Bridges Trade BioRes • Volume 8 • Number 17 • 3rd October 2008
US launches guidelines for GM animal approval
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The US Food and Drug Administration (FDA) is putting in place guidelines for the regulation of genetically modified (GM) animals for human consumption.
On 18 September, the FDA announced draft guidelines for the regulation of GM animals, paving the way for their commercialisation. The guidelines are up for public comment until 18 November. While the biotech industry welcomed the draft rules as a large boost for this nascent industry, consumer groups expressed concerns. GM animals are modified to become disease-resistant, grow faster, contain health promoting substances such as omega-three fatty acids, or produce medicines. Often referring to the products as “Frankenfoods,” consumer groups have raised a range of environmental, ethical and health concerns.
The public is especially worried about the secrecy of the approval process, which would not be open to the public, but rather geared towards the needs of industry to protect trade secrets. “The first time that the public will learn about a genetically engineered animal will be the day it is approved,” said Margaret Mellon of the Union of Concerned Scientists. “This requires that you completely trust the FDA to do this right, and I don’t think folks trust FDA that much.”
In addition, only food with altered qualities would be required to be labelled as derived from GM animals. The labels would provide information on the health benefits of the foods, for example, while foods derived from faster-growing or disease-resistant GM animals need not be labelled.
As with GM plants, exported food produced from US GM animals — especially if unlabelled — may meet resistance among consumers in trading partners.
“Rules on Bioengineered Animals,” WASHINGTON POST, 18 September 2008; “FDA Plans Rules for Modified Food Animals,” WALL STREET JOURNAL, 19 September 2008; “FDA Releases Draft Guidance On Genetically Engineered Animals,” FORBES, 19 September 2008.
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