FDA proposes guidelines to regulate GE animals

November 13, 2008

FDA Division of Dockets Management
5630 Fishers Lane Rm 1061
Rockville, MD 20852

Re: Docket # FDA-2008-D-0394 Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs.

On behalf of the 45,000 member/owners of PCC Natural Markets, I’m writing to say that we oppose the genetic modification of animals for food and pharmaceuticals and the proposed guidelines for any such industry (FDA-2008-D-0394).

The FDA’s proposed guidelines will promote unfettered creation of genetically engineered (GE) animals and fish, whose natural species barriers have been crossed artificially. These guidelines do not take a precautionary approach to protecting the environment, the food industry, or consumers.

GM animals raise many ethical and food safety concerns, and it’s troubling that GM animals would be approved through a secretive process. Once approved, there would be virtually no recourse available to consumers. Although the FDA ultimately would release a summary of safety data, details would remain hidden as “confidential business information.”

We ask that applications for gene-altered food animals be aired through an initial public review process and — if commercialized — that the FDA strengthen its system of post-marketing surveillance to watch for unexpected outcomes. The FDA does not have sufficient authority now to address problems caused by GM animals if and when commercialized. This means the FDA would have no way to minimize impacts to consumers or the genetic pool of livestock.

Section II-B, for instance, says the FDA has the authority to decide whether a genetically modified organism “poses human, animal or environmental risk.” This perspective is flawed since there are no established criteria for determining if GM animal products are safe for consumption or not. There also are no minimum requirements for how long GM animals should be tracked or for how long people who consume GM animal products should be tracked.

In addition, the authority to test for food safety is given to the very companies developing GM animals. This is a clear conflict of interest and not sound science.

It’s also very misleading — and wholly unacceptable — that products from GM animals would not be identified by mandatory labels. Since our government says we must know whether our orange juice is from fresh or frozen, certainly consumers should know that mouse genes have been forced into pigs, spider genes into goats, and that cows are altered to produce antibiotics in their milk.

Such gross manipulations of food animals should be banned from the food supply entirely, but at the very least labeled. Consumers have a right to know what’s in their food supply and the right to an informed choice.

The dismissive attitude by FDA toward labeling is outrageous but consistent with its record. Numerous surveys over many years have confirmed that the vast majority of American consumers have less trust in government regulators than grocers, such as us, who make an effort to provide information about food. The surveys show that the vast majority of consumers want to avoid GM foods and they want mandatory labels.

These proposed guidelines — in cryptic language — would institutionalize new loopholes in an already slack oversight system and further erode public trust in a regulatory system that’s supposed to be the guardian of consumers’ interests.


Tracy Wolpert
Chief Executive Officer
PCC Natural Markets

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