^____ "t + zr-r 'U fy J a~ Th *\ initiative. VISTA tants in :s area, >ughout the g Water Quality Criteria (WQC) require as great deal of of species. While costly to develop, this results in re more scientifically valid. The newly proposed method application of arbitrary safety factors which are likely iny chemicals. The GLWQI also uses Bioacculumation ter than the bioconcentration factors used in the previous . in lower WQC values. BAFs, not determined in the by use of food chain multipliers (FCMs). The FCMs itration of chemicals as they move up the food chain to ,r.oach is that the FMCs are estimated and may not be --`>>*-1 --^* , irnmrlr^^ potential to bioaccumulate are likely to result from this process. Bioaccumulative Chemicals of Concern (BCCs), are defined as materials with BAFs >1000. 28 of the 138 chemicals considered in the initiative are considered BAFS. This includes certain chemicals of some potential concern to Vista, i.e., dioxins, chlorinated benzenes, polynuclear aromatics and hexachlorobenzene. Toulene is listed but as a potential BCC. Designation as a BCC has major implications for potential restriction on a chemical (see next section). However, the BCC designation doesn't refer to inherent toxicity, just the potential for significant exposure in certain environmental compartments. Consequently, chemicals of low toxicity and low potential for significant environmental impact may be regulated more stringently than appropriate. In addition to BCCs, EPA has ear-marked other chemicals of concern such as mercury and other metals. These materials will also be subject to the new WQC setting process which will use this new methodology. Setting NPDES Permit Limits This is probably the most controversial portion of the initiative. Using WQSs derived VRD 000201892 To: J. Heinze A Interoffice Communication From: D. Penney Date: September 15, 1993 VIS1A Subject:The Proposed Great Lakes Water Quality Initiative (GLWQI) The GLWQI is the first of EPA's ecosystem-based approache to managing pollutants in the environment. This initiative is only supposed to be applied to the Great Lakes area, however, there is a concern that this approach will be applied inappropriately throughout other US ecosystems. Additionally, there are certain technical concerns about the methodology proposed in this initiative. Current methods for calculating Water Quality Criteria (WQC) require as great deal of ecotoxicity data in a variety of species. While costly to develop, this results in ecotoxicity evaluations which are more scientifically valid. The newly proposes method uses less data and relies on the application of arbitrary safety factors which are likely to be overconservative for many chemicals. The GLWQI also uses Bioacculumation Factors (BAFS) which are higher than the bioconcentration factors used in the previous methodology. This will result in lower WQC values. BAFs, not determined in the laboratory, will be determined by use of food chain multipliers (FCMs). The FCMs account for the increase concentration of chemicals as they move up the food chain to man. The problem with approach is that the FMCs are estimated and may not be appropriate for a specific chemical. Thus, overconservative estimates of a chemicals potential to bioaccumulate are likely to result from this process. Bioaccumulative Chemicals of Concern (BCCs), are defined as materials with BAFs >1000. 28 of the 138 chemicals considered in the initiative are considered BAFS. This includes certain chemicals of some potential concern to Vista, i.e., dioxins, chlorinated benzenes, polynuclear aromatics and hexachlorobenzene. Toulene is listed but as a potential BCC. Designation as a BCC has major implications for potential restriction on a chemical (see next section). However, the BCC designation doesn't refer to inherent toxicity, just the potential for significant exposure in certain environmental compartments. Consequently, chemicals of low toxicity and low potential for significant environmental impact may be regulated more stringently than appropriate. In addition to BCCs, EPA has ear-marked other chemicals of concern such as mercury and other metals. These materials will also be subject to the new WQC setting process which will use this new methodology. Setting NPDES Permit Limits This is probably the most controversial portion of the initiative. Using WQSs derived VRD 0002018923 A from the new methods discussed above, EPA will calculate the total maximum daily load for receiving waters as well as the wasteload allocations for each discharge into the receiving waters and then establish the NPDES permit effluent limitations. This process differs significantly from that used previously in the way it handles mixing zones. Mixing zones are allowed for some materials, but not for BCCs (restriction phased in over ten year period). For BCCs the water quality criteria will have to be met at the end of the pipe. For example, the criteria for dioxin, a BCC, is 0.0000000096 and 0.00000001 /ig/L for wildlife and human health, respectively. The human health criteria for hexachlorobenzene is 0.0001 /xg/L. Since these chemicals are BCCs, these values would be used to set the permit limits required for discharge at the end of the pipe, not the stream since mixing zones are not allowed. Compliance would be judged at or below the detection level for these materials. Permits might also require waste minimization and monitoring features