Field tests inch toward EPA approval - field tests of genetically engineered microbes

Science News, May 4, 1985

Field tests inch toward EPA approval

The Environmental Protection Agency has completed its evaluation of three of the first notifications it has received of proposed field tests of genetically engineered microbes. In each case, the agency decided that an "Experimental Use Permit' (EUP) must be obtained from EPA before testing begins.

Although EPA does not usually require such permits for small-scale field tests of pesticides, the agency is "concerned that nonindigenous and/or genetically altered microbial pesticides may replicate and spread beyond the site of application with potential adverse effects,' Steven Schatzow, director of EPA's Office of Pesticide Programs, told a congressional subcommittee. EPA has asked for additional specific information from the Monsanto Co. of St. Louis, which wants to test a soil bacterium engineered to carry an insecticide (SN: 12/15/84, p. 373), as well as from Steven Lindow of the University of California at Berkeley and from Advanced Genetic Systems, a Berkeley company--both have proposed tests of a bacterium intended to protect crops from frost damages (SN: 8/27/83, p. 132). Previous approval to Lindow by the National Institutes of Health Recombinant DNA Advisory Committee has been tied up in litigation (SN: 3/9/85, p. 148).

"We're obviously a little disappointed,' says David Crosson of Monsanto. "We had planned on going to field in May. Now we assume there will be a delay, but we don't know how much.' The Monsanto research team is planning to meet with EPA officials to determine whether additional experiments will be necessary, or whether the regulators' questiona can be answered from the 800 pages of information already submitted. Crosson says that by requiring an experimental use permit, EPA sets additional reporting requirements and obtains some inspection rights.

"The decision to require an EUP would ensure that testing will be conducted in a manner least likely to result in unreasonable adverse effects on the environment,' Schatzow says. ". . . the types of information required also would be supportive of future product registration. "Schatzow told SCIENCE NEWS, "[Applying for an EUP] should not be a particularly onerous burden. If they provide the information to meet our concerns, it will be approved.'