US biotechs welcome proposed FDA GM test crop regulations

02 August 2002 19:35  [Source: ICIS news]

HOUSTON (CNI)--The US biotech industry Friday welcomed a proposed regulatory initiative by the Food & Drug Administration (FDA) to ensure greater safety in the development of genetically modified (GM) crops.

Lisa Dry, spokeswoman for Washington, DC-based Biotechnology Industry Organization (BIO), said the trade group's more than 1000 member firms are "wholly supportive" of the new regulatory process proposed earlier today by the Bush administration.

In a formal announcement in today's Federal Register, the FDA outlined its intent to establish a regulatory process involving a total of three federal agencies to ensure that development and field testing of new GM crops do not pose a risk to existing crop variants or to the public at large.

The proposed regulatory set-up would have the FDA along with the Environmental Protection Agency (EPA) and the US Department of Agriculture (USDA) involved in ensuring that various GM crop strains under development are completely safe for small-field testing.

The proposal put forward today by FDA on behalf of the other two agencies outlines the general principles and procedures each agency would take in ensuring that actual field tests of developing GM crop types are allowed only after the particular GM strain has been determined to not pose risks to nearby established crops or the human food chain in general.

BIO's Dry said the important feature of the proposed regulation structure is that "they [FDA, EPA and USDA] will look at GM crops earlier and [research and development] data packs earlier than under current federal policy."

In addition, said Dry, under the proposed regulation program, companies developing and testing GM crops "will get a letter from the FDA saying the altered food is safe for small-scale testing." This, said Dry, will "provide a higher degree of safety assurance for the industry and the public much, much earlier in the process."

The FDA is accepting comments on the proposed regulatory process until 30 September. Dry said the new regulatory program will likely be put in place by mid-2003.

By: Joe Kamalick
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