09 August 2000

EPA Initiates Extensive Review of Genetic Plant Pesticides' Use

By Merle D. Kellerhals, Jr.
Washington File Staff Writer

Washington -- The U.S. Environmental Protection Agency (EPA) will undertake a comprehensive scientific and public review of its current approval for corn (maize) and cotton seeds genetically engineered to contain a gene pesticide that is widely used in the United States.

The reassessment is intended to assure that the decisions on the renewal of the approvals "are based on the most current health and ecological data," the EPA said August 9 in a Federal Register notice. The notice is on the Internet at
http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2000_register&docid=00-20174.

The EPA announcement is part of President Clinton's initiative announced May 3 to strengthen U.S. regulatory oversight of genetically engineered foods and to focus on current and future safety issues. The announcement also expands the level of public comment in the regulatory process.

The decision affects Bacillus thuringiensis (Bt) corn (maize) and (Bt) cotton seeds developed through the use of genetic engineering. Bacillus thuringiensis is a naturally occurring soil bacterium that acts as a pesticide when a Bt gene is inserted into selected corn and cotton genes.

Bt corn, which became commercially available in 1997, is resistant to the European corn borer insect, according to the U.S. Department of Agriculture (USDA). Bt cotton has been genetically altered to control the tobacco budworm, bollworm and pink bollworm. Neither genetically modified (GM) seed has been shown to present any human or animal hazards, according to USDA.

EPA is one of three U.S. agencies charged by federal law with regulating agricultural biotechnology products. Regulation is also provided by the USDA's Animal and Plant Health Inspection Service (APHIS) and the Food and Drug Administration (FDA).

Under the current regulatory process, EPA must approve the registration of a new pesticide before it can be sold or distributed in the United States. An EPA registration is a pre-market licensing of pesticides based on scientific evidence that they are safe and will have no adverse effects on human health.

EPA said it will publish its risk assessment of the two GM seeds for public comment and conduct a scientific peer review of its assessment by the EPA's Scientific Advisory Panel (SAP). Because the process announced August 9 will take additional time, EPA says it will extend the existing license approval of Bt cotton and Bt corn until September 30, 2001.

"EPA has strengthened resistance management requirements for both corn and cotton in the past year and believes these strengthened requirements, along with the original registration conditions, are more than adequate to be protective during the extension period," the EPA notice said.

The evaluation process requires five phases:

• First to complete the comprehensive risk assessments, which are currently under way.

• Second to seek scientific and public comment on the risk assessments by fall 2000.

• Third to incorporate comments from SAP, the National Academy of Sciences, public and the administration view by fall 2000 and winter 2000/01.

• Fourth to revise risk assessments and propose registration decisions by winter 2000/01 to early spring 2001.

• Fifth to issue final re-registration decisions by summer 2001.

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