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JOSEPH E KEI.LER JEROME H HECKMAN CHARLES M MEEMaN WZLE2AM U. BORGUESAMl, ROBERT R TIERNAN VAYNE V BLACK X>AV1D L HILL Kartin W bercovici PETER M, KEMKOV JOSEPH E. HADLEY, JR. Carole c Harris MICHAEL r HORRONE UKRY S. SOLOMON JOHN B. DUBECK CHRISTINE A MEAGHER SHIRLEY S. FL'JIMOTO JOHN S. ELBRED law offices Keller and Heckmak 1150 17UJ STREET, N W SHITE lOOO WASHINGTON, JD. C. 2003(3 August 30, 1978 received SEP 5 1978 R. X. G.QIJsiw\pj TELEPHONE 202 4S7-UOO CABLE ADDRESS"KELKAN" WRITER'S DIRECT DIAL NUMBER 202/457-1112 To: SPI-PVC Safety Group SPI-PVC Manufacturing Technology Committee SPI-PVC Communications Committee SPI-PVC Health Committee SPI-PVC Lawyers Subcommittee Re: SPI-VCM/PVC -- EPF v. Train Ladies and Gentlemen The Environmental Defense Fund (EDF) Motion to ReOpen Proceedings and for an Order Requiring Compliance with Prior Consent Degree and Order of Dismissal in the abovecaptioned case has been denied. The denial is without prejudice to EDF's renewal of the Motion if the Environ mental Protection Agency (EPA) fails to act within a "reason able period of time." As you will see from the attached Order, the court has apparently relied upon EPA's representation that it is reassessing its overall policy regarding airborne car cinogens prior to taking any additional action regarding vinyl chloride. Furthermore, it seems that the Agency action required within a "reasonable period of time" in cludes progress in developing an overall policy for all airborne carcinogens and is not limited to Agency action to reduce the emission levels established by the National Emission Standard for Vinyl Chloride. Accordingly, as long as EPA is proceeding in its attempt to establish an overall policy for airborne carcinogens, EDF may well be precluded from forcing additional EPA action on vinyl chloride. COLORITE 009257 August 30, 1978 Page Two As always, should you have any questions, comments, or suggestions relative to any item discussed herein, please do not hesitate to let us know. Cordially yours. Enclosure cc: John B. Stohlton, Esq. COLORITE 009258 r Uniixit states (Etfurf of Appeals FOR THE DISTRICT OF COLUMBIA CIRCUIT No. 76-2045 Environmental Defense Fund, Inc., Petitioner v Russell E. Train, Administrator Environmental Protection Agency, Respondent September Term, 19 77 United States Court of Appeals for the District of Ccl-jmbia Circuit FiLED AUG 2 9 1978 GEORGE A. FISHER CLERK Society of the Plastics Industry, Air Products and Chemicals Inc. Goodyear Tire and Rubber Co. Intervenors Inc. BEFORE: Fahy, Senior Circuit Judge ; Robb, Circuit Judge ORDER VJe have considered petitioner's motion to re-open proceedings and for an order requiring compliance with prior consent decree and order of dismissal, the opposition thereto by respondent and intervenors, and the record in this case. Respondent represents by affidavit that it has not yet taken final action concerning vinyl chloride because it is reassessing its overall policy concerning all airborne carcinogens (of which vinyl chloride is one). We believe petitioner's motion should be denied' without prejudice to its renewal if the agency fails to act within a reasonable period of time. it is so ORDERED. Per Curiam . ;-,,y* " --!L;=.w 4 *. COLORITE 009259 vinVucTOdride i HV I think that this "report could be greatly strengthened by including data in the ERA Report issued June 1975 -- #EPA-600/6-75-004 of a star series. It could also be strengthened if the time of exposure to produce carcinogenic effects is discussed, in other words, it is important in carcinogens to relate concentrations to time of exposure in any such scholarly discussion. The statement that all human contact with vinylchloride should be avoided is a wise one. No data on the aquatic toxicity of this compound are presented and none are known to us at this time. The high volatilization rate of vinyl chloride would of course make both besting and interpretation difficult. Q^y (fLcp X> ^ COLORITE 009260 Criterion CRITERIA DOCUMENT VINYL CHLORIDE Human exposure should be minimized. - *8 * 10 * 14 Available data do not support the recommendation of a * 14.2 g*iterion at this time. * 14.3 Introduction * 18 V_inyl chloride is used in the manufacture of polyvinyl chloride-, which * 20 is the most widely used synthetic plastic material throughout the world. * 21 It is estimated that 12 million tons of vinyl chloride is produced