Document Z4QGwmJdddrR2yE1dpYkeNDBd

C*C* ?+*dL The Breakers !' uni iv.u. h Kx'nO.t JW cc H&umU C-oJJur TtovA FV BOR 010180 The Society of the Plastics Industry, Inc 3d5 Lex:r,g;cn'.e.-. ;r-' i212)573-9400 - VCM-PVC MANAGEMENT SUMMARY OM THE REGULATORY FRONT Vol. II, No. 5 EPA: 5PI Charges EPA Made "Secret Deal" To Placate EPF On June 2, the EPA published proposed amendments to VCM regs per its "outof-court settlement" with Environmental Defense Fund (EDF) ... Amendments require EPA cut current 10 ppm emission standard to 5 ppm within three years ... SPI denounced EPA's actions as "secret deal which flouts ... the very concept of open government." SPI President, Ralph Harding, said industry will "strongly object" to revisions in rules on grounds they were arrived at in closed conferences which excluded industry. Court Dismisses SPI Petition To Review On June 24, U.S. Court of Appeals dismissed SPI's Petition to Review in case of EDF vs. Train (Russell E. Train, former EPA Administrator) ... SPI had filed motion with Court on December 9, 1976, asking to intervene in (Nov. 19) petition of EDF for review of EPA's national emission standard for VCM ... SPI's motion stated any modifica tion of standard could disrupt and render moot efforts underway to meet strict statutory compliance deadlines set by EPA. SPI Requests "Hybrid" Public Hearing Date on VC Standard Earlier on June 24, SPI formally requested EPA Administrator Douglas Costle provicfc "hybrid" public hearing in mid-October to give industry "fair opportunity to find out what EPA is proposing and to properly respond" to new amendments to VCM emission standards ... under plan concocted by EPA and EDF, public hearing to be held July 19 and all public comment submitted by August 1 ... Ralph Harding and SPI attorneys in statement to Costle, said: ... "SPI certifies that the industry cannot make the necessary studies, collect the necessary data and formulate its conclusions in the short amount of time allowed by your office for comment and hearing procedures" ... "Hybrid" hearing procedure allows more opportunity to permit industry to present case with greater accuracy. BOR 010181 FDA: Bureau of Foods Reviewing SPI Food Additive Petition SPI petition to FDA to amend regulatory definition of "food additive" reportedly receiving "serious consideration" in initial review by FDA's Bureau of Foods ... source at FDA indicates agency ma^co^rac^J^i^^tudy^^hro^n^j^^^I^.aM^^m ... SPI petition proposes substance poscuvg"n^special tox^^^gical problems and not detected migrating to food with analytical procedure sensitive to 50 ppb would, by definition, not be considered food additive. ON THE LEGISLATIVE FRONT In Congress As follow-up to furor created by FDA proposal to ban saccharin, three major bills to amend the "Delaney Clause" have emerged ... H.R.5166 sponsored by Rep. James G. Martin (R-NC) provides for "the use of risk-benefit analysis considerations in determin ing whether a 'food additive' should be banned as a carcinogen..." Rep. Thomas L. Ashley's (D-Ohio) H.R.6979 complements Martin bill ... provides for deregulation of trace migrants from packaging materials ... bill would amend defini tion of "food additives" so substances not reasonably expected to contribute more than 50 ppb to contacted food would be generally excluded from FDA jurisdiction ... Rep. Paul G. Rogers' (D-Fla.) H.R.7599 would put off for 18 months any action bv FDA on saccharin ... Rogers' bill would have National Academy of Sciences (NAS) evaluate scientific knowledge available on ability to predict human toxicity or carcino genicity of food additives found to produce cancer in animals. In the States California: California Occupational Safety and Health Standards Board has approved amend ments to VCM standard that includes all changes supported by SPI ... new sentence added to amendment on safe use of recognized cancer-causing substances said: ... "reporting requirements would not apply to the use, processing, storage, packaging or repackaging of polyvinyl chloride." New Jersey: On June 24, representatives of B.F. Goodrich and Tenneco Chemicals testified before New Jersey Senate Environment Committee on New Jersey Cancer Control Bill (S.3Q35) .. A.R. Webber, plant manager, and Dr. B.M.G. Zwicker, director of technical planning for Goodrich, said proposed Cancer Control Council would be "a redundancy in regulations" as rules already exist for safe use of VCM as enforced by OSHA and EPA ... they voiced support forS.1758 and S.3034 which provide for cancer registry and cancer research ... they pointed out research and changed production techniques have reduced human exposure to VCM and industry continues to be major sponsor of research into health effects of VCM."This belies any assertion that industry doesn't care about worker health," they said ... BOR 010182 3 Dr. Roy T. Gottesman, Tenneco's director of environment and regulatory affairs said S.3035 is "just plain bad legislation" disavowed by industry, labor, the medical profession and environmentalists ... Dr. Gottesman pointed out bill would set up control council with majority of citizen-appointees having unspecified qualifications and they would have vital power over proposals and actions of State executive agencies charged with carrying out intent of legislature. ON THE TECHNICAL FRONT British PVC Study Shows Lower Mortality Rate Mortality study of over 7,000 British men exposed to VCM in manufacture of PVC ll showed significant reduction in liver cancer compared with national rates, February 1977IJ British Journal of Medicine reports ... of four cases of angiosarcoma found, two confirmed as angiosarcoma and two not confirmed ... the two cases of angiosarcoma were in men who had been exposed to high concentrations of monomer ... study concluded ... "there is no evidence to support the hypothesis that cancers other than those of the liver are associated with exposure to vinyl chloride monomer." No Definite Data Linking Angiosarcoma To Non-Occupational Exposure To VCM Because of short period of time since large-scale development of VCM/PVC industry, another 10 years is required before defnitive statements can be made concerning a link between