Cloned animals

GROUPS TELL FDA, KEEP FOOD FROM CLONED ANIMALS OFF OUR DINNER PLATES

Legal Petition to FDA Highlights Unresolved Food Safety, Animal Welfare and Ethical Issues and Calls for a Federal Moratorium on Cloned Food

FOR IMMEDIATE RELEASE
October 12, 2006

CONTACT: Center for Food Safety, Joseph Mendelson or Jaydee Hanson, (202) 547-9359; Will Rostov, 415-826-2770

Washington, DC – The Center for Food Safety, along with reproductive rights, animal welfare, and consumer protection organizations, today filed a legal petition with the Food and Drug Administration (FDA) calling for a moratorium on the introduction of food products from cloned animals. While the biotechnology industry is rushing to commercialize cloned food, there is serious scientific concern about the food safety of products from clones. Moreover, many are concerned that the cloning process results in deformities and other animal health problems that bring new animal cruelty issues to agriculture. The petition also asserts that Americans do not want to eat cloned food and many have strong religious and ethical objections to animal cloning which should be addressed in the regulatory process.

“Cloning is completely unnecessary and will increase animal cruelty in food production, yet the industry wants to test their cloned foods on the American public,” said Joseph Mendelson III, Legal Director for the Center for Food Safety (CFS). “We believe that all Americans want to protect our children from these potentially unsafe foods and would reject cloned foods that jeopardize animal welfare protections.”

The petition calls on FDA to enact a moratorium on foods produced from cloned animals and establish mandatory rules for pre-market food safety and environmental review of cloned foods. The petition also calls for the Department of Health and Human Services to establish a federal review committee to advise FDA on the troubling ethical issues raised by animal cloning.

Recent polls show that Americans would refuse to buy food from cloned animals, and that Americans have serious concerns about the ethics of animal cloning. An independent poll last year found that 2/3 of Americans are uncomfortable or strongly uncomfortable with animal cloning, and 77% were unsure about the safety of cloned food, including 43% who stated that cloned food would be unsafe. A food industry-sponsored poll last year similarly found that 63% of Americans would not buy cloned food, even if FDA deemed the products safe.

The safety of food from clones is far from assured. The legal petition filed today notes that there is scant data on the safety of food from clones, and that cloned animals are often unhealthy and can have hidden health defects that may lead to food safety risks. A 2004 New England Journal of Medicine report stated that “[G]iven the available evidence, it may be exceedingly difficult, if not impossible, to generate healthy cloned animals….” In 2003, FDA’s draft assessment on cloned food safety relied on just a single study on cloned milk, and no studies on meat from cloned animals. A 2004 National Academy of Sciences report said that the safety of cloned food could not be asserted because “the paucity of evidence in the literature on this topic makes it impossible to provide scientific evidence to support this position.”

Despite the lack of safety data, the biotechnology industry is rushing to market food from cloned animals. FDA has no regulations prohibiting the sale of food from cloned animals; in 2003, the agency asked cloned animals to keep their food products off the market voluntarily. But last year, the Associated Press reported that one cloning company had cloned pigs and beef cattle ready for commercialization. Cloned dairy cows have been producing milk on farms in the U.S. for at least five years, and some in the cloning industry have suggested that they may disregard FDA’s request.

Animal welfare organizations also strongly oppose cloning, as recent cloning research has resulted in high failure rates, premature deaths, and such abnormalities as intestinal blockages; diabetes; shortened tendons; deformed feet; weakened immune systems; dysfunctional hearts, brains, livers, and kidneys; respiratory distress; and circulatory problems. "The Humane Society of the United States is committed to scientific advancement, but only that which has a legitimate social value and improves--not decreases--animal welfare, two critical components lacking in the case of developing commercial cloning of farm animals," said Wayne Pacelle, President and CEO of HSUS, a co-petitioner on today’s legal filing. "As recently as June 2005, an FDA representative stated that cloned animals were more likely to suffer birth defects and health problems when very young, demonstrating these problems have not been resolved."

Religious and reproductive rights groups also oppose cloning for food production. "Supporters of reproductive choice know that this technology has nothing to do with women’s health,” said Reverend Carlton W. Veazey, President and CEO of the Religious Coalition for Reproductive Choice. “Animal cloning companies are not interested in promoting healthy options for women; they are seeking quick profits from food experiments that raise troubling ethical concerns.” In 2001, more than 100 reproductive rights and women's health organizations called on Congress to ban human reproductive cloning.

Previously, many religious organizations have raised ethical objections to new genetic technologies. In 1995, more than 200 U.S. religious leaders, including those from the Protestant, Catholic, Jewish, Muslim, Hindu and Buddhist faiths, announced a joint opposition to the patenting of animal genes, tissue, organs, and organisms. The groups cited their belief that genetic manipulation and life patenting shifted “authorship” of life from ‘God’ to scientists and lab-technicians. The petition today asserts that these widespread and strongly held beliefs, along with animal cruelty and other concerns calls for broad public participation before animal cloning is used for greater industry profits.

The CFS petition asserts that, under the Federal Food and Drug Cosmetic Act (FFDCA), any animal clone intended for food should be regulated as a new animal drug. Under the FFDCA, the term “drug” means any “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” Petitioners argue that cloning fits within this broad definition. FDA is already regulating genetically engineered animals as new animal drugs under this provision of the FFDCA, and the agency has told Congress that any human cloning research could not proceed without a similar investigational new drug review under FFDCA.

Also joining CFS in petitioning FDA today are the Consumer Federation of America, Food and Water Watch, Friends of the Earth, the American Anti-Vivisection Society, Humane Society of the United States, the Religious Coalition for Reproductive Choice and the Center for Environmental Health. The petition, along with an Executive Summary and other background information on the risks of animal cloning are online at www.centerforfoodsafety.org.

Joseph Mendelson III| joemend@icta.org
Legal Director

Center for Food Safety &
Int'l Center for Technology Assessment

660 Pennsylvania Ave., SE Suite 302
Washington, DC 20003
www.centerforfoodsafety.org