The F.D.A. and Engineered Food
New York Times, October 13 2008
http://www.nytimes.com/2008/10/13/opinion/l13fda.html?ref=opinion

To the Editor:

We agree with you that the Food and Drug Administration's proposed regulation of genetically engineered animals is more rigorous than its regulation of genetically engineered crops or cloned animals. Unfortunately, however, the F.D.A. will not be as rigorous as it needs to be.

The agency may assess environmental impact, but it is not required to prohibit an animal that causes environmental damage.

Although the F.D.A. says it will protect the animal's health, we note that it approved the sale of milk and meat from cloned animals even though the data show that more than 50 percent of cow clones are born with an abnormality known as large offspring syndrome, which adversely affects their health.

Perhaps more important, the F.D.A. proposal has one glaring defect: there is no requirement to label food that comes from genetically engineered animals. Surveys clearly show that the vast majority of Americans want genetically engineered animals to be labeled as such. By not requiring labeling, the F.D.A. will take away a consumer's right to know and right to choose what she eats.

Michael Hansen
Senior Scientist, Consumers Union
Yonkers, Oct. 6, 2008

To the Editor:

The Food and Drug Administration's proposed policy is inconsistent and unwise. The introduction of a gene into an animal is not the same as the administration of a drug, and the F.D.A. has not previously required pre-market reviews of food or non-food animals that contain genes from disparate sources, such as the beefalo (a cow-bison combination) or mule (a horse-donkey genetic hybrid).

A better approach would be that taken for food products by the F.D.A.'s Center for Food Safety and Nutrition, which requires a pre-marketing safety review only for certain high-risk ingredients. These include any food additive that becomes a component of or otherwise affects the characteristics of a food if it is "not generally recognized as safe (GRAS) by qualified experts for its intended use."

Traditionally, the combination of two GRAS substances is also GRAS. Similarly, because adding a GRAS gene to a GRAS organism is likely to yield a GRAS outcome, an F.D.A. pre-marketing review would not be necessary for many animals with a newly introduced gene.

Henry I. Miller
Stanford, Calif., Oct. 5, 2008
The writer, a doctor and fellow at the Hoover Institution, was an official at the F.D.A. from 1979 to 1994.

To the Editor:

What is especially troubling about the Food and Drug Administration's decision to consider commercializing genetically modified animals is that consumers currently have no way of knowing which products sold in stores are, or contain, genetically modified organisms.

If the F.D.A. is going to introduce genetically engineered fish and beef into supermarkets, then transparency must extend to labeling. Regardless of whether the agency determines that the new organisms are safe, we have a right to the information that will enable us to choose whether we want to buy them.

Alissa A. Hamilton
Toronto, Oct. 5, 2008
The writer is a food and society policy fellow at the Thomas Jefferson Agricultural Institute.

To the Editor:

Your editorial identifies two major problems with the Food and Drug Administration's proposed regulation of genetically engineered animals: a totally secret process and the inability to address potential environmental issues.

Unfortunately, conducting public meetings and consulting with experts from other agencies cannot fix the fundamental flaws in the law that the F.D.A. is applying to regulate those products. Congress needs to step in and eliminate the current secrecy requirements, so the safety data submitted to the agency and the F.D.A.’s analysis would be provided to the public to review and comment on.

Also, Congress should give the F.D.A. (and other agencies) the legal authority to assess and address any environmental concerns engineered animals might pose. Only with Congressional help will the federal government be able to establish an open and comprehensive regulatory system for engineered animals.

Gregory Jaffe
Washington, Oct. 6, 2008
The writer is director of the Biotechnology Project, Center for Science in the Public Interest.