Priority plan urged for pesticides regulation Life cannot be made simple for the Environmental Protection Agency's Office of Pesticide Programs, and the pace of federal pesticide regulation can be speeded up very little, if at all, a National Research Council panel says in a new report. The office, faced with the task of reviewing and reregistering some 35,000 pesticides while at the same time registering new pesticides, urgently needs a plan of operation that will direct its attention at the earliest possible time to those pesticides whose uses present the gravest threats to public health and the environment, the panel says. Thus, the panel's first and most important recommendation is that the office review the 500-odd active ingredients used in registered pesticides and identify the ones that appear to be significantly toxic and in widespread use. Priorities then should be assigned to those active ingredients, determined by relative toxicity and extent of use. The panel says the office should consider registered pesticides for its Rebuttable Presumption Against Registration proceedings in order of the priorities assigned to their active ingredients. A related recommendation is that
the EPA office, early in its review of a pesticide, should identify alternative pesticides for its major uses. If any of them are presumed to present a potential toxic hazard and have not been reviewed, they should be reviewed as soon as possible. Further, the panel says, the office should abandon its attempts to produce numerical estimates of the effects of the use of pesticides on human mortality and morbidity, unless reliable human epidemiological data are available. Instead, the effect on public health of continued use of a pesticide or its alternatives should be presented in the form of estimates of the doses to which pertinent segments of the population would be exposed under the various regulations being considered. Included among the panel's other recommendations are that EPA staff members involved in reviewing a pesticide make routine visits to sites where it is applied and/or formulated and handled. It also recommends that estimates of both lifetime exposure and the economic benefits of a pesticide be based on a reasonable estimate of its economic life, and that estimates subject to substantial ranges of uncertainty be presented as a pair of numbers, one showing the exposure deemed most probable and the other the maximum exposure likely to be experienced. D
Clinical tests begin on insulin from bacteria Clinical testing of insulin produced by bacteria bearing the gene for human insulin has begun in the U.K. Dista Products, a U.K. subsidiary of Eli Lilly & Co., is conducting the tests. Lilly will apply soon to the U.S. Food & Drug Administration for permission to begin clinical tests in the U.S. Testing in this country could begin in September. In addition, Lilly has earmarked $40 million to build production facilities for such insulin in Indianapolis and at Dista Products in Speke, England. The firm expects the facilities to be on stream in 1982. Lilly has no estimate on when FDA might approve human insulin from recombinant DNA techniques for U.S. marketing. The U.K. clinical tests involve eight healthy nondiabetic volunteers. Skin tests so far have shown no immunological reactions to the product, according to Lilly research vice president Irving Johnson. And blood sugar lowering effects in the eight volunteers injected with five to 10 units per day are identical to those produced by comparable doses of animal pancreas insulin, Johnson says. 12
C&EN July 28, 1980
This application of recombinant DNA techniques to human insulin production comes at a time when Lilly, FDA, and the American Diabetes Association estimate that shortages of animal pancreas insulin may appear in 10 to 20 years. The number of Americans diagnosed as diabetics is increasing 4% per year, whereas the supply of animal pancreas insulin is not growing. Lilly estimates that there are 6 million diabetics in the U.S., of which 1.25 million are maintained on insulin. The supply of animal pancreases depends on fluctuating cattle and pig prices and on numbers of animals sent to slaughterhouses for meat. This development of recombinant DNA technology also comes at a time when Lilly has signed a consent decree requiring it to make certain patents and know-how on all insulin production available for licensing. According to the consent decree, signed Sept. 19, 1979, with the Federal Trade Commission, all patents acquired by Lilly from in-house research and from work done for it by other firms must be made available for the next five years. Know-how
gained from outside firms' work, but not from Lilly's in-house research, is also covered. Some of Lilly's patents and know-how in the area came from contractual work with Genentech, South San Francisco, Calif. (C&EN, March 17, page 15). The decree covers insulin produced from bacteria as well as from animal pancreases. D
Ethical aspects of science to be studied The National Science Foundation is pairing up with the National Endowment for the Humanities to sponsor two programs to study the ethical dimensions of science, engineering, and medicine. Sixteen grants, totaling just over $500,000, have been awarded. Present plans are to continue the project at about this level for at least the next few years. With the exception of medical ethics, the ethical questions that underlie development of science and choices that are made in adopting a technology have received very little investigation, an NSF program administrator explains. The new programs will try to get scientists to think about the ethical questions involved in their work, and social scientists and philosophers to look more closely at science as an arena where ethical decisions are made. The aim is to make both groups better able to make informed comments on the issues of scientific ethics. The first awards fall into two categories. Twelve are for individual research projects that team a humanities scholar with a scientist specialist to examine a particular issue. For example, a civil engineer at Howard University in Washington, D.C., will work with a philosopher at Rensselaer Polytechnic Institute in Troy, N.Y., to examine the ethical decisions engineers make in the design, construction, and maintenance of high-technology projects. Another award teams a philosopher from Mills College, Oakland, Calif., with a biologist from San Francisco State University to investigate the ethical considerations in the theory and practice of biological research. The other type of award is called a sustained development grant. Four of these have been awarded to develop permanent university programs to study the ethics of science, technology, or medicine. These programs will be set up at the University of Delaware; the University of California, Santa Cruz; Dartmouth medical school; and Cornell University medical college. D