for BCCs as well. All of this means increased costs for compliance. Industry Response The chemical manufacturer's association (CMA) has been attempting to influence this initiative for some time. CMA has addressed a whole host of issues, including others besides those mentioned above, in the form of comments and recommendations offered at public hearings, pre-proposal meetings and directly to the GLWQI steering committee. Both generic and chemical-specific groups, such as the phthalate ester group which Vista is a member of, have provided EPA with specific comments on the proposal. The effectiveness of these efforts is doubtful. We probably won't know how successful they have been until the final regulation is issued. However, CMA admits that their previously voiced concerns were not addressed in the proposed regulation. I am not aware of any response to this issue from the Vinyl Institute, Chlorine Coordinating Council, or SDA. Obviously, various member companies of these organizations may have responded individually, or as part of CMA. Impact on Vista The current impact of this proposed regulation on Vista is minimal. We do not have plants in the Great Lakes area and none of our products are specifically targeted. We might suffer some indirect effect from some customers in the area who are affected more directly. Concern for Vista would be heightened if the provisions of the initiative were to be adopted "as is" for the Gulf Coast area, which is an area of concern for the Congress and EPA. This initiative would potentially affect all of our manufacturing sites in any designated area. Recommendations Vista should monitor water quality criteria activity through internal surveillance, our associations with Texaco and, for sometime, with the CMA phthalate ester panel (Vista membership on this panel is due to expire at the end of this year). We should also monitor the proposed 1994 environmental and economic study of the Gulf Coast area. &C\ l cr> > J m m iM A A ************************ -com. JOURNAL- ******** DATE SEP-28-1993 ***** TlPE 11504 ****** R. l MODE-TRANSMISSION FILE NO.= 001 NO. COM ABBR.NO. 01 OK STATION NAME/ TELEPHONE NO. 914043954529 START-SEP-20 10:Sl END-SEF-28 11:04 PAGES PRG.NO. PROGRAM NAME 003/003 ********************************** -VISTA R&D -U1STA R8.D -- ***** -- 512 331 2594- *********** t^swt brand fax transmittal memo 7671 To: IntaraffU* Communication Promt Dote: Subject: V. Messick r"%v/3T'^a9 D. Penney i" September 16,1993 VIS1A Union Carbide report of Pancreatic Cancers in a PVC processing operation 1 spoke with Dr. Jane Teta of Union Carbide about a report of an increased risk of pancreatic cancer in workers involved in PVC processing. Dr. Teta said that Carbide had recently reported the study to EPA, however, she was not willing to make a copy of the study available for wider distribution before it was accepted for publication. However, Dr. Teta offered to meet with the Vinyl Institute to discuss her findings. 1 told her that I would contact her if such a meeting was desired. Dr. Teta briefly summarized the study as follows. Twenty-eight male pancreatic cancer cases which were compared to 140 control cases with no pancreatic tumors were included in the study. Workers were assigned to work areas where both PVC and polyethylene were processed. Men assigned for more than sixteen years to these areas experienced slightly over a seven-fold increased incidence of pancreatic cancer. Ho excess was seen amongst workers with shorter duration of assignments. Seven of the nine cases of pancreatic cancer began working in this area in the 1940s. All but three cases had worked 20 years or more. While recognizing that the workers in this study were assigned to units in which both PVC and polyethylene were processed, Teta places most of the blame for the excess pancreatic tumor rate on the PVC processing. She believes this is because PVC processing practices of the time resulted in higher chemical exposures and involved working with more hazardous raw materials than polyethylene. Teta does not believe the increase of pancreatic tumors was due to vinyl chloride exposure. This Is primarily because there were no cases of angiosarcoma of the liver. She instead points the finger at the phthalate plasticizers used in PVC, citing diethylhexyl phthalate being reported as carcinogenic in mice and rats. Teta also expressed concern for stabilizers, some of which contain cadmium and lead, which have been demonstrated to produce cancer in animals. Teta maintains that chemical exposure of workers during PVC processing prior to the 1950s was very high because materials were weighed and fed manually into a blender. Workers climbed inside the blenders to scrape off excess chemical residues whenever different additives were required for different vinyl products. She says that this occurred ,,j' VRD 0002(718925 A 9162IUS08 an A Division of The Society of The Plastics Industry, Inc. VINYL INSTITUTE ISSUES MANAGEMENT COMMITTEE Michael Barish Borden Chemicals and Plastics P.O. Box 427, Highway 73 Geismar, Louisiana 70734 Phone: (504)-673-0684 Fax: (504)-673-0672 Frank Borrelli Georgia Gulf Corporation 42C Reads Way Newcastle, Delaware 19720 Phone: (302)-323-8116 Fax: (302)-323--8105 William Carroll Occidental Chemical Corporation 5005 LBJ Freeway Dallas, Texas 75244 Phone: (214)-404-2845 Fax: (214)-404-2884 Beverly Gholson Georgia Gulf Corporation P.O. Box 105197 Atlanta, Georgia 30348 