Federal Reviews of Bioengineered Crops
Deemed 'Superficial'

JILL CARROLL / Wall Street Journal 21feb02

WASHINGTON -- The National Academy of Sciences, in a study on how the government evaluates possible environmental risks posed by bioengineered crops, said federal regulators provide only superficial reviews of some crops and keep too much information confidential to protect corporate trade secrets.

The report, which could be released as soon as Thursday, found that the Agriculture Department's review of crops that contain pesticides is "generally superficial" when it comes to assessing their effects on other organisms and in making bugs resistant to pesticides.

The academy, however, praised the USDA for "substantially" improving its review process as more is learned about genetically altered crops. In a blow to some environmental advocates critical of bioengineering, the report finds that the department has adequate regulations to deal with such crops, in which scientists have introduced genes that give plants desirable traits such as resistance to pests.

The report's findings could add fuel to the debate over bioengineered crops. They are expected to carry significant weight in the scientific community and likely will prompt changes in USDA procedures.

Companies developing genetically altered crops need approval from the USDA's Animal Plant Health Inspection Service in order to test the crops outdoors before selling them. The inspection service reviews about 1,000 applications for testing bioengineered crops a year. The USDA is developing new rules for reviewing gene-altered crops after Congress updated a major plant law to account for the new types of crops.

The USDA couldn't be reached for comment late Wednesday night.

Opponents of biotech crops say the USDA and other agencies have cobbled together an ineffective regulatory regime for such food from old laws adopted before genetic engineering was developed.

In an executive summary of the report, the academy said the USDA's review process for genetically altered crops needs to "be made significantly more transparent and rigorous" with more public input and evaluation by outside scientific experts. It said the amount of information kept secret because it is considered proprietary "hampers external review and transparency of the decision-making process." The report noted that it wasn't clear if the USDA has the power to lessen the amount of information kept secret, but that agencies in other countries aren't as restrictive.

The academy recommends the USDA convene an advisory committee before changing regulations and seek other input to dispel the perception that it is "only superficially responsive to comments" made from outside groups about the review of genetically altered crops.

The report also said the USDA needs to start evaluating the environmental impact of plants with multiple altered genes. In addition, improvements in genetic mapping mean the USDA should look at the entire genetic sequence of an altered crop, not just parts of it, as is done under current practice, the report said.

"I think they certainly make the case that USDA is ill prepared for the future," said Richard Caplan, an environmental advocate at the U.S. Public Interest Research Group, a consumer and environmental advocacy group.

Regulation of Transgenic Plants Should Be Reinforced
Field Monitoring for Environmental Effects Is Needed.

NAS Press RElease 21feb02

WASHINGTON -- The U.S. Department of Agriculture should more rigorously review the potential environmental effects of new transgenic plants before approving them for commercial use, says a new report from the National Academies' National Research Council. The committee that wrote the report also said the public should be more involved in the review process and that ecological testing and monitoring should continue after transgenic plants have entered the marketplace.

Appropriate environmental risk analysis and public acceptance of transgenic plants depend on a federal regulatory system and culture that communicates to society the seriousness with which potential environmental risks are being addressed, the report emphasizes.

"USDA has substantially 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, William Neal Reynolds Professor of Entomology, North Carolina State University, Raleigh. "Our report provides a detailed road map for the federal government to follow as it reinforces its assessment of environmental risks."

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. This is the case despite the fact that the committee did not find any strict distinctions between the types of environmental risks posed by plants genetically engineered through modern molecular techniques and those modified by conventional breeding practices. There is typically no formal assessment of potential environmental effects of newly introduced crop varieties produced by conventional breeding. There is no immediate need to regulate conventionally bred crops, but their potential environmental effects should be re-evaluated.

The Animal and Plant Health Inspection Service (APHIS) -- 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 there is no public or independent scientific input in this process, and no limit to the acreage that can be planted.

There also is a need to re-examine which transgenic plants should be tested and allowed to grow commercially through notification, the committee said. It discovered one case, for example, where it appears that a variety of corn that produces a protein with insecticidal properties, known as avidin, was grown commercially under the notification process.

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. More detailed investigations should be conducted only when preliminary testing indicates a possible risk.

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 said that before making precedent-setting decisions regarding field-testing or deregulation, APHIS should solicit broad 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.

Some transgenic plants are engineered to produce a pesticide, which could potentially harm or kill non-target organisms or allow pests to develop immunity to the pesticide. However, the committee found that APHIS's treatment of these two issues in its environmental assessments is generally superficial. The agency should 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.

Because APHIS considers deregulation final, it does not conduct post-commercialization monitoring for environmental effects. The committee said that without systematic monitoring, however, there is no way to ensure that environmental damage has not occurred. It recommended that such monitoring take place to validate the pre-commercialization environmental testing and to spot unanticipated or long-term environmental impacts. Large-scale planting might cause environmental effects or impact non-target organisms in ways that could go undetected in the pre-commercialization testing phase. Validation testing can be carried out through existing USDA programs, but field-monitoring will require the development of an interactive program involving government agencies and academic scientists. Additional funding will be needed in both instances.

The study was sponsored by the U.S. Department of Agriculture. The National Research Council is the principal operating arm of the National Academy of Sciences and the National Academy of Engineering. It is a private, nonprofit institution that provides science and technology advice under a congressional charter. A committee roster follows.

The report Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation is available on the Internet at http://www.nap.edu. Copies are available for purchase from the National Academy Press; tel. (202) 334-3313 or 1-800-624-6242. The cost of the report is $49.95 (prepaid) plus shipping charges of $4.50 for the first copy and $.95 for each additional copy. Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).

NATIONAL RESEARCH COUNCIL Division on Earth and Life Studies Board on Agriculture and Natural Resources Board on Life Sciences

source: http://www4.nationalacademies.org/news.nsf/isbn/0309082633?OpenDocument 21feb02