each * 22 year of which 25 percent is manufactured in the U.S. (World Health * 23 Organization, 1975) Polyvinyl chloride is used for numerous products in * 24 the building and automobile industries, for electrical`wire insulation, * 25 cables, piping, household equipment, clothing, toys, packaging for food * 26 products and medical supplies. The rubber, paper, and glass industries * 27 also depend heavily on the production of vinyl chloride. - * 27 Vinyl chloride, a gas at normal temperature and pressure, is polymerized * 29 in liquified form at 50 degrees C and therefore the process is conducted * 30 in pressurized vessels (Barnes, 1976). The reaction is exothermic and * 31 in most processes water is included in the reaction to dissipate the * 32 1 INTERIM DRAFT NO. II November 5, 1977 PV/Kmm *3 *4 *5 *6 COLORITE 009261 generated heat. vinyl chloride has a strong affinity for polyvinyl chloride and after stripping about 500 mg/1 of the monomer is oresent in the polymer. Vinyl chloride is further removed from the insoluble polyvinyl chloride by extracting with water. Jets ot pressurised water are also used to clean the walls of the reaction vessels. Therefore, during the polymerization process, water is used extensively and becomes contaminated with vinyl chloride. Disposal of this water could lead to contamination of the aquatic environment. Thus far, the nrincipal route of exposure for people working at or living near vinyl chloride industries is thought to be air inhalation, but sources of increased importance for the copulation in general may include water. Only recently has vinyl chloride been shown to be an occupational carcinogen resulting in liver angiosarcomas in men in the vir.vl chloride industry (Creech and Johnson, 1974; sgiro Eeoort, 1975) . The uncontrolled disease is fatal and can be cured by surcrical excision of the lesion only if it is detected early and the lesson is well-localized (Block, 1974) . Physical and Chemical Properties 2 INTERIM DRAFT 70. II November 5, 1977 PV/'Xmn COLORITE 009262 vinyl chloride has a density slightly more than twice that of air and has a molecular weight of 62.5 (3raker and Mossmein, 1971). I 51 I 52 INTERIM DRA5T MO. II November 5, 1977 PV/Kmm COLOR!TE 009263 The structural formula is given below: - 5U Vinyl chloride boils at -13.9 degrees C; it is a gas at normal ] 56 atmospheric pressure and temoerature and is highly flammable. rts | 58 solubility in water at 29 degrees is 0.11 g/100 g and it is soluble in j 59 alcohol and very soluble in ether, vinyl chloride can be produced bv | 60 reacting acetylene and HC1 or by thermal 'dehydrochlorination of 1,2 dichlor^ethane^ (V.s. SPA, 1975a). Dissolved vinyl chloride In water I 61 | 62 will readily escape Into the- gas phase, but chemical reactions' can occur J 6 3 with water impurities which may inhibit its release. Many salts have ] SU the ability to torn complexes with vinyl chloride and can increase its | 64 solubility. Theretore, the amounts ot vinyl chloride in water could be ) 56 influenced significantly by the presence of salts (n.s. EPA, 1975a). | 67 4 INTERIM DRAFT November 5, PV/Kmm ' NO. II 1977 I3 |4 I5 I6 COLORITE 009264 Toxicological Data ] 6Q Concern for the toxicity of ,,vinyl chloride has been with the exposure of ) 71 people working at or near vinyl chloride and polyvinyl chloride plants. In the last few years, vinyl chloride has been shown to be a potent ^ | 72 | 73 carcinogen in many animal test systems. 1 74 The first report of carcinogenicity of vinyl chloride was reoorted bv Viola at al,, _[1971), in rats exposed to 30,000 ppm in air for a ] 76 1 77 hours/day 5 times a week for ten months. Neoplasms ot the skin, lungs, and bone tissues were identified. Maltoni and Lefemine, (1974), * extended Viola's study but at lower exposure levels. At the end of 131 weeks after inhalation of air containing vinyl chloride at 250 ppm 4 hours/day 5 days a week, the tumor incidence in rats was 16 percent. j 78 1 79 | 80 | 81 | 31 Nephroblastomas and liver angiosarcomas were found. Fifty dofi vinyl chloride did not cause tumor development. However, at the end of 135 weeks exposure to 50 ppm vinyl chloride, nephroblastomas, liver angiosarcomas and mammary carcinomas were diagnosed. Seventeen percent ot the rats had two or more tumors. None was found in the controls. Golden hamsters inhaling 50 ppm vinyl chloride under similar conditions for thirty weeks developed skin trichoepithiomas, basaliomas and melanomas, and for stomach eoithelial tumors. Twontv-five percent had | 93 I sa | 94 j 66 | 37 | 38 ] 39 I 90 5 INTSKIM DRAFT November 5, PV /Ikmm MO. II 1977 I3 |4 |5 16 COLORITE 009265 multiple tumors. The offspring of breeder rats exposed durinn prsnancv for 7 weeks developed tumors, indicating that vinyl chloride can cross the placental barrier. Keplinqer et al., (1975), exposed mice to vinyl chloride vapors in air at 50 ppm for 7 hours/day for 5 days a week. At the end of eiuht months, lung adenomas, liver angiosarcomas and mammary carcinomas were found in some of the animals. Nne was observed in control animals. 