Phone: (404)-395-4521 Fax: (404)-393-2597 Fred Krause (Chairman) The Geon Company 6100 Oak Tree Boulevard Cleveland, Ohio 44131 Phone: (216)-447-6214 Fax: (216)-447-6408 Kim Mathieu Elf Atochem 617 Valley Road Havertown, Pennsylvania Phone: (215)-449-7184 Fax: (215)-449-7184 19083 Ron McCreedy Dow Chemical Company 2020 Willard H. Dow Center Midland, Michigan 48674 Phone: (517)-636-1824 Fax: (517)-636-9899 Dave Penney Vista Chemical Company P.O. Box 200135 Austin, Texas 78720 Phone: (512)-331-2468 Fax: (512)-331--2560 Mike Reynolds Vista Chemical Company 900 Threadneedle Houston, Texas 77224 Phone: (713)-588-3210 Fax: (713)-588--3119 Margaret Rogers Dow Chemical Company 1776 Eye Street, NW, St.575 Washington, D.C. 20006 Phone: (202)-429-3403 Fax: (202)--429--3467 Peter de la Cruz Keller and Heckman 1001 G Street, N.W. Washington, D.C. 20001 Phone: (202)-434-4141 Fax: (215)-434-4646 5/93 Wayne Interchange Plaza II 155 Route 46 West Wayne, NJ 07470 (201) 890-9299 Fax #(201) 890-7029 To: V. Messick Interoffice Communication From: Date: Subject: D. Penney September 16, 1993 Union Carbide report of Pancreatic Cancers in a PVC processing operation I spoke with Dr. Jane Teta of Union Carbide about a report of an increased risk of pancreatic cancer in workers involved in PVC processing. Dr. Teta said that Carbide had recently reported the study to EPA, however, she was not willing to make a copy of the study available for wider distribution before it was accepted for publication. However, Dr. Teta offered to meet with the Vinyl Institute to discuss her findings. I told her that I would contact her if such a meeting was desired. Dr. Teta briefly summarized the study as follows. Twenty-eight male pancreatic cancer cases which were compared to 140 control cases with no pancreatic tumors were included in the study. Workers were assigned to work areas where both PVC and polyethylene were processed. Men assigned for more than sixteen years to these areas experienced slightly over a seven-fold increased incidence of pancreatic cancer. No excess was seen amongst workers with shorter duration of assignments. Seven of the nine cases of pancreatic cancer began working in this area in the 1940s. All but three cases had worked 20 years or more. While recognizing that the workers in this study were assigned to units in which both PVC and polyethylene were processed, Teta places most of the blame for the excess pancreatic tumor rate on the PVC processing. She believes this is because PVC processing practices of the time resulted in higher chemical exposures and involved working with more hazardous raw materials than polyethylene. Teta does not believe the increase of pancreatic tumors was due to vinyl chloride exposure. This is primarily because there were no cases of angiosarcoma of the liver. She instead points the finger at the phthalate plasticizers used in PVC, citing diethylhexyl phthalate being reported as carcinogenic in mice and rats. Teta also expressed concern for stabilizers, some of which contain cadmium and lead, which have been demonstrated to produce cancer in animals. Teta maintains that chemical exposure of workers during PVC processing prior to the 1950s was very high because materials were weighed and fed manually into a blender. Workers climbed inside the blenders to scrape off excess chemical residues whenever different additives were required for different vinyl products. She says that this occurred A po C3 eo o59 < as often as twice a day. Teta pointed out that the blenders that were used in polyethylene processing were not cleaned very often because there was little variation in the additives used. Teta cites, as confirmatory evidence, four previous studies which she says have shown elevated risk of digestive cancer linked to PVC processing. COMMENTS The results of this new study bear careful consideration due to the strong excess cancer risk reported. However, its interpretation is complicated by the fact that, as with many other epidemiological studies, all the workers were exposed to a variety of different chemicals in the work place. This makes it impossible to prove that the excess cancer risk is associated with a specific chemical or combination of chemicals. Dr. Teta stated that the observed excess in pancreatic cancer risk may have been due to practices early on in the industry which resulted in workers being exposed to high concentrations of a variety of chemicals associated with PVC manufacturing. Dr. Teta acknowledged that she was not very familiar with current PVC processing and formulating operations, such as the phasing out of lead and cadmium-based stabilizers. It would be helpful for the industry to document the changes in processes and work practice which have occurred over the years. I am not aware to what degree Dr. Teta is aware of the toxicological controversy about the potential human carcinogenicity of diethylhexyl phthalate. Many reputable scientists question whether the results obtained in animal studies on this material are applicable to humans. I think we should ask Dr. Teta to give a presentation on her study to the Vinyl Institute. 826H3ZS00 GNA A ********ro************** -com. JOURNAL- ******** DATE SEP-28-1993 ***** TIME 10:06 ****** P.l MODE-TRANSMISSION FILE NO.- 001 NO. COM A6BR.NO. 01 OK STATION NATE^ TELEPHONE NO. 917135003119 START-SEP-28 10:01 END-SEP-28 10:06 PAGES PRG.NO. PROGRAM NAME 003/003 ********************************** -uista R8.D 9 79 To: V. Messick -JJISTA R2.D - -- ***** -- 512 331 2594- *********** brand fax transmittal memo 7S711 * lA-s Fi*m .,l/YC.t-vC-. 