Scientists oppose plan to expand biotech regulation

More than 60 members of the National Academy of Sciences (NAS) have written EPA Administrator Lisa Jackson to protest what they describe as a proposal "to further expand [EPA's] regulatory coverage over transgenic crops in a way that cannot be justified on the basis of either scientific evidence or evidence gained over the past several decades..."

The three-page letter, which also was signed by Nobel laureates James Watson and Gunter Blobel, among others, addresses a March 16 Federal Register notice in which EPA proposes a rule to codify data requirements for plant-incorporated protectants (PIPs). PIPs are pesticidal substances produced by plants, such as the Bt trait, as well as genetic material necessary for plants to produce such substances.

"Based on initial reviews of that draft proposal and recent EPA actions associated with biotechnology-derived crops, it is clear that the agency is departing from a science-based regulatory process, walking down a path towards one based on the controversial European 'precautionary principle' that goes beyond codifying data requirements for substances regulated as PIPs for the past 15 years," the scientists say.

They say they are "particularly troubled by proposals to expand EPA's oversight into areas such as virus resistance and weediness that have been adequately addressed by USDA since 1986. Already, EPA has expanded its oversight into virus resistance, which previously had been the purview of USDA's Animal and Plant Health Inspection Service (APHIS) and which EPA exempted from its regulations in 1994. With the draft proposed rules, EPA would further expand its regulations and data demands to other areas historically covered by [APHIS] without the slightest justification based on either data or experience."

The letter adds that it is "most troubling that EPA also is proposing to increase its regulation to cover matters which are still not deemed to be threats even after years of study, such as potential gene transfer from plants to soil microorganisms. In other actions, EPA has expressed its right to regulate plants engineered for altered growth (e.g., by suppression of ethylene production), the same way it regulates synthetic plant growth regulators. The agency does so based on a generous interpretation of the enabling legislation, despite the absence of any scientifically credible hazard."

The scientists warn in their letter that EPA's proposed regulatory expansion would: (1) create a duplicative regulatory system for very low risk products; (2) increase costs, reduce efficiency and prolong the review times, thereby discouraging innovation; (3) dramatically increase the hurdles already facing academic institutions and companies attempting to improve specialty crops; and (4) adversely affect trade in commodities produced by US growers because of the stigma attached to anything characterized as a "pesticide."