91 92 93 95 95 97 97 Bartsch and Montesano, (1975), investigated the mutagenicity of vinvl chloride in Salmonell a tvohimurium TA15 3Q in which histidine-*- revertant frequency was measured. In the presence of mouse liver microsomes, exposure to 0.2 percent vinyl chloride j.n air (volume/volume) for U8 hours resulted in a four-fold increase in the spontaneous mutation frequency in the bacteria. Exposure to the higher concentrations of vinyl chloride led to greater mutation frequencies. 99 10 10 10 10 10 10 Lopreine et al,, (1977), measured forward mutations in five adenine loci Schizosaccharomvces combe and the gene conversions in the ade-2 locus of the yeast, Sacharomvces cerevisiae. Exposure or s^_ pombe to 1.0 g vinyl chloride for one hour at 37 degrees C _in the presence of microsomes caused a five-told increase in the spontaneous mutation frequency. 2hen S. cerevisiae were exposed to 190 mcr vinyl chloride plus mouse 10 10 11 11 11 11 6 INTERIM DRAFT November 5, PV/Kmm NO. II 1977 3 a 5 6 COLORITE 009266 microsomes, the gene conversion frequency was twice the control. Chloroethylene oxide, the suspected ultimate carcinogen, in the absence of microsomes was a much better inducer of gene mutations and gene conversions than vinyl chloride. | 11 | 17 ] 11 j 11 Human Studies | 11 The emergence m 1974 of epidemiological evidence showing vinyl chloride ] 12 as a new occupational carcinogen for people workina in the vinyl | 12 chloride industry focused attention on controlling i.'-s presence in the ] 12 environment (Creech and Johnson, 1974; WHO Report, 1975). Anoiosarcoma | 12 of the liver is an extremely rare disease and in a survey bv the j 12 American Cancer Society one case of liver angiosarcoma was found among j 12 78,000 deaths in the general copulation in 1974 {Selikoff, 1974). | 12 However, the relative risk of>developing liver angiosarcoma among vinyl j 12 chloride workers _is about 3,000 times greater than tne general ] 12 population (0.S. SPA, 1975a). | 12 jtn addition to the carcinogenic effects of vmvl chloride, the occurrence of many other pathological disorders have been reoorted as a result of exposure to this chemical (Lilis et al., 1975). They include acroosteolysis, changes in peripheral circulationskin chances, | 13 j i3 j 13 | 13 7 INTERIM DRAFT November 5, ?V/Fmm NO. II 1977 I3 |4 |5 |6 COLORITE 009267 hacatosplehomeqaly and abnormalities in many liver function tests. In common with other carcinogenic chemicals recent studies have snown that workers exposed to vinyl chloride have an increased number of chromosomal abnormalities in circulating lymphocytes which is indicative of a mutagenic effect of vinyl chloride in humans (Purchase et ai., 1976) . _In 1972 the average exposure levels of vinyl chloride to workers in two monomer plants was 53 npm (Suici et al^., 1975) . r Environmental Eats and Effects Green and Hathwav (1975), measured the excretion of 250 mn/kg iuc-vinvl chloride administered to rats by intragastric, intravenous (femoral vein) and intrapentoneal routes. During the first 24 hours after injections more than 90 oercent was excreted from the animals. The rats given vinyl chloride, i.n., exhaled 3.7 percent as vinyl chloride, 12.6 percent as C02, 71.5 percent labeled material in the urine, and 2.3 oercent in the feces. Intravenous injections resulted in 99 percent exhaled as vinyl cnloride and, for i.p. experiments, 43.2 percent was exhaled as vinyl chloride (10.3 oercent as CO 2, 41.5 cercent of the label was excreted in the urine and 1.6 percent in the feces). 3olt et al.