1') \ * Mona it * -2> ^ f"Sl IntarofRc* Communication Fran: Date: SntyMts D. Penney hSeptember 16, 1993 VISTA Union Carbide report of Pancreatic Cancers in a PVC processing operation 1 spoke with Dr. Jane Tcta of Union Carbide about a report of an increased risk of pancreatic cancer in workers involved in PVC processing. Dr. Teta said that Carbide had recently reported the study to EPA, however, she was not willing to make a copy of the study available for wider distribution before it was accepted for publication. However, Dr. Teta offered to meet with the Vinyl Institute to discuss her findings. I told her that I would contact her if such a meeting was desired. Dr. Teta briefly summarized the study as follows. Twenty-eight male pancreatic cancer cases which were compared to 140 control cases with no pancreatic tumors were included in the study. Workers were assigned to work areas where both PVC and polyethylene were processed. Men assigned for more than sixteen years to these areas experienced slightly over a seven-fold increased incidence of pancreatic cancer. No excess was seen amongst workers with shorter duration of assignments. Seven of the nine cases of pancreatic cancer began working in this area in the 1940s. All but three cases had worked 20 years or more. While recognizing that the workers in this study were assigned to units in which both PVC and polyethylene were processed, Teta places most of the blame for the excess pancreatic tumor rate on the PVC processing. She believes this is because PVC processing practices of the time resulted in higher chemical exposures and involved working with more hazardous raw materials than polyethylene. Teta does not believe the increase of pancreatic tumors was due to vinyl chloride exposure. This is primarily because there were no cases of angiosarcoma of the liver. She instead points the finger at the phthalate plasticizers used in PVC, citing diethylhexyl phthalate being reported as carcinogenic in mice and rats. Teta also expressed concern for stabilizers, some of which contain cadmium and lead, which have been demonstrated to produce cancer in animals. Teta maintains that chemical exposure of workers during PVC processing prior to the 1930s was very high because materials were weighed and fed manually into a blender. Workers climbed inside the blenders to scrape off excess chemical residues whenever different additives were required for different vinyl products. She says that this occurred 6Z6810U00 CM A VR 0002018954 AAPPLIEDAd EPIDEMIOLOGY) INC. / September 22,1993 Tom Grumbles, Manager Safety Health and Environment Vista Chemical 900 Threadneedle Houston, TX 77079-2990 Dear Tom: Enclosed is a description of Applied Epidemiology, Inc. I look forward to assisting you with whatever epidemiological support you may need. Please do not hesitate to call if you would like additional information. Thank you for your interest in Applied Epidemiology, Inc. Sincerely yours, enclosure Kenneth A. Mundt, Ph.D. P.O. BOX 2424 AMHERST, MA 01004 ^ (413) 256-3556 FAX (41 3) 256-3503 <VRD 0002016955 Applied Epidemiology, Inc. DESCRIPTION APPLIED EPIDEMIOLOGY INC. jtyD 0002018956 Applied Epidemiology, Inc. DESCRIPTION BACKGROUND Applied Epidemiology, Inc. is a full-service epidemiological consulting firm specializing in occupational and environmental health, as well as biostatistical, methodological and interpretational issues. We have extensive experience ranging from formal epidemiological studies, to critical reviews and interpretations of the human health and medical literature, to educational and instructional programs. Founded in 1989 and incorporated in 1991, Applied Epidemiology, Inc. has provided consulting services to a variety of North American and European clients including government agencies, non-profit organizations, industry trade groups, as well as private corporations. This heterogeneity of clientele is indicative of our strong philosophical commitment to scientific objectivity, as well as our general goal of providing practical solutions derived from an epidemiological perspective. We at Applied Epidemiology, Inc. invite you to discuss with us your occupational and environmental health interests, or research or instructional needs. Mailing address: P.O. Box 2424 Amherst, MA 01004 Office address: South Towne Commons 479 West Street, Suite 90 Amherst, MA 01002 (413) 256-3556 (Telephone) (413)256-3503 (FAX) -1- QUA* PEOPLE Applied Epidemiology, Inc. enjoys and benefits from the participation of a variety of professionals as staff and associates. The following individuals are available on a regular basis to address most project needs: Kenneth A. Mundt. Ph.D.. is President and Senior Epidemiologist of the Company. He received an M.S. in Epidemiology from the University of Massachusetts and a Ph.D. in Epidemiology from the University of North Carolina at Chapel HilL Dr. Mundt holds university appointments in the Department of Biostatistics and Epidemiology at the University of Massachusetts; Akademie fur Offentliche Gesundheit at the Ruhr Universitat in Bochum, Germany; and the Institut fur Epidemiologie und Sozialmedizin at the Westfalische Wilhelms Universitat in Munster, Germany. Linda D. Dell. M.S.. is Project Manager and Epidemiologist She received her M.S. in Epidemiology from the