USDA needs tougher biotech reviews


WASHINGTON – The USDA should more rigorously review the potential environmental effects of new transgenic plants before approving them for commercial use.

That’s the recommendation from a new report from the National Academies’ National Research Council and commissioned by the USDA.

But while USDA’s Bobby Acord, administrator of the Animal and Plant Health Administration, responds that it is reassessing options for monitoring already commercialized transgenic plant products, “new transgenic plants receive greater regulatory scrutiny than conventional plants,” a fact duly noted by the report.

While the committee called for an enhanced regulatory process for transgenic plants, it also noted that the current level of regulation for such plants is higher than for other agricultural products and practices. There is typically no formal assessment of potential environmental effects of newly introduced crop varieties produced by conventional breeding.

The report authors indicated there is no immediate need to regulate conventionally bred crops, but their potential environmental effects should be re-evaluated.

Yes, but … Yes, the report says, USDA has improved its regulation of transgenic plants, “but the process could be improved further by soliciting greater public input, enhancing scientific peer review, and more clearly presenting the data and methods behind regulatory decisions,” said committee chair Fred Gould, entomologist at North Carolina State University.

The Animal and Plant Health Inspection Service – the arm of USDA responsible for regulating transgenic plants – reviews about 1,000 applications each year from biotechnology companies wishing to field-test new transgenic plants or petitioning to have a plant deregulated altogether.

Field-testing of most transgenic plants is approved through the “notification” process, whereby applicants notify APHIS that a plant meets general guidelines for not causing unwanted environmental effects. If the agency agrees, the plant can be grown while the company conducts further field-testing to rule out adverse environmental effects.

But, the report authors criticized the USDA because there is no public or independent scientific input in this process, and no limit to the acreage that can be planted.

At the same time, however, the committee called notification an important step in effectively streamlining the field-testing review process. In fact, given what APHIS has learned about certain plant traits, it should be able to quickly screen many of the current generation of transgenic plants for potential environmental risks.

Few comment. Most biotech companies commercialize transgenic plants by petitioning for non-regulated status – in essence requesting APHIS to determine that there is no environmental risk associated with a specific transgenic plant. As part of this process, APHIS always conducts a formal environmental assessment that it publishes in the Federal Register, providing the public with a 60-day comment period.

But the committee found that almost no one comments. It recommended APHIS solicit external scientific and public review well beyond the use of the Federal Register, and that the agency should convene a scientific advisory group before any changes in regulatory policy are made.

The report authors also recommended the agency either increase the rigor of its analysis of pest resistance and impacts on non-target species, or completely defer to the U.S. Environmental Protection Agency, which also assesses these risks.

Post-testing. Because APHIS considers deregulation final, it does not conduct post-commercialization monitoring for environmental effects. The committee recommended that such monitoring take place to validate the pre-commercialization environmental testing and to spot unanticipated or long-term environmental impacts.


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