> (1976), have studied the tissue disposition of 14C-vinvl chloride in air for 5 hours the percent incorporated vinyl chloride radioactivity 3 INTERIM DRAFT November 5, PV/Kmm NO. II 1977 COLORITE 009268 per g tissue was highest for kidney (2.13), liver (1.86) and spleen (0.73). Forty-eight hours after the beginning of exposure, labeled material could still be detected in these tissues. Present data indicate that vinyl chloride must be metabolized within the animals to an activated carcinogen electrophile (Van Durren, 1975; Montesano and Bartsch, 1976; Kappus, et al_., 1976) and is therefore capable of covalently reacting with nucleophilic groups or cellular macromolecules. * 154 * 155 * 157 * 157 * 158 * 158 * 158 * 160 Criterion Formulation * 162 At this time, the available aquatic toxicological data are incomplete and an ambient water quality criterion can not be recommended. * 163.1 * 163.2 Airbone exposure to vinyl chloride represents the greatest risk to the population in the v_icinity of the emission source, because of its high rate of volatilization (U.S. EPA, 1975a). The majority of environmental exposures to vinyl chloride is believed to occur via inhalation because of its high rate of volatilization. * 174 * 175 * 176 * 177 * 177 Concentrations of 5.6 ug/1 and 0.27 ug/1 were detected in the water supplies of two American cities (U.S. EPA, 1975b). In 1974 vinyl chloride contents in liquid discharges were found to be as high as * 179 * 181 * 181 9 INTERIM DRAFT NO. II November 5, 1977 PV/Kmm *3 *4 *5 *g COLORXTE 009269 * 184 * 185 * 185 * 186 10 INTERIM DRAFT NO. II November 5, 1977 PV/Kmm *3 *4 *5 *6 COLORXTE 009270 Reference 19 2- Sarnes, A.w. 1976- vinyl Chloride and theproduction of pvc.Proc. Roy 3oc. Med. 6 9 : 277. | 1 | -jg 2. Bartsch, H. and Montesano, R, 1975. Mutagenic andCarcinogenic effects of vinly Chloride. Mut. Res. 32:93. | 19 | 19 2- 3lock, J.3. 1974. Angiosarcona of the liver following vinvl chloride | 19 exposure. Jour. Ameri. Med. Assoc. 229:53. | 19 2- Bolt, H..M., et al. , 1976. Disposition of (1,2- C) vinyl chloride in the rat. Arch. Toxicol. 35: 153. | 2C j 2C 5. 3raker, W. and v0ssmein, A.L. 1971. Matheson Gas Data 3ook, 5th edition. Cast Rutherford, M.J., Mateson Gas products, o. 5bl. J 2^ | 2C 6- Creech, J.L. and Johnson _M. N. 1974. Angiosarcoma of liver in the manufacture of polyvinyl chloride. Jour. Occur. Med. 16:150. | 2' I 2' 11 INTERIM DRAFT November 5, PV/Xmm NO. II 1977 3 4 5 5 COLORITE 009271 7. Green , T. and 0. E. Hathway, 1975. The biological fate in rats of vinyl chloride m relation to its oncoqencity. chem.-Biol. Interactions 11:545. | 21 J 21 | 21 3. Kapous, h. et a_l. , 1975. Liver microsomal uptake of ( C) . Vinyl Chloride and Transformation to protect Alkylating Metabolites tn vitro. Toxicol. Applied. Pharmacl. 37:461. | 21 | 21 | 22 9. Keplinger, M.L., et al. , 1975. Interim results of exposure of rats, hamsters, and mice to vinyl chloride. Ann. M.Y. Acad. 5ci. 246:219. | 22 | 22 JO. Lilis, R. , et al., 1975. Prevalence of disease among vinyl chloride and polyvinyl chloride workers. Ann. N.Y. Acad. Sci. 246:22. j 22 | 22 n. Lopreine, N. , et al. , 1977. Can. Pes. 36 :253. | 23 J2. Maltoni, L. and G. Lefemine. 1974. Carcinogenicity bioassays of vinyl chloride. Env. Res. y:387. | 23 | 23 J3. Montesano, R. and H. 3artsch. 1976. Mutagencitv and metabolism of Vinyl Chloride. In: Proceedings of the Sixth International Symposium on the Biological Characterisation of Humans Tumors. Vol. 3 EioLoaical | 23 | 23 | 24 12 INTERIM DRAFT Movemfcer 5, PV/Kmm MO. II 1977 !3 |4 |5 |6 COLORITE 009272 Characterization of Homan Tumors, w. Davis and c. Maitoni, eds Elsevier Publishinc Co, New York, p.242. 9 /; 24 J.4. Purchase, I.E.H., et al. , 1976. Chromosomal Effects in ?ecQptual Lymphocytes. Proc Hoy. Soc, Med. 69: 291. ) 24 | 24 J_5. Selikoff, i.j. , 1974. Testimony Presented at Public Hearina Proposed | 24 Standard for Occuoational Exposure to vinyl chloride, u.s. Department of | 24 Labor. Nashincton, D.C. June 25, 1974. j 25 26* Suici, I. et a_l-' 1975, Clinical manifestations of vinyl chloride poisoning. Annals of the N.Y. Acad. Sci. 246:53. | 25 ! 25 17. u.s. Environmental Protection Agency. 1974. Preliminary Assessment of the Environmental Problems Associated with Vinyl Chloride and Polyvinyl Chloride. EPA-560/4-74-001, Office of Toxic Substances, Washington D.C. od. 30. | 25 | 25 | 25 i 25 29. U.S. Environmental Protection Agency. 