University of Massachusetts, and has experience in industrial epidemiology from her work in the corporate epidemiology department ofa major chemical company. Ms. Dell also has interest and experience in environmental epidemiology as well as reproductive epidemiology. Carol Bigelow. Ph.D., serves as Biostatistician for the Company. Dr. Bigelow received both an M.S. and Ph.D. in Biostatistics from the University of Washington at Seattle, and holds a faculty appointment in the School of Public Health of the University of Massachusetts. Dr. Bigelow is expert in multivariate analytical techniques, and teaches biostatistics and computer analysis in our "Intensive Course in Occupational Epidemiology" (ICOE). Rainer Noess is an information management specialist, and provides hardware and software developmental support for the Company. Mr. Noess has extensive experience in managing data from large epidemiological studies, as well as Health and Safety and Occupational Surveillance databases. Elizabeth Mundt is office manager of the Company, and provides support services in data entry, word processing, accounting, and library search and retrieval. -2- <VRD 000 20 189 5 8 PEOPLE (continued) Associates of Applied Epidemiology, Inc. provide expertise and a broader perspective to certain projects and activities, as well as facilitate our ability to meet the needs of clients in Europe or other locations. Joseph P. Tritschler. Ph.D.. is an agricultural environmental expert with particular interest in applying epidemiological methods to the study of environmental determinants of animal and human health, especially nutrition and parasites. Dr. Tritschler received his Ph.D. from the University of Florida at Gainesville, and holds a faculty appointment at the University of Hawaii at Hilo, where he also serves as Extension Service and Research Station Director. Walter Bieckmann. Dipl, rer. Soc.. is Manager of the ICOE, and other European projects. Mr. Dieckmann is a medical sociologist by training, and holds an academic appointment at the Ruhr Universitat in Bochum, Germany. Two epidemiologists of international recognition serve as external advisors to the Company: Carl M. Shv. M.D.. Dr.P.H.. Professor and Chair, Department of Epidemiology, University of North Carolina at Chapel Hill Harvev Checkowav. Ph.D.. Professor of Epidemiology, Department of Environmental Health, University of Washington at Seattle. Dr Checkoway also serves as an instructor in the ICOE. In addition, Applied Epidemiology, Inc. maintains an extensive network of experts and support staff available on a project-specific basis, or as needed, representing the following areas: Occupational Medicine Toxicology and Risk Assessment Industrial Hygiene and Environmental Monitoring Workplace Health Education and Health Promotion -3- VRD 0002016959 EXAMPLES OF RECENT PROJECTS Research Developing an epidemiological occupational surveillance system and survey to determine the health status of employees at a chemical plant; Preparing a research plan for an organization interested in identifying workplace stress and evaluating preventive measures and interventions, including study design, analysis and interpretation; Analyzing data on toxic metal exposure and reproductive outcome to determine shape of risk curve; Advising company on epidemiological approach to determine possible health effects of an accidental chemical release to the community; Comprehensively reviewing and critiquing health literature on human health effects of low-level exposure to mercury. Short Courses Intensive Course in Occupational Epidemiology (ICOE), held May 25-30, 1993 and to be held again June 5-10,1994 in Wermelskirchen, Germany. ICOE will be held in Kiev, Ukraine in 1995; Occupational and Environmental Epidemiology, held August 12-16, 1991 at the Cancer Registry of Norway, Oslo, Norway. Establishing an Occupational Epidemiology Program, held March 12,1991 for the Chemical Manufacturer's Association, Washington, D.C. -4- 096H0Z000 OH* RESOURCES Applied Epidemiology, Inc. utilizes both Macintosh and IBMcompatible computers. We maintain an extensive library of textbooks and references on epidemiology, toxicology, medicine, environmental health, biostatistics, etc. A partial listing of our journal subscriptions includes American Journal of Epidemiology American Journal of Industrial Health American Journal of Public Health American Scientist Applied Occupational and Environmental Hygiene Archives of Environmental Health British Journal of Industrial Medicine Epidemiology Occupational Health and Safety Occupational Medicine: State of the Art Reviews Scandinavian Journal of Work Environment and Health Science News Additionally, we receive numerous newsletters, government publications, mailings and catalogues on relevant topics. Because Applied Epidemiology, Inc. is located in central Massachusetts, we have direct access to several local libraries including the University of Massachusetts, Smith College, Hampshire College, Mount Holyoke College and Amherst College. All relevant databases and search services are available in addition to their collective holdings. Specialized collections at the University of Massachusetts Medical School Library and the Countway Library at Harvard University Medical School are located nearby. -5- VRD 0002018961 A LIST OF RECENT CLIENTS Allied-Signal, Inc., Morristown, New Jersey Akademie fur offentliche Gesundheit, Bochum, Germany American