Document G3r0oyavZNpbKyqBBwV63mzx

THE OIL DAILY. Monday, July 14. 1975 Plastics Society Supports Move To Assure No PVC in Foodstuffs NEW YORK - Immediate ac tion by the U.S. Food & Drug Admn. to adopt a food' additive regulation governing safe use of polyvinyl chloride (PVC) food packaging materials has been urged by the Society of the Plastics In* dustry to answer what the industry called an "ill-founded" petition by an organization which calls itself the Health Research Group. Ralph L. Harding Jr.. SPI presi dent. said: "We are advised that FDA is ready to publish a proposed rulemaking which would impose a 'no detectable' criterion^on any potential vinyl chloride monomer (VCM) migrating into foods from packaging materials. Industry has been working diligently to provide the technical input and we would support such a standard. Indeed, as a practical matter, it is our firm belief that no migration of vinyl monomer into., foodstuff is taking place now." HARDING said the Health Research Group, which petitioned for a related action, could have determined "easily" that FDA was preparing to publish its ruling in stead of petitioning the agency to prohibit 'vinyl chloride in any amount' in food contact packaging. The SPI spokesman added that it has taken some time to develop the supporting data and test . methodology but that the informa tion provided to FDA should give assurance that there is no hazard from meats orany other foodstuff packaged in PVC materials. SIMILARLY, the industry has been working to resolve any problem of vinyl chloride monomer migrating into the packaged food (or cosmetics) and believes that such migration, first detected three, yean ago when certain liquor was experimentally packaged in PVC. now has been corrected. Harding stated. Very little of the monomer remains in the PVC and steps have been takes by industry to reduce this content further, he related. Libyan Service Co. TRIPOLI (Reuters) -- Libya has set up a 100 million dinar Libyan oil services company. Libyan news agency ARNA reports. ! EC- 2451 18 July 1975, Volume 189, Number 4198 LITTtHS Vinyl Chloride and DDT; Environmental Effects The report of the AAAS Committee on Scientific Freedom and Responsibility, ab breviated as an article by John T. Edsall (16 May. p. 687), requires comment. The section entitled "The case ofdata suppres sion concerning the carcinogenicity of vi nyl chloride" (p. 690) contains omissions and errors that are inconsistent with the committee's concern for scientific freedom and responsibility. Since so much pertinent information has been omitted concerning this matter, readers may be misled into believing the report. Edsall states that, until May 1970, "there had apparently been no research in the plastics industry concerning the pos sible hazards of vinyl chloride___ " This is untrue. In fact, the basic published data on vinyl chloride toxicity came from Ameri can industry (/, 2). The information in (2) had been publicly disclosed and presented before their publication dates. Further more. the investigations of Viola and of Maltoni have been supported by European industries. Edsall correctly states that Manufac turing Chemists Association (MCA) mem ber companies entered into an agreement with the European sponsors of Maltoni's work not to reveal preliminary Italian data. The agreement was not dissimilar to those commonly made between American sponsors (government, industry, and aca demic) and research institutions that new data remain the property of the institution and that final results be disclosed through proper scientific channels when a study is completed and evaluated. There was no in tention of withholding adverse data. Under MCA rules, all data developed under its auspices must be promptly reported pub licly. Without exception, this has been done with all data on vinyl chloride. U S. government scientists knew of Maltoni's preliminary results early in 1973 but considered them to be as preliminary as did U.S. industry. At the Second Inter national Symposium on Cancer Detection and Prevention in Bologna, Italy, 9 to 12 April 1973, Maltoni showed a table of pre liminary results linking vinyl chloride with cancer formation (which was not published until 1974j (J). Umberto Safliotti, asso ciate director of carcinogenesis at the Na tional Cancer Institute, was present at the meeting and subsequently discussed