Top officials at the U.S. Department of Agriculture (USDA) announced last January that they are reviewing rules governing releases of genetically engineered (GE) organisms. Meanwhile, the National Research Council (NRC) of the National Academy of Sciences (NAS) and the Pew Initiative for Food and Biotechnology, both in Washington, D.C., issued reports reinforcing the notion that a careful review is warranted, while suggesting that some of the rules and procedural safeguards for releasing GE organisms are inadequate.

            USDA officials are promising to prepare a comprehensive environmental impact statement (EIS), according to Agriculture Secretary Ann M. Veneman. The effort is intended to verify that the regulatory system is “both rigorous and flexible, and based on sound science principles and mitigation of risks,” she says. That review will examine an

approach for regulating biotechnology that dates to 1986, when the USDA Animal and Plant Health Inspection Service (APHIS) was asked to frame rules for GE plants based on a federal law that, despite categorizing them as pests, proved workable.

            By now, officials within the APHIS Biotechnology Regulatory Services (BRS) have compiled considerable experience regulating GE plants--altogether reviewing more than 10,000 crop field tests and deregulating 61 GE plant varieties. With that track record, future field tests can be evaluated on the basis of criteria such as risk, familiarity, and intended use in the case of plants modified to produce pharmaceuticals or other useful chemicals, according to BRS Deputy Administrator Cindy Smith. As part of conducting the EIS, officials will also consider the value of exempting some GE organisms while freeing resources to review “new GE products with unfamiliar risks.”

            Meanwhile, experts outside USDA caution that several important questions about regulating GE organisms remain ambiguous while safeguards, which depend on confining some GE organisms while they are being evaluated or even after they are commercialized, might not be so robust as thought and thus demand careful appraisal.

            The NRC report, “Biological Confinement of Genetically Engineered Organisms,” which USDA officials commissioned, recommends that developers of GE organisms plan on using more than one confinement method to lower the chance of a failure--that is, a GE organism escaping and causing damage. For instance, the report considers biological methods for confining different classes of organisms, including microbes, for which it describes two main approaches. One approach involves engineering bacteria or fungi to use so much energy or nutrients that they could not compete with their native counterparts. However, the rapid adaptability of microbes raises uncertainties about the effectiveness of this method. A second approach involving a chemical to trigger “suicide” genes in microorganisms if they escape confinement has not been field-tested, the report notes.

            Most GE organisms “won't require confinement, but some will, and they should be evaluated on a case-by-case basis,” says NRC committee member Anne Kapuscinski, a biologist from the University of Minnesota, St. Paul. However, “ensuring confinement for some of these new organisms may become one of the requirements for regulatory approval,” committee members note. Appropriate assessments should come early during development, and developers should consider using integrated confinement systems and building redundancy into the approaches to reduce risks, she and other committee members say.

            Meanwhile, the report from the Pew Initiative, “Bugs in the System? Issues in the Science and Regulation of Genetically Modified Insects,” is more emphatic in cautioning regulators. It explicitly criticizes the current federal approach to regulating GE insects, says that lingering jurisdictional ambiguity among several federal agencies--including USDA--is problematic, and questions whether this system will measure up when it is asked to inspire public confidence and provide the scientific community with adequate guidance. 


Jeffrey L. Fox