Chrome & Chemicals, Corpus Christi, Texas Association of Schools of Public Health, Washington, D.C. BASF AG, Ludwigshafen, Germany Bayer AG, Leverkusen, Germany The Cancer Registry of Norway, Oslo Chemical Manufacturers of America, Washington, D.C. The Chlorine Institute, Washington, D.C. E. I. Du Pont de Nemours, Wilmington, Delaware Epach, Inc., Amherst, Massachusetts GeoTrans, Inc., Sterling, Virginia The Global Center for Occupational and Environmental Health Studies, Inc., Albany, New York Health Protection Branch, Health and Welfare, Canada Hoechst AG, Frankfurt, Germany International Chrome Development Association, Paris Industrial Health Foundation, Pittsburgh (continued) -6- <VRD 0002018962 LIST OF RECENT CLIENTS (continued) New York State Department of Health, Albany, New York Occidental Chemical Corporation, Dallas Occusafe, Inc., Chicago, Illinois Ruhr-Universitat, Bochum, Germany State of Colorado (Office of the Attorney General), Denver UOP, Chicago, Illinois The World Bank, Washington, D.C. -7- C968UZBB0 ON* Curriculum Vitae KENNETH ARTHUR MUNDT, Ph.D. CURRENT POSITIONS Assistant Professor (1989-present) Department of Biostatistics and Epidemiology School ofPublic Health 403 Arnold House University of Massachusetts Amherst, MA 01003 Telephone (413) 545-2861 Fax (413)545-1645 Visiting Assistant Professor (1991-1996) Abteiiung fur Sozialmedizin und Epidemiologie Ruhr-Universitat Bochum Postfach 10 21 48 D-4630 Bochum 1 Germany Senior Epidemiologist (1989-present) Applied Epidemiology, Inc. P.O. Box 2424 Amherst, MA 01004 Telephone (413) 256-3556 Fax (413) 256-3503 EDUCATION Ph.D., Epidemiology University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 1990. M.S., Epidemiology University of Massachusetts at Amherst, Amherst, Massachusetts, 1986. M.A., English University of Virginia at Charlottesville, Charlottesville, Virginia, 1982. A.B., English Dartmouth College, Hanover, New Hampshire, 1981. H 6 8 1 H 0 0 0 AHA A (Mundt C.V., p.2) UNIVERSITY RESEARCH 1993 Principal Investigator Healy Endowment Award. Lead Prevalence Study (1993-4) $5,000 Principal Investigator/Convenor. Second National Conference on Occupational Surveillance, University of Massachusetts, Amherst, MA (March 9-11, 1993) $26,000 Sponsors: E.L Du Pont de Nemours Monsanto Eastman Kodak Unocal Dow Chemical 1992 Principal Investigator. E.I. Du Pont de Nemours Company. Educational Aid Program. Occupational Epidemiology Unit (1992-4) $l5,000/year Co-Investigator. Chemical Manufacturers ofAmerica. Definition and Strategies for Developing Occupational Surveillance. (1992-3) $38,000 Principal Investigator. Faculty Research Grant Epidemiological Surveillance. (1992-3) $4,940 Principal Investigator. Faculty Research Grant for Conference/Performance Travel. Third Annual Symposium on Environmental and Occupational Health in Central & Eastern Europe in Poland. (1992) $600 Investigator. Occidental Chemical Corporation. Development of a Corporate Epidemiological Surveillance System. (1991-2) $50,000/year 1991 Principal Investigator/Convenor. National conference, "Occupational Surveillance" University of Massachusetts, Amherst, MA (April 28-30, 1991) $22,000 Sponsors: Occidental Chemical E.I. Du Pont de Nemours Exxon Monsanto Eastman Kodak General Electric American Industrial Health Council VRD 0002018965 A (Mundt C.V., p.3) UNIVERSITY RESEARCH (continued) 1990 Investigator. Chemical Manufacturers of America. Development of Resource Materials for Occupational Epidemiology. (1990) $75,000 Principal Investigator. National Institute of Occupational Safety and Health. Immuno-Epidemiology of Crab-Induced Occupational Asthma. (1989-1990) $43,500. 1989 Principal Investigator. United Way of North Carolina. Immuno-Epidemiology of Crab-Induced Occupational Asthma: Pilot and Preparatory Phases. (1989) $4,000. Principal Investigator. Biomedical Research Support Grant, School of Public Health, University of North Carolina. Production ofAntigen Solutions for Skin Testing. (1988-1989) $5,886. RELEVANT EXPERIENCE 1993 - 1994 1993 - present 1993 1992 - present 1992 - present 1992 - present 1991 - present 1990 - present Guest Editor, Journal of Ambulatory Care Management (April, 1994 issue on Occupational Health). Director, Occupational Epidemiology Unit School of Public Health, University of Massachusetts. Member, 1993 Internship Program Objective Review Committee, Association of Schools of Public Health/Centere for Disease Control/Agency for Toxic Substances Disease Registry. Founder and Director, Surveillance Resource Center, Occupational Epidemiology Unit. Epidemiologist, Northeast Regional Environmental Public Health Center, School of Public Health, University of Massachusetts. Member, Human Subjects Committee, School of Public Health, University of Massachusetts. Member, Union Carbide Scientific Board of Advisors. Member, International Chrome Development Association, Health, Safety and Environment Committee, Paris, France. viD 00020 1896 7 (Mundt C.V., p.4) RELEVANT EXPERIENCE (continued) 1990 - present Epidemiologist, Chromium Environment, Health and Safety Committee, industrial Health Foundation, Pittsburgh, PA 1989 -1993 Founder and CO-Director, Occupational Epidemiology Unit, School of Public Health, University of Massachusetts. 1988 - 1989 Research Assistant to Carl M. Shy, M.D., Dr.P.H., on Oak Ridge Universities Occupational Studies of Department of Energy Employees, and on North Carolina Dusty Trades Occupational Health Studies, University of North Carolina. 