the re sults with Maltoni at his Italian laboratory 14) Salhotti felt that the work should be included in "a well documented report" to be asses d by a review panel of the World Health Organization's International Agency for Research on Cancer (of which the United States is a member). This panel also considered Maltoni's data to be pre liminary at that time and "decided to post pone compilation of the definitive review to the next meeting of the committee" (4). After a period in which epidemiological and animal studies were being established, MCA, on 17 April 1973, asked the Euro peans to jointly make presentations to U.S. and European government author ities. The Europeans readily agreed, and on 15 June 1973, MCA called the National Institute for Occupational Safety and Health (NIOSH) and requested an oppor tunity to bring new information to that agency's attention. The appointment was set by NIOSH for 17 July. Five European and American industry representatives presented to NIOSH the information that tumors had been found in animals exposed to vinyl chloride concentrations below those that Viola had reported caused can cer in rats. At that time, no human cancer cases had been reported; therefore, no spe cial significance could be attached to the types of tumors observed by Maltoni. The precautionary label suggested by MCA and referred to by Edsall was illus trated in MCA's Chemical Safety Data Sheet (SD56) on vinyl chloride, revised in April 1972. Section 10.1 on "Health haz ards" refers to Viola's published studies. The Data Sheet states, "Recent research studies reported from Italy indicate that repeated, long-term high level exposures of rats to vinyl chloride monomer vapor can result in the development of malignant tu mors. However, many years of industrial experience with human exposures to con centrations frequently far above current standards have not demonstrated any car cinogenicity to humans." Thus the state ment by Edsall that MCA ",.. appears to have deliberately deceived NIOSH regard ing the true facts" is inaccurate and mis leading. Albert C. Clark Manufacturing Chemists Association. 1825 Connecticut Avenue. NW, Washington, D C. 20009 Rifcram 1. T. R. Torkctson. F. Oytn, V, K, Row*. Am. I*d. Hyg Assoc. / 22. 3M (1961* R. H Wilson, W t McCormick. C F. Tatum, J. L. Creech. / Am Med Assoc. 201. 577 (1967k ti. D BarcUa, R. D Stewart, J. E. Mulchler. Am fmd. //rr Ammt J J0.537 (1969). 2. h D Dinman, W. A Cook.W M. Whiichnuse, II. J MagnuMifi. T Dttvheck. An`k Envinm Heohh 22,61 (!97|>; W A Cook. P M (jiever. R I), Dmmafl. H. J Magnuson, ihid, p 74. V N. Ifctdw>n, B. t> Dinman. W. M. Whilehounc, A. N M. Niiw, H J. Magmison. ihid * p Hj; C. G. Kramer, and J I- Mulchler. Am tod Htt dunr J, .U 19 <1972). 1 (' Maltoni. F.trrcptQ Med tm i'omgt Set No 2?UI974).p 4 4 G Saffiotli. in (IS Senate, Committee on Com merce. Subcommittee on FfivinHimcnt, Vinii i Murid* (93rd Conprru. 2nd wanton. 1974k 191 %4 56. John T. Edsall errs in crediting DDT with halting a cholera epidemic in Naples during World War II. A National Acad emy of Sciences committee stated in 1970 (/) that "DDT has prevented 500 million deaths due to malaria that would otherwise have been inevitable." However, the Naples miracle involved typhus rather than cholera or malaria. It is unfortunate that Edsall selected an undergraduate student's term paper (2) as "a useful short history of the use of DDT," for several well-informed scientists have written articles and books on DDT which would be more appropriate sources for AAAS articles. He also refers to "the long persistence of DDT in soil," perhaps being unaware that Stringer et al. (3) found the half-life of DDT to be only 3 years in orchard soil after 17 successive years of heavy spraying. Edsall cites DDT's "pro gressive concentration in food chains" as having "led to the killing of great numbers of certain birds and fish"; however, the lack of food chain magnification, espe cially in marine environments, has been pointed out by Moriarty (4), Hamelink et al. (J), Harvey (d), and in two committee draft reports of the National Academy of Sciences (7). While Edsall did not recommend halting DDT use for malaria control, some "envi ronmentalists" are again seeking to halt all DDT exports from the United States. It is encouraging to see no such proposals in the AAAS committee report. J. Gordon Edwards Department ofBiological Sciences. San Jost State University. San Josi, California 95192 Rtfintii I. Committee on Science and Public Policy. The Lift Sciences (Nation*! Aadem> of Sciences. W ash* ington, D.C,, 1970). p. 432. 