U.S. Eyes Regulatory Overhaul

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Since 1987, the USDA has overseen genetically modified organisms through the Animal and Plant Health Inspection Service. APHIS’s Biotechnology Regulatory Services (BRS) regulates GE organisms based on “plant pest risk.”

USDA has said it wants to make changes that ensure safety while making the process more transparent to the public, and more efficient and easier for the companies developing the technologies to navigate.

Still, the USDA has been formally debating regulatory changes for more than six years and issued proposed new rules in fall 2008, allowing public comment through last summer, as it must under the law.

The proposed overhaul drew more than 15,000 comments, many of them expressing fears that the regulatory changes as laid out would not address key concerns.

In one public comment, physician Amy Dean, a board member for the research and education group American Academy of Environmental Medicine which is seeking a moratorium on GM food, said the proposed changes would “significantly weaken or eliminate oversight of GM crops.”

And Robert Peterson, a Montana State University scientist and leader of the university’s “biological risk assessment” program, told regulators that while he agreed with some of the proposed regulatory changes, he thought the agency’s risk assessment protocols were “fundamentally flawed.

“Recent research reveals that the approach advocated by APHIS is not scientifically sound and can lead to bad decisions,” Peterson said.

At the FDA, genetically engineered organisms are treated much the same as foods from all other plant varieties.

GE developers are not required to consult with FDA on safety issues, and the agency sees no need now for risk-based monitoring efforts for GE crops because there are no current safety concerns, FDA spokeswoman Rita Chappelle said.

The agency stressed that the burden for ensuring safety lies with the companies. “Manufacturers have an obligation to ensure that their products continue to be safe each and every day,” Chappelle said.

At the EPA, officials also say the burden of proof is with the corporate developers of the technology. And they say they have at least 20 scientists conducting comprehensive analyses for the products that come before the agency, such as BT corn and BT cotton, which are altered to protect the plants against pests. The agency also routinely seeks outside advice from experts who sit on its scientific advisory panels.

Over the last several months, the EPA has also started allowing more public input into its review of new products.

Further to its mission of environmental protection, EPA officials said the agency reviews products every 15 years for adverse effects. EPA senior policy adviser Bill Jordan said glyphosate, the popular weed-killing chemical, could come under review soon.

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