News of the Week a number of additional provisions, such as ones giving the plaintiffs right-of-participation in developing the final rule and giving them a special comment period in addition to the normal public one or provide that the agency will do certain stud ies. Depending on the subject mat ter, the decrees can get fairly com plex, he notes. The new policy, according to Lucero, seems to say, "If you sue us, you're going to have to litigate it, as opposed to the agency, saying, 'You've got us. Let's try to find a way to solve it.' We're not going to settle up front." One area that Lucero doesn't see being affected by the new policy is settlement agreements that are entered into with responsible parties calling for the cleanup or payment for the cleanup of abandoned hazardous waste sites under the Superfund law. D
EPA fines biotech firm and stays test permit The Environmental Protection Agen cy has used the full weight of its authority to reprimand Advanced Genetic Sciences for violating its rules about testing genetically engi neered microorganisms. EPA will fine the company $20,000 and sus pend the experimental use permit for field testing AGS's product Frostban. The company has indicat ed it probably will pay the fine. The EPA enforcement action came quickly following an investigation into charges received in February that the company had violated agen cy guidelines by testing its geneti cally engineered bacteria outdoors. The fine is the largest EPA can ap ply in this case. The agency found that AGS had violated the guide lines four times and levied $5000 for each instance. Under the EPA decision, AGS will be required to provide the agency with new data before the suspension of the exper imental use permit can be lifted. The case involves an experiment done last year by AGS on fruit and nut trees to determine if its prod ucts, two genetically engineered bac teria variations of Psuedomonas fluo6
March 31, 1986 C&EN
rescens and Pseudomonas syringae that can reduce frost damage to plants, caused any harm to the trees. Al though company officials have stat ed that they thought they were doing nothing wrong, the experi menters violated EPA guidelines by injecting the bacteria into branches of trees on the open roof of the AGS facility (C&EN, March 24, page 17). In a letter to AGS president Jo seph A. Bouckaert following the in vestigation, EPA director of the Of fice of Pesticide Programs Steven Schatzow says that although the tests do not show any pathogenic effects attributable to the bacteria, they were conducted in such a poor man ner that EPA is obliged to suspend the field experiment permit. Schat zow added that there does not ap pear to be any problem with other experimental data submitted by AGS, and that the agency still be lieves release of the experimental bacteria in a field test will not re sult in any significant risk to hu man health or the environment. The company already is prepar ing to repeat the tree pathogenicity experiment, this time in a proper containment facility and under ad equately controlled conditions. The tree tests will take several months to complete and leave open when the time will be right for AGS to perform the field test again. Another problem EPA had with the earlier field test was its loca tion. The agency approved the test without visiting the proposed site, and it came to light later that it is near a residential area. As one of the conditions for allowing AGS to proceed with the test, EPA is asking that the company find a new site that is more acceptable to EPA rep resentatives and the local Monterey County, California, government, which had raised loud objections to the location of the proposed spray ing. Because of the delay caused by new testing and approvals, it is pos sible AGS won't be the first bio technology company to field test a genetically engineered product un der the new guidelines. Two other proposals, one from Monsanto and one from Steven Lindow of the Uni versity of California, Berkeley, are under review by EPA. Π
Human skin grown in lab for toxicity testing Toxicity testing using cultures of human skin could begin as early as this summer at the University of Michigan. Scientists there have de veloped a new way to grow cells from the outer layer of human skin in a laboratory dish. If the cultures can be employed successfully in tox icity and radiation testing, their use will provide an alternative to sub jecting animals to such tests. "The culture is designed to ulti mately replace animals in the stud ies," says Frizell Vaughan, associate professor of environmental and in dustrial health at the university's School of Public Health. "We're not at that stage yet, but [we hope] we will soon be able to reduce the num ber of animals used in toxicity testing." "We have started growing human skin but haven't yet started using it in toxicity tests," Vaughan says. Currently, the toxicity of a number of substances is being tested on epi dermal cells taken from rats and cultured in the lab. Future studies, using cultures of human skin, will examine the effects of cosmetics, household substances, dishwashing soaps, detergents, cleaning sub stances, and radiation. Standard cultures from epidermal cells haven't been adequate for tox icity testing because they are grown submerged in a fluid. The new method begins with the tissue cul ture submerged, where it grows for seven to 14 days. But then, the liq uid level is lowered so that the top surface of the culture is exposed to air. The culture, paper thin, is al lowed to grow for another 14 days with the top exposed to air and the bottom resting on a moist glass-fiber pad. The University of Michigan re search project is funded by the U.S. Army Medical Research & Devel opment Command and the Johns Hopkins Center for Alternative Test ing, which, in turn, receives funding from the cosmetics industry. The university notes that the skin cul ture could be used not only for tox icity testing but in studies of the way skin heals. D