1975(a). A Scientific and ] 26 Technical Assessment Report on Vinyl Chloride and Polyvinyl Chloride. | 26 EPA-600/6-75-004, office of Research and Development, Washinaron D.C. op j 2b 13 INTERIM DRAFT November 5, PV/Kmm NO. II 1977 3 COLORITE 009273 The Society of the Plastics industry, Inc^ VCM-PVC MANAGEMENT SUMMARY Vol. Ill, No. 5 ON THE LEGISLATIVE FRONT California Sets 0.01 PPM Ambient VC Standard On May 24, the California Air Resources Board (CARB) passed a resolution setting a state ambient air quality vinyl chloride (VC) standard of 0.01 parts per million (ppm) averaged over 24-hours ... the resolution calls for "immediate enforcement action if warranted." CARB Chairman Tom Quinn, explaining the Board's action, said "The evidence shows that high concentrations of vinyl chloride have caused various forms of cancer, brain damage, miscarriages and birth defects ... it is clear that vinyl chloride is a very dangerous substance." In setting the standard, CARB said it relied on the recommendation from the State Department of Health that "the lowest concentration level at which reliable measurements can be made is 0.01 ppm." The Society of the Plastics Industry's (SPI) legal counsel and associate legal counsel in California are exploring possible challenges to the new standard ... under the Cali fornia Government Code, administrative remedies would have to be exhausted prior to seeking judicial relief ... the law requires that an administrative challenge to a regulation be filed no later than 60 days after the date of the decision involved ... this means SPI has until July 25, 1978, to file a request that the Board reconsider its decision. On April 24, a group of industry representatives and consultants testified before CARB ... John T. Barr, speaking for SPI, asked CARB to hold off imposing the state's vinyl chloride regulations until air emission standards imposed by the Environmental Protection Agency (EPA) in 1976 have been implemented and evaluated." ... the final witness. Dr. Richard Wilson of Harvard University, compared the yearly risk of vinyl chloride exposure after full implementation of the EPA regulations to "the equivalent of smoking l/7th of a cigar ette, spending 100 hours in a smoke-filled room, eating two tablespoons of peanut butter or drinking one half pint of municipal drinking water." In late April, prior to CARB's decision on the vinyl chloride standard, an industry briefing team called on media in San Francisco and Sacramento to inform them of the plastics industry's position regarding the proposed standard ... interviews were obtained with a number of newspapers, radio and television stations in both areas. COLORITE 009274 ON THE REGULATORY FRONT OSHA: OSHA Occupational Cancer Policy Hearings Underway On May 16, the first of a long string of government witnesses begain testifying at the Occupational Safety and Health Administration's (OSHA) generic occupational cancer policy public hearings in Washington ... during the next month more than 45 witnesses from govern ment agencies, universities and institutes generally supported the OSHA proposal although some potentially serious problems with the policy were pointed out by Environmental Protec tion Agency (EPA) spokesmen in the third week of the hearings. The first industry witnesses began testifying on June 20 ... before the hearings con clude late in July, more than 300 industry representatives from major companies and associa tions will have had an opportunity to present their views to OSHA on the controversial generic carcinogen policy. CWPS Faults OSHA on AN Standards Analysis On May 19, Barry P. Bosworth, Director of the President's Council on Wage and Price Stability (CWPS), sent Dr. Eula Bingham, Assistant Secretary of Labor for OSHA, a lengthy report criticizing OSHA for failing to properly analyze the proposed permanent standards for occupational exposure to acrylonitrile (AN) ... pointing out that important elements are missing in the AN proposal, the report states that "OSHA's position that exposure to carcinogens should be reduced to the lowest level feasible is not information enough upon which to base a standard unless it is intended to eliminate all risks regardless of the consequences" ... as an operational procedure, the report states, the OSHA goal is "empty," since in order to eliminate all risks, "industry would have to shut down. Just as there is no absolutely 'safe' level, there is no absolute 'feasible' level." The CWPS report concludes that "it appears that OSHA has not given adequate considera tion to the risk reductions produced by the overall and specific parts of the alternative standards" ... "OSHA's analysis also inadequately