2- G. Mclntirtv Environment (Si Lorn 114 (No. 6V 14(1972). 3. A. Stringer. J, A. Pickard, C. H. Lvons. Feme Set 5,5*7 (1974V 4. F.Monarty, New Set. 53.594(1972). 5- J- L. Hamelink, R. C. Waybram. R. C. BalL Trans Am. Fisk.Soe. |00,2O7(|Q7R 6. G. R. Harvey, Octants I*. I9(W?4V 7. J. W. Kanwiihcr, "DOT m tbc marine environ* mem" (chairman's draft of an ad hoc committee report. National Academy of Sciences. Washing* ton. DX\. 1973V G. R Harvey. "DDT m the marine environment -A revten of present under* standing" (draft of an ad hoc committee report. National Academy of Sciences. W ashington. D C1973). I am glad to note that, as Clark's letter points out. there was research by Ameri can industry on the toxicity of vinyl chlo ride. beginning several years before In this work, however, what haw pro,ed to be the major hazards were not disco, et cl. if they had been, the later story would li.i, c been very different. I am obliged also lot Clark's correction regarding the piccaul'onarv label, winch did in tact make relerrnec to malignant tumors in rats pio- EC- 2452 duced by "repeated long-term high level exposures." The attitude expressed in Clark's letter, however, illustrates the ma jor point that caused concern to Lhe Com mittee on Scientific Freedom and Respon sibility. The extremely ominous findings in the animal studies did not trigger any ma jor alarm until cases of cancer in factory workers exposed to vinyl chloride began to be reported. This has been in the past the general attitude regarding such problems; I believe that it is now out of date. New re agents introduced into industry on a large scale should be regarded as dangerous un til proved safe. Precautions to protect workers from inhaling or absorbing them should be built in from the very start, rath er than being superimposed later, after damage has become apparent. Carcino genic substances usually take years to pro duce cancers; we should not wait for the cancers to appear in human subjects before taking action. Fortunately the work of Ames et al. (/) and others has shown that carcinogens are generally mutagens. Screening of chemicals for mutageni city can be carried out fairly rapidly. With the techniques available today we can thus often obtain an early warning of danger, but negative results on mutagenicity tests should not be cause for complacency. Highly toxic substances may be nonmutagenic. I thank Edwards and others for correct ing the erroneous statement that DDT brought a halt to a cholera epidemic. It was of course a typhus epidemic that was halted by DDT. How this error slipped through 1 do not know; the error is in any case mine, not that of the committee. This point will be corrected in all reprints. One can' add to the references cited by Edwards a recent review on insecticides by Jukes (2) which contains a vigorous de fense of the value and safety of DDT. Some of the environmental damage that has been charged to DDT was probably unreal or greatly exaggerated; some was probably due to other substances, such as the polychlorinated biphenyls (PCB's), which most analysts long failed to distin guish from DDT and its breakdown pro ducts. Nevertheless the official decision to ban DDT for nearly all uses in the United States was not arbitrary or capricious; it was taken after prolonged hearings, with presentation of a profusion of evidence by both sides. The case for using DDT in countries where malaria is a serious prob lem is far stronger. To my knowledge there is no adequate substitute for the'spraying of interior walls of houses with DDT solu tions as an essential element in a malaria control program. I would oppose any poli cy of denying such countries the ability to purchase and use DDT for these purposes. The need of the future, however, is to de velop less persistent and more specific pes ticides that cah be directed against a nar row range of target species, while doing little or no damage to others. John T. Edsall Biological Laboratories. Harvard University, Cambridge. Massachusetts 02138 Reference* 1. B. Ames, F. D. Lee, W. E Demon, Proc. Nall. Sri. US.A. 70.782(1973). 2. T. Jukes, NaturwUsmeha/itii *1,6 (1974). EC- 2453