Are GE Animals Coming to a Store Near You?

Recently, the Food and Drug Administration (FDA) paved the way for cloned animals to be sold for food. Now, with consumers outraged and food companies wrestling with the issue, the FDA is clearing the way for another controversial technology. The FDA has released draft guidelines outlining how it plans to regulate genetically engineered (GE) animals, including ones destined for the food supply.

Animals used for food are being engineered to alter their nutritional content, growth rate, or susceptibility to diseases associated with factory farming. Researchers are also attempting to create GE animals for many other uses, including for pharmaceutical production, as sources for tissues/organs for human transplant, and as research models and designer pets.

Genetic engineering, however, is not a predictable technology. Errors and unintended effects are common, which is why it takes hundreds to thousands of animals to make one GE animal who can be commercialized, and unanticipated diseases and pathological conditions are inherent throughout the process. For example, pigs genetically modified to grow faster and produce less fat were found to suffer many painful, unanticipated side-effects, such as crippling arthritis, liver and kidney damage, ulcers, diarrhea, protruding eyes, and reproductive abnormalities. Overall, less than one percent of genetic modification attempts are successful.

Because of concerns about animal welfare, environmental impact, consumer safety, and the ethical implications of genetically modifying animals, there is a pressing need to regulate this experimental technology. As such, AAVS welcomes the FDA’s proposal, as well as the U.S. Department of Agriculture’s (USDA) request for public input on the issue.

However, the FDA’s proposed guidance falls far short of the comprehensive regulations needed to protect human, animal, and environmental health, as well as the interests of consumers. Under the proposed plan, the FDA’s review process would be confidential, and GE animals could be on grocery store shelves, unlabeled, without full consideration of animal welfare impacts or a discussion about the ethics of genetically modifying animals. No approval should be granted for a GE animal until an open and public ethical discussion occurs concerning whether genetically engineered animals should even be developed for sale to consumers.

What You Can Do! 1) Please contact the FDA before November 18, 2008 and let the agency know that you want a public discussion on animal welfare and the ethics of genetic engineering before any GE animal is allowed on the market.

You may submit your comments online by clicking the first yellow "Add Comments" bubble on this page. A sample letter is provided below, but your letter will be more effective if you use your own words.

Or you can mail your comments to:

Docket No. FDA-2008-D-0394
Division of Dockets Management (HFA-305)
5630 Fishers Lane, Room 1061
Rockville, MD 20852

2) Then, please let us know you took action by filling out the form on this page.

Sample Letter

To Whom it May Concern:

I would like to take this opportunity to comment on the FDA's Draft Guidance for Industry: Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs (Docket No. FDA-2008-D-0394).

I am highly concerned that the FDA is rushing to allow GE animals on the market, perhaps even without labels, and that there is little to no opportunity for public input. Genetic engineering is a risky, experimental technology that causes a tremendous amount of animal suffering and death. The health and welfare of all animals involved in genetic engineering experiments need to be protected. Indeed, before allowing any animal to be genetically engineered, there needs to be a public discussion about the ethics of manipulating animals in this way and subjecting them to such risks. In the meantime, no food or other products from GE animals should be allowed on the market.

With an issue as controversial as genetic engineering, I strongly encourage the agency to initiate discussions with the public and with both the executive and legislative branches to address the animal health, welfare, and ethical implications of genetic engineering before any GE animal is approved for commercialization.

Sincerely,

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