addresses the advantage of performance standards and standards that provide incentives for the development of risk reducing technology." EPA: EPF Asks Court to Re-Open "EPF vs. Train" On June 8, the Environmental Defense Fund (EPF) filed a "Motion to Re-Open the Pro ceedings in the EDF vs. Train" case in the U.S. Court of Appeals, District of Columbia ... the EDF has continually threatened the EPA with such action if the Agency did not promulgate an amendment to the National Emission Standard for Vinyl Chloride as it announced it would do in June 1977 ... the EDF hopes its move will prompt the EPA to take some action regarding vinyl chloride. COLORITE 009275 3 On June 19, in response to the EPF action, SPI filed with the court a "Motion to Extend Time for Responding to the Motion to Re-Open Proceedings" ... SPI's Motion asked that the time for filing its response be extended to and including June 26, 1978 ... in support of the Motion, SPI stated that both the EDF and the Government had been informed and had consented to the extension ... the Motion was granted and responses were filed by the Government and by SPI June 26. EPA to Take Lead in Chronic Hazard Regulation The "first crack" at the chronic hazard regulation should belong to the EPA, the White House recommends in draft legislation, the May 29 Product Safety Letter reports ... proposed by the President's Office of Management and Budget (OMB), the Toxic Substances Act would be amended to require whenever the Consumer Product Safety Commission (CPSC) gets a petition or otherwise decides that regulation of a chronic chemical hazard is called for, EPA would have 90 days to decide whether it should regulate before the CPSC is allowed to take jurisdiction. FDA" Court Extends Time for Filing AN Briefs On May 12, the United States Court of Appeals for the District of Columbia extended the time for filing petitioners' briefs through June 20, 1978, in the appeal of the Food and Drug Administration's (FDA) acrylonitrile beverage container decision ... in a postscript to its May 12 order, the Court, on May 25, requested petitioners to report, within 10 days, on their briefing plans in the case ... the order also asked petitioners to consider filing a joint brief, or a joint brief on common issues and supplemental briefs as to other issues. FDA and AN Discussed at Packaging Institute The FDA's position stated at the acrylonitrile hearing was designed "to win on contest, and will not necessarily always be FDA's policy towards indirect additives, Richard J. Ronk, Director of the FDA's Division of Food and Color Additives, said at a recent meeting of the Packaging Institute ... however, he said," although there may be changes in policy, FDA will regulate to protect the public for "real risks." Rutgers University's Dr. Seymour G. Gilbert, another speaker, said the FDA acrylo nitrile decisions defined "assumptions" about migration, saying that science will show whether these "assumptions are valid or merely figments of somebody's imagination ... The burden of proof," Dr. Gilbert said, "is on the FDA assumption" ... J. Virgil Waggoner of Monsanto told the audience that "migration studies capable of detecting AN at 10 parts per billion (5 times lower than the new maximum being proposed) have repeatedly failed to detect AN in the contents of the bottles, under intended conditions of use." SPI General Counsel Jerome H. Heckman predicted that it may be close to a year before there is a court decision on the industry appeal from FDA's acrylonitrile decision ... in a letter to SPI Committee members, on April 28, Mr. Heckman pointed out that until the court rules on the case or until "experimental data" can be developed and submitted to FDA that demonstrate that the diffusion model relied upon in the AN beverage container decision is not valid at low residual monomer levels, we do not expect FDA to reconsider explicitly the regulatory status of AN beverage containers." COLORITE 009276 -4- CPSC: CPSC Votes Tough New Carcinogen Rules On June 1, the CPSC voted unanimously to establish formal procedures for screening. classifying, evaluating and regulating potential cancer-causing agents ... by its action, the CPSC became the first independent federal agency to develop a formal carcinogen policy ... the Commission will use test results from the National Cancer Institute (NCI) or another, unspecified, laboratory ... with the new policy, the CPSC will take