The U.S. Environmental Protection Agency (EPA) next month will propose relaxed controls on field tests of genetically altered creatures. Genetic alteration of living things--a technique sometimes called gene splicing, or genetic engineering, or recombinant DNA, and known generally as biotechnology--gives new characteristics to the altered creatures. The new characteristics are permanent and are passed on to successive generations. The alterations are intended to make the creatures more useful to humans (and thereby more profitable to the people doing the altering). The U.S. Patent Office ruled last year that genetically altered creatures can be patented, thus opening the way for large profits to be gained from biotechnology. The first patent on a genetically-altered creature (a mouse) was awarded to Harvard University earlier this year.

The potential benefits from biotechnology appear to be large. But the potential for unanticipated harm may also be large. Genetic mechanisms are complex, so it is difficult to gain confidence that one can predict all the changes that will occur in a living creature when its genetic structure is altered.

Since most of today's environmental problems have been caused by unexpected side-effects of new technologies, people are understandably concerned that biotechnology should be carefully controlled and that genetically-altered creatures should not be released into the environment before their safety has been established.

The Reagan administration two years ago set up a framework for control of biotechnology. The Agriculture Department has responsibility for altered plants and animals on farms; the Food and Drug Administration regulates creatures intended for pharmaceutical use; and the EPA is responsible for bacteria and viruses intended for use as pesticides, fertilizers, and industrial products. These agencies have overlapping responsibilities.

Next month the EPA will propose to relax its rules governing small-scale field experiments in which genetically-altered creatures are released into the environment to see what effects they may have. To date, four such field trials have been conducted and a fifth is nearing completion now. The proposed rules would relax control over experiments in which genes were transplanted from one microbe to another very similar microbe. The relaxation of control would not affect experiments involving transplant of a gene from one species to another, or experiments where hazards were anticipated.

Under the EPA's proposal, companies conducting outdoor experiments in which no hazard is expected would have to file much reduced paper work with the EPA; in some cases, the EPA would not have to be notified of experiments at all.

Under the proposed new rules, authority for reviewing and approving small field trials would be transferred to permanent committees of experts established by biotechnology companies and universities. In other words, the experimenters would be given permission to regulate themselves.

The EPA says it is proposing the rule change because a consensus is developing among practitioners that some classes of altered creatures are not as hazardous as federal regulators had initially feared. Critics of the proposed rule change point out that a handful of field trials do not provide a scientific basis for changing the rules. Furthermore, asking the companies to regulate their own activities puts them in a conflict of interest position. There are enormous profits to be made from biotechnology and it is a fiercely competitive business. Pressure to cut corners is always present, and the EPA seems to be inviting trouble by relaxing the rules. For further information, contact Ronald Evans, Biotechnology Project Manager, Chemical Control Division, Toxic Substances Control Office, U.S. EPA, 401 M Street, SW, Washington, DC 20460; phone (202) 3823856.
--Peter Montague, Ph.D.

Descriptor terms: epa; biotechnology; dna; doa; fda; regulation; proposals; ronald evans;