2006P-0415 Petition Seeking Regulation of Cloned Animals
FDA Comment Number : EC227
Submitter : Ms. Jocelyn Emerson Date & Time: 01/03/2007 10:01:53
Organization : Boston University
Category : Individual Consumer
Issue Areas/Comments
Andrew C. Von Eschenbach
Acting Commissioner
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061 (HFA-305)
Rockville, MD 20852

Dear Commissioner Von Eschenbach,

I would like to express my support for the petition submitted by the Center for Food Safety, the American Anti-Vivisection Society, and several other animal welfare, consumer, and environmental organizations seeking regulation of cloned animals (Docket Number 2006P-0415).

Given that the safety of food from cloned animals has not been rigorously tested for safety in terms of human consumption over an extended period, I believe it is not in the best interest of the American public to make this food available until the appropriate rigorous, scientific testing has been done.

I also have numerous serious concerns about the effects of animal cloning on animal welfare and the environment. The FDA needs to address these concerns thoroughly before deciding if cloned animals can be approved for the marketplace.

It's clear from the available data that cloning is neither safe nor effective for the cloned animals or the surrogate mothers. On average, only 0.4-5% of cloned embryos will be delivered, and of those that survive, severe health problems and abnormalities are common.

Although these health problems may also occur with animals who are conceived using assisted reproductive technologies such as artificial insemination, cloned animals suffer from these problems at a far greater, and extremely alarming, frequency. For example, approximately one-third of the cloned animals who survive birth will die from health complications within 6 months, compared to only 5% of artificially inseminated or naturally bred animals. The significance of such an increase in health risks needs to be studied before food products from cloned animals enter the food supply.

Like the majority of Americans, I have serious ethical concerns regarding animal cloning; the FDA must consider the complex ethical issues before making decisions on animal cloning. Just because a food can be produced does not mean that it should or that it is the best way to meet peoples' needs.

In addition, given the lack of data, there isn't a sound basis on which the FDA can ensure that milk and meat from cloned animals is safe for human consumption. Lack of data is not the same thing as evidence of safety.

I also have concerns about the impact that the widespread introduction of cloned animals would have on biodiversity, ecosystems, and the environment in general. Evidence regarding the unintentional migration of genetically modified plants and seeds indicates that containment and control of these technologies is really a chimera.

These are significant issues that need to be addressed through the new animal drug application process, the preparation of an environmental impact statement, and the establishment of an ethics Advisory Committee. These steps are necessary to maintain my trustin the FDA's ability to ensure my safety and represent my interests as a consumer.


Jocelyn Emerson