a more aggressive stance ... for example, under the new rules the Commission can take "precautionary action" without establishing proof of a chemical's harm. The New CPSC policy calls for categorizing all tested substances into one of four areas based on the strength of the evidence of carcinogenicity ... Category A, "potential carcino gens," would be banned outright ... Category B, "suspected carcinogens" and Category C, "questionable carcinogens" would be subject to continuing Investigation and may be subject to warning labels or other immediate regulation depending on the danger posed ... category D, "negative carcinogens," would require no action by the agency. Barbara Franklin, one of the commissioners, termed the CPSC rules a "tough policy on the side of public health and safety" but said other factors would be taken into considera tion "like economics, social aspects, and the like" in determining regulatory action. CPSC Bans VCM in Self-Pressurized Containers On May 30, the CPSC published in the Federal Register confirmation of its final order banning as of June 22, 1978, the use of any self-pressurized container containing vinyl chloride monomer (VCM) ... the final order which was issued March 24, 1978, classified VCM as a "banned hazardous substance" ... the order covers "self-pressurized products intended or suitable for household use manufactured or imported after October 7, 1974, that contain vinyl chloride monomer (VCM) as an ingredient or propellant." USITC: PVC Imports Likely to Hurt Domestic Industry On April 12, the United States International Trade Commission (USITC), reported to the Secretary of the Treasury that the domestic industry is being or is likely to be injured by the importation of certain polyvinyl chloride (PVC) sheet and film from the Republic of China (Taiwan) ... the Commission's investigation began in January 1978 under section 201 of the Anti-Dumping Act of 1921 ... the complaint which led to the investigation was filed by counsel representing the Plastics Import Action Committee. ON THE MEDIA FRONT SPI Terms "New West" PVC Article "inflammatory" "The article 'The Great Saugus Cancer Scare' in the June 5 Issue of New West not only contains serious errors of fact regarding polyvinyl chloride and vinyl chloride but by its COLORITE 009277 The sentence "A little cancer shouldn't stand in the way of an Industry accounting directly and indirectly for 700,000 jobs and one percent of the GNP," was the"most irrespon sible" statements in the article, Mr. Collins said ... "it is grossly unfair to a responsible industry that brought this occupational health hazard to the attention of the government and the public and has spent literally millions of dollars in research and development to meet rigid governmental safety and health standards." ON THE TECHNICAL FRONT New Laser Sensor Can Monitor VC From Afar A new light sensor that can identify and measure harmful gases from long distances has been developed by Stanford University engineers ... among the substances the "tunable" laser can monitor, according to its developer. Prof. Robert L. Byers, is vinyl chloride ... here's how it works: the laser sends out pulses of light at different wave lengths ... each type of gas has its own vibration frequency, like a fingerprint, at which it absorbs the light hitting it ... the atmosphere reflects the light back, like radar, and it is gathered by a 16-inch telescope and measured and analyzed by a computer ... since the laser beam can be timed it can be set to transmit at different frequencies to identify specific molecules ... the National Science Foundation has sponsored the Stanford laseir project. Background Papers on Vinyl Chloride Health Effects Two new basic background papers on vinyl chloride health effects have been prepared by the SPI for members and other interested parties ... the first, "Vinyl Chloride and Birth Defects," deals with the issues of birth defects in communities adjacent to PVC plants and that of stillbirths and miscarriages among wives of PVC workers ... the second, "Vinyl --- P Chloride and Community Safety," examines the question of vinyl chloride air emissions and the entire EPA situation ... three additional background papers -- on occupational health problems, the FDA situation and a general risk-benefit backgrounder -- are in preparation ... Copies of the first two papers can be obtained from John Lawrence at SPI. // # // COLOR!TE 009278