FDA bans bottle made of acrylonitrile - C&EN Global Enterprise (ACS

As it promised, the Food & Drug Administration last week banned the use of plastic beverage containers made with acrylonitrile. Monsanto, the largest ...
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sociated with the University of Montreal. Davignon said that this trial shows that the new drug is effective in most hypercholesteremic patients, is safe, and produces a further cholesterol-lowering effect after serum lipid levels have been reduced by a diet low in saturated fat. Dow's new drug puts the company in a $35 million U.S. market dominated by clofibrate, a substance structurally related to estrogen first reported by Imperial Chemical Industries in the U.K. in 1962. Lorelco's own discovery in 1964 came out of a screening program by Dow on compounds from Consolidation Coal, now a division of Continental Oil. D

FDA bans bottle made of acrylonitrile As it promised, the Food & Drug Administration last week banned the use of plastic beverage containers made with acrylonitrile. Monsanto, the largest U.S. maker of the bottles, promptly sued the federal government seeking removal of the ban. At the same time the agency announced that it will change its regulations for other acrylonitrile-based plastic food packaging to reduce the amount of the monomer that gets into foods such as margarine, vegetable oil, and other nonbeverage products. FDA previously justified its action by citing industry-supplied data that showed that when fed to animals in large doses, acrylonitrile caused toxic effects and pathological changes (C&EN, Feb. 21, page 8). Coca-Cola is the only U.S. soft drink maker to use the Monsanto bottle, called Cycle-Safe. Another firm, Musselman Fruit Products, has sold its fruit juices in acrylonitrilebased containers made by BorgWarner Corp. The Monsanto bottle is made from an acrylonitrile-styrene copolymer called Lopac. In announcing its ban, FDA said that it would not recall Coke bottles already on grocery shelves, since the bottles are not yet in widespread use, and because animal studies only showed toxicity at dose levels that "exceeded by far the amount to which any consumer would be exposed." Coca-Cola has marketed its 32-oz plastic bottle in 11 states. Three weeks ago, in the wake of FDA's promise of a ban, Monsanto closed its three bottle-making plants and one plastic resin plant. Monsanto executive vice president E. S. Bauer calls the FDA action "regrettable and unwarranted for a number of reasons." In its petition to the U.S. Court of Appeals for the

District of Columbia, the firm objected on scientific grounds that FDA has not established that there is any migration of acrylonitrile into beverages. Bauer also declared that "if we had any question about the safety of these bottles, we would have voluntarily stopped making and selling them." Ironically, almost at the same time that FDA announced its ban on the bottles, Canadian health officials

approved the use of acrylonitrile in containers for everything except alcoholic beverages. In Atlanta, a Coca-Cola spokesman says that the firm has ordered all its plants to stop using the Cycle-Safe bottle, even though the company says that "all evidence is that this bottle . . . is totally safe." Coca-Cola says it doesn't know if it will resume using the bottles even if the Monsanto suit succeeds. D

Academy forum airs DNA research dilemmas Like a typical March, last week's three-day National Academy of Sciences forum on research with recombinant DNA, held in Washington, D.C., began on a blustery note. The forum—the fifth in a series designed to aid in resolving dilemmas in science—invited scientists, government officials, and a variety of interested citizens to join in discussions that included formal lectures, case history presentations, and open workshops. Critics jumped quickly into the fray, demanding that the forum agenda be "totally redirected toward the basic social and moral issues of recombinant DNA." Cochairman David A. Hamburg, president of the academy's Institute of Medicine, pointed out that major last-minute changes in the agenda were not feasible, but the program's workshops permitted unusual flexibility. Though the meeting threatened to deteriorate into banner waving and cat-calling, Hamburg's patience under fire helped calm the opening session. The forum's workshops and freewheeling discussions did prove to be open and flexible. Most speakers responded to a demand that they specify their sources of support—only to prove that no illicit sources of income beyond grants and occasional retirement benefits were available to the majority of recombinant DNA scientists. More serious discussions ranged widely—from the effectiveness of physical and biological containment, for example, to the ethical and moral issues at stake. The question of continuing any recombinant DNA research is pivotal to critics. For example, a new group called the Coalition for Responsible Genetic Research held its own news conference last week to call for an "immediate, international moratorium on all research that would produce novel genetic combinations between distant organisms." Members of the group, such as Harvard biologist George Wald, say the big question is whether scientists should follow this line of research at all.

Hamburg: patience under fire

Eîut there is no accord on stopping the research. Those engaged in recombinant DNA research now permitted under NIH guidelines say that doubts cannot be resolved until further information is obtained. To do that, research should continue, under the guidelines. It seems increasingly clear, however, that recombinant DNA techniques will be under continued and growing scrutiny. Indeed, many scientists, including several industrial spokesmen, are beginning to welcome federal regulations as inevitable, and preferable to a series of fragmented local statutes. Congressional hearings, which begin this week, will look into federal regulation of recombinant DNA research. D

Dow details costs of federal regulations Dow Chemical has added some specifics to its complaints of overregulation of business activities by the federal government. In what appears as a consequence of various company conflicts with regulatory agencies, Dow has estimated details of costs it incurred during 1975 in dealing with March 14, 1977 C&EN

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