1988 -1989 Visiting Researcher, Duke University Marine Biomedical Center, Duke Marine Laboratory, Pivers Island, Beaufort, North Carolina. 1983 -1984 Commissioned Officer Student Training Extern Program (COSTEP). United States Public Health Service, Health Resources and Services Administration, Silver Spring, Maryland. TEACHING EXPERIENCE 1989 - present 1987 -1988 Assistant Professor University of Massachusetts, School of Public Health: "Principles of Epidemiology" "Applied Epidemiology" "Occupational Epidemiology" "Special Topics in Occupational Epidemiology" "Departmental Doctoral Seminar" Numerous Independent Study Projects Teaching Assistant to David G. Kleinbaum, Ph.D. University of North Carolina, School of Public Health. "Special Topics in Epidemiological Methods" "Advanced Methods in Epidemiology" SHORT COURSES 1993 Applied Epidemiology, Inc. and Akademie fur offentliche Gesundheit, Wermelsckirchen, Germany. May 23-28: Intensive Course in Occupational Epidemiology1 I rD 000 201 896 8 (Mundt C.V., p.5) SHORT COURSES (continued) 1991 Cancer Registry of Norway, Oslo, Norway. August 12-16: "Occupational and Environmental Epidemiology" 1989, 1990, 1991 International Summer School for Epidemiology, World Health Organization and the Akademie fur offentliche Gesundheit, Bochum, Germany "Occupational and Environmental Epidemiology" HONORARY AND PROFESSIONAL SOCIETIES American Conference of Governmental Industrial Hygienists (Full Member) American Public Health Association Delta Omega, Public Health National Honor Society International Society for Environmental Epidemiology Massachusetts Public Health Association Sigma Xi, Scientific Research National Honor Society Society for Epidemiologic Research PRESENTATIONS 1993 Mundt K.A "Occupational Epidemiology in a White-Collar Setting." Invited Speaker, The World Bank, May 11-12, 1993. Mundt KA "Occupational Surveillance: Concepts and Goals." Second National Conference on Occupational Surveillance, University of Massachusetts, Amherst, MA, March 9-11,1993. Mundt KA "Practical Stretegy for Developing Epidemiological Surveillance." Design and Analysis Workshop, Second National Conference on Occupational Surveillance, University of Massachusetts, Amherst, MA, March 9-11,1993. 1992 Mundt KA and Weiland S. "The Association of Asthma Symptoms and Allergic Rhinitis with Traffic Density on Street of Residence." Annual meeting of the International Societies for Environmental Epidemiology and of Exposure Analysis, Cuernavaca, Morelos, Mexico, August 26-29,1992. (Mundt C.V., p.6) PRESENTATIONS (continued) Pastides H and Mundt KA "Retrospective Estimation of Exposure to Hexavalent Chromium in an Occupational CohortAnnual meeting of the International Societies for Environmental Epidemiology and of Exposure Analysis, Cuernavaca, Morelos, Mexico, August 26-29, 1992. Pastides H and Mundt KA. "Epidemiological Occupational Surveillance." Surveillance, in Europe and the EEC, Devonshire Park Centre, Eastbourne, Sussex, United Kingdom, July 1-3, 1992. Mundt KA "Occupational Surveillance as a Strategy for Policy Development and Disease Preventioa" Protecting Workers, the Environment and Health in a Market Economy: Translating Science into Policy and Action. The United StatesCentral and Eastern Europe Exchange for Occupational and Environmental Health, third annual symposium, Pultusk, Poland, June 26 - July 1,1992. Pastides H, Austin R, Lemeshow S, Klar J, Noess R, and Mundt KA "A Retrospective Cohort Study of Health Risks Among Chromate Production Workers." Annual Meeting of the Society for Epidemiologic Research, Minneapolis, MN, June 10-12, 1992. Weissman L and Mundt KA "Prevalence of Immediate Hypersensitivity in Black Women: A Re-evaluation of Skin Prick Test Data from the Second National Health and Nutrition Examination Survey (NHANES II) and Comparison with an Occupational Study." Annual Meeting of the Society for Epidemiologic Research, Minneapolis, MN, June 10-12, 1992. Mundt KA Leeser J, Adams R. "Establishing a Mercury Biological Exposure Index (BEI)." American Conference of Governmental Industrial Hygienists (ACGIH) BEI and Threshold limit value (TLV) Committees, Orlando, Fla., March 21-22, 1992. 1991 Mundt KA "Epidemiological Approach to Occupational Health." Annual Scientific Meeting, Industrial Health Foundation, Pittsburgh, PA November 6-7,1991. Mundt KA "Role of Epidemiology in an Occupational Medical Department" Bayer Chemical, Leverkusen, Germany, June 19,1991. Mundt KA "Occupational Epidemiological Studies and the Social Context" Department of Epidemiology, State University of New York at Albany, April 18, 1991. Mundt KA "Use of Skin Tests in Epidemiological Research." Clinical Epidemiology Department, University of Pennsylvania, Philadelphia, PA March 14, 1991. Pastides H and Mundt KA "Establishing an Occupational Epidemiology Program." Chemical Manufacturers Association, Washington, D.C., March 12, 1991. VRD 0002018969 A (Mundt C.V., p.7) PRESENTATIONS (continued) 1990 Mundt KA. "Studies to Document the Healthy Worker Effect" Department of Work Environment, University of Lowell, Lowell, MA, December 11,1990. Mundt KA and Miller I. "Use of Industrial Hygiene Data in Epidemiology Research." Occidental Chemical Industrial Hygiene Annual Meetings, Houston TX and Atlantic City, NJ, November 12-14, 1990. Mundt KA and Shy C "Occupational Allergies and the Healthy Worker Effect" Annual Meeting of the Society for Epidemiologic Research, Snowbird, Utah, June 12-15, 1990. Mundt KA. "Health Effects of Vinyl Chloride Monomer (VCM)." Occidental Chemical Company, Plastics and Polymers Group, Berwyn, PA, May 11,1990. 