angiosarcoma and non-occupational exposure to VCM .. so said Dr. William J. Nicholson, of Mount Sinai School of Medicine in April issue of Cancer ... during the years of uncontrolled emissions from U.S. monomer and polymer production facilities, average exposure level to the population within five miles of the plants was about 17 ppb, Professor Nicholson said ... he concluded: "At this time, no definite data exist linking angiosarcoma to non-occupational exposure to vinyl chloride." Effects of Inhaled VC on Fetal Development Rats, mice and rabbits were exposed to 50 ppm, 500 ppm, and 2,500 ppm of VCM in studies to evaluate effects on embryonal and fetal development. Toxicology and Applied Pharmacology, (Vol. 39) reports ... study concluded: ... "while maternal toxicity was observed, vinyl chloride alone did not cause significant embryonal or fetal toxicity and was not teratogenic in any of the species at the concentrations tested." ON THE COMBUSTIBILITY FRONT SPI Heads Off Further PVC Conduit Restrictions Advance work by SFI*s PVC Safety Group headed off move to impose severe fire restrictions on PVC conduit in National Electrical Code at National Fire Protection Association annual meeting. May 18 ... prior to meeting, VCM/PVC Fire Safety Subcommittee sent key organizational voting members of the NFPA informational pamphlets on issue by SPI ... at meeting, after first of four proposals by PVC conduit opponents was soundly defeated on floor, the other three were quickly tabled ... PVC Safety Group anticipates BOR 010183 continued need at local and regional levels to prove advantages of PVC conduit in face of arguments by opponents ... copies of two booklets plus two additional ones are available from SPI Literature Department. ON THE MEDIA FRONT Environmental Cancer Primarily A "Lifestyle" Problem Dr. Ernst L. Wynder, president of American Health Foundation, and Dr. Gio B. Gori of National Cancer Institute (NCI) put "environmental cancer" into perspective in an editorial published in April 1977 Journal of the National Cancer Institute ... editorial concludes: "lifestyle" factors (cigarette smoking, alcohol consumption, improper diet) are prime causes of "environmental cancer" ... food additives, air and water pollu tion and toxic chemicals in workplace relatively minor contributing factors to world's cancer problem, the doctors said. Cancer Related to "May of Life" ACS Says In article in May 12 Washington Post, Dr. R. Lee Clark, president of American Cancer Society (ACS) and Dr. Frank J. Rauscher, senior vice president of ACS, state that to many writers "environmental sources'' of cancer signify dangerouschemicals in our air, food and water ... actually, they say, real meaning of concept is many cancers are extrinsically induced and are related to our health habits and ways of life, as well as to things beyond our personal control ... "smoking and perhaps diet are related to onehalf to three quarters of all killing cancers in this country,"the doctors said ...petween one and two percent occur because of intense exposure to carcinogens in the workplace; an estimated three percent are related to long-term exposure in the general environments; and perhaps five percent are related to the use of medications in controlling human diseases Medical Journal Says "Modify Delaney Clause" In the lead editorial of current Journal of Preventative Medicine, Doctors Ernst L. Wynder and John Weisburger of the American Health Foundation, call for "modification of the Delaney Clause to establish a new method for arriving at decisions on matters which have far-reaching medical and social consequences while at the same time achieving control of environmental substances which are hazardous to human health," ... citing saccharin situation as the need to revise the law, the scientists propose new multiple review process ... first would be a review of animal experimentation by appropriate federal agency ... if possible carcinogenicity is Indicated, second review would involve medical risk evaluation by expert committees conversant with human risk assessment ... should first two steps lead to conclusion that human risk does exist or may exist, finding would be forwarded to Select Panel appointed by Science Advisor to the President or Secretary of HEW ... Select Panel would review recommendations in light of overall utility or detriment to society which would result from use of or ban of material in question. BOR 010184 I NEWS BRIEFS SPI Following Up on Tennessee Prison Fire On June 26, a fire set by prisoner in padded cell in Maury County Prison in Columbia, Tenn., caused deaths of 42 persons ... SPI assigned fire investigator to go to Columbia and dig out facts from local and state fire officials and medical examiners .. early news accounts indicated padding material was flexible polyurethane foam covered with PVC ... confirmation awaited from the National Bureau of Standards which picked up samples of material for testing ... On June 29, the Associated Press carried story describing polyurethane and PVC as "the most dangerous" home furnishings materials from a fire safety point of view ... On July 4, UPI reported that blood samples from victimes showed all died from carbon monoxide, and not from cyanide fumes as originally thought. "Common Sense" New OSHA Priority Major shift made in OSHA program to focus more resources on serious occupational disease and eliminate or simplify unnecessary regulations, the Washington Star reports ... Labor Secretary Ray Marshall called new emphasis ... "an important turning point in the history of OSHA," which businessmen often cite as most obnoxious example of federal regula tion ... Dr. Eula Bingham, new OSHA administrator, said ... "We're going to get tough on |J health hazards in the workplace that cause irreversible damage -- cancer, nerve damage, U leukemia, lung disease, and all the rest." NAS Finds Suspect Carcinogens in Drinking Water U.S. drinking water contains at least 22 organic compounds known or suspected carcinogens, according to new report by NAS ... of 22 reports says, VCM is only confirmed carcinogen .. report concluded: ... more and better research needed on all 22 substances. # it # BOR 010185