EPA exempts Monsanto Bt soybean from residue limits

WASHINGTON, May 4, 2015—The Environmental Protection Agency (EPA) announced a final rule recognizing that a soybean developed by Monsanto genetically engineered to produce an insecticidal protein is safe to humans in any expected exposure.

Monsanto’s product, Intacta RR2 PRO soybean, is a soybean genetically engineered to express the protein naturally produced by the bacteria species known as Bacillus thuringiensis (Bt). The plant itself produces the protein that kills insects when they try to eat the plant, allowing farmers limit the practice of spraying pesticides.

EPA said the product is exempt from tolerance because the active insecticidal protein has already been thoroughly evaluated and has been determined to be safe for humans and animals at any relevant dose that could be achieved through the diet. Thus, no dietary tolerances (residue limits) are required for any crop.

EPA granted an exemption from the requirement to establish a maximum permissible level for residues of the Bt protein, Cry2Ab2, in or on soybean, according to the final rule written by EPA’s Jack Housenger, director of the Office of Pesticide Programs.

The final rule will be published in the Federal Register on Tuesday.

There are currently no Bt soybean varieties approved for commercial use in the U.S.

Monsanto and Dow AgroSciences both have Bt soybean varieties, which are primarily sold in South America. According to a Monsanto spokesperson, the federal register announcement is an experimental use permits the company is pursuing with the EPA.

“This will help support our efforts in South America with expanded seed production and breeding in the U.S., not cultivation or commercial sales,” Monsanto noted.

This story was updated on May 7, 2015.


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