1989 Mundt KA. "Skin Testing for Allergies in an Occupational Setting." Clinical Epidemiology Seminar Series, University of Massachusetts Medical Center, Worcester, MA, December 20, 1989. Mundt KA. "Immuno-Epidemiology of Crab-Induced Occupational Asthma: Methodological Issues." Visiting Researcher Program, Duke University Marine Biomedical Center, Beaufort, North Carolina, January, 12-13,1989. 1987 Mundt KA and Heiss G. "Measuring Ankle Systolic Blood Pressure: Interaction Between Ankle Geometry and Method of Applying Blood Pressure Cuff" National Heart, Lung and Blood Institute Seminar, Bethesda, Maryland, November 3, 1987. Mundt KA and Pastides H. "Microcomputer-Based Instruction: Applications in Epidemiology." Annual Meeting of the American Public Health Association, New Orleans, Louisiana, October 18-22,1987. 1986 Mundt KA. "Distribution of Selected Mineral Concentrations in Urban Children's Hair." Annual Meeting of the American Public Health Association, Las Vegas, Nevada, September 28 - October 2,1986. vrd 0 m e i m 0 A VRD 0002018971 (Mundt C.V., p.8) PUBLICATIONS AND REPORTS 1993 Weiland SK, Mundt KA, Riickmann A and Keil U. Self-reported wheezing and allergic rhinitis in children and traffic density on street of residence (accepted for publication) Annals of Epidemiology. Pastides H and Mundt KA. Establishing an Epidemiological Occupational Surveillance Program. Chemical Manufacturers ofAmerica, Washington, D.C., 1993. Pastides H, Austin R, Lemeshow S, Klar J, Noess R and Mundt, 1C Retrospective estimation of exposure to.hexavalent chromium in an occupational cohort (accepted for publication) American Journal of Industrial Medicine. 1992 Pastides H, Austin R, Lemeshow S, Klar J, Noess R and Mundt, K. Occupational cohort study ofchrome chemical manufacturers (submitted for publication). Mundt KA Occupational surveillance as a strategy for policy development and disease prevention (in press) In: Proceedings of the Third Annual Symposium on Environmental and Occupational Health during Societal Transition in Central and Eastern Europe. Protecting Workers, the Environment and Health in a Market Economy: Translating Science into Policy and Action, June 26 - July 1,1992. Mundt KA The Workplace as Laboratory. Business Digest, June 1992;34. Mundt KA, Chambless LE, Burnham CB and Heiss G. Measuring ankle systolic blood pressure: Validation of the Dinamap 1846 SX. Angiology, 1992:43(7);555-566. Mundt KA Letter to the Editor: RE: "Exposure to residential electric and magnetic fields and risk of childhood leukemia" and "Case-control study of childhood cancer and exposure to 60-HZ magnetic fields." American Journal of Epidemiology 1992:135(9);1070-1075. Health, Safety and Environment Committee, International Chromium Development Association. Health, Safety and Environment: Industry Guidelines. Paris, France, April, 1992. Pastides H, Miller JR, Mundt KA, Klar J, Adams RF, Olendorf T. A characterization of occupational static magnetic field exposures at a diaphragm-cell and a mercury-cell chlor-alkali facility. Applied Occupational and Environmental Hygiene 1992;7:42-48. 1991 Mundt KA Epidemiological Review of the American Conference of Governmental Industrial Hygienists (ACGIH) Recommended Biological Exposure Index (BEI) for Urinary Mercury. The Chlorine Institute, September 30, 1991. *^RD 0002018972 (Mundt C.V., p.9) PUBLICATIONS AND REPORTS (continued) Pastides H and Mundt KA. Resource Manual for Occupational Epidemiology, Chemical Manufacturers of America, Washington, D.C, 1991. 1990 Walker A and Mundt KA. Feasibility of Conducting an Industry-wide Study of Respiratory Cancer Related to Ceramic Fiber Inhalation, Final Report to Thermal Insulators Manufacturers Association (TIMA), Epidemiology Resources, Inc., Boston, MA, November, 1990. Mundt KA. Immuno-epidemiology ofcrab-induced occupational asthma, doctoral dissertation, University of North Carolina, 1990. 1986 Pastides H, Mundt KA, McKnigfat CJ and Tuthill RW. Formulating case definitions and identifying cases for analysis (computer-assisted instructional software). In "Applied Epidemiology," Centers for Disease Control, Atlanta, Georgia, 1986. Pastides H, Mundt KA, McKnight CJ and Tuthill RW. Descriptive analysis of the disease outbreak (computer-assisted instructional software). In "Applied Epidemiology," Centers for Disease Control, Atlanta, Georgia, 1986. Pastides H, Mundt KA, McKnight CJ and Tuthill RW. Formulating and testing hypotheses (computer-assisted instructional software). In "Applied Epidemiology," Centers for Disease Control, Atlanta, Georgia, 1986. Mundt KA. Distribution of selected mineral concentrations in urban children's hair. Masters thesis, University of Massachusetts, 1986. 1985 Tuthill RW and Mundt KA. An evaluation of hazard abatement activities in selected state-funded lead screening programs. Final report to Massachusetts House of Representatives Post Audit and Oversight Committee, June 27,1985. 1979 Mundt KA and Polk BF. Identification of site urinary-tract infections by antibody-coated bacteria assay. Lancet 1979;2:1172-5. Mundt KA and Polk BF. Predictive value of a single diagnostic test: a belated correction. New England Journal of Medicine 1979;300(15):859. Revised 7115193